Tag: FDA

Categories
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.

Categories
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.

Categories
Health

F.D.A. Attaches Warning of Uncommon Nerve Syndrome to Johnson & Johnson Covid Vaccine

F.D.A. Will Attach Warning of Rare Nerve Syndrome to Johnson & Johnson Vaccine

The database shows only one possible death of a recipient of the Johnson & Johnson shot from Guillain-Barre Syndrome. But the man, a 57-year-old Delaware man, had also suffered a heart attack and stroke in the past four years, which raised questions about his April death.

Although it only requires a single dose and is easier to store than Pfizer and Moderna vaccines, Johnson & Johnson vaccination played only a minor role in the US vaccination campaign. One of the reasons for this is that a plant in Baltimore that was supposed to supply most of the cans in the country was closed for three months for violating the law. The factory, operated by Emergent BioSolutions, a subcontractor, was forced to discard the equivalent of 75 million cans on suspicion of contamination, significantly delaying deliveries to the federal government.

At the same time, demand for the shot collapsed after the safety break in April. At that time, 15 women in the United States and Europe who received the Johnson & Johnson injection were diagnosed with the coagulation disorder; three died. The CDC has now confirmed 38 cases of the disorder.

Regulatory authorities and federal health officials warned that women under the age of 50 in particular should be aware of the “rare but increased” risk of clotting. In the nearly three months since the hiatus ended, only about five million people in the U.S. have taken Johnson & Johnson’s recording, and state officials report that people are much more cautious. Millions of cans distributed by the federal government sit unused and expire this summer.

Alex Gorsky, CEO of Johnson & Johnson, said last month he was still confident that the vaccine, which has been used in 27 countries, will help contain the pandemic overseas. The company has pledged up to 400 million cans to the African Union. Regardless, Covax, the global vaccine exchange program, is set to receive hundreds of millions of doses.

Studies have shown that the Johnson & Johnson syringe protects people from more contagious variants of the coronavirus, including the Delta variant, and is highly effective in preventing severe Covid-19, hospitalizations, and death.

The Food and Drug Administration shares responsibility for vaccines with the CDC, but is solely responsible for issuing product warnings. The Guillain-Barré cases will be discussed at an upcoming meeting of a committee of external experts advising the CDC, the agency said.

Categories
Health

F.D.A. Will Connect Warning of Uncommon Nerve Syndrome to Johnson & Johnson Vaccine

F.D.A. Will Attach Warning of Rare Nerve Syndrome to Johnson & Johnson Vaccine

The Food and Drug Administration is planning to warn that Johnson & Johnson’s coronavirus vaccine can lead to an increased risk of a rare neurological condition known as Guillain–Barré syndrome, another setback for a vaccine that has largely been sidelined in the United States because of manufacturing problems and a temporary safety pause earlier this year, according to several people familiar with the plans.

Although regulators have found that the chances of developing the condition are low, they appear to be three to five times higher among recipients of the Johnson & Johnson vaccine than among the general population in the United States, according to people familiar with the decision.

Federal officials have identified roughly 100 suspected cases of Guillain-Barré disease among recipients of the Johnson & Johnson shot through a federal monitoring system that relies on patients and health care providers to report adverse effects of vaccines. The reports are considered preliminary. Most people who develop the condition recover.

The F.D.A. has concluded that the benefits of the vaccine in preventing severe disease or death from the coronavirus still very much outweigh any danger, but it plans to include the proviso in fact sheets about the drug for providers and patients

“It’s not surprising to find these types of adverse events associated with vaccination,” said Dr. Luciana Borio, a former acting chief scientist at the F.D.A. under President Barack Obama. The data collected so far by the F.D.A., she added, suggested that the vaccine’s benefits “continue to vastly outweigh the risks.”

In a statement released Monday, the Centers for Disease Control and Prevention said the cases have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older.

The database reports indicate that symptoms of Guillain-Barré developed within about three weeks of vaccination. One recipient, a 57-year-old man from Delaware who had suffered both a heart attack and a stroke within the last four years, died in early April after he was vaccinated and developed Guillain-Barré syndrome, according to a report filed to the database.

