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Health

F.D.A. Grants Full Approval to Pfizer-BioNTech Covid Vaccine

F.D.A. Grants Full Approval to Pfizer-BioNTech Covid Vaccine

The Food and Drug Administration on Monday gave Pfizer-BioNTech’s coronavirus vaccine full approval for people aged 16 and over, making it the first to go beyond emergency status in the United States.

The decision will trigger a cascade of vaccine requests from hospitals, colleges, corporations, and other organizations. Secretary of Defense Lloyd J. Austin III will send vaccination guidelines to the country’s 1.4 million active military personnel, the Pentagon said on Monday.

United Airlines recently announced that its employees must provide proof of vaccination within five weeks of regulatory approval.

Oregon has introduced a similar requirement for all government employees, as have a variety of universities in the states of Louisiana through Minnesota.

Approval comes as the nation’s fight against the pandemic has re-intensified, with the highly contagious Delta variant dramatically slowing the country’s progress in the first half of the year. The Biden administration hopes the development will motivate at least some of the roughly 85 million unvaccinated Americans eligible for syringes.

President Biden plans to commemorate this in a speech urging vaccination, which is scheduled for 1:30 p.m. Eastern time on Monday afternoon. “If you haven’t been vaccinated, now is the time,” the president said on Twitter.

“While millions of people have safely received Covid-19 vaccines, we recognize that FDA approval of a vaccine may now create additional confidence for some to get vaccinated,” said Dr. Janet Woodcock, acting FDA commissioner, in a statement. “Today’s milestone brings us one step closer to changing the course of this pandemic in the US”

Pfizer said it provided the FDA with data from 44,000 participants in clinical trials in the United States, the European Union, Turkey, South Africa and South America. The company said the data showed the vaccine 91 percent prevented infection – a slight decrease from the 95 percent effectiveness rate the data showed when the FDA decided to approve the emergency vaccine in December. Pfizer said the decrease reflects the fact that researchers had more time to capture infected individuals.

A recent survey by the Kaiser Family Foundation, which tracked public attitudes during the pandemic, found that three in ten unvaccinated people said they were more likely to be vaccinated with a fully approved vaccination.

But pollsters and other experts warned that the percentage could be exaggerated. “I think that’s a tiny number of people in real life,” said Alison Buttenheim, an associate professor of nursing at the University of Pennsylvania and an expert on vaccination hesitation.

More important, says Dr. Buttenheim, is the effect of requirements. “Mandates make things easier for people,” she said.

Government action gives doctors more leeway to prescribe patients a third shot of the Pfizer vaccine, but federal officials strongly advised people not to seek additional vaccinations until regulators decide they are safe and effective. Pending regulatory approval, the federal government plans to offer booster syringes for adults next month.

The vaccine continues to be approved for emergency use in children ages 12-15 as Pfizer collects the data necessary for full approval. A decision on whether to approve the vaccine for children under the age of 12 could be at least several months away, and Dr. Woodcock said no child this age should get a Covid-19 vaccine due to a lack of safety data from regulators.

To date, more than 92 million Americans – 54 percent of those fully vaccinated – have received Pfizer vaccinations. Most of the others got the vaccine from Moderna.

Dr. Peter Marks, the FDA’s lead vaccine regulator, said the approval of Pfizer vaccine followed a rigorous review of hundreds of thousands of pages of data and included inspections of the factories where the vaccine is made. “The public and the medical community can rest assured that while we were swiftly approved this vaccine, it met our existing high standards for vaccines in the United States,” he said.

He said federal health officials would continue to monitor the safety of the vaccine and that the FDA would require Pfizer to assess the risks of myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the membrane surrounding the heart, including long-term results for the recipients. The FDA added warnings to the Pfizer-BioNTech and Moderna vaccines in June indicating a possible increased risk for these conditions after the second dose.

Although Pfizer can now market the drug under the Comiraty name, the company said only the federal government will be distributing doses in the United States.

Understand US vaccination and mask requirements

    • Vaccination rules. On August 23, the Food and Drug Administration fully approved Pfizer-BioNTech’s coronavirus vaccine for people aged 16 and over, paving the way for increased mandates in both the public and private sectors. Private companies are increasingly demanding vaccines for employees. Such mandates are legally permissible and have been confirmed in legal challenges.
    • Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in public places indoors in areas with outbreaks, reversing the guidelines offered in May. See where the CDC guidelines would apply and where states have implemented their own mask guidelines. The battle over masks is controversial in some states, with some local leaders defying state bans.
    • College and Universities. More than 400 colleges and universities require a vaccination against Covid-19. Almost all of them are in states that voted for President Biden.
    • schools. Both California and New York City have introduced vaccination mandates for educational staff. A survey published in August found that many American parents of school-age children are opposed to mandatory vaccines for students but are more likely to support masking requirements for students, teachers and staff who are not vaccinated.
    • Hospitals and medical centers. Many hospitals and large health systems require their employees to have a Covid-19 vaccine, due to increasing case numbers due to the Delta variant and persistently low vaccination rates in their communities, even within their workforce.
    • New York City. Proof of vaccination is required by workers and customers for indoor dining, gyms, performances, and other indoor situations, though enforcement doesn’t begin until September 13. Teachers and other educational workers in the city’s vast school system are required to have at least one vaccine dose by September 27, with no weekly testing option. City hospital staff must also be vaccinated or have weekly tests. Similar rules apply to employees in New York State.
    • At the federal level. The Pentagon announced that it would make coronavirus vaccinations compulsory for the country’s 1.3 million active soldiers “by mid-September at the latest. President Biden announced that all civil federal employees would need to be vaccinated against the coronavirus or undergo regular tests, social distancing, mask requirements and travel restrictions.

