Tag Archives: FDA

U.S. CDC advisers recommend COVID-19 vaccine for young children

By Michael Erman

(Reuters) -Advisers to the U.S. Centers for Disease Control and Prevention (CDC) on Tuesday unanimously supported broad use of Pfizer and BioNTech’s COVID-19 vaccine in children ages 5 to 11, with shots potentially going into young arms as soon as Wednesday.

They said the benefits of vaccination outweigh the risks of the vaccine. Much of their discussion stemmed from rare cases of heart inflammation that have been linked to the vaccine, particularly young men.

CDC Director Rochelle Walensky must sign off on recommendations before the United States can begin administering the vaccine to children in the age group. The U.S. Food and Drug Administration granted emergency use authorization of the vaccine in 5-11 year old’s on Friday.

The FDA authorized a 10-microgram dose of Pfizer’s vaccine in young children. The original shot given to those age 12 and older is 30 micrograms.

At the outset of the meeting Walensky said that pediatric hospitalizations had surged during the recent wave driven by the Delta variant of the coronavirus.

The risk from COVID-19 “is too high and too devastating to our children and far higher than for many other diseases for which we vaccinate children,” she said.

Walensky said school closures have had detrimental social and mental health impacts on children.

“Pediatric vaccination has the power to help us change all of that,” she said.

The U.S. government and Pfizer have already begun distributing the vaccine in preparation for a widespread rollout for children, many of whom are back in school for in-person learning.

Earlier this week, the White House said the United States has enough supply of the Pfizer/BioNTech vaccine for all 28 million children aged 5 to 11. While some children may be able to get their first shots as soon as Wednesday, the plans is for the U.S. pediatric vaccine program to be running at full strength by next week, a Biden administration official said.

Only a few other countries, including China, Cuba and the United Arab Emirates, have so far cleared COVID-19 vaccines for children in this age group and younger.

(Reporting by Michael Erman in New Jersey, Julie Steenhuysen in Chicago and Manas Mishra, Manojna Maddipatla in Bengaluru; Editing by Bill Berkrot)

U.S. FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children

By Manas Mishra and Michael Erman

(Reuters) -An expert panel will weigh authorization of Pfizer Inc and BioNTech’s COVID-19 vaccine for U.S. children aged 5 to 11 on Tuesday as it prepares to vote on a recommendation for the federal Food and Drug Administration.

An authorization is an important regulatory step toward reaching about 28 million children of these ages, most of them back in school for in-person learning.

The FDA need not follow the advice of its outside experts, but usually does.

While children rarely become seriously ill or die from COVID-19, some develop complications, and COVID-19 cases in unvaccinated children have risen due to the contagious Delta variant.

The age group is “far from being spared from the harm of COVID-19,” with the virus now one of the top 10 causes of deaths in American children, FDA official Peter Marks told the panel. He said there had been close to 100 deaths in that age group so far, and 1.9 million infections.

“In addition, infections have caused many school closures and disrupted the education and socialization of children,” he said.

FDA staff, in documents posted before the meeting, said the likely vaccine benefits in that age group clearly outweigh the potential harms, including the rare risk of heart inflammation.

Only a few other countries, including China, Cuba and the United Arab Emirates, have cleared COVID-19 vaccines for children in this age group and younger.

Since May, the World Health Organization has been urging rich countries to reconsider plans to vaccinate children and instead donate COVID-19 shots to the COVAX scheme for poorer countries.

The advisers are expected to pay close attention to the rate of the rare cases of heart inflammation called myocarditis that have been linked to both the Pfizer/BioNTech and Moderna vaccine, particularly in young men.

Pfizer and BioNTech are seeking clearance for a lower, 10-microgram dose version of the vaccine in children, versus 30 micrograms for everyone over the age of 12. The shot has been authorized for ages 12-15 since May and cleared for everyone over 16 since December.

The companies have said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.

After the FDA, a panel to the U.S. Centers for Disease Control and Prevention will make a recommendation on the administration of the vaccine. The director of the agency will make the final call.

Top U.S. infectious disease expert Anthony Fauci said on Sunday that it was likely the vaccine will be available to children in the first week or two of November.

If the number of myocarditis cases in the younger age group turns out to be similar to that in 12- to 15-year-olds, the hospitalizations prevented for COVID-19 would outnumber those prevented for myocarditis in most scenarios analyzed, FDA staff reviewers said.

“No matter what size of the safety database, there will always be uncertainties regarding benefits and risks, including for example, the risk of vaccine-associated myocarditis,” said Doran Fink, the FDA’s deputy director for vaccine development.

These uncertainties have to be addressed in surveillance data and studies following authorization, Fink told the panel.

