Tag: Approved

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Health

How an Unproven Alzheimer’s Drug Acquired Authorized

How an Unproven Alzheimer’s Drug Got Approved

The idea of accelerated approval came up briefly toward the end, raised by Dr. Rick Pazdur, head of F.D.A.’s oncology center, who was not a council member. It was not discussed in detail, but after the meeting, given the council’s rejection of standard approval, accelerated approval appeared to be the only way to make the drug available.

On April 26, Dr. Patrizia Cavazzoni, Dr. Dunn’s boss and director of the Center for Drug Evaluation and Research, led a smaller meeting about accelerated approval, which had never been used for Alzheimer’s drugs.

In fact, the F.D.A.’s most recent guidance for Alzheimer’s drugs, issued by Dr. Dunn in 2018, says “the standard for accelerated approval” had not yet been met for the disease, “despite a great deal of research.” The guidance says that is because “there is unfortunately at present no sufficiently reliable evidence” that attacking amyloid plaques or other biomarkers of Alzheimer’s “would be reasonably likely to predict clinical benefit.”

And at the November advisory committee meeting, Dr. Dunn said that in considering whether to approve aducanumab, “we’re not using the amyloid as a surrogate for efficacy.”

Under accelerated approval, while a drug is on the market, a company must conduct an additional trial, a costly undertaking. Biogen said its goal was standard approval, which it believed its data warranted.

At the April 26 meeting, Dr. Cavazzoni invited two officials not involved with neurological drugs who had used accelerated approval frequently: Dr. Pazdur and Dr. Peter Marks, the top vaccine regulator. They and Dr. Cavazzoni voted to grant such approval to aducanumab, as did Dr. Issam Zineh, director of the Office of Pharmacology, and Dr. Jacqueline Corrigan-Curay, who led the internal review of the F.D.A-Biogen collaboration.

The director of the office of translational sciences, Dr. ShaAvhrée Buckman-Garner — who supervises both the pharmacology and biostatistics offices — did not vote yes or no, saying she understood both arguments. The only clear no vote, F.D.A. documents say, was the director of the office of biostatistics, Dr. Sylva Collins, “stating her belief that there is insufficient evidence to support accelerated approval or any other type of approval.”

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Politics

Bitcoin ETF ought to have been accredited some time in the past, SEC regulator Peirce says

Bitcoin ETF should have been approved a while ago, SEC regulator Peirce says

Hester Peirce, Commissioner for the U.S. Securities and Exchange Commission (SEC), Center, listens during a House Financial Services Committee hearing in Washington, DC, the United States, on Tuesday, September 24, 2019.

Andrew Harrer | Bloomberg | Getty Images

Hester Peirce is at a loss.

For years, the Securities and Exchange Commission, of which Peirce is a member, has rejected requests from national stock exchanges and financial companies to list securities that track the performance of the popular digital currency Bitcoin.

Back in the day – let’s say 10 years ago – concerns about possible market manipulation and liquidity might have made sense, but things have changed.

“This is probably the biggest and most frequently asked question I get: When will the SEC approve a Bitcoin publicly traded product?” Commissioner Peirce said in an interview with CNBC on Thursday.

“I thought if we had applied our standards as we applied them to other products, we would have already approved one or more of them,” she said. “With every day that goes by, the rationale we have used in the past for not being approved seems to be weakening.”

The SEC applies a “unique, elevated standard” to filings related to digital assets, it wrote in 2020. And it has argued that the agency is asking exchanges and potential ETF sponsors for assurances beyond what they do for traditional, stock-based demands products.

“People with a regulatory mindset say, ‘Oh wait, the market for Bitcoin looks a little different from the markets we’re used to,'” said Peirce on Thursday.

Now, she added, the Bitcoin market looks more like an established market with more institutional and established retail investors involved.

“So I think the markets have matured quite a bit,” said Peirce.

Renewed demands for a SEC-approved Bitcoin ETF come just weeks after the regulator announced its ruling on approving an application by VanEck to list shares of its Bitcoin Trust on the Chicago Board of Exchange’s BTZ Exchange move.

Regulators said in a letter dated June 16 that they would take additional time to seek comments from the public. In particular, the SEC asks investors and scientists for their opinion on whether Bitcoin ETFs could be susceptible to manipulation or whether Bitcoin itself is sufficiently distributed and therefore resistant to similar underhand manipulation.

But Peirce, a Republican named one of the SEC’s five commissioners by former President Donald Trump, has long denounced what she sees as double standards for Bitcoin products in her own agency.

Perhaps her sharpest objection came in a dissent in 2018, when she argued that the SEC should have approved an application by the Chicago Board of Exchange’s Bats BTZ Exchange to list and trade shares in the Winklevoss Bitcoin Trust.

“By excluding the approval of cryptocurrency-based ETPs for the foreseeable future, the Commission is operating a performance regulation,” she wrote at the time. “Bitcoin is a new phenomenon and its long-term viability is uncertain. It can be successful, it can fail. However, the commission is not well positioned to assess the likelihood of either outcome for Bitcoin or other assets. “

Three years later, VanEck’s current filing – much like pending Bitcoin ETF filings from Fidelity, Cathie Wood’s Ark Invest, and a few others – is viewed by the industry as an SEC litmus test now led by a cryptocurrency expert, Chairman Gary Gensler becomes.