Health experts and state officials welcomed the development. With the delta variant driving up case numbers across the country, “full approval could not come at a more important time,” said Dr. Richard Besser, President of the Robert Wood Johnson Foundation and former acting director of the Centers for Disease Control and Prevention. He urged schools and businesses to require a vaccination before people can gather indoors.

Less than two months after the spread of the virus appeared to be contained, the US is now recording an average of around 150,000 new cases per day and more than 90,000 hospitalized Covid-19 patients. An average of around 1,000 per day die from Covid-19 – a toll that federal health experts recently dismissed as highly unlikely before the delta variant fully caught on. Many children under the age of 12 also become infected.

Vaccination rates have also risen in the past few weeks, in part because of the greater fear of the virus. Vendors were delivering approximately 837,000 shots a day, a significant increase from earlier this summer.

Some experts estimated that full consent could only convince five percent of the unvaccinated to get injected. Even if that is the case, “that is still a huge part of the people,” Dr. Thomas Dobbs, the Chief Health Officer of Mississippi, a state particularly hard hit by the Delta variant. He said the approval will help “get rid of this false claim that the vaccines are an ‘experimental’ thing”.

Dr. Marks, the vaccines agency, cited a number of other myths about the vaccines as a major stumbling block in fighting the pandemic, including false claims that the vaccinations cause infertility, promote Covid disease rather than prevent it, or have resulted in thousands of deaths. “Let me be clear. These claims are just not true,” he said.

The FDA is in the middle of a decision marathon related to coronavirus vaccines. The next important question emerging for regulators is whether or not to approve booster injections. The Biden government said last week it plans to offer third vaccinations starting September 20, for adults who received the Pfizer and Moderna vaccines eight months after their second injection. Third vaccinations are already approved for some people with immunodeficiency, but the risk-benefit ratio is different for the general population.

Federal health officials said that both Pfizer-BioNTech and Moderna’s vaccines, which are based on similar technology, lose effectiveness over time. That trend is converging with the advent of the particularly dangerous Delta variant, making those who completed their vaccinations earlier in the year increasingly more susceptible to infection.

Some health experts have challenged the decision to recommend booster vaccinations as premature, as the data showed the vaccines withstand serious illness and hospitalization, including the Delta variant. Boosters would only be justified if the vaccines didn’t prevent hospital stays with Covid-19, some of these experts said.

Regulators are still examining Moderna’s application for full approval of its vaccine. This decision can take several weeks. Johnson & Johnson is expected to file for full approval shortly.

Helene Cooper contributed to the reporting.

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Health

FDA approval for Pfizer Covid vaccine might come Monday, report says

FDA approval for Pfizer Covid vaccine could come Monday, report says

Empty Pfizer COVID-19 vaccine vials will be delivered on Jan.

Paul Hennessy | NurPhoto | Getty Images

The Food and Drug Administration is working on the approval of the Pfizer-BioNTech Covid-19 vaccine on Monday, the New York Times reported, citing sources.

The review process could go beyond that date, the Times said, as paperwork and negotiations with the company continue.

The move would make it the first Covid vaccine to move from emergency approval to full FDA approval.

The FDA declined to comment on the Times report to CNBC.

White House senior medical advisor Dr. Anthony Fauci, told the Associated Press on Aug. 8 that he hoped vaccines would get full approval “within the month of August,” adding that full approval would lead to more companies and schools requiring vaccines.

U.S. companies have tightened vaccination regulations for employees as Covid cases have increased across the country in recent weeks, and some cited full FDA approval as part of the decision-making process.

Full approval could also help convince people who are reluctant to get vaccinated until the FDA has fully approved the vaccination.

According to CDC data on Friday, more than 203 million doses of the Pfizer BioNTech vaccine have been administered nationwide, fully vaccinating more than 91 million people in the United States.

Pfizer and BioNTech began applying for their biologics license for the two-dose vaccine in May after receiving emergency clearance from the FDA in December. The FDA sets a six month target for approval of high priority drugs.

If formally approved, Pfizer and BioNTech’s vaccine would remain available in the market after the pandemic ended and the companies could promote the vaccine directly to consumers. Pharmaceutical manufacturers with an EUA are banned from promoting their vaccines, CNBC previously reported.

The companies announced on Aug. 16 that they had initiated the approval process for a booster dose for fully vaccinated individuals after submitting clinical trial data to the FDA.

Top health officials from agencies like the Centers for Disease Control and Prevention, the White House and the FDA said in a statement Wednesday that the effectiveness of mRNA vaccines declines over time, especially in those with compromised immune systems. They said the US would start distributing booster shots to the public in September.

Read the full New York Times report here.