The Biden administration is expected to announce the new warning as early as Tuesday. European regulators may soon follow suit. No link has been found between Guillain-Barré syndrome and the coronavirus vaccines developed by Pfizer-BioNTech or Moderna, the other two federally authorized manufacturers. Those rely on a different technology.

Nearly 13 million people in the United States have received Johnson & Johnson’s shot, but 92 percent of Americans who have been fully vaccinated received shots developed by Pfizer-BioNTech or Moderna. Even though it requires only one dose, Johnson & Johnson’s vaccine has been marginalized by manufacturing delays and a 10-day pause while investigators studied whether it was linked to a rare but serious blood clotting disorder in women. That investigation also resulted in a warning added to the fact sheet.

The new safety concern comes at a precipitous moment in the nation’s fight against Covid-19. The pace of vaccinations has slowed considerably just as a new, more contagious variant called Delta is spreading fast in under-vaccinated areas. Federal health officials are worried that the news could make some people even more hesitant to accept the vaccines developed by Pfizer-BioNTech or Moderna, even though well over 100 million people have received those vaccines, according to the Centers for Disease Control and Prevention.

Updated 

July 12, 2021, 2:12 p.m. ET

Almost one-third of the nation’s adults remain unvaccinated. The Biden administration has shifted away from relying on mass vaccination sites and is now enlisting community workers in door-to-door campaigns, supplying doses to primary care doctors and expanding mobile clinics in an attempt to convince the unvaccinated to accept shots.

Johnson & Johnson’s vaccine has played a minor role in the nation’s inoculation campaign partly because the Baltimore plant that was supposed to supply most of the doses to the United States has been shut down for three months because of regulatory violations. The factory, operated by Emergent BioSolutions, a subcontractor, has been forced to throw out the equivalent of 75 million doses because of suspected contamination, severely delaying deliveries to the federal government.

Demand for the shot also plummeted after the April safety pause. At that time, 15 women in United States and Europe who had received the Johnson & Johnson shot had been diagnosed with the disorder. Three had died.

Regulators ultimately decided that the risk was remote and far outweighed by the benefits. They attached a warning to the drug and cleared it for use, but state officials have said that the perception that the vaccine might be unsafe hurt it.

Alex Gorsky, Johnson & Johnson’s chief executive, said last month that he was still hopeful that the vaccine, which has been used in 27 countries so far, would help contain the pandemic overseas. The company has promised up to 400 million doses to the African Union. Separately, Covax, the global vaccine-sharing program, is supposed to receive hundreds of millions of doses.

Studies have showed that the Johnson & Johnson shot protects people against more contagious virus variants, including the Delta variant, and is highly effective at preventing severe Covid-19, hospitalizations and death.

The F.D.A. shares jurisdiction over vaccines with the Centers for Disease Control and Prevention but is responsible for issuing product warnings. The Guillain-Barré cases are expected to be discussed in an upcoming meeting of a committee of outside experts who advise the C.D.C.

The F.D.A. has also attached a warning to the Pfizer-BioNTech and Moderna vaccines, but some health officials described that as less serious than the warnings about Johnson & Johnson. Last month, the agency warned about an increased risk of inflammation of the heart or the tissue surrounding it — diseases known as myocarditis and pericarditis — particularly among adolescents and young adults who had received Pfizer-BioNTech or Moderna shots. But the C.D.C. said in most cases, symptoms promptly improved after simple rest or medication.

The Guillian-Barré syndrome is more likely to result in medical intervention, officials said. It occurs when the immune system damages nerve cells, causing muscle weakness and occasional paralysis, according to the F.D.A. Several thousand people — or roughly 10 out of every one million residents — develop the condition every year in the United States. Most fully recover from even the most severe symptoms, but in rare cases patients can suffer near-total paralysis.

The suspected cases were reported in the Vaccine Adverse Event Reporting System, or VAERS, a 30-year-old federal monitoring system. So far, researchers have not identified any particular demographic pattern, but the many of the reports in the publicly available database indicate that the patients were hospitalized.

