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Health

‘Please get vaccinated now,’ Biden urges after FDA approves Pfizer Covid photographs

United States President Joe Biden speaks in the East Room of the White House in Washington, DC on Wednesday, August 18, 2021.

Pete Marovich | Bloomberg | Getty Images

President Joe Biden again urged more Americans to get vaccinated against Covid-19 on Monday, saying the majority of deaths and hospitalizations in the United States from the virus are unvaccinated.

“Those who have been waiting for full approval should take their chance now,” Biden said during a press conference at the White House hours after the Food and Drug Administration completed the full Covid vaccine from Pfizer and BioNTech for people aged 16 and over Had granted approval.

He said the US agency had evaluated “mountains” of clinical study data and determined “without question” that the Covid syringe was safe and highly effective.

“The overwhelming majority of people hospitalized with Covid-19, or almost all of those who have died of Covid-19, are not vaccinated, not vaccinated,” he told reporters. “If you are fully vaccinated – both vaccinations plus two weeks – your risk of developing serious Covid-19 is very, very small.”

“Please get vaccinated now,” added Biden.

According to the agency, FDA scientists evaluated “hundreds of thousands of pages” of vaccine data from 40,000 study participants before granting approval. The two-dose vaccine was found to be 91% effective in preventing Covid – slightly lower than the 95% effectiveness rate study data shown when the vaccine was approved late last year and before the Delta variant prevailed in the USA

So far, the mRNA vaccine, marketed as Comirnaty, has been on the US market under emergency approval granted by the FDA in December. Since then, more than 204 million Pfizer shots have been administered, according to the Centers for Disease Control and Prevention.

Biden’s latest plea comes because coronavirus cases are still safe nationwide, filled by the highly contagious Delta variant. The president said U.S. health officials are beginning to see signs that new cases may decline in some regions of the nation. Still, he said, cases are increasing overall, especially among the unvaccinated.

US officials believe vaccination is the best way to stave off rising cases. According to the Centers for Disease Control and Prevention, about 51% of the entire US population will be fully vaccinated against Covid as of Sunday.

The US approval is expected to spark a new wave of vaccine mandates from American companies and schools. Large companies have already told some or all of their employees that they need to get a full Covid vaccination this fall. Still, despite having legal authority to do so, health experts say some private companies and other institutions may be reluctant to request the shots before full approval.

Earlier in the day, New York City officials said they are now requiring all 148,000 public school teachers and employees to receive their Covid-19 vaccine shots this fall. They had previously said that employees could avoid the vaccines if they had regular weekly Covid tests.

During his speech, Biden urged other schools and companies to prescribe the vaccine.

“All over the world people want these vaccines here in America,” he said. “They’re free, convenient, and waiting for you. So today please go for yourself, for your loved ones, for your neighbors, for your country.”

– CNBC’s Rich Mendez and Bob Towey contributed to this report.

Categories
Health

F.D.A. Approves Xywav, a GHB drug, for Uncommon Sleeping Dysfunction

On the black market, homemade GHB — also known as liquid ecstasy, goop and G — can be bought by the capful for $5 to $25. But nightly treatments of Xyrem and Xywav cost roughly $100,000 a year. The new approval will make it much easier for hypersomnia patients to get insurance coverage for Xywav.

Many doctors and patients have never heard of idiopathic hypersomnia, Mr. Cozadd said, but Jazz will aim to change that. “There’s an educational effort that we’ll be part of,” he said, “which is really making sure there’s a better understanding among treaters and among patients of the condition and its treatment.”

The F.D.A. said its decision was significant because it is the first drug approved to treat the disorder.

“Idiopathic hypersomnia is a lifelong condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder,” said Dr. Eric Bastings, deputy director of the agency’s Office of Neuroscience, in a statement.

In March, Jazz and the Hypersomnia Foundation, a patient advocacy group, began an awareness campaign — “I have IH” — which included an online survey of health care providers’ knowledge of the condition (it was low), and advertisements in Times Square.

“I never thought I’d live to see that day — it was very emotional,” said Betsy Ashcraft, the treasurer of the foundation’s board of directors, whose adult son has idiopathic hypersomnia. (Jazz paid the foundation for board members’ time consulting on the campaign, she said.)

GHB is an old drug, first synthesized by a Russian chemist in 1874. A century later, it was sold as a dietary supplement in the United States, and academic researchers began reporting that it greatly improved the nighttime sleep of people with narcolepsy and curbed their daytime attacks of paralysis, called cataplexy.

Categories
Politics

Home approves choose committee to analyze pro-Trump Capitol rebel

A supporter of U.S. President Donald Trump sprays smoke during a “Stop the Steal” protest outside of the Capitol building in Washington D.C. January 6, 2021.

Stephanie Keith | Reuters

The House passed legislation Wednesday that will form a select committee to investigate the violent Jan. 6 riot in which Donald Trump supporters stormed the U.S. Capitol. 

The measure passed in a 222-190 party-line vote. Only two Republicans, Reps. Adam Kinzinger, R-I.L., and Liz Cheney, R-W.Y., voted in favor of it.

 “We have the duty, to the Constitution and the Country, to find the truth of the January 6th Insurrection and to ensure that such an assault on our Democracy cannot happen again,” House Speaker Nancy Pelosi wrote in a letter to House members Wednesday morning. 

Pelosi announced the legislation after Senate Republicans blocked a bill in May that would have created an independent and bipartisan commission, modeled after the 9/11 commission, to probe the attack. GOP leaders asserted that it would only duplicate existing investigation efforts by the Justice Department and congressional committees. 

Under the newly approved legislation, the select committee will be led by Democrats and consist of 13 members. Pelosi will appoint one chairperson and all members to the committee, 5 of whom will be appointed in consultation with Republican House minority leader Kevin McCarthy, according to the legislation.  

The committee will investigate and report the facts and causes of the event, such as activities of intelligence and law enforcement agencies and technological factors that may have motivated the attack, the legislation says. It will also develop recommendations to prevent similar events from occurring in the future. 

All findings, conclusions and recommendations made by the committee will be issued in a final report to the House, according to the legislation. 

“Will we investigate how our democracy was attacked or will we send a green light to allow it to be attacked again? Will we stand with the cops or roll with the cop killers? Do we want the truth, or will we allow history to be erased? And are we for the constitution or are we for chaos?,” Representative Eric Swalwell said on the House floor.  

“January 6 was a crime against our democracy and the heroes of this Capitol. Now we must investigate it. Failing that, we are lawless. And lost.”

Rep. Michelle Fischbach, R-M.N., urged Republicans not to vote for the legislation, stating that it is “rife with partisan politics at its worst.”

A mob of Trump supporters stormed the Capitol on Jan. 6 in an effort to thwart Congress’ confirmation of President Joe Biden’s electoral victory. The attack left five people dead, including Capitol police officer Brian Sicknick. 

Pelosi invited Capitol Police Officer Harry Dunn and Metropolitan Police Officers Michael Fanone and Daniel Hodges to sit in during the House debate and vote. Gladys Sicknick, the mother of the police officer who died, was expected to attend as well. 

Police officers who responded at the Capitol and Gladys Sicknick have all lobbied for the independent select committee, the Associated Press reported Friday. 

Fanone and Dunn met with McCarthy last Friday, asking him to publicly condemn statements made by GOP members who have downplayed the attack and voted against honoring police for defending the Capitol, according to the Associated Press. 

Dunn, who had fought the rioters in hand-to-hand combat and was subject to racial slurs, told the Associated Press after the meeting that the goal is “accountability, justice for everybody that was involved.”

Fanone, who had described being shocked with a stun gun and beaten by rioters, added that he asked McCarthy not to put “the wrong people” on the select committee.

Categories
World News

Israel’s Parliament Approves New Authorities, Ousting Netanyahu

Here’s what you need to know:

VideoIsrael’s Parliament, the Knesset, approved a new coalition government by a single-vote margin on Sunday. The vote, 60 to 59 with one abstention, officially ended the longtime reign of Benjamin Netanyahu.CreditCredit…Dan Balilty for The New York Times

The long and divisive reign of Benjamin Netanyahu, the dominant Israeli politician of the past generation, officially ended on Sunday, at least for the time being, as the country’s Parliament gave its vote of confidence to a precarious coalition government stitched together by widely disparate anti-Netanyahu forces.

Israel’s Parliament, the Knesset, approved the new government by just a single vote — 60 to 59, with one abstention.

After his supporters cheered the announcement of his election, Naftali Bennett then exchanged a brief handshake with Mr. Netanyahu before walking to the rostrum at the front of the parliamentary chamber and taking the oath of office as prime minister.

Yair Lapid, a centrist leader, is set to take Mr. Bennett’s place after two years, if their government can hold together that long.

They lead an eight-party alliance ranging from left to right, from secular to religious, that agrees on little but a desire to oust Mr. Netanyahu, the longest-serving leader in the country’s history, and to end Israel’s lengthy political gridlock.

In a speech made before the confidence vote, Mr. Bennett hailed his unlikely coalition as an essential antidote to an intractable stalemate.

“We stopped the train before the abyss,” Mr. Bennett said. “The time has come for different leaders, from all parts of the people, to stop, to stop this madness.”