Former chairman of the Commodity Futures Trading Commission, Gary Gensler, testifies at a US Senate Banking Committee hearing on systemic risk and market oversight on Capitol Hill in Washington on May 22, 2012.

Jonathan Ernst | Reuters

His appointment as head of the SEC by President Joe Biden, and his subsequent Senate confirmation, met with optimism from many in the crypto community as he is seen as a skilled hand in creating novel financial rules.

Gensler, who taught crypto courses at the Massachusetts Institute of Technology, is perhaps best known for his influential tenure as chairman of the Commodity Futures Trading Commission in the Obama administration. There Gensler helped develop and introduce a new supervisory system for the swap market, which was largely unregulated before the financial crisis.

Even if the Democrat Gensler does not necessarily agree with the Trump-appointed Peirce on all issues, they can join a more proactive SEC on Bitcoin regulation.

Rejecting Bitcoin ETF applications not only carries the risk of double standards, it can also provide few, more dangerous alternatives to thousands of investors.

“The Complications of Not Approval [an application] get stronger because people are looking for other ways to do the same things that they would do with an exchange traded product, “she said.” They are looking for other types of products that are not that easy to get in and out of maybe look at companies that are somehow related to bitcoin or crypto in a broader sense. “

Bitcoin itself has taken a violent start to summer and has fainted its price by more than 40% in the past three months. Although it remains one of the most actively traded digital assets, some market watchers say Bitcoin is at a critical juncture.

“It looks like it might be preparing for a $ 30,000 retest, and that could be critical,” Art Cashin, director of NYSE floor operations at UBS, said Thursday. “If you crack $ 30,000, traders will see if there is a trapdoor, a cascade sell-off, to follow.”

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Its dizzying ups and downs even come as a growing number of companies and banks, including payment companies Square and PayPal, began to facilitate Bitcoin transactions.

Meanwhile, the Bank of New York Mellon announced in February that it would start funding Bitcoin, a major development given that it is both the oldest bank in the country and a leader in custody banking.

Late on Friday morning, Bitcoin rose 1.6% to $ 33,550.

Despite the volatile fluctuations in the price of the currency, Peirce remains convinced that a Bitcoin ETF is overdue.

It is not the SEC’s job to approve or deny requests based on the merits of the investment itself, she said Thursday, especially if the exchanges meet legal requirements to protect investors from fraud.

“Bitcoin is so decentralized now. The number of nodes involved in Bitcoin is large and the number of people who have an interest in keeping this work decentralized is very large, ”she said. “People should make their own decisions: if people don’t want to buy bitcoin because they think it’s tampered with, they shouldn’t buy bitcoin.”

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Health

Biogen’s Alzheimer’s drug accredited by FDA, first new remedy in almost 20 years

Biogen’s Alzheimer’s drug approved by FDA, first new therapy in nearly two decades

The Food and Drug Administration approved Biogen’s Alzheimer’s drug aducanumab on Monday, making it the first U.S. regulator-approved drug to slow cognitive decline in people with Alzheimer’s and the first new drug for the disease in nearly two decades.

The FDA’s decision was eagerly awaited. The drug, which is marketed under the name Aduhelm, is also expected to generate billions in sales for the company offers new hope to friends and families of patients living with the disease.

Biogen stock was on hold for the announcement. The stocks later resumed trading, rising more than 60% at times before reducing that gain by 40% to $ 400.83.

“We are aware of the attention associated with this approval,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “We know that Aduhelm has drawn the attention of the press, the Alzheimer’s patient community, our elected officials and other interested stakeholders.”

“With treatment for a serious, life-threatening disease in balance, it makes sense that so many people followed the outcome of this review,” added Cavazzoni.

The FDA said it would continue to monitor the drug when it hits the US market. The agency granted approval on the condition that Biogen conduct another clinical study. The Massachusetts-based biotechnology company announced Monday that the list price of aducanumab is $ 56,000 a year; $ 4,312 per infusion.

Biogen CEO Michel Vounatsos told CNBC’s “Power Lunch” later Monday that he thought the price of the drug was “fair,” but also vowed the company would not raise its price for four years.

It reflects “two decades without innovation” and will also allow the company to continue investing in its pipeline of drugs for other diseases, he said.

Alzheimer’s disease is a progressive neurodegenerative disease that slowly destroys memory and thinking skills. The Alzheimer’s Association estimates that more than 6 million Americans live with it. According to the group, this number is expected to rise to almost 13 million by 2050.

“It’s a new day,” said Harry Johns, CEO of the Alzheimer’s Association, in a statement. “This approval gives people with Alzheimer’s more time to live better. For families, it means being able to hold onto loved ones longer. It’s about resuscitating scientists and companies in the fight against this scourge of disease. It’s about hope it. “

To date, there have been no FDA-approved drugs that can slow the mental decline of Alzheimer’s, the sixth leading cause of death in the United States. The agency has approved Alzheimer’s drugs that are aimed at relieving symptoms rather than slowing the disease itself down.

Federal agencies have come under intense pressure from friends and family members of Alzheimer’s patients to speed up aducanumab, but the road to regulatory approval has been controversial since it showed promise in 2016.