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Health

Pfizer submits information to FDA for approval

Pfizer submits data to FDA for approval

Walgreens health professional Luis S. Solano prepares a dose of Pfizer BioNTec’s vaccine against coronavirus disease (COVID-19) on February 22, 2021 at the Victor Walchirk Apartments in Evanston, Illinois.

Kamil Krzaczynski | Reuters

Pfizer and BioNTech announced on Monday that they had submitted clinical trial data to the Food and Drug Administration as part of their U.S. application for approval of a Covid vaccine booster for all 16 and older – not just people with weak immune systems Have submitted early stage.

In a phase 1 study, a booster dose of the vaccine produced “significantly higher neutralizing antibodies” against the original coronavirus strain and the beta and delta variants, the companies said in a press release. Study participants received a third shot of the two-dose vaccine around eight to nine months after the second shot, they said.

“The data we’ve seen so far suggest that a third dose of our vaccine elicits antibody levels well in excess of those on the primary two-dose schedule,” said Albert Bourla, Pfizer CEO. “We are excited to provide this data to the FDA as we continue to work together to address the evolving challenges of this pandemic.”

The companies said the results of the late-stage trial evaluating the third dose are expected shortly and will also be presented to the FDA and other regulatory agencies worldwide.

The drug makers’ announcement comes after federal health officials on Friday approved the administration of Covid booster shots of Pfizer and Moderna vaccines to Americans with compromised immune systems, including cancer and HIV patients and people with organ transplants.

New data from the US suggests that immunocompromised individuals do not generate adequate immune responses after receiving two doses of a Covid vaccine.

The latest data from Pfizer investigates the booster’s safety and immune response in people with otherwise healthy immune systems.

Federal health officials are not currently recommending booster doses for the general public, but White House senior medical adviser Dr. Anthony Fauci, has said that everyone is “likely” to need a booster at some point.

Covid vaccine makers, including Pfizer and Moderna, have repeatedly claimed that everyone will need a booster dose at some point and possibly additional doses each year, just like they did with seasonal flu.

Pfizer cited data from Israel, where state officials last month said the two-dose vaccine was only 39% effective against the disease, attributing the drop in performance to the highly contagious Delta variant. When Pfizer submitted its original application to the FDA in December, it said its vaccinations were about 95% effective at preventing Covid infections.

The vaccine is still considered highly effective against serious illness, hospital admissions and deaths, according to Israeli health officials.

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Health

F.D.A. Goals to Give Remaining Approval to Pfizer Vaccine by Early Subsequent Month

F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month

WASHINGTON — With a new surge of Covid-19 infections ripping through much of the United States, the Food and Drug Administration has accelerated its timetable to fully approve Pfizer-BioNTech’s coronavirus vaccine, aiming to complete the process by the start of next month, people involved in the effort said.

President Biden said last week that he expected a fully approved vaccine in early fall. But the F.D.A.’s unofficial deadline is Labor Day or sooner, according to multiple people familiar with the plan. The agency said in a statement that its leaders recognized that approval might inspire more public confidence and had “taken an all-hands-on-deck approach” to the work.

Giving final approval to the Pfizer vaccine — rather than relying on the emergency authorization granted late last year by the F.D.A. — could help increase inoculation rates at a moment when the highly transmissible Delta variant of the virus is sharply driving up the number of new cases.

A number of universities and hospitals, the Defense Department and at least one major city, San Francisco, are expected to mandate inoculation once a vaccine is fully approved. Final approval could also help mute misinformation about the safety of vaccines and clarify legal issues about mandates.

Federal regulators have been under growing public pressure to fully approve Pfizer’s vaccine ever since the company filed its application on May 7. “I just have not sensed a sense of urgency from the F.D.A. on full approval,” Dr. Ashish K. Jha, the dean of the Brown University School of Public Health, said in an interview on Tuesday. “And I find it baffling, given where we are as a country in terms of infections, hospitalizations and deaths.”

Although 192 million Americans — 58 percent of the total population and 70 percent of the nation’s adults — have received at least one vaccine shot, many remain vulnerable to the ultracontagious, dominant Delta variant. The country is averaging nearly 86,000 new infections a day, an increase of 142 percent in just two weeks, according to a New York Times database.

Recent polls by the Kaiser Family Foundation, which has been tracking public attitudes during the pandemic, have found that three of every 10 unvaccinated people said that they would be more likely to get a shot with a fully approved vaccine. But the pollsters warned that many respondents did not understand the regulatory process and might have been looking for a “proxy” justification not to get a shot.

Moderna, the second most widely used vaccine in the United States, filed for final approval of its vaccine on June 1. But the company is still submitting data and has not said when it will finish. Johnson & Johnson, the third vaccine authorized for emergency use, has not yet applied but plans to do so later this year.

Full approval of the Pfizer vaccine will kick off a patchwork of vaccination mandates across the country. Like most other employees of federal agencies, civilians working for the Defense Department must be vaccinated or face regular testing. But the military has held off on ordering shots for 1.3 million active-duty service members until the F.D.A. acts.

The City of San Francisco has said its roughly 44,500 employees must be fully vaccinated within 10 weeks of F.D.A. approval. The State University of New York, with roughly 400,000 students, is on a parallel track.