Before and after the fragile new government was announced on June 2, Mr. Netanyahu and his right-wing allies labored hard to break it before it could take office. They applied intense pressure on right-wing opposition lawmakers, urging them to peel away from their leaders and refuse to support a coalition that includes centrists, leftists and even a small Arab Islamist party.

It was a watershed moment for politics in Israel, where Mr. Netanyahu, 71, had served as prime minister for a total of 15 years, including the last 12 years uninterrupted. But given Mr. Netanyahu’s record as a shrewd political operator who has defied many previous predictions of his political demise, few Israelis are writing off his career.

Even out of government and standing trial on corruption charges, he remains a formidable force who will likely try to drive wedges between the coalition parties. He remains the leader of the parliamentary opposition and a cagey tactician, with a sizable following and powerful allies.

Israel has held four inconclusive elections in two years and has gone much of that time without a state budget, fueling disgust among voters with the nation’s politics. No one was able to cobble together a Knesset majority after the first two contests, and the third produced an unwieldy right-center coalition that collapsed after months in recriminations.

The new coalition proposes to set aside some of the toughest issues and focus on rebuilding the economy. But it remains to be seen whether the new government will avoid another gridlock or crumble under its own contradictions.

Some of its factions hope to see movement away from the social policies that favored the ultra-Orthodox minority, whose parties were allied with Mr. Netanyahu. But Mr. Bennett’s party, which has a partly religious base, is wary of alienating the Haredim, as the ultra-Orthodox are known in Hebrew.

Supporters also hope for a return to a long tradition of Israel cultivating bipartisan support in the United States. Mr. Netanyahu has grown more aligned with Republicans and was embraced by Donald J. Trump, the former president. It was uncertain where relations would go under President Biden.

Credit…Dan Balilty for The New York Times

Naftali Bennett, Israel’s new prime minister, is a former high-tech entrepreneur best known for insisting that there must never be a full-fledged Palestinian state and that Israel should annex much of the occupied West Bank.

The independently wealthy son of immigrants from the United States, Mr. Bennett, 49, entered the Israeli Parliament eight years ago and is relatively unknown and inexperienced on the international stage. That has left much of the world — and many Israelis — wondering what kind of leader he might be.

A former chief of staff to Benjamin Netanyahu, Israel’s longest-serving prime minister, Mr. Bennett is often described as more right-wing than his old boss. Shifting between seemingly contradictory alliances, Mr. Bennett has been called an extremist and an opportunist. Allies say he is merely a pragmatist, less ideological than he appears, and lacking Mr. Netanyahu’s penchant for demonizing opponents.

In a measure of Mr. Bennett’s talents, he has now pulled off a feat that is extraordinary even by the perplexing standards of Israeli politics: He has maneuvered himself into the top office even though his party, Yamina, won just seven of the 120 seats in the Parliament.

Mr. Bennett has long championed West Bank settlers and once led the council representing them, although he is not a settler. He is religiously observant — he would be the first prime minister to wear a kipa — but he will head a governing coalition that is largely secular.

He leads a precarious coalition that spans Israel’s fractious political spectrum from left to right and includes a small Arab party — much of which opposes his ideas on settlement and annexation. That coalition proposes to paper over its differences on Israeli-Palestinian relations by focusing on domestic matters.

Mr. Bennett has explained his motives for teaming up with such ideological opposites as an act of last resort to end the political impasse that has paralyzed Israel.

“The political crisis in Israel is unprecedented on a global level,” he said in a televised speech on Sunday. “We could end up with fifth, sixth, even 10th elections, dismantling the walls of the country, brick by brick, until our house falls in on us. Or we can stop the madness and take responsibility.”

Mr. Netanyahu and his wife leaving the White House in Washington in 2018.Credit…Tom Brenner/The New York Times

Educated in the United States, speaking flawless East Coast English, warning in pungent sound bites about the threats posed by Islamic terrorism and a nuclear Iran, the Benjamin Netanyahu who stormed into Israeli politics in the 1990s was like no politician his citizens had ever seen.

Before long, he would capture the prime minister’s office, lose it, then seize it again a decade later, becoming Israel’s longest-serving leader and inspiring such admiration that supporters likened him to the biblical King David. His political agility got him out of so many tight spots that even his detractors called him a magician.

He presided over an extraordinary economic turnaround, kept the perennially embattled country out of major wars and kept casualty tolls to historic lows. He feuded with Democratic American presidents, then capitalized on a symbiosis with the Trump administration to cement historic gains, including the opening of a U.S. embassy in Jerusalem.

He compartmentalized the Palestinian conflict, snubbing the endless peace talks that had stymied his predecessors, unilaterally expanding the Jewish presence in the occupied West Bank and treating Palestinians largely as a security threat to be contained.

While the chance for a lasting peace with the Palestinians — the singular achievement that could give Israelis the long-term stability and worldwide acceptance — receded on his watch, he struck watershed accords with four Arab countries that had long shunned Israel in solidarity with the Palestinians. Those agreements overturned decades of conventional wisdom that peace with the Palestinians had to come first, and constitute perhaps his most far-reaching achievement.

Still, he was a deeply polarizing figure, governing from the right, branding adversaries as traitors, anti-Israel or anti-Semitic, obsessed with power and comfortable deploying street-fighter tactics to retain it.

The intuitive media savvy that sped his rise to power curdled in time into an almost narcissistic obsession. His efforts to control his image, including allegations that he bribed media executives for favorable news coverage, led to criminal charges that haunted his final years in office.

Even as he surpassed the tenure of David Ben-Gurion, Israel’s founding leader, in 2019, he drove Israelis to exhaustion with four elections in two years in which the main issue was him, and the electorate split down the middle each time.

Now, Mr. Netanyahu leaves power nearly a quarter-century after he first became prime minister in 1996.

Knesset member Itamar Ben-Givr of the Jewish Power party being held back while shouting during the session on Sunday. At least seven members were escorted from the chamber after outburts. Credit…Emmanuel Dunand/Agence France-Presse — Getty Images

Heckling and mayhem in the Knesset, an intimate parliamentary chamber transformed by anger, marked the end of Benjamin Netanyahu’s divisive 12-year rule over Israel and the start of Naftali Bennett’s term as prime minister.

Mr. Bennett, a hard-right politician whose decision to join an eight-party coalition including left-wing parties has enraged Mr. Netanyahu’s center-right Likud party, struggled for 43 minutes to make himself heard as his opponents hurled abuse and held up posters saying, “Shame on you.”

Mr. Netanyahu gave a 35-minute speech full of venom, contempt for Mr. Bennett and dire warnings about Israel’s security without him.

“Try to damage as little as possible of the magnificent economy we are handing over to you, so that we can fix it as fast as possible when we return,” he said in a typically unapologetic speech that oozed scorn and confidence that he would soon be back.

A measure of calm returned only after several hours as voting began in the 120-member Israeli Parliament. The sound of “Ba’ad,” meaning “in favor,” and “Neged,” meaning “against,” alternated. The vote yielded a razor-thin 60-to-59 victory for the new coalition, with one abstention from a member of the Raam Islamist party, which is joining the government.

Mr. Netanyahu, wearing a black mask, was impassive, even when members of Israel’s new government congregated around its centrist architect, Yair Lapid, and embraced.

An era had ended, just.

Earlier, proceedings had slowed to a crawl as yelling filled the chamber.

At least seven members of Parliament were escorted out. They accused Mr. Bennett of being unfit to lead Israel because his party, Yamina, has only a handful of seats; told him he was “selling” the Negev desert because he has agreed to accommodate some Bedouin demands; and assailed him as a “liar” and traitor to his right-wing voters.

In the blue-carpeted, wood-paneled chamber, the departing speaker had to call several times for order, to little avail. The turmoil was an apt portrait of a country bitterly divided after four elections since 2019.

“We stopped the train a step before the abyss,” Mr. Bennett said, explaining that the “turmoil of elections and hatred” had to be end.

Such was the tumult that Mr. Lapid skipped his planned speech. He asked for forgiveness of his 86-year-old mother, whom he had brought to Parliament to watch because he “wanted her to be proud of the democratic process in Israel.” He added, “Instead, she, along with every citizen of Israel, is ashamed of you.”

Celebrations in Tel Aviv’s Rabin Square on Sunday night.Credit…Corinna Kern/Reuters

Ecstatic Israelis descended onto Tel Aviv’s Rabin Square on Sunday for a celebration marking the ouster of Benjamin Netanyahu and the swearing-in of a new — if precarious — government.

The euphoric atmosphere reflected the relief of many Israelis that a new day had sprung and that a public figure that many in the liberal enclave disdain had at last been dispatched.

As music blasted into the square, it was blanketed in people of all ages carrying Israeli flags, rainbow flags and pink flags, the color adopted by members of the movement to oust the prime minister.

Many wore shirts saying simply “Go,” in a font matching Mr. Netanyahu’s Likud party logo. Others wore shirts emblazoned with references to the various corruption scandals during Mr. Netanyahu’s tenure.