In March 2019, Biogen withdrew from development of the drug after analysis by an independent group found it was unlikely to work. The company then shocked investors a few months later by announcing that it would apply for regulatory approval for the drug after all.

Biogen’s shares soared in November after the company received support from FDA officials who said the company had very “compelling” evidence of aducanumab’s effectiveness and “an acceptable safety profile that would make its use in individuals would assist with Alzheimer’s disease “, submitted.

But two days later, a panel of external experts advising the US agency unexpectedly declined to approve the experimental drug, citing inconclusive data. It also criticized the agency’s staff for rating it too positively.

When Biogen filed for approval for the drug in late 2019, its scientists said a new analysis of a larger data set showed that aducanumab “reduces clinical decline in patients with early-stage Alzheimer’s disease.”

Alzheimer’s experts and Wall Street analysts were immediately skeptical, wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it difficult for other companies to enroll patients in their own drug trials.

Some doctors have said they won’t prescribe aducanumab when it hits the market because the mixed data package helps the company’s use.

Supporters, including advocacy groups and family members of patients desperately looking for a new treatment, have admitted the data is not perfect. However, they claim it could help some patients with Alzheimer’s, a progressive and debilitating disease.

Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid that scientists expect to play a role in the devastating disease. The company previously estimated that approximately 1.5 million people with early-stage Alzheimer’s in the United States could be candidates for the drug, according to Reuters.

The approval is “interesting because the FDA is essentially confirming that the beta-amyloid hypothesis has been validated,” said Salim Syed, a senior biotech analyst at Mizuho Securities, on Monday, adding that the decision had a major impact will have future clinical trials. Some experts are not convinced that targeting the compound will slow cognitive decline.

The FDA’s decision is expected to reverberate across the biopharmaceutical sector, RBC Capital Markets analyst Brian Abrahams said in a June 1 announcement to customers.

That prognosis was apparently confirmed on Monday by comments from Dr. Vas Narasimhan, CEO of Novartis, confirmed.

“I think it is a reflection of the immense unmet needs of these patient populations that regulators are looking for ways to advance therapeutics, and it certainly opens doors,” Narasimhan said in an interview with CNBC’s The Exchange.

“We have a lot of neurodegenerative research and development and will certainly be putting pens on paper – or at least hammering on our computers – this coming weekend to really think about how we can speed up our own programs.”

The FDA said Monday it found there was “substantial evidence” that the drug is helping patients. “With Aduhelm approved by the FDA, an important and critical new treatment is available to patients with Alzheimer’s disease to combat the disease,” the statement said.

– CNBC’s Kevin Stankiewicz contributed to this report.

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Business

China’s Sinopharm Vaccine Authorised for Emergency Use By W.H.O.

China's Sinopharm Vaccine Approved for Emergency Use By W.H.O.

Developing countries looking for coronavirus vaccines now have another reliable option – and China’s reputation as an emerging scientific superpower has just gotten a big boost.

The World Health Organization on Friday declared a vaccine from the Chinese company Sinopharm as a safe and reliable way to fight the virus. The statement marks a significant step in dispelling doubts about the vaccine after the Chinese government and company released little data on late-stage clinical trials.

WHO emergency approval enables Sinopharm vaccine to be included in Covax, a global initiative to provide free vaccines to poor countries. The possible inclusion in Covax raises the hope that more people – especially in developing countries – will have access to recordings at a crucial moment.

Rich countries hoard vaccine doses. India, a major vaccine maker, has stopped exporting to deal with the deepening coronavirus crisis. Safety concerns led health authorities in some countries to temporarily stop using AstraZeneca and Johnson & Johnson vaccines.

“The addition of this vaccine has the potential to quickly accelerate access to Covid-19 vaccines for countries that want to protect health workers and vulnerable populations,” said Dr. Mariângela Simão, WHO Deputy Director General for Access to Health Products, in a statement.

Reliable access to vaccines could improve even further next week if WHO considers another Chinese shot from a company called Sinovac. But the fanfare can be short-lived. While China has claimed it could produce up to five 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.”

China’s vaccination campaign got off to a slow start, partly because the government gave export priority and residents did not feel rushed to get vaccinated. The country is now accelerating its national vaccination campaign and aims to vaccinate 40 percent of its 1.4 billion people by the end of June.

Sinopharm and Sinovac are producing about 12 million doses a day, slightly more than the 10 million doses China plans to give daily to meet the domestic target. According to a calculation on data from Bridge Consulting, a Beijing-based consultancy focused on China’s impact on global health, companies would have to produce around 500 million additional doses to meet other countries’ demands.

The vaccine shortage in China underscores the complexity of launching a mass vaccination campaign for the world’s most populous nation and attempting an ambitious export program. Companies involved in the vaccine supply chain, such as syringe manufacturers, work overtime.

Updated

May 7, 2021, 2:53 p.m. ET

“This vaccine is lacking all over the world,” said Pearson Liu, a Sinovac spokesman. “The demand is just too great.”

To make up for the deficit, Chinese officials said those who get vaccinated in China could delay the second shot for up to eight weeks or combine the same type of vaccine from different companies. You said the shortage should subside by June.

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.”

China’s vaccines have been launched in more than 80 countries, but have met with considerable skepticism, partly because the companies have not released data on phase 3 clinical trials to allow scientists to independently evaluate vaccine efficacy rates. A WHO advisory group released the data this week.

