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CDC clears reformulated Covid pictures concentrating on omicron in time for varsity

Millions of Americans could be eligible for a new Covid refresher

Justin Sullivan | Getty Images

The Centers for Disease Control and Prevention have released reformulated Covid shots targeting the latest Omicron subvariants for the fall, allowing many people to get an extra boost in days.

The agency’s independent committee on vaccines voted 13-1 in favor of the shots on Thursday after reviewing the available safety and efficacy data in a nearly seven-hour session. CDC Director Dr. Rochelle Walensky approved the injections a few hours later, clearing the way for pharmacies to administer the injections soon.

Pfizer’s Omicron boosters were approved for ages 12+, while Moderna’s updated shots were approved for ages 18+. The eligible age groups can receive the boosters no earlier than two months after the completion of their primary series or their last booster with the old vaccinations.

Walensky said her decision followed “a thorough scientific evaluation and sound scientific discussion.”

“If you are eligible, there is no bad time to get your Covid-19 booster and I strongly encourage you to get it,” she said in a statement.

Pfizer plans to ask the Food and Drug Administration to also approve the new boosters for children ages 5 to 11 in early October, company executives told the committee Thursday.

The original vaccines are no longer used as a booster dose in people aged 12 and over as the reformulated vaccines are now online.

Public health officials expect another wave of Covid infections this fall as immunity to the legacy vaccines wanes, more contagious omicron subvariants spread and people spend more time indoors as the weather turns colder and families close gather for the holidays.

The CDC and FDA hope the new boosters will provide more durable protection against infection, mild illness, and serious illness. The reformulated shots target omicron BA.5, the dominant variant of Covid, as well as the strain that emerged in China more than two years ago.

The US has so far secured 171 million doses of the new boosters from Pfizer and Moderna. More than 200 million people are entitled to the recordings, according to the CDC. dr Sara Oliver, a CDC official, told the committee Thursday there should be enough vaccine supplies to meet demand this fall.

No omicron BA.5 human data

There is no human trial data on the new BA.5 boosters, so it is unclear how they will perform in the real world. The CDC and FDA used human clinical trial data for vaccinations against the original version of Omicron, BA.1, which elicited a stronger immune response than the old vaccines.

Pfizer and Moderna originally developed Omicron boosters for BA.1, but the FDA told the companies to change gears in June and develop BA.5 shots instead after the subvariant became dominant. The decision to focus on BA.5 did not leave enough time to wait for data from human trials before a vaccine launch in the fall.

The lack of human data for the BA.5 vaccines has caused some controversy, but Dr. Peter Marks, a senior FDA official, said the agency has followed the same process it has used for years to change strains for flu vaccines. Marks said Wednesday flu vaccine strains are being changed even without human clinical data.

dr Pablo Sanchez, the only committee member who voted against the injections, called the recommendation premature and said the US should have waited for human data before proceeding with the boosters.

“There’s already a lot of hesitation with vaccines — we need the human data,” said Sanchez, a professor of pediatrics at Ohio State University. But Sanchez said he believes the new boosters are safe and he will likely receive one himself.

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Board member Dr. Oliver Brooks, chief medical officer at Watts HealthCare Corporation in Los Angeles, questioned why the FDA chose a BA.5 vaccine when clinical data is available for the BA.1 vaccine that vaccine manufacturers are initially developing had. Brooks eventually voted for the shots.

But dr Sarah Long, also a committee member, said there was no reason to believe the BA.5 boosters will be inferior to the old vaccines as they also contain the original Covid strain and have the potential to increase hospitalizations and deaths along the way in the future to reduce autumn and winter. Long also voted in favour.

mouse studies

FDA and CDC officials have said that the omicron BA.1 and omicron BA.5 boosters are similar enough that the immune response data of the BA.1 vaccine should give a good indication of how the BA.5 vaccine will work. Omicron BA.1 and BA.5 are according to Dr. Jacqueline Miller, who works on vaccine development at Moderna, are closely related and share a difference of four mutations.

Moderna completed enrollment in clinical trials on the BA.5 shots last week and should have results by the end of the year, Miller told the CDC committee on Thursday. Pfizer’s clinical trial is also ongoing, although the company hasn’t said when it expects results.

Health authorities also reviewed data on the BA.5 shots from mouse studies. Moderna presented data showing that the BA.5 shots increased antibodies in mice more than four-fold compared to the old shots. The mice express the same cellular protein as humans, to which the virus attaches. Pfizer’s BA.5 booster increased antibodies in mice by 2.6-fold compared to the original vaccine.

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According to the FDA, the most common side effects from the human trials of BA.1 injections were pain, redness, swelling at the injection site, fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting, and fever.

Oliver, the CDC official, told the committee that health officials do not expect a difference in the safety profile of the BA.1 and BA.5 shots because the subvariants differ by only a few mutations.

However, Oliver noted that the risk of myocarditis following a BA.5 booster dose is unknown. Young men and adolescent boys are at increased risk of myocarditis after the second dose of Pfizer and Moderna, but the risk of myocarditis from Covid infection is higher, according to the CDC.

“We know that the risk of myocarditis is unknown, but expect a risk similar to that seen after the monovalent vaccines,” Oliver said. The monovalent vaccines are the old vaccines that have been given to millions of people in the US over the last two years.

Old vaccines are losing their effectiveness

The original vaccines, which were first approved in December 2020, no longer offer any meaningful protection against infection because the virus has mutated so much in the last two years. The shots were developed against the first strain to appear in China, so they are no longer tailored to attack the expanding Omicron subvariants.

Infections, hospitalizations and deaths have all fallen dramatically since last winter’s massive Omicron outbreak, but have leveled off at stubbornly high levels this summer. Omicron BA.5 is the most contagious and immune-avoidable variant to date, and breakthrough infections have become increasingly common as a result.

The effectiveness of the old vaccines against hospitalization also decreased after omicron BA.5 became dominant. A third dose was 77% effective at preventive hospitalization four months after receiving the shot, but protection dropped to as much as 34% at 120 days, according to CDC data. A fourth dose in people aged 50 and over was 56% effective in preventing hospitalization at four months.

Deaths and hospitalizations from Covid among people aged 65 and older have increased since April, according to Heather Scobie, a CDC epidemiologist who presented data during Thursday’s meeting. The number of deaths has increased, particularly among people aged 75 and over, Scobie said.

The CDC has shifted to a more focused public health response, with a focus on protecting the most vulnerable — the elderly, those with serious illnesses and those with weakened immune systems. Though there’s no data on the real-world effectiveness of the new boosters, the US is moving quickly to introduce them in hopes they’ll protect people this fall.

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Health

Decide Clears Purdue Pharma’s Restructuring Plan for Vote by Hundreds of Claimants

Judge Clears Purdue Pharma’s Restructuring Plan for Vote by Thousands of Claimants

“It’s not unprecedented, but it’s highly controversial” for a bankrupt company’s owners to be released from future litigation as part of a settlement, said Adam J. Levitin, a law professor specializing in bankruptcy at Georgetown University Law Center. “It’s not even clear that the bankruptcy court has the jurisdiction to do this,” as the Sacklers are not parties to the bankruptcy themselves.

Judge Drain has long urged the negotiators to work quickly, because no money can flow to the claimants until the bankruptcy case is concluded.

According to the plan, the reconstituted, as-yet unnamed company would fund about a half-dozen trusts, including separate ones for tribes, adults and children. Proceeds from the sales of the nonprofit’s overdose-reversing medications as well as from moderate quantities of OxyContin would continue to be pumped into these trusts.

But more than 100,000 individual claimants, including relatives of people who died from prescription overdoses, would receive relatively paltry compensation, ranging roughly from $3,000 to $48,000 apiece — before lawyers’ fees and costs are deducted.

Indeed, more than a half-billion dollars overall will go toward fees and costs accrued by plaintiffs’ public and private lawyers.

The oversight of the new trusts will also be expensive. The trust distribution is incredibly complex, said Lindsey Simon, an assistant professor at the University of Georgia School of Law, who has closely followed the case. “From my perspective, the biggest question is how much money will get eaten up in the administration of all those trusts,” she said.

Scott Bickford, a lawyer who represents individuals, families and babies who showed symptoms of withdrawal from drugs they were exposed to in utero, noted that the current proposal did dedicate $60 million for programs to assist these children and a fund to compensate them, an improvement from earlier versions.

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Politics

Biden Administration Clears three Guantánamo Detainees for Launch

Biden Administration Clears 3 Guantánamo Detainees for Release

The Biden government has approved three detainees in Guantánamo Bay for release to countries that have agreed to impose security conditions on them, including the oldest of the remaining prisoners of war, lawyers and government officials in the United States, said Monday.

The permits increased the number of 40 prisoners currently in war prison who were approved for transfer to other countries to nine. However, it is unclear where the three men will go or when, in part because the State Department will have to make diplomatic and security agreements with countries to accommodate them.

Some of the other detainees who have been released for release over the years have waited a decade for another country to agree to accept them. In some cases, countries are asked to continue detaining detainees or bring them to justice. In most cases, they will be asked to prevent them from traveling abroad for at least two years.

Among those granted permission is Saifullah Paracha, 73, from Pakistan, who was captured in Thailand in 2003. Not only is he the oldest of the inmates, but he has also been referred to as one of the sick with heart disease and diabetes, and high blood pressure.

The other two were Abdul Rabbani, 54, also a Pakistani citizen, and Uthman Abdul al-Rahim Uthman, 40, a Yemeni. None of them have been charged with any crime by the United States in the two decades they have been in custody.

Of the other detainees who remained, 12 were charged with war crimes, one was convicted and 19 are considered too dangerous to be placed in another country’s custody.

The news that the men had been allowed to be released originally came from their lawyers, who heard about it from prisoners in phone calls between lawyer and client. Two government officials upheld the three dismissal decisions, but on condition of anonymity as they were not authorized to discuss them.

The decision to approve the three releases was made early last week by the attorney general, the director of the national intelligence service, the chairman of the joint chiefs of staff and the secretaries of defense, homeland security and state. All have representatives who sit on the Periodic Review Board, the organization that assesses the threat posed by the detainees.

Mr. Rabbani was captured during a 2002 security police raid in Karachi, Pakistan, with his brother, who is also held as a prisoner of war in Guantánamo Bay. Both Rabbani brothers were held by the CIA for more than 500 days before being placed in US military custody.

Mr. Uthman was held the longest of the three. He was brought to Guantánamo as a suspected member of Osama bin Laden’s bodyguard corps within days of the opening of Camp X-Ray in January 2002. Most recently, he was rejected for release in 2018, also because he “lacked credible plans to support himself during the transfer” and he had not said how his family could support him.

Despite a commitment to renew efforts by the Obama administration to end the detention operations at the naval base in Cuba, the Biden administration has yet to restart renditions. It currently has not appointed a senior US official to negotiate business with other countries.

The Trump administration shut down the office of the Special Envoy for the Closure of Guantánamo and transferred only one prisoner, a seasoned Saudi terrorist who was repatriated in 2018 to serve his war criminal sentence in a former jihadist rehabilitation center.

The last known US rendition of a prisoner from Guantánamo to Pakistan was in 2008. The US stopped repatriating Yemenis in 2010 because it feared that the Yemen government could not monitor the men and prevent them from coming back to join an Al Qaeda franchise there.

Mr. Paracha, a former businessman and long-time legal resident of New York, was captured in July 2003 during an FBI stab operation in Thailand. He was lured from his home in Karachi, Pakistan, to Bangkok to discuss what turned out to be a sham merchandising deal with representatives from Kmart. Instead, secret service agents seized, covered and shackled him and flew him to Afghanistan.

He was viewed by US intelligence as an intermediary who helped the man accused of plotting the September 11, 2001 attacks, Khalid Shaikh Mohammed and Mohammed’s nephew, Ammar al-Baluchi, with financial transactions in Pakistan after the attacks. Both men are charged with conspiring in the September 11th attacks, a capital incident.

Mr Paracha admitted having secured about $ 500,000 for her, but said he was unaware of her identity or her ties to al-Qaeda. He claimed he helped them as he would any other Muslim.

At the time of Mr. Paracha’s capture, his eldest son, Uzair Paracha, was arrested in the United States on suspicion of supporting terrorism. Uzair Paracha was then tried, his conviction overturned, and returned to Pakistan last year in an agreement with prosecutors to drop the case if he gives up his permanent residence status.

Saifullah Paracha’s younger son, Mustafa Paracha, said in an interview last year that his father would like to spend time with his family after his return to Pakistan and that his first concern is to attend to his health needs. At the beginning of his detention, US military doctors flew a cardiac catheterization laboratory and surgical team to Guantánamo, but he refused to consent to the procedure because of concerns about the quality of medical care available there.

Typically, the Periodic Review Secretariat, which manages the Board of Directors, publishes the justifications for the release decisions on its website. The decisions usually contain a recommendation on how to ensure safety and the committee’s recommendations on rehabilitation, repatriation or resettlement of the prisoner who has been admitted for transfer. But it hadn’t done that until Monday evening.

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Health

FDA clears use in children ages 12 to 15

Daily U.S. data on April 20

The Food and Drug Administration on Monday approved Pfizer and BioNTech’s motion to allow their Covid-19 vaccine to be given to children ages 12-15 in an emergency so states can vaccinate middle school students before the fall.

The U.S. agency, which grants the use of the shot in teenagers, will also accelerate the country’s efforts to fight infection, say public health officials and infectious disease experts.

The two-dose vaccine is already approved for use in people aged 16 and over. The Centers for Disease Control and Prevention’s Vaccine Advisory Board scheduled a meeting on Wednesday to review the recordings for children. If approved by the CDC as expected, it could be distributed to teens as early as this week.

Acting FDA Commissioner Dr. Janet Woodcock said the decision “moves us closer to a return to a sense of normalcy and an end to the pandemic”. She assured parents that the agency “did a rigorous and thorough review of all available data” before approving it for teenage use.

The companies announced in late March that the vaccine was 100% effective in a clinical study involving more than 2,000 adolescents. They also said the vaccine produced a “robust” antibody response in the children that outperformed that in a previous study in older teenagers and young adults. The side effects were generally consistent with those seen in adults, they added.

Vaccinating children is seen as critical to ending the pandemic. The nation is unlikely to achieve herd immunity – if enough people in a given community have antibodies to a given disease – until children can be vaccinated, health officials and experts say.

According to the government, children make up around 20% of the total US population. According to experts, between 70% and 85% of the US population must be vaccinated against Covid to achieve herd immunity and some adults may refuse to get the shots. Although now more experts say herd immunity becomes less likely as variants spread.

The Chief Medical Officer of the White House, Dr. Anthony Fauci, said in April that the US could start vaccinating older children against Covid-19 from the fall, while elementary school-age children may get their shots early next year.

The vaccine is given in two doses three weeks apart, according to the FDA, with the same regimen according to the FDA for people aged 16 and over.

FDA approval for children under the age of 12 could come in the second half of this year. In a presentation to coincide with the company’s earnings release on May 4th, Pfizer expects to file for approval of its toddler vaccine in September and toddler vaccine in November. The filing process for full FDA approval for people aged 16 and over has already begun, the company announced on Friday.

In late March, Pfizer and BioNTech started a clinical trial testing their vaccine in healthy 6-month-old to 11-year-old children. Moderna and Johnson & Johnson, whose vaccines are approved for people aged 18 and over, are also testing their recordings in younger age groups.

The FDA’s announcement also comes in the context of President Joe Biden’s push to reopen schools for personal learning. Biden’s government has already announced that it will invest $ 10 billion in Covid testing for schools to accelerate returns to face-to-face courses across the country.

Vaccinating children can also give the green light to after-school activities such as sports, arts, and other personal activities.

While parents feel relieved that their children can be vaccinated, some health experts have questioned whether doses should be kept for children who are considered less at risk for serious illness while leaving vulnerable people around the world unprotected.

Dr. Craig Spencer, director of global health and emergency medicine at Columbia University Medical Center, said there need be no either-or choice between vaccinating children and distributing shots to the rest of the world. The US can do both, he said. But he’s frustrated that the US has stopped focusing on getting the rest of the world vaccinated.

“If I were to ask you whether a 12 year old with no medical problems or a 57 year old healthcare worker who cares for Covid patients every day should be vaccinated, the answer is very clear, right?” he said. “Why does this calculation change when it comes to a health worker from another country?”

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Business

F.D.A. Clears Moderna’s Covid Vaccine

F.D.A. Clears Moderna's Covid Vaccine

The Food and Drug Administration on Friday authorized the coronavirus vaccine made by Moderna for emergency use, allowing the shipment of millions more doses across the nation and intensifying the debate over who will be next in line to get inoculated.

The move will make Moderna’s vaccine the second to reach the American public, after the one by Pfizer and BioNTech, which was authorized just one week ago.

The F.D.A.’s decision sets the stage for a weekend spectacle of trucks rolling out as expert committees begin a new round of discussions weighing whether the next wave of vaccinations should go to essential workers, or to people 65 and older, and people with conditions that increase their risk of becoming severely ill from Covid-19.

Jockeying for the next shots in January and February has already begun, even though there is still not enough of the two vaccines for all the health care workers and nursing home staff members and residents given first priority. Uber drivers, restaurant employees, morticians and barbers are among those lobbying states to include them in the next round along with those in the more traditional categories of the nation’s 80 million essential workers, like teachers and bus drivers.

The rapid progress from lab to human trials to public inoculation has been almost revolutionary, spurred by the nation’s urgent need to blunt the pandemic that has broken record after record in U.S. deaths, hospitalizations and economic losses. In the last week alone, there has been an average of 213,165 cases per day, an increase of 18 percent from the average two weeks earlier. And the daily death toll in recent days has surpassed 3,200.

Dr. Anthony S. Fauci, the nation’s top infectious disease expert, called the advent of two vaccines “an historic moment.”

“This to me is a triumph of multiyear investment in biomedical research that culminated in something that was not only done in record time, in the sense of never before has anybody even imagined you would get vaccines to people in less than a year from the time that the sequence was made known,” Dr. Fauci said.

“This is an example of government working. It worked really well,” he added.

Moderna, a company based in Cambridge, Mass., worked with Dr. Fauci’s agency at the National Institutes of Health to create a vaccine that, along with Pfizer-BioNTech’s, shepherds in a new technology based on genetic material called messenger RNA or mRNA. In clinical trials in tens of thousands of volunteers, the vaccines proved 94 to 95 percent effective. Each requires two shots.

Both products are reaching an anxious public before vaccines made with traditional approaches, and have become even more critical as other companies’ efforts have faltered in recent months.

The emergency authorization kicks off a swift and complex drive to distribute some 5.9 million doses of the Moderna vaccine around the country, with shipping to begin on Sunday and deliveries starting on Monday. The first Moderna vaccinations could then be given hours later.

Because Moderna’s vaccine, unlike Pfizer-BioNTech’s, does not need extreme-cold storage and is delivered in smaller batches, states are hoping to provide it to less populated areas, reaching rural hospitals, local health departments and community health centers that were not at the top of the distribution list.

Three places that did not receive the Pfizer-BioNTech vaccine — the Marshall Islands, Micronesia and Palau — will receive the Moderna vaccine for that reason, according to a federal health official familiar with the government’s distribution plans.

And in contrast to Pfizer’s rollout last week, the Moderna vaccine deliveries will be managed by the federal government under the funding of Operation Warp Speed, the administration’s program to develop and distribute vaccines as fast as possible.

Supplies of a second vaccine cannot come soon enough. Several governors and state health officials said on Friday that they were dismayed to learn they would be getting less of the Pfizer-BioNTech vaccine next week than the federal government had promised.

Dr. Mark Levine, commissioner of the Vermont Department of Health, said in a Friday briefing: “All my colleagues in the region are reporting a 25 to 35 percent decrease in their allocation for next week. As we were walking in, I learned as many as 975 doses out of an expected 5,850 doses would not be coming in when we expected. That doesn’t mean we won’t be getting all of those doses. It just means they won’t be coming in when we expected.”

He added, “What everyone around the country is upset about, in addition to just the number, is there’s been no communication, so there’s no understanding of what this really means.”

Covid-19 Vaccines ›

Answers to Your Vaccine Questions

With distribution of a coronavirus vaccine beginning in the U.S., here are answers to some questions you may be wondering about:

    • If I live in the U.S., when can I get the vaccine? While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.
    • When can I return to normal life after being vaccinated? Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.
    • If I’ve been vaccinated, do I still need to wear a mask? Yes, but not forever. Here’s why. The coronavirus vaccines are injected deep into the muscles and stimulate the immune system to produce antibodies. This appears to be enough protection to keep the vaccinated person from getting ill. But what’s not clear is whether it’s possible for the virus to bloom in the nose — and be sneezed or breathed out to infect others — even as antibodies elsewhere in the body have mobilized to prevent the vaccinated person from getting sick. The vaccine clinical trials were designed to determine whether vaccinated people are protected from illness — not to find out whether they could still spread the coronavirus. Based on studies of flu vaccine and even patients infected with Covid-19, researchers have reason to be hopeful that vaccinated people won’t spread the virus, but more research is needed. In the meantime, everyone — even vaccinated people — will need to think of themselves as possible silent spreaders and keep wearing a mask. Read more here.
    • Will it hurt? What are the side effects? The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection into your arm won’t feel different than any other vaccine, but the rate of short-lived side effects does appear higher than a flu shot. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. The side effects, which can resemble the symptoms of Covid-19, last about a day and appear more likely after the second dose. Early reports from vaccine trials suggest some people might need to take a day off from work because they feel lousy after receiving the second dose. In the Pfizer study, about half developed fatigue. Other side effects occurred in at least 25 to 33 percent of patients, sometimes more, including headaches, chills and muscle pain. While these experiences aren’t pleasant, they are a good sign that your own immune system is mounting a potent response to the vaccine that will provide long-lasting immunity.
    • Will mRNA vaccines change my genes? No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.

Gov. Charlie Baker of Massachusetts said on Friday, “We’re certainly frustrated,” referring to the reduced number of Pfizer-BioNTech doses his state would receive next week — 42,900 instead of 59,000. Demand for the vaccine is high.

“So far, hospitals are reporting overwhelming acceptance from doctors, nurses and other workers who are eligible to be vaccinated,” he said.

Pointing out how hard hit Wisconsin has been, Gov. Tony Evers complained that the state was receiving significantly less of the Pfizer-BioNTech vaccine than it had been promised — 35,100 doses instead of 49,725. In a statement on Friday, he said, “We call on the federal government to send us more vaccine without delay.”

Because Moderna’s vaccine requires two doses, federal officials are holding another 5.9 million doses for shipment four weeks after the first wave, as the doses are spaced a month apart. The federal government also plans to reserve more than 500,000 doses in case of problems with the initial shipment.

Officials expect to inform states next week the number of doses they plan to send in the second wave of shipments.

The emergency authorization Friday was the product of an F.D.A. review process that compressed an extraordinary amount of work into weeks, and occurred at the same time regulators were poring over materials for the Pfizer-BioNTech vaccine.

The overlap led to a grueling schedule for the reviewers. Large teams organized into specialties — epidemiology, statistics and manufacturing among them — and reviewed Moderna’s application day and night once the company submitted its data in late November.

Among the review’s components were teams that examined company production facilities and clinical trial sites to affirm that records corresponded to the materials Moderna had submitted to federal regulators.

The F.D.A.’s advisory panel also had to consider new information — reports of severe allergic reactions, two in Britain and two in the United States, in people who received the Pfizer-BioNTech vaccine after it was authorized. Although that vaccine is not identical to Moderna’s, they are similar. The agency and the Centers for Disease Control and Prevention are investigating the cases, but say the vaccines can be safely administered to most people who have allergies, with careful monitoring.

The F.D.A.’s authorization also represented a capstone to a sprawling government-led effort that began in January, when scientists at the National Institutes of Health and Moderna designed the vaccine within two days of China’s releasing the genetic sequence of the new virus.

The company had never brought a product to market, giving it an underdog status as its vaccine was tested on the same timetable as Pfizer-BioNTech’s. Moderna enjoyed an unusually intimate relationship with Operation Warp Speed, which has monitored its supply on an almost hourly basis this year. The company benefited from nearly $2.5 billion in federal funds used to buy raw materials, expand its factory and enlarge its work force by 50 percent.

Public health experts and federal officials still estimate that it will be at least six months, if not longer, before most Americans can be vaccinated. And that depends on whether other vaccines in trials are successful and receive emergency approval.

The federal government is counting on building supplies from vaccines under development by several others — one from Johnson & Johnson, one from Sanofi of France and GlaxoSmithKline of Britain, and another from the British-Swedish drug maker AstraZeneca and the University of Oxford.

On Saturday and Sunday, experts advising the C.D.C. will take up Moderna’s vaccine and ultimately vote on the next tiers of people who should get the vaccines. The committee vote on Sunday will most likely set off a frenzy of difficult decision-making at the state level that could be further complicated by bumps in the vaccine production process.

Behind the scenes is McKesson, based in Irving, Texas, one of the country’s largest distributors of drugs and medical supplies. The company has a long history of distributing vaccines and is the largest distributor of the seasonal flu vaccine in the United States.

McKesson also played a central role in the opioid epidemic and is part of a group of companies closing in on a potential $26 billion settlement with state and local governments.

The company will be the main distributor of the Moderna vaccine. Pfizer-BioNTech itself is distributing its vaccine, which needs to be kept at minus 94 degrees Fahrenheit.

McKesson is also producing kits that include the supplies needed to administer both vaccines.

McKesson is assembling the kits at two of its distribution centers, one near Louisville, Ky., a major hub for UPS, and another near Memphis, where FedEx is based.

While McKesson has its own fleet of trucks, it is largely relying on FedEx and UPS to ship the kits and vaccines.

Each kit includes needles, syringes, alcohol prep pads, face shields and surgical masks, administration sheets for health care providers, and vaccination record and reminder cards for patients.

McKesson has outfitted at least two of its distribution centers with specially designed, 10,000-square-foot freezers designed to store millions of doses of the Moderna vaccine. Altogether, McKesson has added more than 3.3 million square feet of space to manage the project.

When the time comes to send the Moderna doses out, McKesson will pack the doses into coolers it sourced from Cold Chain Technologies, a company in Franklin, Mass. Those coolers will be packed with coolant packs, and then sent to administration sites via FedEx and UPS. The coolers also contain monitoring devices that indicate whether the vaccines ever got too warm.

McKesson has hired more than 1,000 people to help with the effort, and expects to hire up more than 2,500 more in the months ahead.

David Gelles, Katherine J. Wu, Sharon LaFraniere and Reed Epstein contributed reporting.

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Politics

Congress Clears Two-Day Spending Extension to Finalize Stimulus Deal

Congress Clears Two-Day Spending Extension to Finalize Stimulus Deal

The negotiators worked until Friday evening to finalize the key details of the business cycle compromise, continue negotiations on how long unemployment benefits should last, how federal aid to small businesses should be distributed, and extend a federal eviction moratorium. The plan should revitalize the Paycheck Protection Program, a loan program for small businesses in trouble.

Since Republicans insisted on keeping the total cost of the measure below $ 1 trillion, it was significantly less than the $ 2.2 trillion stimulus bill passed in March when the consequences of the pandemic were just becoming clear. It fell well short of the scope of recovery action most economists believe is necessary and will guarantee that Mr Biden will have to quickly tackle another rescue package, which he has already signaled will be his first priority.

The stimulus payments of $ 600 and weekly unemployment benefits of $ 300 per week were half the amounts approved at the time.

In the Senate, Senators Josh Hawley, Republican of Missouri, and Bernie Sanders, regardless of Vermont, made renewed attempts to approve US $ 1,200 direct payments to Americans.

New York Senator Chuck Schumer, the Democratic leader, also endorsed efforts to send out another round of $ 1,200 in direct payments.

Wisconsin Republican Senator Ron Johnson blocked both attempts, calling it “a shotgun approach” on Friday and criticizing broader efforts to send another round of taxpayers’ money to prop up the stuttering economy.

“We are not going to have learned the lessons of our very urgent, very urgent, very massive previous aid packages,” Mr Johnson said in the Senate. “We’re just going to make more of it, another trillion dollars.”

The coverage was contributed by Jeanna Smialek, Nicholas Fandos, Luke Broadwater and Jim Tankersley.

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F.D.A. Clears Pfizer Vaccine, and Tens of millions of Doses Will Be Shipped Proper Away

F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away

Die Food and Drug Administration hat am Freitag den Covid-19-Impfstoff von Pfizer für den Notfall zugelassen und damit Millionen von stark gefährdeten Menschen den Weg frei gemacht, innerhalb weniger Tage mit dem Impfstoff zu beginnen.

Die Genehmigung ist ein historischer Wendepunkt in einer Pandemie, bei der in den USA mehr als 290.000 Menschen ums Leben kamen. Mit der Entscheidung sind die Vereinigten Staaten neben Großbritannien, Bahrain, Kanada, Saudi-Arabien und Mexiko das sechste Land, das den Impfstoff freigibt. Weitere Genehmigungen, auch von der Europäischen Union, werden innerhalb von Wochen erwartet.

Die Entscheidung der FDA folgte einer außergewöhnlichen Abfolge von Ereignissen am Freitagmorgen, als der Stabschef des Weißen Hauses, Mark Meadows, dem FDA-Kommissar Dr. Stephen Hahn sagte, er solle überlegen, ob er seinen nächsten Job suchen könne, wenn er die Notfallgenehmigung nicht erhalten würde am Freitag nach Angaben eines hochrangigen Verwaltungsbeamten, der unter der Bedingung der Anonymität sprach, weil er nicht befugt war, die Angelegenheit zu erörtern. Dr. Hahn befahl daraufhin den Impfstoffaufsichtsbehörden der Agentur, dies bis zum Ende des Tages zu tun.

Die Genehmigung löste eine komplizierte Koordinierungsmaßnahme von Pfizer, privaten Schifffahrtsunternehmen, staatlichen und lokalen Gesundheitsbehörden, dem Militär, Krankenhäusern und Apothekenketten aus, um die erste Woche mit etwa drei Millionen Dosen so schnell wie möglich an Mitarbeiter des Gesundheitswesens und Pflegeheime zu bringen möglich, während der Impfstoff bei ultrakalten Temperaturen gehalten wird.

Pfizer hat mit der US-Regierung einen Vertrag über die Lieferung von 100 Millionen Dosen des Impfstoffs bis zum nächsten März abgeschlossen. Im Rahmen dieser Vereinbarung sind die Aufnahmen für die Öffentlichkeit kostenlos.

Jedes Bundesland hat zusammen mit sechs Großstädten der Bundesregierung eine Liste der Standorte – hauptsächlich Krankenhäuser – vorgelegt, an denen der Pfizer-Impfstoff zunächst versandt werden soll. Im bevölkerungsreichen Florida werden die ersten Empfänger fünf Krankenhäuser in Jacksonville, Miami, Orlando, Tampa und Hollywood sein. Im winzigen ländlichen Vermont werden nur das Medical Center der University of Vermont und ein staatliches Lagerhaus versorgt.

Die McKesson Corporation, ein riesiger medizinischer Zulieferer, sendet Kits mit Spritzen, Alkoholtupfern, Gesichtsschutz und anderen Verbrauchsmaterialien an dieselben Standorte, wo sie sich mit den Impfstoffen treffen, die Pfizer in speziellen, mit Trockeneis verpackten Kartons versendet Halten Sie sie bei minus 94 Grad Fahrenheit.

Die Pfizer-Verpackung enthält ein Gerät, das den Standort der Box verfolgt, sowie eine Wärmesonde, die sicherstellt, dass die Tiefkühlung während der gesamten Fahrt von den Vertriebsstandorten des Unternehmens in Michigan und Wisconsin aufrechterhalten wird.

Die Entscheidung ist ein Sieg für Pfizer und seinen deutschen Partner BioNTech, die vor 11 Monaten mit der Arbeit an dem Impfstoff begonnen haben. Die Entwicklung von Impfstoffen dauert in der Regel Jahre. Die späte klinische Studie der Unternehmen, an der fast 44.000 Personen teilnahmen, erwies sich als zu 95 Prozent wirksam.

Ein Expertengremium, das die FDA am Donnerstag beriet, genehmigte den Impfstoff von Pfizer für Personen ab 16 Jahren, und die Agentur plante, die formelle Zulassung am Samstag freizugeben. Diese Frist wurde um einen halben Tag verkürzt, nachdem Präsident Trump Dr. Hahn angegriffen hatte, weil er einen Impfstoff nicht schneller zugelassen hatte. Es wurde jedoch nicht erwartet, dass die beschleunigte Ankündigung die Lieferung von Impfstoffen im ganzen Land beschleunigen würde.

Herr Trump sagte Dr. Hahn am Freitagmorgen auf Twitter, er solle “aufhören, Spiele zu spielen und Leben retten !!!” Er nannte die FDA “eine große, alte, langsame Schildkröte”, die voller Geld ist, aber in Bürokratie versunken ist.

Herr Trump hat wiederholt die FDA und die Arzneimittelhersteller selbst beschuldigt, das Zulassungsverfahren nur langsam durchlaufen zu haben, um ihm politisch Schaden zuzufügen. Die Verbündeten von Dr. Hahn sind seit Wochen in Atem und erwarten, dass er jeden Tag gefeuert wird.

Der Präsident schrieb, dass die Regierung mit „meinem Drängen“ die Entwicklung von Impfstoffen um Jahre verkürzt habe. “Holen Sie die Dammimpfstoffe JETZT raus, Dr. Hahn”, schrieb er und schrieb den Spruch falsch.