Pediatric vaccinations are an important public health tool to prevent infectious diseases, even ones that do not cause high rates of mortality or hospitalization for children.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New Jersey; Editing by Caroline Humer, Richard Chang and Jonathan Oatis)

White House lays out plan to vaccinate kids ages 5 to 11

By Susan Heavey

WASHINGTON (Reuters) -The Biden administration on Wednesday outlined its plan to vaccinate millions of kids ages 5 to 11 as soon as the COVID-19 shot is approved for younger children, readying doses and preparing locations ahead of the busy holiday season.

It is working to set up vaccination clinics in more than 100 children’s hospital systems nationwide as well as doctor’s offices, pharmacies and potentially schools, it said.

If Pfizer Inc and BioNTech SE’s vaccine wins wider approval, the plan would ensure “it is quickly distributed and made conveniently and equitably available to families across the country,” the White House said in a statement, noting regulators will independently weigh approval.

Food and Drug Administration officials are reviewing the Pfizer/BioNTech application seeking approval of its 2-dose vaccine for younger children, with its panel of outside advisers scheduled to weigh in on Oct. 26. The FDA typically follows the advice of its panel but is not required to do so.

Advisers to the Centers for Disease Control and Prevention will next weigh in on recommendations for the vaccine at a Nov. 2 and 3 meeting, which its director will use in making her own recommendation.

“We will be ready to begin getting shots in arms in the days following a final CDC recommendation,” the White House said ahead of an 8:45 a.m. (1345 GMT) news briefing with U.S. President Joe Biden’s White House COVID-19 response team.

Once approved, roughly 28 million more children in the United States would be eligible to receive what would be the first U.S.-approved vaccine to ward off the novel coronavirus in younger kids. The Pfizer/BioNTech shot is already approved for those ages 12-17, and the companies are still studying it for those younger than 5.

“We have to be prepared to ensure that we can get vaccines to families as soon as the FDA and the CDC issue their decision,” U.S. Surgeon General Dr. Vivek Murthy told NBC News’ “Today” program.

Murthy said the administration was not looking to get ahead of health regulators but wanted to lay the groundwork to ease distribution to ensure there is ample supply and access to vaccination locations.

While children have a lower rate of death from COVID-19, many still face illness and long-term symptoms that are still being studied. Many adults who have been hesitant or opposed to the COVID-19 vaccine, and even some who did not oppose the vaccine for themselves, are expected to resist giving the shot to their children.

(Reporting by Susan Heavey, Editing by Nick Zieminski and Philippa Fletcher)

FDA proposes rule to make many hearing aids cheaper

(Reuters) – The U.S. Food and Drug Administration on Tuesday proposed creation of a new category of over-the-counter (OTC) hearing aids to be sold directly to millions of Americans in an effort to make the devices more affordable.

White House spokeswoman Jen Psaki said the proposed rules should be finalized next year and should increase competition to drive down prices, so the devices cost “hundreds instead of thousands of dollars.”

The changes “will help millions of Americans with mild to moderate healing loss get access to cheaper and more convenient access to hearing aids,” she told reporters, adding just one-fifth of the estimated 37.5 million Americans who have trouble hearing use such aids.

The rule allows greater reach to communities of color that have been typically lacked access to hearing aids, said Xavier Becerra, secretary of Health and Human Services.

Under the proposal, hearing aids for severe hearing loss or for users younger than 18 would remain as prescription devices.

The department will take comments on the proposed rule for 90 days and plan to implement the rule 60 days after finalizing it.

“Finalizing this remains a top priority for the agency,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said during a press call.

Representative Debbie Dingell called the announcement “a major step forward for hearing health and will increase the accessibility of affordable hearing aid options for those who need them.”

The proposed rule follows an instruction in President Joe Biden’s broad competition executive order, which had told the Department of Health and Human Services to “promote the wide availability of low-cost hearing aids,” among many other instructions aimed at a wide variety of industries.

(Reporting by Manojna Maddipatla in Bengaluru and Diane Bartz and Trevor Hunnicutt in Washington; Editing by Shinjini Ganguli and Nick Zieminski)

FDA wants less salt in every day American food

(Reuters) – The U.S. Food and Drug Administration on Wednesday is pushing to cut salt levels by 12% in food ranging from packaged meats to cheese, as it tries to clamp down on a growing epidemic of preventable health issues that has plagued the country.

In far-reaching guidelines, which come five years after the agency’s initial recommendation, the FDA is calling for voluntary short-term sodium reduction targets from food manufacturers, chain restaurants and food service operators.