According to the WHO advisory group, the Sinopharm vaccine developed with the Beijing Institute of Biological Products has an effectiveness rate of 78.1 percent. The Sinovac vaccine has different efficacy rates between 50 and 84 percent depending on the country in which phase 3 studies were conducted. Both vaccines are made using a proven technology that uses chemicals to weaken or kill a virus.

The advisory group’s data showed that the Sinopharm vaccine had a “high level of confidence” in preventing Covid-19 in adults, but a “low confidence” for people over 60. The group’s results were for the Sinovac vaccine similar .

The WHO said that Sinopharm could not estimate the effectiveness of the vaccine for this group because Sinopharm had only included a few adults over 60 years of age in its studies. However, WHO said it would not restrict use of the vaccine in this age group, as preliminary data suggests that “the vaccine is likely to have protective effects in the elderly”.

There is limited data on how well the vaccine works against the many coronavirus variants that are found around the world. Chinese vaccines are overall less effective than those manufactured by Pfizer-BioNTech and Moderna.

But for China’s leaders, WHO’s approval can still be seen as a badge of honor. Xi Jinping, China’s leader, is committed to making a Covid-19 vaccine a “global public good.”

After India announced export restrictions on vaccines last month, Indonesia and the Philippines said they would turn to China for help. Last week, China’s foreign minister offered to give South Asian countries access to vaccines.

Indonesia said it would receive additional doses of Sinovac after President Joko Widodo held talks with Mr. Xi. In a speech that same week, President Rodrigo Duterte of the Philippines said he owed China “gratitude” for its vaccines.

It remains to be seen whether WHO’s approval will change Beijing’s approach to vaccine distribution. China has only given Covax 10 million doses, despite having independently donated 16.5 million doses and sold 691 million doses to 84 countries, according to Bridge Consulting. Many of the donations went to developing countries in Africa and Asia.

“They don’t like to have their generosity in their products under one UN brand,” said J. Stephen Morrison, director of the global center for health policy at the Center for Strategic and International Studies. “You are in a historic phase,” he said. “They want recipients to know this is China delivering.”

Jason Gutierrez contributed to the coverage. Elsie Chen contributed to reporting and research.

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Health

J&J’s one-shot Covid vaccine accredited by Europe

J&J's one-shot Covid vaccine approved by Europe

Crystal Jones, 52, head of the Athens City Department of Health, loads syringes of the vaccine on the first day of Johnson and Johnson’s vaccine.

SOPA pictures | LightRocket | Getty Images

The European Medicines Agency on Thursday recommended approval of the one-off coronavirus vaccine developed by Johnson & Johnson, which may add another weapon to the armory used to fight Covid-19.

The vaccine will now be sent to the EU Commission for approval later on Thursday.

The vaccine has the added benefit of only requiring a single dose and can be stored in most standard refrigerators at temperatures of 2 to 8 degrees Celsius (or about 36 to 46 degrees Fahrenheit), making transportation and storage easier and cheaper makes.

Once delivery begins, the shot could add a lot to Europe’s difficult vaccination program and is the fourth to be approved by the EMA. Two-dose vaccines developed by Pfizer-BioNTech, Moderna and AstraZeneca, and Oxford University have also been approved.

While easier to distribute, the vaccine has been found not to be as effective as the Pfizer and Moderna shots in preventing Covid infection. However, the data shows that it offers an adequate level of protection: data from clinical trials from the United States have shown that J & J’s vaccine is 72% effective against moderate to severe Covid (although it has been found to be less effective in studies elsewhere which gives it an overall efficacy of 66% protection) compared to about 95% for the other two vaccines.

The speed at which the EU can introduce the J&J vaccine is not yet clear. The EU has ordered 200 million cans of the shot, with an option for an additional 200 million, Johnson & Johnson said in a statement last October.

However, it was reported on Wednesday that, like other vaccine suppliers in the EU (Pfizer-BioNTech and AstraZeneca), delivery of the J&J vaccine to the block may be slower than expected.

An unnamed EU official told Reuters that Johnson & Johnson had told the EU it was facing supply issues that could complicate plans to deliver 55 million doses of its vaccine to the block in the second quarter of the year. CNBC has contacted J&J for additional comments on the report and has yet to receive a response.

The European Commission, the EU’s executive branch, said on Wednesday that it had not been informed of any delays from J&J.

Another delay in vaccine supply would exacerbate the already lethargic introduction of vaccines in the EU, which has faced issues due to a slower ordering process than the UK and US, slower deliveries, bureaucracy and hesitant vaccines.

In the US, J&J has signed a contract with the US government to supply 100 million cans by the end of June. On Wednesday, the Biden government announced plans to buy an additional 100 million cans. The announcement came as the White House is working to ramp up production of the vaccine after learning earlier this year that the company had fallen behind in production.

Last week, Biden announced that pharmaceutical company Merck would help manufacture J & J’s Covid vaccine. Under the terms of the agreement, Merck will deploy two facilities in the US for J & J’s vaccine. One will make the vaccine and the other will provide “fill-finish” services when the vaccine is put into vials.

– CNBC’s Berkeley Lovelace Jr. contributed to this story.

Correction: This story has been updated to reflect the correct approval process within the EU.