Omer Ziv, dancing under a large “Crime Minister” banner with Mr. Netanyahu’s image on it, was thrilled. “We feel like the democracy is back, and we’re super happy about it,” she said.

Chany Gross said she felt “high, high in the sky,” declaring that Israel had “finally got rid of the horrible person — I don’t want to say his name.”

“We are in heaven,” she said.

But even as they basked in the moment, some spoke of mixed emotions. They remain wary of Naftali Bennett, Mr. Netanyahu’s replacement, since he hails from a hard-right party not necessarily aligned with their views.

Aviv and Inbal Adashi found a babysitter for the evening so they could attend the gathering. While Mr. Adashi feels ambivalent about Mr. Bennett’s elevation and initially harbored doubts over Yair Lapid, another key player in the coalition, he was relieved to see Mr. Netanyahu go.

“It’s been a very bad dream for a very long time,” Mr. Adashi said. “It’s been a nightmare.”

Noam Goodman, also unsure of the new prime minister, was still optimistic, given the presence of other parties in the coalition.

“I think it’s a little pathetic that somebody with so few voters became prime minister, it’s not ideal,” Mr. Goodman said. “But I think the main thing is not who’s prime minister, it’s who’s in control, and who’s in the government.”

Shoval Sadde expressed relief that the coalition had come together after weeks of uncertainty.

“Today is final,” she said. “There are no secret magics anymore that Bibi can pull out of a hat. It’s final.”

Some saw a moment of closure.

Yuval Geni, 76, said he felt “reborn,” noting the significance of the celebration’s location: in the square named after Yitzhak Rabin, the prime minister assassinated there in 1995 at a peace rally. Mr. Netanyahu ascended to the premiership for the first time months later.

“It’s a kind of balancing,” Mr. Geni said.

Mr. Geni was hopeful that Mr. Netanyahus’ reign, the longest of any Israeli prime minister, would ultimately be a footnote in the country’s history.

“Bibi will go,” he said. “He’ll be forgotten. It won’t take long.”

Mr. Bennett, in his speech at the Knesset on Sunday, said that renewing the nuclear agreement with Iran would be a mistake.Credit…Dan Balilty for The New York Times

Among the most important issues that the new Bennett government will confront is how to manage political, military and intelligence coordination with the Biden administration, which will affect how it addresses almost all other foreign, national security and economic policy challenges. At the center of current dialogue is the soon-to-be-concluded, revived nuclear deal with Iran.

The defense establishment of Israel, including the military and the intelligence agencies, see Iran as the main enemy of the country, and the most difficult challenge of all.

Benjamin Netanyahu took the position that the original nuclear deal, negotiated in 2015 and known as the Joint Comprehensive Plan of Action, did not give Israel enough security from the possibility that Iran would try to develop a nuclear bomb. He also objected that the deal did not cover any other crucial topics like Iranian support for militias in neighboring countries.

This view was generally shared across the political spectrum in Israel, and was backed by most of the country’s defense establishment.It is apparently the position of the new government, as well.

“The renewal of the nuclear agreement is a mistake,” Naftali Bennett said in his opening remarks in the Knesset, Israel’s Parliament, before Sunday’s vote made him prime minister. “Israel will not allow Iran to acquire nuclear weapons and will maintain full freedom of action,” he added, using words similar to those used at various times by Mr. Netanyahu and members of his government.

The sabotage and assassination campaign against the Iranian nuclear project led by the Mossad, Israel’s spy service, continued even after President Biden was elected and negotiations to rejoin the deal began. And the Mossad’s new director, David Barnea, has hinted that these tactics could still be on the table.

“The probable agreement with the superpowers only reinforces the sense of isolation we are in on this issue,” he said in a speech he made when taking on the new post on June 1.

Mr. Barnea said that if Iran continues with its nuclear program, “it will come up against the full force of the Mossad.” Referring to Iran’s nuclear efforts, he hinted at Israel’s possible responses, saying the Mossad was “well aware of the program’s various components, the officials active within it, as well as those who give them the orders how to operate.”

Still, Mr. Bennet is considering trying to influence some terms of the new deal, an effort that Mr. Netanyahu refused to contemplate. If that happens and some of the Israeli requests are fulfilled, Israel’s opposition to the deal may decrease.

Mr. Bennet and his chief partner, Yair Lapid, have agreed that Israel will try to keep public disagreements with the United States to a minimum and not take the adversarial stand it did under the Obama administration, according to a person familiar with the negotiations that led to the formation of the new coalition. To do that, Mr. Bennet is considering replacing Gilad Ardan, the current ambassador to Washington and a longtime Netanyahu political ally, with a confidante of his own.

From left, Yair Lapid, Neftali Bennett and Mr. Abbas agreed to join forces on Wednesday.Credit…United Arab List, via Reuters

The agreement on the coalition that ousted Benjamin Netanyahu as Israel’s prime minister after a dozen years in power includes an independent Arab party in the government for the first time, blowing up fault lines in Israeli politics and opening a potential new era.

With Parliament’s backing of the eight-party coalition on Sunday comes the tantalizing possibility that Palestinian citizens of Israel, who account for about a fifth of the population, might play a more active role in politics, to unifying effect.

The decision by a small Arab party known by its Hebrew acronym, Raam, to join the government so soon after last month’s violent clashes between Jewish and Arab mobs in Israel last month reflected a growing realization that the marginalization of Arab parties brings only paralysis and repetitive elections. It also suggested a desire among some Palestinian citizens of Israel to exert more political influence.

Fakhira Halloun, an expert in conflict resolution, said: “Usually the dominant discourse is one of perceiving Palestinians inside Israel as an internal enemy. We need to change this perception by not being always in the opposition.”

Certainly, Raam, with four seats in Parliament, will be critical to the survival of the coalition, even if it will not hold any cabinet posts. The coalition will have to consider the interests of the Palestinian minority in a different way.

Practically, Raam’s leader, Mansour Abbas, is likely to press for increased spending for Arab communities, who lag Israel’s Jewish population in the quality of schools, sports facilities and infrastructure. They also suffer from denial of access to land. Revocation of the so-called Kaminitz Law, which disproportionately penalizes unlicensed construction in Arab communities, has been discussed.

“I do not think that the two-state solution or reconciliation with the Palestinians will be achieved in the coming year or two,” said Jafar Farah, the director of the Mossawa Center, an advocacy group for Arab citizens of Israel. “But I do think that it is an opportunity for the Palestinian community in Israel to become a game changer.”

Israeli nationalists marching last month. The new government will have to decide whether to permit a march planned for Tuesday through Arab neighborhoods.Credit…Ariel Schalit/Associated Press

Members of the new Israeli government put together by Naftali Bennett, the new prime minister, have referred to their coalition as a “government of change.” But a big question is whether there will be changes in Israel’s foreign and defense policies, which have been almost exclusively controlled by Benjamin Netanyahu since 2009, when he began his last term in office.

Most of the members of the Bennett security cabinet have served in the past as senior members of the various Netanyahu cabinets over the past 12 years, and have backed the outgoing prime minister’s policies: Mr. Bennett was Mr. Netanyahu’s defense minister; Avigdor Lieberman was foreign minister and defense minister; Yair Lapid was finance minister; and Benny Gantz was defense minister, and before that, the chief of staff of the military.

Moreover, the new government, composed of parties across the wide political spectrum, is not expected to initiate significant changes on controversial issues — like the Israeli-Palestinian conflict and the questions of establishing an independent Palestinian state or continuing to establish settlements in the occupied West Bank.

Israel is also unlikely to significantly change its policy of waging a so-called “war between the wars,” on or close to its borders. This includes hundreds of Israeli attacks, almost all from the air, with the aim of preventing the continuation of the military buildup in Syria by Iran and Hezbollah, and the development of advanced precision weaponry for the Lebanese Shiite militia.

The policy was shaped by the new government’s defense minister, Benny Gantz, when he led Israel’s military, together with others. But Mr. Netanyahu’s ability to conduct this war without allowing it to deteriorate to an all-in conflict depended in part on his close ties with President Vladimir V. Putin, which helped prevent clashes between Israeli forces and Russian force in Syria.

Mr. Bennet does not have such a relationship with Mr. Putin, and it will be difficult for him to shape one against the background of the tension between Moscow and Washington.

The new leaders of Israel, however, may want to make some changes to distinguish themselves from Mr. Netanyahu, diverging from his path in some areas like relations with the Palestinian Authority, which Mr. Netanyahu wanted to weaken.

One possible such shift could be to follow the military’s recommendation at the end of the recent hostilities with Hamas to cut off the flow of funds from Qatar to the Islamist regime in Gaza, and instead direct it to the Palestinian Authority. This could change the balance of power between Hamas and the Palestinian Authority.

One of the first issues to confront Mr. Bennet is whether to allow a provocative “flag parade” scheduled to be held on Tuesday through Arab areas of Jerusalem by ultranationalist Jewish Israelis.

Security officials have warned that the parade could spark a new round of Arab-Jewish violence, including a possible rocket attack on Israel by Hamas in Gaza, and the predictable Israeli military retaliation.