High sodium consumption has long been linked to high blood pressure, which is a leading cause of heart attacks and strokes. More than 4 in 10 American adults suffer from high blood pressure, according to the agency.

Salt is an ubiquitous ingredient in almost every food item. But the agency focused on 163 categories of processed, packaged and prepared foods, including different types of cheese, pickles, nuts, sauces, deli meats, crackers and poultry products – all the things Americans love to eat. Even more so during the pandemic.

Some health experts, however, said the regulator needs to take a stronger stance.

“The FDA’s targets represent an important step forward, but lowering sodium intake to 3,000mg per day is not enough,” the American Heart Association said in a statement.

“We urge the FDA to follow today’s action with additional targets to further lower the amount of sodium in the food supply and help people in America attain an appropriate sodium intake.”

The new recommendation released on Wednesday seeks to decrease average sodium intake to 3,000 mg per day, about a 12% reduction, from 3,400 milligrams over the next two and half years.

Still, the average intake would be above the Dietary Guidelines for Americans’ recommended limit of 2,300 mg per day for those 14 and older.

The FDA said even these modest reductions made slowly over the next few years will substantially decrease diet-related diseases and said it plans to issue revised, subsequent targets to further lower the sodium content incrementally.

According to the FDA, more than 70% of total sodium intake is from salt added during food manufacturing and commercial food preparation.

The agency said the public health benefit of limiting salt intake is estimated by researchers to result in tens of thousands fewer cases of heart disease and strokes each year, as well as billions of dollars in healthcare savings over time.

Laura Abshire, director of food and sustainability policy for the National Restaurant Association, said in a statement that it is reviewing the FDA’s final guidance and that “the restaurant industry continues to provide options to address customers’ desires and health needs.”

(Reporting by Oishee Majumdar and Manojna Maddipatla in Bengaluru; Writing by Ankur Banerjee; Editing by Shinjini Ganguli, Bernard Orr)

Pfizer, BioNTech seek U.S. COVID-19 vaccine clearance for children 5-11

WASHINGTON (Reuters) -Pfizer Inc and BioNTech SE have asked U.S. regulators to authorize emergency use of their COVID-19 vaccine for children ages 5 to 11, a group for whom no shot is currently allowed, Pfizer said on Thursday.

The U.S. Food and Drug Administration has set a date of Oct. 26 for its panel of outside advisers to meet and discuss the application, making it possible for children in this age group – numbering around 28 million – to begin receiving the two-dose Pfizer/BioNTech vaccine shortly afterward.

“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer wrote on Twitter.

The vaccine already has won U.S. emergency use authorization in teens ages 12 to 15 and is fully approved by regulators for people ages 16 and up.

The Pfizer/BioNTech vaccine is one of three in use in the United States, along with the two-dose Moderna vaccine and the single-dose Johnson & Johnson version, neither of which has won full regulatory approval for any age group.

A rapid authorization of the Pfizer/BioNTech vaccine in young kids could help mitigate a potential surge of cases in the coming weeks and months, with schools open nationwide and colder weather driving activities indoors. If given regulatory authorization, the two-dose Pfizer/BioNTech vaccine would become the first COVID-19 shot made available to children 5 to 11 in the United States.

The Pfizer/BioNTech vaccine has been shown to induce a strong immune response in 5 to 11 year old’s in a 2,268-participant clinical trial, the companies said on Sept. 20.

The two drugmakers are also testing the vaccine in children ages 2 to 5 years old and children ages 6 months to 2 years, with data expected in the fourth quarter.

The vaccine could be ready for roll out as early as November pending approval from federal regulatory health agencies, White House COVID-19 response coordinator Jeffrey Zients said on CNN.

Once the authorization is granted, Zients said: “We are ready. We have the supply. We’re working with states to set up convenient locations for parents and kids to get vaccinated including pediatricians’ offices and community sites.”

The United States leads the world in COVID-19 cases and deaths.

Children currently make up about 27% of all U.S. coronavirus cases and an increasing percentage of hospitalizations, according to the American Academy of Pediatrics. That reflects the high contagiousness of the coronavirus Delta variant among unvaccinated people.

While children are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations more at risk of severe illness.

A Pfizer spokesperson said the application to the FDA has been completed.

(Reporting by Susan Heavey in Washington and Manas Mishra and Manojna Maddipatla in Bengaluru; Editing by Will Dunham, Timothy Heritage and Saumyadeb Chakrabarty)

U.S. FDA advisers may vote on COVID-19 boosters for older adults after rejecting broad approval

By Manojna Maddipatla and Michael Erman

(Reuters) – A panel of expert outside advisers to the U.S. Food and Drug Administration voted against broadly approving COVID-19 vaccine booster shots, but may vote on a narrower approval for older adults later on Friday.