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Politics

U.S. intel says Saudi crown prince authorised killing of Jamal Khashoggi

U.S. intel says Saudi crown prince approved killing of Jamal Khashoggi

Saudi Crown Prince Mohammed bin Salman approved an operation to arrest or kill journalist Jamal Khashoggi in 2018. This emerges from a US intelligence report that could have far-reaching implications for US-Saudi Arabia relations.

The report released on Friday by the Office of the Director of the National Intelligence Service mentioned the Crown Prince’s control over decision-making in Saudi Arabia, as well as the involvement of a key advisor and members of his protection department in the operation in which Khashoggi was killed.

“Since 2017, the Crown Prince has had absolute control over the kingdom’s security and intelligence organizations, so it is highly unlikely that Saudi officials would have carried out an operation of this type without the Crown Prince’s approval,” the report said.

The CIA-led assessment that had so far been classified comes from President Joe Biden, who aims to reshape US relations with Saudi Arabia after years of the Trump administration’s condemnation of the kingdom’s human rights abuses despite condemnation in Congress and ignored at the United Nations.

Khashoggi, a 59-year-old U.S. citizen and Washington Post employee who criticized the Saudi royal family, entered a Saudi consulate in Turkey on October 2, 2018 and never left the country. He was killed by a group of assassins who then dismembered his body. His remains were never recovered.

“The Crown Prince viewed Khashoggi as a threat to the kingdom and largely supported the use of violent measures to silence him,” the US intelligence report said. “Although Saudi officials planned an unspecified operation against Khashoggi in advance, we don’t know how far in advance Saudi officials decided to harm him.”

In a diplomatic reprimand to the Crown Prince this week, the White House made it clear that Biden does not see 35-year-old bin Salman as his counterpart and will instead have relationships through his aging father, King Salman. The younger bin Salman has been the public face of the kingdom since he became crown prince in 2017.

Robert Mahoney, Deputy Executive Director of the Committee for the Protection of Journalists, speaks during a press conference to appeal to the United Nations on the disappearance of Saudi journalist Jamal Khashoggi at the United Nations in New York, United States on October 18, 2018.

Shannon Stapleton | Reuters

“Regarding Saudi Arabia, I would say that we made it clear from the start that we would recalibrate our relationship with Saudi Arabia,” said White House press secretary Jen Psaki on Tuesday from the White House.

On Thursday, in his first conversation with the 85-year-old King, Biden reiterated “the importance the United States attaches to universal human rights and the rule of law,” according to a White House ad.

Biden also told Salman that he “will work to make bilateral relations as strong and transparent as possible,” the White House said. Khashoggi’s name was not mentioned in the advertisement.

The chairman of the Intel Committee of the House of Representatives, Rep. Adam Schiff, called on the White House to impose “serious repercussions on those responsible for Khashoggi’s assassination” and to reassess US relations with Saudi Arabia in the course of the intelligence service Report.

“We need to make sure that foreign governments targeting journalists just for their jobs are not immune from severe repercussions and sanctions, because to restore confidence in American leadership we must act in accordance with the values ​​that America sets.” for a long time, “said the Californian Democrat.

“The government should take further steps to reduce the United States’ dependence on Riyadh and reaffirm that our partnership with the Kingdom is not a blank check,” added Schiff.

The Saudi authorities initially denied any knowledge of Khashoggi’s death and later claimed that the journalist was involved in a fight at the consulate and died in the clash. The Saudi authorities eventually admitted that Khashoggi was killed in a “rogue operation” while denying bin Salman was involved.

A United Nations investigator concluded in a June 2019 report that Khashoggi was “the victim of a premeditated, premeditated execution, an extrajudicial killing for which the state of Saudi Arabia is responsible under international human rights law.”

Trump publicly tried to cast doubts about the Crown Prince’s involvement in Khashoggi’s death, even after multiple outlets reported that the CIA bin Salman itself had concluded that the journalist had been killed. Trump said the CIA had “nothing in particular” while claiming the oil-rich kingdom would remain a “steadfast partner” with the US

“It could very well be that the Crown Prince was aware of this tragic event – maybe he did it and maybe he didn’t!” Trump said less than two months after Khashoggi’s death. Trump’s conciliatory stance contrasted sharply with outrage from members of Congress and the media over the Khashoggi assassination.

The Trump administration maintained relationships through the Crown Prince, who maintained close personal relationships with members of the Trump family, particularly Jared Kushner, the son-in-law of former President Donald Trump.

Trump made Saudi Arabia his first stop in the Middle East when he made his debut in the region in 2017. The kingdom rolled out the red carpet for the former reality star.

The Trump administration used its ties with the Gulf monarchies to normalize relations between Israel, the United Arab Emirates and Bahrain.

The former president also vetoed attempts by Congress to block billions in arms sales to Saudi Arabia and the United Arab Emirates and an attempt to end US involvement in the war in Yemen.

Biden’s review of relations with Saudi Arabia is part of a broader US foreign policy shift in the Middle East.
The president has ended US support for Saudi Arabia’s war in Yemen and is trying to return to the negotiating table with Iran, Riyadh’s enemy, through its nuclear program.

The US president called Israeli Prime Minister Benjamin Netanyahu last week, his first conversation with a Middle Eastern leader since taking office. The Saudis and Israelis are de facto allies, although they do not have formal diplomatic ties to counter Iranian influence in the region.