Die Bedrohung für Dr. Hahns Arbeit wurde erstmals von der Washington Post gemeldet. In einer Erklärung bestritt Dr. Hahn, dass Herr Meadows ihm sagte, er solle in Betracht ziehen, einen anderen Job zu suchen, und nannte ihn “eine unwahre Darstellung des Telefonanrufs”. Stattdessen, so Dr. Hahn, wurde seine Agentur “ermutigt, zügig weiterzuarbeiten. ”

Obwohl die FDA den Pfizer-Impfstoff auf jeden Fall genehmigen würde, warnten einige Experten, dass der Der Druck des Weißen Hauses könnte das Vertrauen der Öffentlichkeit in die Entscheidungsfindung der Agentur untergraben.

“Dies kann tatsächlich mehr schaden als nützen, denn alles, was es tun wird, ist, mehr Politik in einen wissenschaftlichen Prozess einzubringen”, sagte Dr. Aaron S. Kesselheim, Professor am Brigham and Women’s Hospital und an der Harvard Medical School.

Ein ähnlicher Impfstoff, der von Moderna entwickelt wurde, wird derzeit von der FDA geprüft und könnte bald für den Notfall freigegeben werden. Am Freitag gab die Bundesregierung bekannt, dass sie weitere 100 Millionen Dosen bei Moderna bestellt habe, was diesen Sommer zu einer Vereinbarung über die Erstversorgung mit 100 Millionen Dosen beitrage. Andere Impfstoffe, einschließlich der von Johnson & Johnson und AstraZeneca entwickelten, befinden sich in späten Studien und könnten in den nächsten Monaten zugelassen werden.

In Erwartung der Ankunft des Impfstoffs im ganzen Land äußerten die Amerikaner sowohl Hoffnung als auch Besorgnis.

Der Weg zu einem Coronavirus-Impfstoff ›

Antworten auf Ihre Impfstofffragen

Wenn sich der Coronavirus-Impfstoff der US-Zulassung nähert, sind hier einige Fragen, über die Sie sich möglicherweise wundern:

    • Wenn ich in den USA lebe, wann kann ich den Impfstoff bekommen? Während die genaue Reihenfolge der Impfstoffempfänger von Staat zu Staat unterschiedlich sein kann, werden die meisten Ärzte und Bewohner von Langzeitpflegeeinrichtungen an erster Stelle stehen. Wenn Sie verstehen möchten, wie diese Entscheidung getroffen wird, hilft dieser Artikel.
    • Wann kann ich nach der Impfung wieder zum normalen Leben zurückkehren? Das Leben wird erst wieder normal, wenn die Gesellschaft als Ganzes ausreichend Schutz gegen das Coronavirus erhält. Sobald die Länder einen Impfstoff zugelassen haben, können sie in den ersten Monaten höchstens einige Prozent ihrer Bürger impfen. Die nicht geimpfte Mehrheit bleibt weiterhin anfällig für Infektionen. Eine wachsende Anzahl von Coronavirus-Impfstoffen zeigt einen robusten Schutz vor Krankheit. Es ist aber auch möglich, dass Menschen das Virus verbreiten, ohne zu wissen, dass sie infiziert sind, weil sie nur leichte oder gar keine Symptome haben. Wissenschaftler wissen noch nicht, ob die Impfstoffe auch die Übertragung des Coronavirus blockieren. Selbst geimpfte Menschen müssen vorerst Masken tragen, Menschenmassen in Innenräumen meiden und so weiter. Sobald genügend Menschen geimpft sind, wird es für das Coronavirus sehr schwierig, gefährdete Personen zu finden, die infiziert werden können. Je nachdem, wie schnell wir als Gesellschaft dieses Ziel erreichen, könnte sich das Leben im Herbst 2021 einem normalen Zustand nähern.
    • Muss ich nach der Impfung noch eine Maske tragen? Ja, aber nicht für immer. Die beiden Impfstoffe, die möglicherweise in diesem Monat zugelassen werden, schützen die Menschen eindeutig vor einer Krankheit mit Covid-19. Die klinischen Studien, die diese Ergebnisse lieferten, waren jedoch nicht darauf ausgelegt, festzustellen, ob geimpfte Personen das Coronavirus noch verbreiten können, ohne Symptome zu entwickeln. Das bleibt eine Möglichkeit. Wir wissen, dass Menschen, die von Natur aus mit dem Coronavirus infiziert sind, es verbreiten können, ohne Husten oder andere Symptome zu haben. Die Forscher werden diese Frage bei der Einführung der Impfstoffe intensiv untersuchen. In der Zwischenzeit müssen sich selbst geimpfte Menschen als mögliche Spreizer vorstellen.
    • Wird es wehtun? Was sind die Nebenwirkungen? Der Impfstoff gegen Pfizer und BioNTech wird wie andere typische Impfstoffe als Schuss in den Arm abgegeben. Die Injektion unterscheidet sich nicht von denen, die Sie zuvor erhalten haben. Zehntausende Menschen haben die Impfstoffe bereits erhalten, und keiner von ihnen hat ernsthafte gesundheitliche Probleme gemeldet. Einige von ihnen haben jedoch kurzlebige Beschwerden verspürt, darunter Schmerzen und grippeähnliche Symptome, die normalerweise einen Tag anhalten. Es ist möglich, dass die Leute planen müssen, nach dem zweiten Schuss einen Tag frei zu nehmen oder zur Schule zu gehen. Obwohl diese Erfahrungen nicht angenehm sind, sind sie ein gutes Zeichen: Sie sind das Ergebnis der Begegnung Ihres eigenen Immunsystems mit dem Impfstoff und einer starken Reaktion, die eine dauerhafte Immunität gewährleistet.
    • Werden mRNA-Impfstoffe meine Gene verändern? Nein. Die Impfstoffe von Moderna und Pfizer verwenden ein genetisches Molekül, um das Immunsystem zu stärken. Dieses als mRNA bekannte Molekül wird schließlich vom Körper zerstört. Die mRNA ist in einer öligen Blase verpackt, die mit einer Zelle verschmelzen kann, so dass das Molekül hineinrutschen kann. Die Zelle verwendet die mRNA, um Proteine ​​aus dem Coronavirus herzustellen, die das Immunsystem stimulieren können. Zu jedem Zeitpunkt kann jede unserer Zellen Hunderttausende von mRNA-Molekülen enthalten, die sie produzieren, um eigene Proteine ​​herzustellen. Sobald diese Proteine ​​hergestellt sind, zerkleinern unsere Zellen die mRNA mit speziellen Enzymen. Die mRNA-Moleküle, die unsere Zellen herstellen, können nur wenige Minuten überleben. Die mRNA in Impfstoffen ist so konstruiert, dass sie den Enzymen der Zelle etwas länger standhält, sodass die Zellen zusätzliche Virusproteine ​​bilden und eine stärkere Immunantwort auslösen können. Die mRNA kann jedoch höchstens einige Tage halten, bevor sie zerstört wird.

Dr. Samu Queen, eine Ärztin in Portland, Oregon, sagte, ihre geriatrischen Patienten seien besonders gespannt auf den Impfstoff. “Sie sind alle sehr besorgt”, sagte sie. “So ziemlich jeder ist bei jedem Termin bereit, es zu bekommen.”

Dr. Queen sagte, sie habe genau beobachtet, wie die ersten Probanden in Großbritannien reagierten. Sie beschrieb sich selbst als “etwas besorgt darüber, wie sicher es ist, im Gegensatz zu nicht”.

Joshua Ball, stellvertretender Geschäftsführer von Shaping Our Appalachian Region, einer Wirtschaftsförderungsgruppe im Osten von Kentucky, war ein Hauptbetreuer seines Vaters, der Anfang dieses Jahres einen Schlaganfall hatte und andere gesundheitliche Probleme hat. Während der Pandemie musste er versuchen, so viel wie möglich aus der Ferne zu helfen.

Ein Impfstoff könnte das ändern. Es könnte ihm auch ermöglichen, in die Kirche zurückzukehren und an den saisonalen Festen teilzunehmen, die für viele kleine Städte in seiner Region ein kulturelles Grundnahrungsmittel sind.

“Ich vermisse die Gemeinschaft, Hände zu schütteln, Menschen zu sehen, Geburtstage, kirchliche Mahlzeiten und eine Ferienbibelschule zu feiern”, sagte er.

Dennoch sind die staatlichen Gesundheitsbehörden nach wie vor zutiefst besorgt darüber, was sie als unzureichende Finanzierung für die größte Impfkampagne bezeichnen, die das Land jemals gestartet hat. Staatliche Gesundheitsbeamte haben den Kongress um mindestens 8,4 Milliarden US-Dollar gebeten, um die Arbeit gut zu machen. Bisher haben sie jedoch nur etwa 350 Millionen US-Dollar von den Zentren für die Kontrolle und Prävention von Krankheiten für die Verteilung und Verabreichung von Impfstoffen erhalten. Zu diesen Aufgaben gehört die Erweiterung der Online-Systeme, um Informationen darüber zu verfolgen und auszutauschen, wer geimpft wurde. Rekrutierung und Ausbildung von Ärzten, Krankenschwestern und Apothekern zur Verwaltung der Aufnahmen; und die Öffentlichkeit davon zu überzeugen, wie wichtig es ist, geimpft zu werden.

Die ausreichende Zufuhr des Impfstoffs hat sich auch als Herausforderung ohne klare Lösung erwiesen. Pfizer musste frühere Schätzungen aufgrund von Rückschlägen bei der Herstellung zurückfahren und hat angekündigt, bis Ende des Jahres bis zu 25 Millionen Dosen und bis März insgesamt 100 Millionen Impfstoffe liefern zu können.

Diese Woche sagten Bundesbeamte, dass die Regierung drei Wochen nach ihrer ersten Impfung nicht alle 6,4 Millionen Dosen verwendet, die die Regierung ursprünglich von Pfizer zur Impfung von Menschen bestellt hatte, sondern die Hälfte des Angebots für einen Auffrischungsschuss an die Empfänger zurückhält. Obwohl in der ersten Woche nur etwa drei Millionen Menschen einen Impfstoff erhalten werden, haben die Beamten ihre Schätzung bestätigt, dass sie zwischen den Impfstoffen von Pfizer und Moderna, für die jeweils zwei Schüsse erforderlich sind, hoffen, mindestens 20 Millionen Menschen ihren ersten Impfstoff zu geben Dosis eines Impfstoffs bis Ende des Jahres.

Es bleiben auch Fragen offen, wie schnell ein Impfstoff für jeden verfügbar sein wird, der einen möchte. Bundesbeamte haben angekündigt, dass sie voraussichtlich Mitte nächsten Jahres den Großteil der US-Bevölkerung impfen können, aber die jüngsten Rückschläge haben diese Schätzungen in Frage gestellt. Pfizer hat der Bundesregierung mitgeteilt, dass sie aufgrund von Vereinbarungen mit anderen Ländern möglicherweise nicht in der Lage ist, den Vereinigten Staaten vor Mitte nächsten Jahres zusätzliche 100 Millionen Dosen zuzuführen. Drei weitere experimentelle Impfstoffe, die von Novavax, Sanofi und AstraZeneca entwickelt wurden, mussten Verzögerungen bei ihren klinischen Studien hinnehmen.

Ellen Barry und Will Wright haben zur Berichterstattung beigetragen.