The panel voted overwhelmingly against approving boosters for Americans age 16 and older, potentially undermining the Biden administration’s plan to roll out third shots of the Pfizer/BioNTech vaccine as soon as next week.

But there was widespread support among panelists for a third dose for older Americans, who are at higher risk of severe COVID-19 and may be more likely to have waning immunity after the first rounds of shots. FDA officials said that a vote to recommend approval for such groups was possible later on Friday.

The FDA will take the panel’s recommendation into consideration in making its decision on the boosters. But it can reject the advice as it did recently in approving Biogen Inc’s controversial Alzheimer’s drug

Many committee members were critical of the booster plan, arguing that the data presented by Pfizer and the FDA was incomplete and that the request for approval for people as young 16 is too broad. Most of them said they were not needed yet for younger adults.

Top FDA members have been split on the necessity of the boosters, with interim head Janet Woodcock backing them and some of the agency’s top scientists arguing they are not needed yet.

If the FDA goes ahead and approves the booster, a separate panel advising the U.S. Centers for Disease Control and Prevention (CDC) will meet next week to recommend which groups should get them.

The White House said it was ready to roll out boosters next week if health officials approve the plan.

(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru, Mike Erman in New York and Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill Berkrot)

U.S. to begin offering COVID-19 vaccine booster shots in September

By Carl O’Donnell and Ahmed Aboulenein

(Reuters) -The U.S. government said on Wednesday it plans to make COVID-19 vaccine booster shots widely available starting on Sept. 20 as infections rise from the coronavirus Delta variant, citing data indicating diminishing protection from the vaccines over time.

U.S. officials are prepared to offer a third shot to Americans who completed their initial inoculation in two-dose COVID-19 vaccines made by Moderna Inc and by Pfizer Inc and BioNTech AG at least eight months ago, the Department of Health and Human Services said in a statement.

Initial booster doses will be given to Americans who received the two-dose vaccines, but U.S. health officials said they anticipate that people who received the single-dose Johnson & Johnson shot, the other COVID-19 vaccine approved in the United States, will also need boosters. The United States did not begin administering J&J shots until March.

The booster shots initially will focus upon healthcare workers, nursing home residents and older people, among the first groups to be vaccinated in late 2020 and early 2021, top U.S. health officials said in a joint statement.

There is mounting evidence that protection from the vaccines wanes after six or more months, particularly in older people with underlying health conditions. The officials cited this in their decision on boosters, but stressed that the U.S.-approved shots have proven “remarkably effective” in reducing the risk of severe disease, hospitalizations and deaths.

The officials included President Joe Biden’s chief medical adviser Anthony Fauci as well as the heads of the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the National Institutes of Health.

“The available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time … and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease,” the officials said.

“We conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability,” they added.

U.S. officials previously authorized a third dose of the vaccines from Pfizer/BioNTech and Moderna for people with weak immune systems.

In recent weeks, several other countries also have decided to offer booster shots to older adults as well as people with weak immune systems, including Israel, France and Germany.

DELTA VARIANT CONCERNS

Vaccinations have been widely available in the United States, unlike many other countries, but the highly infectious Delta variant has caused what experts describe as a pandemic of the unvaccinated as a significant number of people choose not to get inoculated.

The United States leads the world in reported COVID-19 cases and deaths. Daily U.S. cases soared from fewer than 10,000 in early July to more than 150,000 in August as the Delta variant took hold. The new cases include some vaccinated people, though they are far less likely to experience severe disease or death than the unvaccinated.

According to CDC data, more than 72% of Americans 18 and older have received at least one vaccine dose and nearly 62% are fully vaccinated. Of the total population, the CDC said 59.9% have received at least one dose and 50.9% are fully vaccinated.

More than a million Americans independently sought an extra vaccine dose before the official decision on boosters was announced, according to federal data.

A study by an Israeli healthcare provider released on Wednesday found that a third dose of the Pfizer/BioNTech shot is 86% effective in people over age 60.

It followed another Israeli study released this week that showed evidence of waning immunity from COVID-19 vaccines in the months after inoculation, raising the risk of serious infection among the elderly and people with compromised immune systems.

“The surprise factor is the vaccine vulnerability – people who are vaccinated became vulnerable much earlier than expected,” Dr. Eric Topol, a cardiologist and director of the Scripps Research Translational Institute in California, said about the study.

“The whole dynamic of boosters is being rewritten,” Topol added.

The U.S. announcement goes against guidance from the World Health Organization, whose chief scientist said on Wednesday current data does not indicate the need for booster shots. A WHO adviser said vaccine doses should first go to people in poorer countries who have not yet received an initial inoculation.

The decision represented a shift from the optimism of U.S. health authorities in May in curbing the pandemic when Biden set a goal to vaccinate 70% of American adults with at least one dose by July 4. That goal was achieved about a month late.

The U.S. booster plan is dependent on the FDA determining that a third dose of the two-dose vaccines is safe and effective, and a favorable recommendation from CDC advisers.

(Reporting by Carl O’Donnell in New York and Ahmed Aboulenein in Washington; Editing by Will Dunham and Grant McCool)

Former FDA adviser calls for wider probe into Biogen Alzheimer’s drug approval

By Julie Steenhuysen and Deena Beasley

(Reuters) – A federal probe of the U.S. Food and Drug Administration’s approval of a controversial new Alzheimer’s disease drug should look into why that decision was made without clear evidence of patient benefit, a former adviser to the agency said on Tuesday.

Acting FDA Commissioner Janet Woodcock earlier this month asked the Office of the Inspector General at the Department of Health and Human Services to investigate whether FDA representatives’ interactions with drugmaker Biogen Inc were inconsistent with agency policies.

“I happen to think that there’s a lot more to investigate than just that,” said Dr. Aaron Kesselheim of Harvard-affiliated Brigham and Women’s Hospital, who resigned as a member of the FDA advisory panel that reviewed and voted against approval of Biogen’s drug prior to the FDA green light.

Speaking at a live event sponsored by The Forum at the Harvard T.H. Chan School of Public Health, he said more information is needed on FDA’s role in Biogen’s evaluation of clinical trial data, as well as why the agency decided to base its approval on a “surrogate” biomarker rather than the drug’s impact on cognitive function.

The FDA in early June approved Biogen’s Aduhelm, citing evidence that it can reduce brain plaques, a likely contributor to Alzheimer’s disease, rather than proof that it slows progression of the lethal mind-wasting condition.

“If the FDA knows about some really clear scientific evidence … they should share that because I don’t think there is a lot of clarity around that in the field right now,” Kesselheim said.

He was one of three experts who resigned from the FDA advisory panel that recommended late last year that the agency turn down Biogen’s application to market Aduhelm, which the company has priced at about $56,000 a year.

“I think that by all objective measures it is an excessive cost,” Kesselheim said.

(Reporting by Julie Steenhuysen in Chicago; Writing by Deena Beasley in Los Angeles; Editing by Bill Berkrot)

U.S. FDA asks J&J to discard 60 million vaccine doses made at Baltimore plant

(Reuters) -The U.S. Food & Drug Administration has asked Johnson & Johnson to discard 60 million doses of its COVID-19 vaccine manufactured at a problem-plagued Baltimore factory, the New York Times reported on Friday, citing people familiar with the matter.

A further 10 million J&J doses would be allowed to be distributed with a warning that there was no guarantee contract manufacturer Emergent BioSolutions Inc had followed proper practices, the newspaper said.

Without disclosing or confirming the number of vaccine doses, the FDA said in a news release that it had authorized two batches of the vaccine for use, that multiple other batches were not suitable for use and that others were being evaluated.

The agency said it was not yet ready to authorize Emergent’s plant for manufacturing the J&J vaccine. Production of J&J’s vaccine at the Baltimore site was halted by U.S. authorities in April and J&J was put in charge of manufacturing at the plant.

J&J did not have an immediate comment. The FDA declined to comment beyond its statement.

The FDA said its decision allows the J&J doses to be used in the United States or exported. It said that for J&J and Emergent to export these shots, they must agree that the FDA can share information on the batches with the regulatory authorities of the countries in which the vaccine may be used.

Last month, Emergent Chief Executive Robert Kramer said it was his understanding that there are 100 million doses of J&J’s one-shot vaccine ready for FDA review and that regulators had begun the review process.

The April halt followed the discovery that ingredients from AstraZeneca’s COVID-19 vaccine, also being produced at the plant at the time, contaminated a batch of J&J’s vaccine. AstraZeneca’s shot is no longer being made there.

An FDA inspection also turned up a long list of sanitary problems and bad manufacturing practices at the Emergent plant.

Separately, Europe’s drug regulator said on Friday that batches of J&J COVID-19 vaccine made for the region around the time the contamination issues were revealed at the Baltimore plant would, as a precaution, not be used.

The European Medicines Agency did not say how many shots were affected, but Reuters has reported it involves millions of doses, making it harder for J&J to meet a target of delivering 55 million to Europe by end of June.

(Reporting by Mrinalika Roy and Ankru Bannerjee in Bengaluru and Michael Erman in New Jersey; Editing by Bill Berkrot)