Naftali Bennett now leads a new — and shaky — coalition government.Credit…Dan Balilty for The New York Times

Now that the Israeli Parliament has approved a new government coalition — a gravity-defying construction with a right-wing leader and blocs including the left and, for the first time, an independent Arab party — its survival will immediately become its main issue.

Israel’s parliamentary democracy veered in a presidential direction under Mr. Netanyahu. In the end, his increasingly dismissive style had alienated too many people, especially among nominal allies on the right.

An agreement to return to democratic norms may be the underlying glue of an unlikely coalition.

“The parties are disparate, but they share a commitment to reconstitute Israel as a functioning liberal democracy,” said Shlomo Avineri, a prominent political scientist. “In recent years we saw Netanyahu begin to govern in a semi-authoritarian way.”

Success will require constant compromise. “They will not deal with the highly contentious issues between left and right,” said Tamar Hermann, a professor of political science at Israel’s Open University.

In practice, that means a likely concentration on domestic rather than foreign affairs. Israel has not had a budget in nearly two years of political turmoil and repetitive elections. As prime minister, Naftali Bennett, a self-made tech millionaire who is considered to be to the right even of Mr. Netanyahu, is determined to deliver higher standards of living and prosperity to a population weary of such paralysis.

The delicate questions to be deferred or finessed would include any renewed peace negotiations with the Palestinians and any major settlement expansion in the West Bank.

Establishing good relations with the Biden administration, a priority, and improving relations with America’s majority liberal Jewish community, another significant goal, will also require centrist restraint.

“Hard core people of the right, we have the evidence, become more centrist in office,” Ms. Hermann said.

Yair Lapid, 57, a leading architect of the coalition, would become prime minister in two years under the deal that made an alternative to Mr. Netanyahu possible — another incentive for him to help make the government work.

Still, it may not. The parties, ranging from Mr. Bennett’s Yamina party on the right to Labor and Meretz on the left, disagree on everything from L.G.B.T.Q. rights to public transport on Shabbat.

Among measures the government has agreed on is legislation that would set a two-term limit for a prime minister and oblige anyone who has led the country for eight years to spend four years out of the Knesset. In effect, this would preclude any Netanyahu redux.

The prospective government will also pursue legislation designed to make changing Israel’s Basic Law — containing much of its fundamental legal framework — more difficult. Mr. Netanyahu, who had been indicted on fraud and other charges, had eyed curtailing the powers of the Supreme Court and securing immunity from prosecution as prime minister.

Yair Lapid helped coax into existence the fragile coalition to replace former Prime Minister Benjamin Netanyahu’s government over months of phone calls and meetings with faction leaders.Credit…Dan Balilty for The New York Times

When Yair Lapid was a rising newspaper columnist in the late 1990s, his editor, Ron Maiberg, found him a pleasant but self-centered and often intransigent man who regularly failed to cede ground in an argument.

“He would argue with you to death,” said Mr. Maiberg, then a senior editor at Maariv, a centrist newspaper. “Instead of admitting that Raymond Chandler wrote maybe seven novels and not nine or 10 — he would include the short stories to explain his counting.”

More than two decades later, Mr. Lapid, 57, is a man transformed, colleagues and analysts say. Now a leading centrist politician, he is considered gracious and conciliatory. And it is partly because of that transformation that Israel now stands on the cusp of one of the most significant moments in its recent political history.

On Sunday, Israeli lawmakers voted in a new government that replaces Benjamin Netanyahu, the country’s longest-serving leader, as prime minister. The new coalition is a fragile alliance formed from eight ideologically diffuse parties that are united only by their shared dislike of Mr. Netanyahu. If it holds, it will be largely because Mr. Lapid coaxed the unlikely alliance into existence over months of phone calls and meetings with faction leaders.

To cement the deal, Mr. Lapid has even allowed Naftali Bennett, a right-wing former settler leader who wavered over joining forces with centrists, leftists and Arabs, to go first as prime minister — even though Mr. Bennett’s party won 10 fewer seats than Mr. Lapid’s.

In a compromise, Mr. Lapid will take over as prime minister in 2023. But while Mr. Bennett takes the stage first, he does so only because Mr. Lapid vacated the limelight for him.

A protest against Mr. Netanyahu last year.Credit…Menahem Kahana/Agence France-Presse — Getty Images

After 12 years with Benjamin Netanyahu as prime minister, young Israelis and Palestinians — who can barely remember his predecessor — expressed in interviews before Sunday’s vote a wide range of reactions to the possibility of a future without Mr. Netanyahu at the helm.

“Wow,” said Gil Maymon, a Ph.D. candidate at the Hebrew University of Jerusalem, barely concealing her excitement. “We started to think he would never leave, but now it’s finally happening.”

But Ms. Maymon, 30, expressed some reservations about the politician taking Mr. Netanyahu’s place: Naftali Bennett, the leader of the hard-right Yamina party, who strongly supports settlement building.

“Sometimes you don’t get everything you want,” she said.

Young supporters of Mr. Netanyahu, however, said they were not only shocked, but bitter, at the prospect of his exit.

Nathan Moatti, 27, an education student, said he was furious at Mr. Bennett — a former chief of staff to Mr. Netanyahu — for moving to unseat the prime minister. “I feel betrayed,” Mr. Moatti said.

“I very much love and appreciate Netanyahu,” said Mr. Moatti, 27, who lives about 150 feet from the prime minister’s residence in Jerusalem. “He has transformed our economy, defended us against Iran and stood up for our country around the world.”

The government that was inaugurated on Sunday is made up of right-wing, left-wing and centrist political parties, as well as the first independent Arab party to join a coalition in Israel’s history.

But many Palestinians in the occupied West Bank said they doubted that a new prime minister would bring dramatic changes in their lives.

“The same system and strategy — the restrictions on movement, the checkpoints and the wall — will stay,” said Bahaa Nairoukh, 30 an accountant in Ramallah, the seat of the Palestinian Authority, in the West Bank. “It’s hard to imagine anything different because occupation is all I’ve known my whole life.”

Mohammed Wawi, an Arab citizen of Israel, also did not expect a transformation. “It’s true he incited against the Arab community,” he said of Mr. Netanyahu, “but Bennett has also made comments against us.”

Mr. Wawi, 29, a physical therapist from Nazareth, said that while the Arab party that joined the coalition may be able to extract additional money in the budget for Arab towns, it was unlikely to be able to make changes to the nation-state law — legislation passed in 2018 that formally declared Israel to be the nation-state of Jewish people only.

Some on the right praised Mr. Netanyahu, but said that the only way Israel could overcome its political deadlock, after four elections in two years, was for him to leave office.

“The country got stuck,” said Alon Saperia, 30, an industrial engineer who lives in the long-disputed Golan Heights. “The unfortunate reality is he had to go.”

Israeli soldiers standing guard as children play in a Jewish settlement in the West Bank in 2019.Credit…Sergey Ponomarev for The New York Times

If the end of Benjamin Netanyahu’s 12-year reign as prime minister is a political earthquake inside Israel, its tremors stop clearly at Israel’s borders.

The political drama has solicited barely a shrug from Israel’s Arab neighbors, who do not expect it to lead to substantial changes in the issues they care about — namely, Israel’s approach to the Palestinians or to the wider Middle East.

“Truly this is not being talked about or thought about,” said Elham Fakhro, senior analyst for Gulf States at the International Crisis Group. “For those who care about the Palestinian side, they see every Israeli government as similar, they feel like the occupation is going to continue regardless and it doesn’t matter who is the face of it.”

Mr. Netanyahu’s long tenure as Israel’s dominant politician has seen shifts in Israel’s relations with the Arabs. The peace process with the Palestinians has fallen dormant. Israel has stepped up its shadow war against Iran by regularly bombing targets associated with its allies in Syria. And in cooperation with former President Donald J. Trump, Israel reached new agreements to establish diplomatic relations with four Arab states, helping erode what was long considered an Arab consensus against engaging with the Jewish state.

But few in the Arab world expect any of that to change now that Mr. Netanyahu is being replaced at the helm of Israel’s government.

The new prime minister, Naftali Bennett, is at least as hostile to the idea of a Palestinian state as Mr. Netanyahu. And there are no signs that any of the parties to the agreements with the four Arab states, which began with the so-called Abraham Accords with the United Arab Emirates and Bahrain, and were followed by similar deals with Sudan and Morocco, are considering throwing them out.

“The Abraham Accords are not a Netanyahu accord,” said Abdulkhaleq Abdulla, a political scientist in the U.A.E. “They are not even an Israel accord. They are a U.A.E.-driven accord and they will outlast Netanyahu or any Israeli prime minister.”

“The Abraham Accords are here to stay,” he continued, “and that is good for the U.A.E., good for Israel and good for America.”

Mr. Netanyahu’s departure could actually make the agreement easier to preserve, Mr. Abdulla said, since the longtime prime minister was widely seen as arrogant and pretentious.

“It is good for the accord that he is gone,” Mr. Abdulla said, adding that it would have been awkward for Mr. Netanyahu to visit Abu Dhabi, the Emirati capital.

Large parts of the population in many Arab countries still oppose Israel’s existence or strongly oppose its blockade of the Gaza Strip, which it enforces with Egypt, and its decades-old occupation of the West Bank. That gives them little interest in Israel’s internal politics since significant changes to those policies are not on the table.