Guillain-Barré syndrome has also been linked to other vaccines. The Centers for Disease Control and Prevention has said that flu vaccines, including the 1976 swine flu vaccine, led to a small increased risk of contracting the syndrome, although some studies suggested that people are more likely to develop Guillain-Barré from the flu itself than from flu vaccines. Earlier this year, the F.D.A. warned that GlaxoSmithKline’s shingles vaccine, Shingrix, could also increase the risk of the disease.

Only about five million people in the U.S. have taken Johnson & Johnson’s shot since the April pause was lifted. Millions of doses that have been distributed by the federal government are sitting unused and will expire this summer.

Apoorva Mandavilli and Carl Zimmer contributed reporting.

Categories
Health

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.

Categories
Health

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.

Categories
Health

In a Reversal, F.D.A. Requires Limits on Who Will get Alzheimer’s Drug

In a Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug

When the FDA approved Aduhelm a month ago, the original label said the drug was “for the treatment of Alzheimer’s disease.” The surprisingly broad label caused a storm of concern among many Alzheimer’s experts, even those who had supported the drug’s approval.

At a forum sponsored by the Alzheimer’s Association last month that urged Aduhelm to be approved, a panel of Alzheimer’s clinics with differing views agreed on whether the drug should have been approved that its use was strong should be restricted.

Many experts say the drug’s label should not only restrict Aduhelm’s use to mild disease stages, but also require two more stringent clinical trial conditions: that suitable patients have evidence of high levels of a key protein, amyloid, in their brain, and that people with certain diseases (so-called “contraindications”) should be prevented from taking the drug or at least classified as a high-risk group, as this can lead to brain swelling and bleeding.

At the forum, Dr. Stephen Selloway, director of the Memory and Aging Program at Butler Hospital in Providence, RI, who helped conduct the Aduhelm studies and is one of the drug’s most ardent medical advocates, when he saw the label had no contraindications to his The reaction was “oy”.

On Thursday, Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, who also worked on one of the Aduhelm studies and spoke out against the approval of the drug, saying that the new labeling was neglected.

The label should have said, among other things, that people with diabetes, high blood pressure and people who take blood thinners are not allowed to take part in the clinical trials and therefore “no extent is known”. of increased risk ”for these patients.

Dr. Jason Karlawish, a co-director of the University of Pennsylvania’s Penn Memory Center, said the new label was based more on what he and other Alzheimer’s experts believe should originally have been written. But the abrupt revision of the label so soon after a much criticized approval decision was worrying, he said.

Categories
Health

F.D.A. Releases One other Batch of Johnson & Johnson’s Vaccine

F.D.A. Releases Another Batch of Johnson & Johnson’s Vaccine

WASHINGTON — Federal regulators on Friday cleared a batch of vaccine that could furnish up to 15 million doses of Johnson & Johnson’s one-shot coronavirus vaccine, deciding they can be safely distributed despite production failures at the factory that ruined 75 million other doses.

The move brings the total number of Johnson & Johnson doses made at the Baltimore facility and cleared by the Food and Drug Administration for distribution in the United States to roughly 40 million. But Johnson & Johnson remains far short of its commitment to deliver 100 million doses to the federal government by the end of June. European Union officials have said the company is missing its delivery targets there, as well.

The vaccine cleared on Friday is not yet bottled, and the Biden administration’s plans for it remain unclear. But with new coronavirus cases dropping and the country awash in vaccines from two other authorized manufacturers, most new Johnson & Johnson doses produced in the United States are likely destined for export.

Johnson & Johnson has been unable to produce much of its vaccine since April, when regulators shut down the Baltimore factory, operated by Emergent BioSolutions, because of major production errors. Johnson & Johnson had been relying on Emergent, its subcontractor, to produce vaccine for use in the United States as well as to meet its commitments overseas while it expanded its own plant in Leiden, the Netherlands.