A number of health care systems have issued similar mandates to employees, including Beaumont Health, the largest health provider in Michigan, with 33,000 employees, and Mass General Brigham in Massachusetts, with about 80,000 workers.

Updated 

Aug. 3, 2021, 9:15 p.m. ET

Full approval typically requires the F.D.A. to review hundreds of thousands of pages of documents — roughly 10 times the data required to authorize a vaccine on an emergency basis. The agency can usually complete a priority review within six to eight months and was already working on an expedited timetable for the Pfizer vaccine. The F.D.A.’s decision to speed up was reported last week by Stat News.

In a guest essay in The Times last month, Dr. Peter Marks, the agency’s top vaccine regulator, wrote that undue haste “would undermine the F.D.A.’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy.”

The regulators want to see real-world data on how the vaccine has been working since they authorized it for emergency use in December. That means verifying the company’s data on vaccine efficacy and immune responses, reviewing how efficacy or immunity might decline over time, examining new infections in participants in continuing clinical trials, reviewing adverse reactions to vaccinations and inspecting manufacturing plants.

At the same time, senior health officials at the F.D.A. and other agencies are grappling with whether at least some people who are already vaccinated need booster shots. Several officials are arguing that boosters will be widely needed before long, while others contend that the scientific basis for them remains far from settled.

Two people familiar with the deliberations, speaking on the condition of anonymity, said that if booster shots are needed, the administration wants a single strategy for all three vaccines currently authorized for emergency use.

Different recommendations on boosters for different vaccines, they said, could confuse the public. Fully approving a vaccine and then authorizing a booster for it soon after might also offer conflicting messages about its effectiveness.

Understand the State of Vaccine Mandates in the U.S.

While research is continuing, senior administration officials increasingly believe that at the least, vulnerable populations like those with compromised immune systems and older people will need them, according to people familiar with their thinking. But when to administer them, which vaccine to use and who should get shots are all still being discussed.

In a study posted online last week, Pfizer and BioNTech scientists reported that the effectiveness of Pfizer’s vaccine against symptomatic disease fell from about 96 percent to about 84 percent four to six months after the second shot, but continued to offer robust protection against hospitalization and severe disease.

Administration officials said Moderna and Johnson & Johnson needed to present data as well and Moderna had been asked to do so quickly. Officials have said other studies will also influence their decision-making, including data that the government is collecting on the rate of breakthrough infections among tens of thousands of people, including health care workers.

Pfizer is expected to submit an application for a booster shot to the F.D.A. this month. While the F.D.A. could authorize such shots, the Centers for Disease Control and Prevention would need to recommend them after a meeting of its outside committee of experts.

A decision to fully approve Pfizer’s vaccine will give doctors more latitude to prescribe additional shots at least for certain Americans, including those with weakened immune systems. The C.D.C. had been exploring possible special programs for that group, but administration officials said it became clear that by the time any such initiative got underway, the Pfizer vaccine would already be fully approved and doctors could prescribe a third shot.

Roughly 3 percent of Americans — or about 10 million people, by some estimates — have compromised immune systems as a result of cancer, organ transplants or other medical conditions, according to the C.D.C. While studies indicate that the vaccines work well for some of them, others do not produce the immune response that would protect them from the virus.

Some people are trying to get booster shots from pharmacies or other providers on their own, without waiting for the federal government’s blessing. Officials in Contra Costa County, home to 1.1 million people in Northern California, were so eager to offer boosters that on July 23 they told vaccine providers to give extra shots to people who asked for them “without requiring further documentation or justification.”

Then, realizing that policy violated the F.D.A. rules on vaccines authorized for emergency use, the county reversed it this week.

Jennifer Steinhauer contributed reporting. Susan C. Beachy contributed research.

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Health

Biogen’s controversial Alzheimer’s drug generates $2 million gross sales in first few weeks after approval

Biogen's controversial Alzheimer’s drug generates $2 million sales in first few weeks after approval

Aduhelm from Biogen

Source: Biogen

Biogen’s Alzheimer’s drug Aduhelm made $ 2 million in sales in the first few weeks after its approval, the company said Thursday when it released its second quarter results along with an open letter about the controversial drug.

Biogen increased its sales guidance for the year and expected total sales for the year of $ 10.65 billion to $ 10.85 billion. That’s an increase from its earlier estimates of $ 10.45 billion to $ 10.75 billion. The new forecast assumes “modest” income for Aduhelm in 2021, which will then be ramped up, the company said.

Here’s how Biogen performed in the three months ended June 30, compared to Wall Street’s expectations, according to Refinitiv’s average estimates:

  • Adjusted earnings per share: $ 5.68 versus $ 4.54 expected
  • Revenue: $ 2.78 billion versus an expected $ 2.61 billion

The company’s stock rose slightly in early trading.

Aduhelm was approved by the Food and Drug Administration on June 7th. The drug, scientifically known as aducanumab, offers new hope to friends and families of patients living with the disease and is set to generate billions in revenue for the company.

However, its approval has since been questioned, and the head of the FDA is now calling for a state investigation into the interactions between agency employees and the biotech company.

Biogen’s Chief Research Officer, Dr. Al Sandrock, defended the drug in an open letter released Thursday along with the company’s profits, saying its approval was subject to “extensive misinformation and misunderstanding”.

He said it was “normal” for scientists and clinicians to discuss and debate data from experimental and clinical trials, but added that those discussions had taken a turn “outside the boundaries of legitimate scientific reasoning”.

“We welcome a formal review of the interactions between the FDA and Biogen in the process of obtaining aducanumab approval,” said Sandrock. “A better understanding of the facts is good for everyone involved in building confidence in the therapy and the approval process as we prioritize the issues that affect patients.”

Correction: In an earlier version, Aduhelm was misspelled.

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Politics

Biden predicts the F.D.A. will give ultimate approval to a Covid vaccine by the autumn.

Biden predicts the F.D.A. will give final approval to a Covid vaccine by the fall.

President Biden told a town hall audience in Ohio on Wednesday evening that he expected the Food and Drug Administration would give final approval “quickly” for Covid-19 vaccines, as he pressed for skeptical Americans to get vaccinated and stop another surge of the pandemic.

Mr. Biden said he was not intervening in the decision of government scientists, but pointed toward a potential decision soon from the F.D.A. to give final approval for the vaccines, which are currently authorized for emergency use. Many medical professionals have pushed for the final approval, saying it could help increase uptake of the vaccines.

“My expectation talking to the group of scientists we put together, over 20 of them plus others in the field, is that sometime maybe in the beginning of the school year, at the end of August, beginning of September, October, they’ll get a final approval” for the vaccines at the F.D.A., Mr. Biden said.

The president also said he expected children under the age of 12, who are not currently eligible to receive the vaccine, would be approved to get it on an emergency basis “soon, I believe.”

The president’s comments at the town hall came as the spread of the Delta variant has led to a national rise in coronavirus cases. Over the past week, an average of roughly 41,300 cases has been reported each day across the country, an increase of 171 percent from two weeks ago. The number of new deaths reported is up by 42 percent, to an average of 249 a day for the past week.

In some states, such as Missouri, Arkansas, Louisiana and Florida, new infections have increased sharply, also driving an increase in hospitalizations. Cases are increasing more rapidly in states where vaccination rates are low.

In Ohio, where Mr. Biden traveled on Wednesday to talk up what he pitched as the good-paying union jobs that his infrastructure plan would create, the president found himself fielding questions from audience members concerned about low vaccination rates in their communities.

“This is simple, basic proposition,” he said. “If you’re vaccinated, you’re not going to be hospitalized. You’re not going to be in an I.C.U. unit. And you are not going to die.”

Later, Mr. Biden exaggerated the efficacy of the vaccine, even as some vaccinated staffers in the West Wing have recently tested positive for the coronavirus. “You’re not going to get Covid if you have these vaccinations,” he said.

In response to a move by Speaker Nancy Pelosi earlier Wednesday to bar two of former President Donald J. Trump’s most vociferous Republican defenders in Congress from joining a select committee to investigate the Jan. 6 riot at the Capitol, Mr. Biden was unequivocal about what happened that day.

“I don’t care if you think I’m Satan reincarnated, the fact is you can’t look at that television and say nothing happened on the sixth,” he said. “You can’t listen to people who say this was a peaceful march.”

But speaking in a red state that Mr. Trump won in the 2020 election, as he tries to build support for his infrastructure plans, Mr. Biden kept his criticism to some of the lawmakers elected to office, rather than Republican voters who got them there.

“I have faith in the American people, I do, to ultimately get to the right place,” he said. “Many times Republicans are in the right place.”

Jesus Jiménez contributed reporting.

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Health

U.S. Officers Push Again on Pfizer’s Request for Booster Shot Approval

U.S. Officials Push Back on Pfizer’s Request for Booster Shot Approval

Pfizer officials met privately with senior U.S. scientists and regulators on Monday to press for rapid approval of booster coronavirus vaccines amid growing public confusion over whether they are needed and opposition from federal health officials who say that the additional doses are now not required.

The high-level online meeting, which lasted an hour, and at which Pfizer’s chief scientist briefed virtually every top doctor in the federal government, took place the same day Israel began feeding heart transplant patients and others on the third dose of the Pfizer BioNTech vaccine administer weakened immune system. Officials said after the meeting that more data – and possibly several months – would be needed before regulators could determine whether booster injections were needed.

The two developments underscored the intensifying debate about whether booster injections are required in the US, when and for whom. Many American experts, including Dr. Anthony S. Fauci, President Biden’s senior medical advisor on the pandemic, have said there isn’t enough evidence yet that boosters are necessary. However, some say Israel’s move may anticipate a government decision to recommend it to at least the weak.

Pfizer is collecting information on antibody responses from those receiving a third dose, as well as data from Israel, and expects to share at least part of that in a formal application to the Food and Drug Administration for its coronavirus vaccine to expand its emergency clearance in the coming weeks.

However, the final decision on booster vaccination, several officials said after the meeting, will also depend on real-world information the Centers for Disease Control and Prevention has gathered about breakthrough infections – those that occur in people who have been vaccinated – who are serious or ill Cause hospital stays.