Biden “discussed regional security” in his appeal Thursday with King Salman, referring to his government’s efforts to end the war in Yemen “and the US commitment to help Saudi Arabia defend its territory since it did Exposed to attacks by Iranian-centric groups, “the White House ad said.

Biden and Salman “also affirmed the historical nature of the relationship and agreed to work together on issues of mutual interest and concern,” according to the White House.

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Health

AstraZeneca-Oxford Covid vaccine authorised to be used by European regulator

AstraZeneca-Oxford Covid vaccine approved for use by European regulator

Head nurse Sam Foster is holding a vial of Oxford University / AstraZeneca COVID-19 vaccine on January 4, 2021 at Churchill Hospital in Oxford, South West England.

Steve Parsons | AFP | Getty Images

LONDON – The coronavirus vaccine developed by AstraZeneca and Oxford University has been approved by the European Medicines Agency, the European Medicines Agency.

The EMA said on Friday that it had assessed the safety and effectiveness of the Covid vaccine and recommended that the European Commission, the EU’s executive branch, give formal conditional marketing authorization.

It also said the shot would likely work in the elderly after a German vaccine committee recommended Thursday not to give the vaccine to those over 65.

“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to fight the pandemic and protect their citizens,” said Emer Cooke, Executive Director of EMA, in a statement on Friday.

“As in previous cases, the CHMP has rigorously evaluated this vaccine and the scientific basis of our work underpins our firm commitment to protecting the health of EU citizens,” said Cooke, referring to the EMA’s Committee on Medicinal Products for Human Use.

The vaccine is already being used in the UK, having received approval in late December, and now, along with the Pfizer BioNTech shot, which has already been approved for use in the UK, makes up most of the EU shocks administered in the country.

Approval comes at a difficult time for the EU as the vaccination program is at best sluggish and very prone to supply shortages.

He has been dealt two blows in the past few weeks, one from Pfizer, who announced that it would temporarily cut production while improving production capacity at its Belgian facility. Then last Friday it was reported that AstraZeneca would deliver far fewer cans to the block than originally expected due to production problems at its plants in the Netherlands and Belgium this spring.

The delays have sparked a crisis in the EU which has announced it will curb exports of coronavirus vaccines from the bloc to give citizens priority. These controls are expected to last until March.

On Wednesday, the EU called on AstraZeneca to do whatever it takes to deliver its agreement to supply millions of coronavirus vaccines, suggesting that the company is diverting some supplies from its UK manufacturing facilities to the EU.

German doubt

On Thursday, doubts arose about the possible approval of AstraZeneca’s vaccine after the German vaccine committee recommended that the vaccine only be offered to people between the ages of 18 and 64.

This is due to the fact that there is insufficient data to assess the effectiveness in people over 65 years of age.

Older study participants were later admitted to phase 3 clinical trials with the AstraZeneca shot, which took place in the UK and Brazil and earlier in South Africa. As a result, there are fewer data on effectiveness in those over 65.

AstraZeneca said this data would be collected when its study results were published in the medical journal The Lancet in December: “As older age groups were recruited later than younger age groups, there was less time to collect cases and, consequently, efficacy data in these cohorts The number of cases is currently limited, but additional data will be available in future analyzes, “it said.

On Friday when the AstraZeneca approval was announced, the EMA announced that older participants (over 55 years of age) had not yet had enough results to establish a number for the vaccine’s effectiveness in this group. However, it states that “protection is expected because an immune response is observed in this age group and is based on experience with other vaccines”.

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FDA says it hasn’t authorized Moderna Covid vaccine regardless of Trump tweet

FDA says it hasn't approved Moderna Covid vaccine despite Trump tweet

US President Donald Trump gives a speech at an Operation Warp Speed ​​Vaccine Summit on December 8, 2020 at the White House in Washington, USA.

Tom Brenner | Reuters

The Food and Drug Administration has not yet approved Moderna’s coronavirus vaccine, contrary to a tweet from President Donald Trump on Friday that said the agency had “overwhelmingly approved” it and would distribute it immediately.

The FDA did not comment on Trump’s tweet, instead referring CNBC to a statement from FDA Commissioner Dr. Stephen Hahn said Thursday evening that the agency would “work quickly towards finalizing and issuing emergency clearance” for Moderna’s vaccine.

“The agency has also notified the US Centers for Disease Control, Prevention and Operation Warp Speed ​​so that they can implement their plans for a timely distribution of the vaccine,” Hahn said in a joint statement with Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research.

The FDA statement on Thursday “is current,” FDA spokesman Michael Felberbaum told CNBC after Trump’s tweet.

It’s possible that Trump was referring to a vote by the FDA’s Advisory Committee on Vaccines and Related Biological Products Thursday, which voted 20-0, with one member abstaining to approve Moderna’s emergency vaccine advocate. The advisory board plays a key role in approving influenza and other vaccines in the US and verifying that the vaccinations are safe for public use. While the FDA does not need to follow the advisory board’s recommendation, it often does.

The FDA is expected to approve Moderna’s vaccine as early as Friday. The US plans to ship close to 6 million cans next week pending agency approval. This was announced by General Gustave Perna, who oversees the logistics for the Operation Warp Speed ​​vaccination project, to reporters on Monday.