Even with the newly cleared batch, Johnson & Johnson remains nearly 40 million doses short of the 100 million doses called for in its federal contract. The F.D.A. did not disclose the precise number of doses cleared Friday, but multiple people familiar with Emergent’s operation said the batch amounted to as many as 15 million doses.

Also on Friday, European regulators approved the reopening of Johnson & Johnson’s Dutch plant, a piece of good news for the company amid its supply woes. “Today’s approval represents progress in expanding our global manufacturing network to supply our Covid-19 vaccine worldwide,” the company said in a statement.

The Baltimore factory is expected to remain shuttered for at least several more weeks while Emergent tries to bring it up to standard, according to people familiar with its operation who spoke on condition of anonymity. The F.D.A. said in a statement Friday that it was not yet ready to certify that the plant was following proper manufacturing practices.

After the discovery in March that Emergent workers had contaminated a batch of Johnson & Johnson’s vaccine with a key ingredient for AstraZeneca’s Covid vaccine being made at the same plant, regulators cited Emergent for a series of regulatory violations. Emergent was forced to throw out the equivalent of 75 million doses of Johnson & Johnson vaccine. European authorities discarded another 17 million more doses, and South Africa, which is desperate for vaccine, pulled two million more.

The Biden administration also had to pivot from relying on AstraZeneca doses to fulfill its pledge to donate vaccine to poorer nations, swapping in supplies from other makers. The F.D.A. has yet to rule on whether the equivalent of more than 100 million doses of both Johnson & Johnson and AstraZeneca vaccines produced by Emergent are suitable for use.

The F.D.A. has been conducting a painstaking review of every vaccine batch from the Emergent plant, matching up records of deviations from manufacturing standards with production lots to determine whether the batches can be released. In a letter to Johnson & Johnson released late Friday, the agency said the batch it was releasing was suitable for distribution even though the factory was not adhering to proper manufacturing practices at the time it was produced.

As deliveries of Johnson & Johnson’s vaccine stalled, the Biden administration ended up relying almost entirely on doses made by Pfizer-BioNTech and Moderna. With the pandemic now waning in the United States, demand for shots has plummeted. Johnson & Johnson has teamed up with the pharmaceutical giant Merck to make more doses, but the factory they intend to use is not expected to start operating until the fall.

Although the Johnson & Johnson vaccine was once considered a game changer in the nation’s vaccination campaign, state health officials have struggled to use up even the limited supply they received in the spring. Roughly 12.5 million people in the United States have taken the vaccine, accounting for a little more than half of the available supply, and millions of doses are set to expire by August. It is still being used in doctors’ offices and at smaller events, state officials said.

Enthusiasm for the Johnson & Johnson vaccine dropped in part because of a federally recommended pause in its use in April after a rare blood-clotting disorder was discovered in a few recipients.

But federal health officials are still hoping that surplus doses of Johnson & Johnson’s vaccine will be useful overseas, where vaccine doses remain desperately scarce. White House officials said this week that some countries had requested the vaccine because it is easier to store and transport than the others, and because some people prefer a one-shot regimen. The vaccine has been deployed in 27 countries so far.

On Thursday, Johnson & Johnson reported that early results of unpublished studies showed that its vaccine was effective against the highly contagious Delta variant, even eight months after inoculation. That was a reassuring finding for those who have gotten the company’s shot.

The news came after earlier data showed Pfizer’s and Moderna’s mRNA vaccines as effective against the Delta variant, which is much more contagious than previous variants and is expected to quickly become the dominant version of the virus in the United States. Because Johnson & Johnson’s vaccine rolled out more slowly, information about its effectiveness against variants has also lagged.

Categories
Health

FDA provides warning of uncommon coronary heart irritation to Pfizer, Moderna vaccines

CDC group says there isn't enough data yet to recommend booster shots

Vials with Pfizer-BioNTech and Moderna coronavirus disease (COVID-19) vaccine labels are seen in this illustration picture taken March 19, 2021.

Dado Ruvic | Reuters

The U.S. Food and Drug Administration on Friday added a warning to patient and provider fact sheets for the Pfizer and Moderna Covid-19 vaccines to indicate a rare risk of heart inflammation.

For each vaccine, the fact sheets were revised to include a warning about myocarditis and pericarditis after the second dose and with the onset of symptoms within a few days after receiving the shot.

Myocarditis is the inflammation of the heart muscle and pericarditis is the inflammation of the tissue surrounding the heart. Health officials said the benefits of receiving the vaccine still outweigh any risk.

“The risk of myocarditis and pericarditis appears to be very low given the number of vaccine doses that have been administered,” Janet Woodcock, acting FDA commissioner, said in a statement.

“The benefits of Covid-19 vaccination continue to outweigh the risks, given the risk of Covid-19 diseases and related, potentially severe, complications,” she said.

The FDA update follows a review and discussion by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting on Wednesday. 

There have been more than 1,200 cases of a myocarditis or pericarditis mostly in people 30 and under who received the shots, according to presentation slides from the CDC meeting.

About 300 million shots had been administered as of June 11, according to the CDC. There have been just 12.6 heart inflammation cases per million doses for both vaccines combined.

— CNBC’s Berkeley Lovelace Jr. contributed reporting

Categories
Health

Novavax says its Covid vaccine is 90% efficient, plans FDA submission in Q3

Novavax says its Covid vaccine is 90% effective, plans FDA submission in Q3

A woman holds a small bottle with a sticker “Coronavirus COVID-19 Vaccine” and a medical syringe in front of the Novavax logo displayed in this image dated October 30, 2020.

Given Ruvic | Reuters

Biotech company Novavax said Monday its Covid-19 vaccine had been shown to be safe and 90.4% overall effective in a Phase III clinical trial involving nearly 30,000 participants in the United States and Mexico.

In addition, the two-dose vaccine was found to be 100% effective in preventing moderate and severe illness, and 93% effective in some variants. The company plans to file a regulatory filing with the Food and Drug Administration in the third quarter.

The late-stage study “confirms that NVX-CoV2373 has an encouraging tolerability and safety profile,” said Dr. Gregory Glenn, President of Research and Development at Novavax, in a press release. “These data show consistent, high efficacy and reaffirm the vaccine’s ability to prevent COVID-19 amid the virus’ s ongoing genetic evolution.”

With an abundance of vaccines already available in the US, it is possible that the government could donate the Novavax doses to other countries.

The company’s analysis evaluated 77 confirmed Covid infections among the 29,960 participants in the study. Novavax said 63 cases of Covid were seen in the placebo group, up from 14 cases seen in the group that received their two-dose vaccine. That resulted in an estimated vaccine effectiveness of 90.4%, it said.

The vaccine also appeared to be well tolerated, the company said. The most common side effects were fatigue, headache, muscle aches and pain at the injection site, which usually didn’t last more than two or three days, the company said.

All Covid hospital admissions in the study were in the placebo group, the company said.

Novavax said the vaccine appears to be effective against a few variants, including the alpha variant, which was first identified in the UK. About 65% of the cases where sequence data were available were of worrying variants, the company said.

If Novavax’s vaccine is FDA approved, it would follow three Covid-19 vaccines already approved in the U.S. by Pfizer-BioNTech, Moderna, and Johnson & Johnson for emergency use.

The new data comes as federal officials say the U.S. has more than enough doses of Covid vaccine to vaccinate the entire American population. According to the Centers for Disease Control and Prevention, more than 173 million Americans had received at least one dose of a Covid-19 vaccine as of Sunday.

The Biden government has already committed to donating at least 20 million doses of Covid vaccines from Pfizer-BioNTech, Moderna and J&J, and 60 million doses of AstraZeneca’s vaccine, which is not yet approved for use in the United States

Earlier this month, the White House announced it was lifting restrictions under the Defense Production Act, which gives the US priority to vaccines developed by AstraZeneca, Sanofi and Novavax.

Novavax said Monday it is still on track to hit production capacity of 100 million cans per month by the end of the third quarter and 150 million cans per month by the fourth quarter of 2021.