Mickey Levy was elected as the new Knesset Speaker on Sunday.Credit…Dan Balilty for The New York Times

Parliament selected Mickey Levy, a lawmaker from Yair Lapid’s centrist party, Yesh Atid, to be its new speaker on Sunday afternoon.

Mr. Levy’s election was considered a sign that the new government would likely pass the vote of confidence. He beat out Yaakov Margi, an ultra-Orthodox politician who is part of Mr. Netanyahu’s right-wing coalition.

Mr. Levy, 69, is a former police officer who commanded police units in Jerusalem during the second intifada, or Palestinian uprising, in the early 2000s. He later served as a police attaché at the Israeli Embassy in Washington, according to his biography on the Parliament website, and then ran a bus company.

After entering politics with Yesh Atid in 2013, he was deputy finance minister for nearly two years, overseeing the tax authority and serving under Mr. Lapid.

As speaker, Mr. Levy will exert considerable influence over parliamentary procedure, giving his government greater influence over the passage of legislation.

Benjamin Netanyahu has disparaged media coverage of his frustrated attempt to retain power as “total fascism.”Credit…Menahem Kahana/Agence France-Presse — Getty Images

For former Prime Minister Benjamin Netanyahu, Israel witnessed “the greatest election fraud in the history of the country.” For former President Donald J. Trump, defeat last November was “the crime of the century.” The two men’s language overlaps, it seems, because their overwhelming sense of invincibility is confounded by democratic process.

Even as Naftali Bennett, a right-wing nationalist, took office as prime minister Sunday as a leader of a diverse coalition, Mr. Netanyahu’s raging assault on his successor did not abate, describing what had befallen his own 12-year-long tenure as a “deep state” conspiracy.

Mr. Netanyahu accused Mr. Bennett of having conducted a “fire sale on the country.” A “government of capitulation” will now run Israel after a “stolen” election, he said. Mr. Netanyahu disparaged media coverage of his frustrated attempt to retain power as “total fascism.”

In the run-up to the transfer of power on Sunday, doubts had persisted over whether it would be peaceful.

Attacks by Mr. Netanyahu’s Likud party on Mr. Bennett’s small Yamina party were so vicious last week that some Yamina politicians needed security details. And Mr. Netanyahu’s whatever-it-takes tactics left the lingering whiff of potential violence, reminiscent of the Trump-incited mob that stormed the U.S. Capitol in January over Mr. Trump’s unfounded claims that he had been robbed of victory.

But Israel, unlike the United States, is a parliamentary rather than a presidential democracy. Mr. Netanyahu will not disappear to some sunny retreat beside a golf course. As chairman of Likud, he will wield considerable power.

“He is not going away, and he will not be quiet,” said Merav Michaeli, the leader of the Labor Party, a member of the new coalition. “And it will take a long time to repair the damage.”

Ultra-Orthodox Jewish men voting in Israel’s parliamentary election in March.Credit…Oded Balilty/Associated Press

The heterogeneous coalition that ended the 12-year-long tenure of Benjamin Netanyahu as prime minister augurs a stunning loss of the power that has long been wielded by Israel’s ultra-Orthodox Jews.

Still reeling from the worst effects of the country’s coronavirus pandemic, then a deadly stampede at a religious festival, by Sunday’s end the ultra-Orthodox have no role in the new government. It is one of the most striking shifts, and could lead to a relaxation on some of the strictures on life in Israel.

The ultra-Orthodox are known as Haredim, a Hebrew term for those who tremble before God. Their political representatives have sat in most, though not all, governments of Israel since the late 1970s, when the right-wing Likud party upended decades of political hegemony by the state’s socialist founders.

Mr. Netanyahu forged a tight alliance with the two main Haredi parties, which were critical components in his coalitions.

That alliance had given the Haredi parties what many critics saw as disproportionate power over state policy. Their power was punctuated by the successful Haredi defiance of national pandemic restrictions.

The influence and official privileges of the ultra-Orthodox, who make up about 13 percent of the population, have created resentment among mainstream Israelis and alienated many Jews abroad who practice less stringent forms of Judaism. The ultra-Orthodox-run Chief Rabbinate, the state religious authority, dominates official Jewish marriage, divorce and religious conversions and does not recognize the legitimacy of Reform or Conservative rabbis.

Haredi politicians promote a conservative social agenda that opposes civil marriage, gay rights, and work or public transportation on the Sabbath, often blocking a civil rights agenda held dear by many members of the new coalition. They support an independent education system that focuses on religious studies and largely shuns secular education for boys.

The Haredi parties have also secured generous state funding for their people and institutions, enabling many to engage in extended Torah study and avoid the military service that is compulsory for others.

Haredi rabbis have been sounding the alarm over their political setback since the news of the coalition deal first emerged.

“Fear and vigilance among Haredi Jewry,” declared HaMevaser, a daily paper representing the Hasidic wing of one of the ultra-Orthodox parties, United Torah Judaism, in a red banner headline last week.

Maigal al-Hawashleh, one of the founders of Al-Ghara village last week.Credit…Amit Elkayam for The New York Times

For decades, dozens of Bedouin villages in Israel’s Negev desert have been in limbo. Without the state’s recognition of their communities, they have long suffered from a lack of planning and basic services like running water, sewers, electricity, trash collection and paved roads.

But the Israeli coalition government approved on Sunday intends to take significant strides to address the plight of these villages, according to Raam, an Arab party that agreed to join the coalition on a number of conditions, including that more benefits are provided to the Bedouin.

The new government will recognize Khasham Zana and two other villages in the Negev in the first 45 days of its term, Raam said in a statement last week, and it will prepare a plan to deal with other unrecognized villages in the area within its first nine months in power.

Still, such plans are unlikely to bring quick change to the ramshackle communities, said Eli Atzmon, an Israeli expert on the Bedouin, who are part of Israel’s Arab minority. Few of the villages recognized by Israel in recent decades have seen drastic improvements to their livelihoods, he said.

There is also no guarantee that a new initiative to address inequities between the southern Bedouin and other parts of Israeli society will be more successful than previous attempts. In December, the government appeared poised to recognize the village of Khasham Zana and two others, Rukhma and Abda, but the effort stalled because of political infighting.

Some right-wing members of the new government, which includes a diverse set of political parties, have suggested they would not accept efforts to recognize many villages in the Negev. That raises questions about whether the new government will be able to muster enough support to make such moves.

The Bedouin, who say they have lived in the Negev for centuries, were once a seminomadic group. But in the aftermath of the 1948 Arab-Israeli war, most were forced out of the desert or fled to other parts of the region.

The Israeli authorities concentrated those who stayed in a smaller area of the desert, and later built meager townships for them. Today there are roughly 280,000 Bedouin in the Negev, about half of them under 18.

An election billboard in March in Bnei Brak, Israel.Credit…Oded Balilty/Associated Press

The vote to oust Mr. Netanyahu may change more than Israel’s leadership. It could also ultimately affect who leads Mr. Netanyahu’s right-wing Likud party.

Mr. Netanyahu has led the party for all but six of the last 28 years — 15 of which he has spent as prime minister. In a phone interview before Sunday’s vote, Aaron Klein, a senior adviser to Mr. Netanyahu, confirmed that even if he lost his position as prime minister, he intends to continue as leader of the opposition.

But his rivals may not go along with that.

Once Mr. Netanyahu leaves government office, his authority over rivals for the party leadership will diminish because he can no longer promote party allies to coveted ministerial positions, or demote rivals. That will give greater momentum to internal critics who feel the party could have remained in office had Mr. Netanyahu stepped down from the leadership earlier and allowed a colleague to take over.

Three rival right-wing parties might have joined forces with Likud, giving the party a majority in Parliament, had Mr. Netanyahu not been in charge. The three parties were all led by former Likud members who were either former aides or allies of the prime minister, but who fell out with him personally.

Leadership of the party, which has governed Israel for 32 of the past 44 years, is seen as one of the country’s most prestigious roles.

But to oust Mr. Netanyahu from the party leadership, his rivals would have to defeat him in an internal primary in which the 120,000 Likud members would have the final say.

Possible challengers include Yuli Edelstein, the health minister; Nir Barkat, a former mayor of Jerusalem; Israel Katz, the finance minister; and Danny Danon, chairman of Likud’s international branch. Recent polls have suggested that Yossi Cohen, who was until earlier this month the director of Mossad, the Israeli intelligence agency, would be the most popular candidate among Likud members.

In recent days, Israeli news outlets, citing anonymous sources, have written that Mr. Edelstein plans to run against Mr. Netanyahu, a claim Mr. Edelstein has not denied. Mr. Barkat held a rally in Tel Aviv on Thursday, nominally to discuss political policy. But commentators interpreted it as a thinly veiled statement of his leadership ambitions.

The likelihood of a challenge to Mr. Netanyahu depends on how long party colleagues expect the new government to stay in office, said Mr. Danon, who has not yet decided whether he will mount his own leadership bid.

“Within the Likud, people will look at the government to see if it’s functioning or not functioning,” Mr. Danon said. “If the feeling will be that it’s not going to last, I think his position will be stronger. But if they will actually be able to work together and to survive, I think it will be more challenging.”

Betzalel Smotrich, a right-wing Israeli politician, shouting during the Knesset session in Jerusalem on Sunday.Credit…Dan Balilty for The New York Times

Israel’s Parliament broke into pandemonium on Sunday afternoon when allies of Prime Minister Benjamin Netanyahu shouted abuse during a speech by the politician nominated to replace him, Naftali Bennett.

Mr. Bennett, a former aide to the prime minister who later became his rival, began his speech on Sunday afternoon with a conciliatory gesture to Mr. Netanyahu.

“Thank you to the outgoing prime minister, Benjamin Netanyahu, for your many years of service, replete with achievements, for the sake of the State of Israel,” Mr. Bennett said. “As prime minister, you acted throughout many years to embolden Israel’s political, security, and economic strength.”

Mr. Bennett added: “Expressing gratitude is a fundamental principle in Judaism. This is the time for the people to say to you: Thank you.”

But he was quickly interrupted and heckled by right-wing opponents. They view Mr. Bennett, a right-wing former settler leader who opposes Palestinian statehood, as a traitor for breaking with Mr. Netanyahu and allying with a coalition that includes leftist and Arab lawmakers.

At least four lawmakers were thrown out of the session by the speaker, Yariv Levin, while a fifth walked out voluntarily.

“You should be embarrassed,” shouted David Amsalem, a lawmaker from Mr. Netanyahu’s party, Likud.

Despite the frequent interruptions, Mr. Bennett nevertheless continued his speech — and used the heckling to help illustrate why he had made the decision to end Israel’s two-year political deadlock by joining a government of national unity, instead of sticking with Mr. Netanyahu.

“There are points in Jewish history where disagreements got out of control,” he said. “Twice in history we lost our national home exactly because the leaders of that generation were unable to sit together and compromise.”

“I am proud of the ability to sit together with people from different sectors,” he added later. “We stopped the train before the abyss.”

After Mr. Bennett’s speech, his designated deputy, Yair Lapid, a centrist former journalist, unexpectedly renounced his right to make his own full statement. Mr. Lapid stated only that his mother, Shulamit — a renowned author who was born before the state of Israel existed — was ashamed of Mr. Netanyahu and his allies for their lack of statesmanship.

That left the rostrum free for Mr. Netanyahu himself.

Mr. Bennett’s coalition is an ideologically diffuse alliance that includes the far-left, the hard-right and a small Arab party, and is united only by a shared desire to force Mr. Netanyahu from office. It was expected to win the vote by only a narrow margin.

To keep the coalition united, Mr. Bennett said on Sunday, it would focus on economic and infrastructure projects instead of controversial issues, such as a solution to the Israeli-Palestinian conflict, on which the coalition’s members do not agree.

“We will sit together and what we agree on we will run forward with, and what we don’t agree on, we will leave aside for now,” Mr. Bennett said.

“The new government aims for practical solutions to the country’s real problems,” he added.

He also promised to maintain Mr. Netanyahu’s stance on American-led efforts to revive an Obama-era Iran nuclear deal, which faces broad opposition in Israel.

“The renewal of the nuclear agreement is a mistake,” he said. “Israel will not allow Iran to acquire nuclear weapons and will maintain full freedom of action.”

VideoVideo player loadingBefore Israel’s Parliament approved a new government on Sunday, Benjamin Netanyahu gave his final speech as prime minister, promising to remain in politics as leader of the opposition.CreditCredit…Dan Balilty for The New York Times

Benjamin Netanyahu, Israel’s longest-serving leader, spent what might be his last minutes in power by defending his record, promising to remain in politics as leader of the opposition, and denouncing his nominated successor, Naftali Bennett.

At a parliamentary debate ahead of the vote to approve Mr. Bennett’s government, Mr. Netanyahu gave what felt like a valedictory speech, listing what he perceived to be his accomplishments in office.

He noted his efforts to keep Iran from becoming a nuclear power and lauded four diplomatic agreements with Arab countries, completed during his tenure, that upended assumptions that Israel would only shore up relations with the Arab world after it had sealed peace with the Palestinians. He also highlighted several favorable moves by the Trump administration that he championed, including American recognition of Jerusalem as Israel’s capital, and the installation of an American Embassy in the city.

“Our successes turned Israel from a fringe state to a leading power,” Mr. Netanyahu said. Then he warned of the harm that he believes a Bennett-led government poses to Israel, and railed against legislation, proposed by the new government, that would limit the ability of prime ministers to remain in office after eight years in power, as he did.

“If we have to be in opposition, we will do this standing tall — until we bring down this dangerous government and return to lead the state,” Mr. Netanyahu said.

Mr. Bennett is a former aide to Mr. Netanyahu who is considered even further to his right. A former software entrepreneur and settler leader, Mr. Bennett is a longtime opponent of Palestinian sovereignty.

After months of wavering, Mr. Bennett broke with Mr. Netanyahu late last month, allying with an unlikely alliance of hard-right, centrist, far-left and Arab lawmakers who are united only by a shared dislike of Mr. Netanyahu. Mr. Bennett said it was necessary to form a government of national unity in order to end a political deadlock that has left the country without a budget and forced the country through four inconclusive elections in just two years.

Mr. Netanyahu and his allies have framed that decision as an act of treachery, leading several of them to heckle and disrupt Mr. Bennett during his own speech earlier in the afternoon. By contrast, lawmakers largely kept quiet while Mr. Netanyahu spoke, in a sign of respect.

“The right will not forget Bennett’s deception,” Mr. Netanyahu said during his speech. “You call yourself guardians of the democracy, but you are so fearful of democracy that you are willing to legislate fascist laws so I can’t run.”

He then addressed his supporters.

“I say today: Do not let your spirits fall,” Mr. Netanyahu said. “I will lead you in a daily battle against this bad and dangerous left-wing government, and bring it down. And with the help of God, this will happen faster than you think.”

Categories
Health

F.D.A. Approves Alzheimer’s Drug Regardless of Fierce Debate Over Whether or not It Works

“As soon as the product is approved, the cat is out of the bag and the horse out of the stable,” said Dr. G. Caleb Alexander, FDA Advisory Committee member, internist, epidemiologist, and expert on drug safety and efficacy at the Johns Hopkins Bloomberg School of Public Health. “There is no way to regain the ability to understand if the product really works after approval.”

Companies can conduct post-market studies with participants from other countries, but may face similar challenges in recruiting participants if those countries approve the drug before the studies are completed. the drug has not yet been approved outside of the United States, but Biogen has requested regulatory reviews in the European Union, Japan, Brazil, and elsewhere.

Aduhelm is a monoclonal antibody that targets a protein, amyloid, that clumps together in plaques in the brains of Alzheimer’s patients and is believed to be a biomarker of the disease. Critics and supporters of the approval agree: the drug significantly lowers amyloid levels. The FDA said the drug’s effect on a biomarker qualifies it for the accelerated approval program.

However, reducing amyloid is not the same as slowing down symptoms of dementia. In more than two decades of clinical trials, many amyloid-lowering drugs failed to address symptoms, a history that some experts say made it particularly important that aducanumab’s data be convincing.

“Although the Aduhelm data are complicated in terms of clinical benefit, the FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that reducing these plaques is likely to have important benefits for the patient, “said Dr Cavazzoni of the FDA wrote on the agency’s website.

Biogen officials said the drug provided long-awaited support for a theory that if done early enough, an attack on amyloid can help. Proponents of the approval also said it is possible that eliminating amyloid early could help contain the disease over time and provide added benefit beyond the slightly delayed early decline. However, Alzheimer’s experts point out that the assumption is completely untested.

Categories
Health

F.D.A. Approves Alzheimer’s Drug Regardless of Fierce Debate Over Whether or not It Works

The Food and Drug Administration on Monday approved the first new medication for Alzheimer’s disease in nearly two decades, a contentious decision, made despite opposition from the agency’s independent advisory committee and some Alzheimer’s experts who said there was not enough evidence that the drug can help patients.

The drug, aducanumab, which will go by the brand name Aduhelm, is a monthly intravenous infusion intended to slow cognitive decline in people, with mild memory and thinking problems. It is the first approved treatment to attack the disease process of Alzheimer’s instead of just addressing dementia symptoms.

Recognizing that clinical trials of the drug had provided incomplete evidence to demonstrate effectiveness, the F.D.A. granted approval on the condition that the manufacturer, Biogen, conduct a new clinical trial.

During the several years it could take for that trial to be concluded, the drug will be available to patients, the agency said. If the post-market study, called a Phase 4 trial, fails to show the drug is effective, the F.D.A. can — but is not required to — rescind its approval.

“The data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit,” the F.D.A.’s director of the Center for Drug Evaluation and Research, Dr. Patrizia Cavazzoni, wrote on the agency’s website.

But, she said, the agency had decided to approve the drug through a program called accelerated approval, which is designed “to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit.”

Michel Vounatsos, Biogen’s chief executive, called the approval a “historic moment.” He said in a statement that the company believes the drug “will transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come.”