And any booster vaccination recommendations are likely to be calibrated within age groups as well, officials said. For example, if booster shots are recommended, they could first go to residents of nursing homes who received their vaccines in late 2020 or early 2021, while older people who received their first vaccinations in the spring may have to wait longer. And then the question arises, what kind of booster: a third dose of the original vaccine or perhaps a vaccination tailored to the highly contagious Delta variant, which is on the rise in the USA.

“It was an interesting meeting. They shared their data. There was nothing like a decision, ”said Dr. Fauci in a short interview Monday night, adding, “This is just part of a much bigger puzzle, and it’s part of the data, so there’s no question of a compelling case either way.”

Amy Rose, a Pfizer spokeswoman, said in a statement, “We had a productive meeting with US public health officials about elements of our research program and preliminary booster data.”

The Ministry of Health and Welfare, which convened the meeting, issued its own statement confirming the government’s stance. “At this point, fully vaccinated Americans don’t need a booster dose,” it said.

With less than half of the United States’ population being fully vaccinated, some experts said Monday the country must continue to focus on giving all Americans their first dose. The most important task of the Food and Drug Administration is to increase public confidence by granting full approval to the coronavirus vaccines used, which are initially approved in an emergency.

“At this point the most important strengthening we need is vaccinating people,” said Dr. Carlos del Rio, an infectious disease expert at Emory University in Atlanta. The booster doses in Israel, he added, “will help us answer some questions, but at the end of the day I disagree with what they are doing. I think it’s terribly premature. “

Within the Biden government, some fear that if Americans are convinced that coronavirus vaccines only offer short-lived immunity before needing a boost, they are less likely to accept vaccination. Those concerns could fall by the wayside, however, if new data from Israel, expected in the next few weeks, conclusively shows that immunity wears off after six to eight months, significantly increasing the risks for the elderly or other vulnerable populations.

The government convened the meeting on Monday in response to the announcement last week by Pfizer and its German partner BioNTech that they would develop a version of their vaccine targeting the Delta variant and reported promising results from studies with people who A third dose of the vaccine received original vaccine six months after the second.

The new dates Not yet published or peer-reviewed, but as announced by companies that they would submit data to the Food and Drug Administration to approve booster vaccinations surprised the Biden White House.

In an unusual joint statement Thursday evening, hours after Pfizer-BioNTech’s announcement, the FDA and CDC pushed back.

“Americans who are fully vaccinated currently do not need a booster,” the statement said, adding, “We are prepared for booster doses when and when science shows they are needed.”

The move can make economic sense for Pfizer-BioNTech. Since the outbreak of the pandemic, the partner companies have been following a “get to market first” strategy in the manufacture and marketing of their vaccines.

The companies did not accept federal funds or participate in Operation Warp Speed, former President Donald J. Trump’s fast-track vaccine initiative. Not only were they the first to get Food and Drug Administration approval for their coronavirus vaccine, the first to use the novel mRNA technology, but also the first to get their vaccine approved in adolescents.

The strategy has “paid off as well as you could wish,” said Steve Brozak, president of WBB Securities, a biotechnology-focused research investment bank.

Last week, Pfizer and BioNTech said a booster given six months after the second dose of the vaccine increased the effectiveness of antibodies against the original virus and beta variant by five to ten times. But antibody levels may not be the best biological measure of need for booster doses, say experts, who say it’s no surprise that antibodies increase after a third dose.

“The antibody response is not the only measure of immune protection,” said Dr. Leana S. Wen, a former health commissioner for Baltimore. “There have been several studies to suggest that these vaccines also stimulate B-cell and T-cell immunity. Even if there aren’t that many antibodies, it doesn’t mean someone isn’t protected. “

In Israel, the government has agreed to provide Pfizer with data on its vaccine recipients, and Pfizer has cross-checked the Israeli data with the results of its own laboratory tests. Some people familiar with the data say this suggests that those vaccinated may lose immunity after about six to eight months, leading to an increasing number of breakthrough infections.

The participants in Monday’s meeting were a who’s who of government doctors: Dr. Fauci; Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention; Dr. Francis Collins, the director of the National Institutes of Health; Dr. Vivek Murthy, the general surgeon; Dr. Rachel Levine, the assistant secretary of health; Dr. Janet Woodcock, acting FDA commissioner; Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research; and Dr. David Kessler, a former FDA commissioner who, among other things, leads the Biden government’s vaccine distribution efforts.

Dr. Del Rio, of Emory University, complained that the meeting was held privately on Monday instead of Pfizer publicly presenting its dates to the CDC’s Advisory Committee on Vaccine Practices, which will ultimately recommend whether booster injections are needed.

Just over two-thirds of American adults – 67.7 percent – got at least one Covid-19 shot, according to the CDC. The president had hoped to have at least partially vaccinated 70 percent of adults by July 4th.

Still, the national vaccination campaign has made it clear that the vaccine is successful in preventing disease, and studies suggest that vaccines against the Delta variant remain effective. Outbreaks occur in areas with low vaccination rates and the number of national cases has increased recently; according to a database from the New York Times.

World Health Organization officials on Monday stressed the importance of prioritizing global vaccine production and distribution over booster development, given the large gaps between countries’ vaccine programs.

“That doesn’t mean one or the other; it brings order to a crisis, ”said Dr. Michael Ryan, the organisation’s executive director of the emergency health program, on what the organization calls a two-stage pandemic.

Lauren McCarthy contributed to the coverage.

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FDA requires federal investigation into approval

FDA calls for federal investigation into approval

Biogen shares fell on Friday after the head of the Food and Drug Administration called for an investigation into the recent approval of the company’s Alzheimer’s drug, Aduhelm.

Acting FDA Commissioner Dr. Janet Woodcock asked the Office of the Inspector General to investigate interactions between the US agency and Biogen representatives prior to the drug’s approval on June 7.

“I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures,” Woodcock wrote in a letter sent Friday.

Shares of Biogen fell by more than 3% after the announcement.

Biogen’s stock surged last month after the FDA approved the biotech company’s drug, the first medication cleared by US regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.

That decision marked a departure from the advice of the agency’s independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At least three members of the panel have resigned in protest following the agency’s approval.

Federal regulators faced intense pressure from friends and family members of Alzheimer’s patients asking to fast-track the drug, scientifically known as aducanumab. STAT News and other media outlets reported FDA officials used a regulatory shortcut to gain approval in order to get the drug on the market sooner.

Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid, which scientists expect plays a role in the devastating disease.

It’s rare for an FDA chief to call for an investigation into the agency’s own decisions. It’s the latest setback for the company and the drug, which has been controversial since it showed promise in 2016.

In March 2019, Biogen pulled development of the drug after an analysis from an independent group revealed it was unlikely to work. The company then shocked investors several months later by announcing it would seek regulatory approval for the medication after all.

When Biogen sought approval for the drug in late 2019, its scientists said a new analysis of a larger dataset showed aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”

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

Some doctors have said they won’t prescribe aducanumab because of the mixed data package supporting the company’s application.

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F.D.A. Requests Federal Investigation of Alzheimer’s Drug Approval

F.D.A. Requests Federal Investigation of Alzheimer’s Drug Approval

The Food and Drug Administration on Friday called for a federal investigation into the process that led to the approval of a new drug for Alzheimer’s disease that has sparked harsh criticism from lawmakers and the medical community.

In a letter to the independent office of the Inspector General of the Department of Health, Acting Commissioner of the FDA, Dr. Janet Woodcock, the scrutiny the agency has been through regarding the approval process for the drug known as Aduhelm. She pointed to interactions between representatives from drug developer Biogen and the agency, saying that some “may have occurred outside of the formal correspondence process”.

“To the extent that these concerns could undermine public confidence in the FDA’s decision, I believe it is critical that the disputed events be verified by an independent body,” wrote Dr. Woodcock. She noted that the review should investigate whether communications between agency staff and Biogen representatives violated FDA rules.

The unusual request to examine the decision-making process of one’s own employees for an individual drug approval is likely to exacerbate the controversy surrounding the approval of Aduhelm. The FDA approved the drug a month ago, overcoming stout objections from its own independent advisors who said there wasn’t enough evidence to know if the drug was effective.

After the decision, three of these experts left an FDA advisory panel.

Dr. Woodcock’s request for an investigation came a day after the FDA narrowed its recommendations on who should receive the drug. After initially being recommended for all Alzheimer’s patients, the agency’s new guidelines should only prescribe it to people with mild cognitive problems.

Biogen did not immediately respond to a request for comment.

STAT, the medical news organization, first reported that Dr. Billy Dunn, the agency’s head of neuroscience, in early May 2019 held an off-the-book meeting with a Biogen manager, Dr. Al Sandrock, exit. While it is not uncommon for pharmaceutical company executives to meet frequently with FDA officials, it is uncommon to provide data that would be part of an FDA application outside of a formal framework.

A few months earlier, Biogen had discontinued two late-stage studies of the drug after early analysis found the drug would not prove effective. However, the Biogen researchers who analyzed the data soon concluded that the decision to stop the studies was premature and that the drug might be effective after all.

The meeting between Dr. Dunn and Dr. Sandrock was a first step in resuming the talks that led to approval last month.

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Three F.D.A. Advisers Resign Over Approval of Alzheimer’s Drug

Three F.D.A. Advisers Resign Over Approval of Alzheimer's Drug

In a strong rejection of the Food and Drug Administration’s approval of Biogen’s controversial Alzheimer’s drug, three scientists have stepped down from the independent committee that advised the agency on the treatment.

“This could be the worst regulatory decision the FDA has made that I can remember,” said Dr. Aaron Kesselheim, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, who resigned Thursday after six years on the committee.

He said the agency’s approval of the drug aducanumab, marketed as Aduhelm, a monthly intravenous infusion that Biogen has set at $ 56,000 a year, was incorrect “because of so many different factors, including the fact that there is no good evidence ”. that the drug works. “

Two other members of the committee resigned earlier this week and expressed dismay at the drug’s approval, although the committee overwhelmingly opposed it after reviewing clinical trial data in November.

The committee found that the evidence was inconclusive that Aduhelm could slow cognitive decline in people with the early stages of the disease – and that the drug could potentially cause serious side effects of brain swelling and hemorrhage. None of the eleven committee members thought the drug was ready for approval: ten voted against, one was unsure.