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Moderna Covid vaccine FDA accepted for emergency use

Moderna Covid vaccine FDA approved for emergency use

The Food and Drug Administration has approved Moderna’s coronavirus vaccine for emergency use. The vaccine – the second to be approved for use in the US after Pfizer and BioNTech – strengthens the US dose supply. The potentially life-saving shots are badly needed to fight the pandemic that left more than 300,000 Americans dead and hospitals overwhelmed.

With the FDA’s approval for the emergency on Friday, the federal government’s plan to distribute approximately 5.9 million doses of Moderna’s vaccine to 64 states, territories and major cities across the country next week will be approved.

“We’ll probably see gunshots in the arm early next week, I hope Monday or Tuesday,” said Dr. Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases, on the “Today” show on Friday morning.

President Donald Trump said in a tweet: “Congratulations, the Moderna vaccine is now available!”

In addition to Moderna’s vaccine, the U.S. is planning to ship 2 million doses of Pfizer’s vaccine after 2.9 million doses were cleared for shipping this week, General Gustave Perna, who oversees logistics for the Operation Warp Speed ​​vaccination project, said Monday . Both vaccines require two doses three to four weeks apart. Moderna’s Covid vaccine is the first product to be approved by the FDA.

“With the availability of two vaccines to prevent COVID-19, the FDA has taken another crucial step in the fight against this global pandemic, which causes large numbers of hospitalizations and deaths in the US every day,” said FDA Commissioner Dr. Stephen Hahn said in a statement.

US officials hope to vaccinate at least 20 million Americans by the end of the year – mostly healthcare frontline workers and nursing home residents. The initial doses will be limited as production increases. Officials predict it will be months before everyone in the US who wants to be vaccinated is vaccinated. The Centers for Disease Control and Prevention has given states an overview recommending that health workers and nursing homes be prioritized. However, states may distribute the vaccine at their own discretion.

States are already reporting confusion about vaccination plans. In the past few days, state officials said they learned that their second shipment of Pfizer’s vaccine would be smaller than expected or delayed. In Florida, for example, Republican Governor Ron DeSantis said the federal government had told him the state would receive 205,000 Pfizer vaccine doses next week and 247,000 the following week. Those shipments are now on hold, DeSantis said at a press conference Tuesday, and it is unclear when they will arrive.

Moderna’s vaccine, like Pfizer’s, uses messenger RNA or mRNA technology. It’s a new approach to vaccines that uses genetic material to trigger an immune response. Late-stage clinical trial data released last month shows that Moderna Covid’s vaccine is more than 94% effective at preventing, safe and appearing to fight off serious diseases. For maximum effectiveness, the vaccine requires two doses four weeks apart.

The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.

The FDA has approved Moderna’s vaccine for people aged 18 and over. Such authorization by the agency is not the same as a full authorization, which requires more data and can usually take several months longer. Moderna only submitted security data for two months. The agency typically takes six months for full approval and can revoke an EEA for a drug at any time if it doesn’t work as intended or if it proves unsafe. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March but revoked it in June after additional data showed it provided “no evidence of benefit” in coronavirus patients.

The FDA announcement comes after a key agency advisory body voted 20-0 with one abstention on Thursday to recommend the emergency vaccine. The Advisory Committee on Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not need to follow the advisory board’s recommendation, it often does.

Prior to the vote, some committee members stressed their approval of Moderna’s vaccine was not in favor of full FDA approval, and reiterated that the agency needed to review more data on safety and efficacy.

During the meeting, outside medical experts asked the agency about allergic reactions reported in two Alaskan health workers who were taking Pfizer’s vaccine. Doran Fink, deputy director of the FDA’s vaccines and related product applications division, said the agency is looking into the problem.

“As we continue to examine and evaluate the data, we will consider whether additional recommendations need to be made,” he said. “Right now we don’t have enough data to make a definitive recommendation one way or another.”

Fatigue, headaches, and muscle aches are the most common side effects of Moderna’s vaccine, along with some rare symptoms such as persistent nausea or vomiting and facial swelling, which the FDA says are likely caused by the gunfire. Some side effects were tough to shake, although most were resolved within a week, the FDA said.

The FDA said while this isn’t necessarily a side effect, it does recommend monitoring people who receive Pfizer’s or Moderna’s vaccine shots for possible cases of Bell’s palsy, a condition that causes sudden freezing or weakness of facial muscles. The agency also found a higher prevalence of lymphadenopathy, a disease that can cause swollen or enlarged lymph nodes, in the vaccine group compared to the placebo groups in Pfizer and Moderna studies.

According to Moderna, the vaccine will stay stable for up to 30 days at 36 to 46 degrees Fahrenheit, the temperature of a normal household or medical refrigerator. It can be stored at minus 4 degrees Fahrenheit for up to six months. In comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit.

The federal government announced last week it would buy another 100 million doses of Moderna’s vaccine. The US reached an agreement with Moderna in August to purchase 100 million cans for about $ 1.5 billion. Moderna said it charged some customers $ 32 to $ 37 per dose for its vaccine at lower “pandemic prices” this month. The company said it was under discussion for larger volume agreements that will have a lower price.

– CNBC’s Noah Higgins-Dunn and Will Feuer contributed to this report.