Patient advocacy groups had lobbied vigorously for approval of the drug because there are so few treatments available for the debilitating condition and other drugs in clinical trials, while more promising, are most likely three or four years away from potential approval.

But the F.D.A. advisory committee, along with an independent think tank and several prominent experts — including some Alzheimer’s doctors who worked on the aducanumab clinical trials — said the evidence raised significant doubts about whether the drug is effective. They also said that even if aducanumab could slow cognitive decline in some patients, the benefit suggested by the evidence would be so slight that it would not outweigh the risk of swelling or bleeding in the brain that the drug caused in the trials.

Biogen, is expected to reap billions of dollars from the drug. The company has yet to announce a price, but it could be in the range of $10,000 to $50,000 per patient per year, Wall Street analysts project. Beyond that, there will most likely be tens of thousands of dollars in costs for diagnostic testing and brain imaging.

About six million people in the United States and roughly 30 million globally have Alzheimer’s, a number expected to double by 2050. Currently, five medications approved in the United States can delay cognitive decline for several months in various Alzheimer’s stages.

Although the clinical trials for aducanumab were conducted on specific populations of patients — those with mild cognitive impairment or early-stage Alzheimer’s whose brains contained high-than-normal levels of amyloid — the F.D.A.’s label for the drug does not contain any such restrictions. The label simply says the drug is “for the treatment of Alzheimer’s disease.”

The label says that patients should have a brain MRI within the year before starting the drug and should obtain additional MRIs before the seventh and twelfth monthly doses. The label says the “most common adverse reactions” include brain swelling, headache, brain microbleeds and falls.

Infusions will take about an hour and should start at a low dose, which should increase every two months until it reaches the high dose of 10 mg/kg.

In 2012, the F.D.A. revoked its approval of the drug Avastin as a breast cancer treatment after additional studies did not show enough benefit. But some other cancer drugs have retained approval even though additional trials failed to confirm the drugs were beneficial. The agency has also been criticized in the past for failing to make sure the follow-up studies are done.

Alzheimer’s trials are already challenging to conduct because it is often difficult to recruit enough participants. Because the condition can progress very gradually, trials need to be large and continue for many months in order to be able to see if a drug is slowing cognitive decline.

Several experts expressed skepticism that Biogen would be able to recruit many participants in the United States for a post-market trial because patients who can get a drug from their doctors are often reluctant to take the chance of receiving a placebo in a clinical trial.

“Once the product is approved, the cat’s out of the bag, the horse is out of the barn,” said Dr. G. Caleb Alexander, a member of the F.D.A. advisory committee, who is an internist, epidemiologist and expert on drug safety and effectiveness at the Johns Hopkins Bloomberg School of Public Health. “There’s no way to recover the opportunity to understand whether or not the product really works in the post-approval setting.”

Companies can conduct post-market trials with participants from other countries, but may face similar challenges recruiting participants if those countries approve the drug before trials are completed. Aducanumab has not yet been approved outside of the United States, but Biogen has filed for regulatory review in the European Union, Japan, Brazil and elsewhere.

Aducanumab, a monoclonal antibody, targets a protein, amyloid, that clumps into plaques in the brains of Alzheimer’s patients and is considered a biomarker of the disease. One thing both critics and supporters of approval agree on is that the drug substantially reduces levels of amyloid, and the F.D.A. said that the drug’s effect on a biomarker qualified it for the accelerated approval program.

Still, reducing amyloid is not the same thing as slowing symptoms of dementia. Over more than two decades of clinical trials, many amyloid-reducing drugs failed to address symptoms, a history that, some experts say, made it especially important that aducanumab’s data be convincing.

“Although the Aduhelm data are complicated with respect to its clinical benefits, FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients,” Dr. Cavazzoni, of the F.D.A., wrote on the agency’s site.

Biogen officials said that the drug provided long-awaited support for a theory that attacking amyloid can help if done early enough. Supporters of approval also said that it’s possible that clearing amyloid early on could help rein in the disease down the road, providing additional benefit beyond slightly delayed early decline. But Alzheimer’s experts note that supposition is completely untested.

Doctors anticipate there will be tremendous demand for aducanumab from patients desperate to try any approved medication.

Because Alzheimer’s primarily affects older people, most costs are expected to fall to Medicare’s Part B program. Medicare has not yet said how it would cover the drug and its associated costs. The program does not generally pay for PET scans that may be needed to detect whether patients have amyloid levels that indicate if they have mild Alzheimer’s-related impairment.

The crux of the controversy over aducanumab involved two Phase 3 trials with results that contradicted each other: One suggested the drug slightly slowed cognitive decline while the other trial showed no benefit. The trials were stopped early by a data monitoring committee that found aducanumab didn’t appear to be showing any benefit. Consequently, over a third of the 3,285 participants in those trials were never able to complete them.

Biogen later said that it had analyzed additional data and concluded that in one of the trials a high dose of aducanumab could delay cognitive decline by 22 percent or about four months over 18 months. In the trial’s primary measurement, the high dose appeared to slow decline by 0.39 on an 18-point scale rating memory, problem-solving skills and function. A lower dose in that trial and high and low doses in the other showed no statistically significant benefit over a placebo.

“There’s so little evidence for effectiveness,” said Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California and one of many site investigators who helped conduct one of the aducanumab trials. He added, “I don’t know what caught the F.D.A.’s fancy here.”

At the time of the advisory committee meeting, in November 2020, there was not unanimity within the F.D.A. itself. An F.D.A. clinical analyst said there was a sufficient case for approval, but an F.D.A. statistician wrote that another trial was needed because “there is no compelling, substantial evidence of treatment effect or disease slowing.”

After the advisory committee’s blistering rejection, the F.D.A. extended its decision deadline by three months and sought additional information from Biogen, which hasn’t said what it submitted.

Biogen and some researchers who favored approval of the drug said that given the need for Alzheimer’s medications, the single positive trial, plus results from a small safety trial and aducanumab’s ability to reduce amyloid justified making it available to patients now.

Dr. Stephen Salloway, who has received research and consulting fees from Biogen but wasn’t paid for being an aducanumab trial site principal investigator, said that while he understood the concerns about the data, “the totality of the evidence favors approval, and F.D.A. approval will open the door to a new treatment era for Alzheimer’s disease that we can build on.”

The F.D.A. typically follows advisory committee recommendations and usually requires two convincing studies for approval, but it has made exceptions, especially for severe diseases that lack treatments. But some experts worry that aducanumab’s approval could lower standards for future drugs, allowing them onto the market before experts in the field are convinced the benefits outweigh any safety risks.

The risks with aducanumab involve brain swelling or bleeding experienced by about 40 percent of Phase 3 trial participants receiving the high dose. Most were either asymptomatic or had headaches, dizziness or nausea. But such effects prompted 6 percent of high-dose recipients to discontinue. No Phase 3 participants died from the effects, but one safety trial participant did.

Similar side effects have occurred in trials of previous amyloid-lowering drugs, but doctors consider them manageable if a patient is evaluated regularly with brain scans. Still, even supporters of approval said that conducting such safety monitoring was more difficult when not done in the carefully controlled regimen of a study.

“It’s going to be challenging when it’s applied more broadly, outside of a clinical trial,” said Dr. Salloway, director of neurology and the Memory and Aging Program at Butler Hospital in Providence, R.I.

Biogen is expecting to launch the drug quickly, with more than 600 sites across the country expected to administer it. Clinics for patients with cognitive problems have been scrambling to prepare.

Dr. Jeffrey Burns, director of the University of Kansas Health System’s memory clinic and a site investigator for one trial, said he expected “the phone to be ringing off the hook.” He estimates 25 to 40 percent of the clinic’s roughly 3,000 patients might be eligible, but it doesn’t have enough neurologists.

Several Alzheimer’s doctors who believe the case for approving aducanumab is too weak said they would now feel ethically compelled to make it available. They believe that many patients, even when told of the problematic evidence, would try the drug because they would assume there was a compelling reason it received F.D.A. approval.

“I had this conversation with a real patient who was very interested in it,” said Dr. David Knopman, a clinical neurologist at the Mayo Clinic and a site principal investigator for one trial who co-wrote an article saying the evidence was insufficient to show benefit. “I presented the data to the patient and her husband, and they didn’t hear a word I said about my concerns. All they heard was there might be benefit.”

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Business

F.D.A. Approves New Drug to Deal with Vaginal Yeast Infections

The Food and Drug Administration on Tuesday approved a new drug to treat a vaginal yeast infection, which is particularly common in pregnant women who take birth control pills or take antibiotics.

The drug Brexafemme (Ibrexafungerp) manufactured by SCYNEXIS is a one-day oral treatment and the first in a new class of triterpenoid antifungal drugs. The company said the new drug will kill candida – the yeast that can cause infection.

The standard oral drug diflucan (fluconazole) inhibits the growth of yeast, but does not kill it.

But the treatment would most likely not initially be prescribed for common vaginal yeast infections. Dr. David Angulo, the company’s chief medical officer, estimated the drug’s list price at $ 350-450 for the four-tablet treatment. In comparison, GoodRx lists the average retail price of fluconazole at $ 29.81.

He said Brexafemme is approved as a first-line treatment but could also be prescribed to patients whose infections don’t go away easily.

“There is nothing new that can be offered to patients who cannot tolerate it, do not respond well or develop resistance,” said Dr. Angulo.

Dr. Sumathi Nambiar, director of the FDA’s anti-infectives division, said, “This approval of a new antifungal drug provides an additional treatment option for patients with vulvovaginal candidiasis or vaginal or vulvar yeast infections, and represents another step forward in the FDA’s overall effort to be safe and effective To ensure antifungal drugs are available to patients. “

Dr. Denise Jamieson, Chair of Gynecology and Obstetrics at Emory University School of Medicine, said she wasn’t sure the new drug was needed.

“I don’t see any tremendous resistance,” she said. “I can’t really tell if this will be a great addition or not. It is always helpful to have another option and then you have to consider things like costs and tolerances. “

According to Dr. Angulo, in a clinical study used in support of the application, showed 50 percent effectiveness – that is, a complete elimination of all signs and symptoms – 10 days after treatment and 60 percent 25 days after treatment. The other study showed 64 percent effectiveness on day 10 and 73 percent on day 25.

Dr. Michael Carome, director of the Public Citizen’s Health Research Group, was not impressed with the FDA’s approval of Brexafemme.

“This drug is not necessary and few women should need it,” said Dr. Carome. “Fluconazole is very cheap and generally very effective. The cost of this is simply outrageous.

The FDA requires SCYNEXIS to conduct several post-marketing studies, including one to assess the risks to pregnant women, the developing fetus, and newborns; and another to study how much of the product passes into the breast milk of breastfeeding women.

The drug will hit the market later this year.

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Health

UK approves Janssen single-dose Covid vaccine to be used

A box of Janssen COVID-19 vaccine doses from Johnson & Johnson is pictured in Grubbs Pharmacy on Capitol Hill on Monday April 12, 2021.

Tom Williams | CQ Appeal, Inc. | Getty Images

LONDON – The UK Medicines Agency approved Janssen’s single-dose Covid-19 vaccine for use on Friday.

The UK drug and health products regulator announced that doses are expected to be available in the UK later this year.

The UK Government’s Vaccine Taskforce has secured 20 million doses for launch across the UK. She initially received 30 million doses, but changed the order as the vaccination program continues on what the government calls “unprecedented” levels.

Earlier this year, the vaccine was found to be 67% effective in preventing infection and 85% in preventing severe cases of Covid and hospitalization. Janssen is a Johnson & Johnson pharmaceutical company.

UK Health Secretary Matt Hancock said Friday that approval of the Janssen vaccine would boost the country’s “hugely successful” vaccination program.

“As Janssen is a single-dose vaccine, it will play an important role in the months ahead as we redouble our efforts to encourage everyone to get their pokes and possibly start a booster program later this year.” he said in a statement.

The vaccine can be stored in refrigerators at 2 to 8 degrees Celsius, which makes it easier to store and transport than some alternative vaccines.

The vaccine is the fourth to be approved for use in the UK. Together with the alternatives Oxford-AstraZeneca, Pfizer-BioNTech and Moderna, it was approved by the MHRA.

The Vaccine Taskforce has secured early access to more than 500 million doses from eight vaccine candidates, including those developed by Novavax, GlaxoSmithKline and CureVac, and the four that the UK has already approved for use.

Safety and effectiveness

The government said it was in regular contact with the vaccine manufacturers to optimize supplies and prepare for a potential vaccination booster program later in 2021.

Janssen’s Covid-19 vaccine is currently involved in a government study to assess the safety and effectiveness of a third dose to boost immunity to the virus. The Oxford-AstraZeneca, Pfizer-BioNTech and Moderna vaccines each require two doses for patients to achieve optimal immunity.

The UK Joint Committee on Vaccination and Immunization will make updated recommendations on the use of the Janssen vaccine prior to its launch.

Janssen’s vaccine is already being used elsewhere, including the United States and the European Union.

Health officials have raised concerns about possible links between the vaccine and rare blood clots, but regulators have found that the vaccine’s benefits outweigh the risks.

Janssen is considering the possibility of a two-dose program for his vaccine, according to the UK Department of Health and Welfare.

The UK government has set a goal of offering all adults in the country a Covid vaccine by the end of July.

More than 62.6 million vaccines had been administered in the UK as of Wednesday, with 73% of the adult population receiving their first dose. Almost half of British adults were fully vaccinated with both doses.

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Health

U.Ok. Approves Johnson & Johnson Vaccine

Britain’s drug regulator on Friday approved the use of the single-dose shots manufactured by Johnson & Johnson, the fourth coronavirus vaccine to be authorized in the country.

The authorization comes amid growing concerns about the spread in Britain of a coronavirus variant first detected in India. The number of cases of the variant, known as B.1.617.2, has doubled in a week, according to public data, and as of Thursday, nearly 7,000 cases had been detected.

“This fourth approved vaccine adds to our armory,” the British health secretary, Matt Hancock, said on Twitter. “When you’re eligible, get your jab.” Britain has also authorized the use of the vaccines manufactured by Moderna, Oxford-AstraZeneca and Pfizer-BioNTech.

More than 58 percent of Britain’s population has received at least one dose of a coronavirus vaccine, and 36 percent has been fully vaccinated. Britain opened vaccination to adults 30 and older this week, but most of the vaccination campaign’s efforts have in recent weeks focused on second injections.

Johnson & Johnson’s vaccine is 85 percent effective against severe illness from Covid-19, according to the British regulator.

The approval in Britain comes a day after Mexico gave emergency authorization to the same vaccine.

The Mexican government has previously authorized the vaccines from AstraZeneca and Pfizer, as well as Russia’s Sputnik V and China’s Sinovac and CanSino.

In other news around the world:

  • The regional government of Madrid announced on Friday that it would use AstraZeneca’s vaccine for second doses for people under 60, going against a recommendation by Spain’s central government to switch to Pfizer-BioNTech’s vaccine for the second shot. While European Union regulators have said AstraZeneca’s vaccine is safe, it has continued to create tension in Spain, one of the countries that suspended its use briefly in March after reports of blood clots.

  • The Indian government is in talks with Pfizer to obtain 50 million doses of the company’s coronavirus vaccine starting this summer, but is still considering the drug manufacturer’s demand for indemnity from costs related to severe side effects, officials have said.

  • Hong Kong on Thursday recorded no new coronavirus cases for the first time in seven months, a promising sign in the Chinese territory’s efforts to quash a wave of infections that began in November. The city has gone more than a month without recording more than 15 daily cases, increasing calls for the authorities to relax social-distancing measures.

  • Vietnam ordered religious establishments to suspend large gatherings after a cluster of infections was linked to a Protestant congregation in Ho Chi Minh City, part of a nationwide surge in cases. Of more than 6,300 total cases recorded in the Southeast Asian nation since the start of the pandemic, half have come in the past month, the state-run Vietnam News Agency reported.

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World News

W.H.O. approves China’s Sinopharm vaccine for emergency use.

The World Health Organization approved China’s emergency Covid-19 vaccine from Sinopharm on Friday, making it easier for poorer nations to get another much-needed shot to end the pandemic.

The approval enables Sinopharm vaccine to be included in Covax, the World Health Organization’s global initiative to promote the equitable distribution of vaccines around the world.

The need is urgent.

Rich countries hoard cans. India, a major vaccine maker, has stopped exporting to deal with the deepening coronavirus crisis. Questions about the safety of extremely rare side effects led some countries to briefly discontinue the use of AstraZeneca and Johnson & Johnson or to change their guidelines for use.

Reliable access to vaccines could continue to improve next week if WHO considers another Chinese shot from the Sinovac company.

Andrea Taylor, who analyzes global data on vaccines at the Duke Global Health Institute, described the possible inclusion of two Chinese vaccines in the Covax program as a “game changer”.

“The current situation is so desperate for low- and lower-middle-income countries that it is worth mobilizing all the doses we can get out of it,” said Ms. Taylor. “Possibly having two options from China could really change the landscape of the possible in the next few months.”

But the fanfare can be short-lived. While China has claimed it could produce up to 5 billion cans by the end of this year, Chinese officials say they are struggling to make enough cans for their own people and are warning a pandemic-weary world to keep expectations in check .

“This should be the golden time for China to practice vaccine diplomacy. The problem is also that China itself is facing a shortage, ”said Yanzhong Huang, Senior Fellow on Global Health at the Council on Foreign Relations. “In terms of global access to vaccines, I don’t expect the situation to improve significantly in the next two to three months.”

Still, the approval marks a high point in vaccine diplomacy efforts and an opportunity to fill the void that Western nations and drug companies have left in low and middle income countries. Sinopharm is the first Chinese shot to be classified as safe and effective by the WHO, and its approval could allay concerns about the lack of transparency by Chinese vaccine companies.

Regulators from China and other countries have approved the Sinopharm vaccine in the past few months, although the company has not released data on phase 3 clinical trials that scientists can independently evaluate.

The WHO had access to this data prior to the announcement, but there is limited data on how well the vaccine will work against the many coronavirus variants that are found around the world.