“The approval of an ineffective drug has serious potential to interfere with future research into new treatments that may be effective,” said Dr. Joel Perlmutter, a neurologist at Washington University School of Medicine in St. Louis, who first stepped down from the committee.

“In addition, aducanumab therapy will potentially cost billions of dollars to introduce, and those dollars could be better spent developing better evidence for aducanumab or other therapeutic interventions,” added Dr. Mother-of-pearl added.

Shannon P. Hatch, an FDA spokeswoman, said the agency does not comment on matters that affect individual advisory committee members.

Biogen plans to ship the drug in about two weeks. It expects more than 900 locations across the country, usually memory clinics that treat patients with dementia, to be ready to administer the drug soon.

The FDA’s green light decision, announced Monday, marked the first approval of an Alzheimer’s treatment in 18 years. Patient advocacy groups had pushed for approval because there are only five other drugs for the debilitating disease and they only treat dementia symptoms for a few months.

But since last fall, several respected experts, including some Alzheimer’s doctors who worked on the clinical trials of aducanumab, have said that the evidence available casts significant doubts on the drug’s effectiveness. They also said that even if it could slow cognitive decline in some patients, the proposed benefit – slowing symptoms down for about four months over 18 months – might be barely noticeable to patients and outweigh the risks of side effects on the brain would.

In addition to the high price of the drug, the additional cost of screening patients before treatment and having regular MRIs needed to monitor their brain for problems could add tens of thousands of dollars to the bill. Medicare is expected to cover much of that.

“Giving patients a drug that is not working and of course has great risks that require multiple MRIs costing $ 56,000 a year puts patients in a really challenging position and puts doctors in a difficult position.” said Kesselheim.

Aside from believing that the existing evidence of Aduhelm’s benefits is weak, the resigning advisory committee members – as well as several prominent Alzheimer’s experts – rejected two important aspects of the FDA’s approval decision.

One problem is that the FDA has approved the drug for a much broader group of patients – anyone with Alzheimer’s – than many experts expected. In the clinical trials, the drug was only tested in patients with early-stage Alzheimer’s disease or mild cognitive impairment from the disease.

The other problem is that a key part of the FDA’s rationale for granting the approval was that the drug’s ability to attack the amyloid protein in patients’ brains would help slow their cognitive symptoms.

“This is a big problem,” said Dr. Mother-of-pearl.

While amyloid is considered a biomarker of Alzheimer’s disease because its buildup in the brain is an important aspect of the disease, there is very little scientific evidence that reducing amyloid can actually help patients by relieving their memory and thinking problems.

Clinical studies of other amyloid-lowering drugs for more than two decades have shown no evidence that the drugs slow cognitive decline. As a result, many experts had said it was especially important to have solid evidence of Aduhelm’s ability to treat symptoms.

In November, FDA officials told advisory committee members that the agency would not count the drug’s ability to reduce amyloid as an indication of its effectiveness. But in Monday’s decision, the FDA announced that it did just that.

“The FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that reducing these plaques is likely to predict important benefits for patients,” said the director of the Center for Drug Evaluation and Research of the FDA, Dr. Patrizia Cavazzoni wrote on the agency’s website about the decision to make the drug available under a program called accelerated approval.

The advisory committee members said, however, that the committee was never advised that the agency would be considering approval based on amyloid reduction and that their opinion on this significant change was never sought. Dr. Perlmutter said the committee was “unaware of any additional information or statistical analysis to support approval.”

Dr. David Knopman, a clinical neurologist at Mayo Clinic, wrote in an email to FDA officials informing them of his resignation from the advisory committee on Wednesday: “Biomarker justification for approval in the absence of consistent clinical benefit 18 months of treatment is “unreasonable.”

Dr. Knopman, who stepped out of the November meeting for serving as the lead investigator for one of the aducanumab trials, added that “the whole aducanumab approval saga, which culminated in accelerated approval on Monday, is a mockery “The role of the advisory board.

Dr. Peter Stein, who heads the Office of New Drugs at the FDA Center for Drug Evaluation and Research, said in a briefing with reporters following the decision that the agency’s reviewers were convinced of what he saw as a strong relationship between plaque reduction and potential clinical benefit described by Aduhelm, which he said had not been seen in previous studies of amyloid-eradicating drugs.

Dr. Stein also defended the agency’s decision to approve the drug in such a broad patient population, saying it could be relevant beyond the early stages of Alzheimer’s.

“Since amyloid is a hallmark of the disease throughout its course, this drug is expected to provide benefits across this spectrum,” said Dr. Stone.

As a condition of approval, the FDA said Biogen would conduct another clinical trial and give the company approximately nine years to complete. These terms apply to some experts as well. They say the drug will be available without restriction during these years, and if the new study doesn’t prove the drug beneficial, the agency may, but is not required to, withdraw its approval and has not always done so for other drugs.

“The timeframe they gave for the so-called confirmatory study of nine years is problematic,” said Dr. Kesselheim, who also directs Harvard Medical School’s regulation, therapy, and law program. “During this time, the product will be used a lot.”