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Pfizer’s Covid vaccine permitted by FDA for emergency use

Pfizer's Covid vaccine approved by FDA for emergency use

The Food and Drug Administration has approved Pfizer and BioNTech’s coronavirus vaccine for emergency use. This is a monumental turning point in the one-time pandemic that killed nearly 300,000 Americans and devastated the US economy in less than a year.

FDA chief scientist Denise Hinton told Pfizer in a letter Friday that she approved the company’s emergency use of the vaccine.

President Donald Trump called it a “medical miracle” in a video tweet. “We delivered a safe and effective vaccine in just 9 months,” Trump said. “This is one of the greatest scientific achievements in history.”

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the decision “promises to change the course of this pandemic in the United States.” “With the science guiding our decision-making, the available safety and efficacy data to support the approval of the Pfizer-BioNTech COVID-19 vaccine because the known and potential benefits of the vaccine significantly outweigh the known and potential risks,” he said.

FDA approval for the emergency will now boost the federal government’s distribution of the potentially life-saving doses to 64 states, territories and major cities across the country. The government plans to distribute 2.9 million doses of the vaccine within 24 hours, followed by another 2.9 million doses 21 days later, for patients to receive their second shot, General Gustave Perna, who runs the logistics for the Operation Warp vaccination program Speed ​​monitored by President Donald Trump said Wednesday. Pfizer’s vaccine requires two doses three weeks apart.

The vaccine couldn’t come at a more crucial time. Hospitals in the U.S. already have higher numbers of Covid patients than ever before, and the country’s outbreak is poised to break even grimmer records. According to a CNBC analysis of the Johns Hopkins University data, the US reported 3,124 new Covid-19 deaths on Wednesday, the pandemic’s deadliest one-day record to date. The director of the Centers for Disease Control and Prevention, Dr. Robert Redfield, warned earlier this month that the next few months of the pandemic would be “some of the most difficult in the history of this country’s public health.”

Initial doses of the Pfizer vaccine will be limited as production begins. Officials predict it will be months before everyone in the US who wants to be vaccinated is vaccinated. Pfizer has announced that it will ship 50 million doses of vaccine this year, enough to vaccinate 25 million people. The vaccine is expected to be distributed in phases where the most critical U.S. workers and vulnerable people receive it first. The CDC has given states an outline recommending that priority be given to health workers and nursing homes first. However, states may distribute the vaccine at their own discretion.

An emergency permit, or EEA, is not the same as a full permit, which can typically take months. Pfizer has only submitted safety data for two months, but it typically takes the agency six months for full approval. The vaccine has been approved for people aged 16 and over.

On Friday, FDA Commissioner Stephen Hahn said the agency was “working fast” to clear the vaccine in case of emergency. Shortly after Hahn testified, Trump, who has repeatedly said he had urged the FDA to move faster in the vaccine development process, told the agency in a tweet: “Get the dam vaccines out NOW.”

The FDA’s announcement comes after a key agency advisory body voted 17 to 4, with one abstention, to recommend the vaccine for emergency approval on Thursday. The Advisory Committee on Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not need to follow the advisory board’s recommendation, it often does.

FDA approval marks a record breaking time frame for a process that typically takes about a decade. The fastest vaccine development to date against mumps took more than four years and was licensed in 1967. Pfizer and BioNTech announced plans to develop a coronavirus vaccine in March and filed an emergency clearance application with the FDA in November. Health authorities in Canada, the UK and Bahrain have approved Pfizer’s vaccine for most adults.

Pfizer’s vaccine uses messenger RNA or mRNA technology. It’s a new approach to vaccines that uses genetic material to trigger an immune response. Moderna, another front runner in the Covid vaccine race, also uses mRNA technology. Late-stage clinical trial data shows Pfizer’s vaccine is 95% effective against Covid, safe, and appears to ward off serious illness. For maximum effectiveness, the vaccine requires two doses about 21 days apart.

Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit, which poses potential logistical challenges for rural areas and inner cities that may not have good health infrastructure. For comparison: According to Moderna, the vaccine can be stored for up to six months at minus 4 degrees Fahrenheit.

FedEx and United Parcel Service on Thursday expressed confidence in their networks to distribute the vaccines across the country in a Senate hearing and outlined plans to monitor the location and temperatures of the shipments.

The Federal Aviation Administration asked the airports late Friday to ensure that they have adequate staff when the vaccines arrive. In a statement hours before the vaccine was approved, the FAA said airports should consider providing areas for trucks for vaccines to be picked up on arrival. The agency has announced that flights with cans and related supplies will be given priority.

U.S. officials plan to continue to monitor for side effects of the Pfizer vaccine among the health care workers and nursing homes who receive it, said Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, during the agency’s meeting on Thursday. The officers will use an SMS system called v-safe, which is designed to provide early warning of possible side effects of the vaccine.

During the meeting, FDA vaccine reviewer Dr. Susan Wollersheim found that the study data showed a “numerical imbalance” in Bell’s palsy, a condition that causes temporary weakness or paralysis of the muscles in the face. She said there were four cases in the vaccine group and none in the placebo group. Although the frequency of the cases was inconsistent with the general population, the FDA recommended further monitoring once the vaccine becomes more widely distributed.

Read the full letter from the FDA below: