FDA

U.S. Vaccine Panels Approve The Pfizer Vaccine For Five-to-Eleven Year-Olds.

Advisory boards working in the Food and Drug Administration (FDA) as well as for the Centers for Disease Control and Prevention (CDC) have approved the use of the Pfizer jab for five to 11-year olds, outlining that the benefits outweigh the potential risks posed to this age demographic. Although the decision now awaits formal approval from the FDA and CDC as a whole, it is expected that both organisations will confirm the original verdict, meaning that 28 million U.S. schoolchildren will soon be eligible for the vaccine. BBC NEWS has the story.

Following the FDA independent advisory committee’s green light on Tuesday, the CDC is expected to follow suit on November 2nd, meaning jabs for five-year olds could begin as soon as a day later.

The Pfizer vaccine is already approved for American adults and adolescents, but it has not yet been fully approved for most school-aged children.

Among those between five and 11 years-old, there have been about 1.8 million Covid cases confirmed in the US, according to the CDC. Fewer than 200 have died, and most of those had underlying medical conditions.

Some medical experts say that, given the persistence of the Delta variant and the return to in-person schooling, vaccinating children is a crucial next step in fighting the pandemic.

“Parents need to understand the urgency of vaccination because the pandemic is not over”, said Dr. James Versalovic, pathologist in chief at Texas Children’s Hospital (TCH)…

Vaccine hesitancy remains a challenge for US medical authorities. Uptake in the adult population has stalled below 60% over the past several months.

Only a third of parents in a poll last month by the Kaiser Family Foundation said they would get their children vaccinated ‘right away’. Another third said they would like to ‘wait and see’.

Some parents have expressed concern about hundreds of cases of myocarditis, an inflammation of the heart muscle, that have been reported predominantly in young adults who took the vaccine, mostly after the second jab.

Worth reading in full.

Pfizer Will Ask U.S. FDA for Approval of Its Vaccines in 5-11 Year-Olds “In Days”

We’ve not yet finished debating the vaccination of 12-15 year-olds. But Pfizer’s CEO, who hinted at “annual re-vaccinations” against Covid over the weekend, is already looking to go one step further by asking the U.S. Food and Drug Administration (FDA) “in days” to authorise the use of its vaccine in even younger children. MailOnline has the story.

On Sunday, in an appearance on ABC’s This Week, Albert Bourla was asked when the country should expect the shots to be approved in kids between ages five and 11.

The New York-based firm, along with its German partner BioNTech, recently released data that it said showed the vaccine was safe and effective in a [sic] smaller doses in elementary schoolers.

“I think we are going to submit this data pretty soon,” Bourla told host George Stephanopoulos.

“It’s a question of days, not weeks, and then it is up to FDA to be able to review the data and come to their conclusions and approve it or not.”

According to clinicaltrials.gov, Pfizer’s study in younger children worked similarly to the way it did in older children and adults.

A total of 4,500 younger kids from ages six months to 11 years were enrolled at nearly 100 clinical trial sites in 26 U.S. states, Finland, Poland and Spain

About half of the ages five-to-11 group were given two doses 21 days apart and the other half were given placebo shots.

The team then tested the safety, tolerability and immune response generated by the vaccine by measuring antibody levels in the young subjects.

Pfizer said it had selected lower doses for Covid vaccine trials in children than are given to teenagers and adults. …

Bourla assured that Pfizer would be ready to ship these smaller doses across the country if the FDA authorises the shot in younger children. …

Unlike the larger clinical trial conducted in adults, the pediatric trial did not measure efficacy by comparing the number of Covid cases among the vaccine group to the number in the placebo group.

Instead, scientists looked at levels of neutralizing antibodies in young vaccine recipients and compared the levels to those seen in adults.

The companies expect data on how well the vaccine works in children between ages two and five and between six months and two years of age by the end of the year.

Worth reading in full.

U.S. FDA Recommends Against Booster Vaccines for Under-65s

The advisory committee of the U.S. Food and Drug Administration (FDA) says booster jabs should be given to the over-65s and the clinically vulnerable but has voted 16-2 against recommending additional doses for everyone else aged 16 and over. MailOnline has the story.

Members said said [sic] there was not enough evidence that a third dose was safe and effective for use in people under age 65.

The FDA is not bound to follow the advisory group’s recommendations but the agency rarely goes against the guidance of VRBPAC.

The next step before the FDA can issue authorisation is a recommendation for approved by the advisory committee for the Centers for Disease Control and Prevention (CDC).

Pfizer had previously submitted data that the company claimed show its vaccine’s efficacy falls by about six percent every two months following the second and final dose.

But many scientists, including senior officials at the FDA, disagree and argue that the vaccines are still highly effective at preventing severe illness and death.

Last month, boosters were approved for immunocompromised Americans who had received either the Pfizer or Moderna vaccine after data showed they were less likely to develop high antibody levels after two doses.

At least 2.04 million people in the U.S. have received booster doses as of Friday, according to data from the CDC.

The White House also announced last month booster shots would become available for all Americans starting on September 20th due to data suggesting waning efficacy of the initial shots. …

Dr. Phil Krause, Deputy Director of the FDA’s Office of Vaccines Research and Review, said that Pfizer’s data [suggesting that people who received booster doses had high levels of protection] had yet to be independently reviewed by experts.

“One of the issues in this is that much of the data that’s been presented and being discussed today is not peer-reviewed and has not been reviewed by FDA,” he said.

FDA and CDC officials have previously expressed to [sic] their doubts to the White House about the need for extra doses.

Worth reading in full.

FDA Approval of Pfizer Covid Vaccine Will Lead To More Vaccine Mandates, Says Dr. Fauci

Rather than allow the full approval of the Pfizer Covid vaccine by the U.S. Food and Drug Administration (FDA) to simply persuade otherwise sceptical Americans that the jab is safe for use, businesses and universities are likely to use it as an excuse to introduce vaccine mandates, according to Dr. Anthony Fauci. The Chief Medical Advisor to Joe Biden says “you’re gonna see a lot more mandates because there will be institutions and organisations which previously were reluctant to require vaccinations, which will now feel much more empowered to do that”. MailOnline has the story.

In an interview on MSNBC’s Morning Joe on Tuesday, Dr. Anthony Fauci said he thinks approval will help push more Americans to get the Covid vaccine because it might reduce their fears about the safety of the shot.  

But he added that businesses and schools may feel more comfortable requiring workers or students to get a jab that has full authorisation.

“You’re gonna see a lot more mandates [from a range of] institutions…

“That could be organisations, businesses, colleges, universities. We’re even seeing it with the military already.”

However, mandates are a contentious topic with many states outright banning laws that would require workers to be vaccinated. …

Fauci referenced a recent report from the Kaiser Family Foundation that found three in ten unvaccinated adults said they would be more likely to get vaccinated if one of the vaccines were fully approved.

“I think that’s gonna be an important group because if you talk about 30% of the unvaccinated, that’s a lot of people,” he told Morning Joe.

About 90 million Americans who are eligible to get the Covid vaccine have not yet done so, according to the Centers for Disease Control and Prevention. …

At a news conference on Monday morning, Pentagon Press Secretary John Kirby confirmed that the full approval will lead to COVID-19 vaccines being mandated for the U.S. military. 

“Now that the Pfizer vaccine has been approved, the Department is prepared to issue updated guidance requiring all service members to be vaccinated. A timeline for vaccinated completion will be provided in the coming days,” he said. 

And Louisiana State University President William Tate announced two weeks ago that the school will mandate that students receive the vaccine following full FDA authorisation. 

Worth reading in full.

Stop Press: President Joe Biden has called on U.S. companies to introduce Covid vaccine mandates, saying: “Require it. Do what I did last month. Require your employees to get vaccinated or face strict requirements.”

U.S. Medicines Regulator Will Decide Whether to Fully Approve the Pfizer Covid Vaccine by January 2022

The Food and Drug Administration (FDA) will decide on whether to fully approve the use of the Pfizer Covid vaccine in the U.S. for those aged 16 and over no later than January 2022, it has been announced. The vaccine is currently only authorised for emergency use in Americans aged 12 and over and has been given to millions of people across the world. The MailOnline has the story.

According to a press release from the [Pfizer and BioNTech] on Friday, the federal health agency’s goal date for a decision is by January 2022.

If approved, the vaccine will be the first fully approved Covid shot and could help ease vaccine hesitancy among some Americans due to the longer-term data required for full FDA approval. 

As of Friday, more than 186.5 million shots of the vaccine have been administered in the U.S., according to data from the Centers for Disease Control and Prevention (CDC). 

Because Pfizer’s vaccine is currently approved for use on an emergency basis, it is still considered somewhat experimental despite data showing it is safe and effective.

Additionally, emergency use authorisation requires less clinical trial data, with the FDA only requiring two months of follow-up before approving the shot for those 16 and older in December 2020.

The designation is also intended to be temporary.

If and when the shot is fully approved, companies and schools may feel more comfortable requiring employees and students to get it. 

The decision would also allow the vaccine makers to market their shots directly to the general public.

According to the press release, Pfizer and BioNTech completed the rolling submission of data to the FDA in May 2021.

It includes data from the Phase III trial completed last year and six months of follow-up data rather than two months.

Although the shot is currently approved for use in teenagers and adults, the full approval would only be for those aged 16 and older because emergency authorization for Americans aged 12 to 15 only occurred in May.

The companies plan to apply for full approval in teens as well, but only after six months of follow-up data is available, the press release states. …

Moderna Inc has also filed for full approval from FDA for its Covid vaccine, announcing the news on June 1st. …

The decision to fully approve Moderna’s vaccine will likely come after the Pfizer decision due to Moderna submitting its application later.   

Worth reading in full.

U.S. Medicines Regulator to Add Warning to Pfizer and Moderna Vaccines Over Link to Heart Inflammation

The U.S. Food and Drug Administration (FDA) is set to add a warning to the Covid vaccines made by Pfizer and Moderna after the Centers for Disease Control and Prevention (CDC) said there is a “likely link” between them and cases of heart inflammation, particularly in children and young adults. The MailOnline has the story.

The CDC made the announcement Wednesday during a presentation. 

The Covid Vaccine Safety Technical (VaST) Work Group discussed nearly 500 reports of heart inflammation, known as myocarditis, in vaccinated adults under the age of 30.

The group of doctors said the risk of myocarditis or pericarditis following vaccination with the mRNA-based shots in adolescents and young adults is notably higher after the second dose and in males  

It comes as the Advisory Committee on Immunisation Practices (ACIP) is set to meet this week to assess the possibility of a link between the heart condition and the mRNA vaccines. 

The Moderna and Pfizer vaccines use mRNA technology, while the Johnson & Johnson vaccine uses the more traditional virus-based technology. 

According to the presentation, there have been 484 preliminary reports of myocarditis or pericarditis in young people under age 30 as of June 11th.

So far, 323 have been confirmed by CDC and 148 are still under review.

In total, 309 patients were hospitalized, of which 295 were discharged and 79% have since recovered.

Nine patients are still hospitalized with two in intensive care units. There was no data available for five patients. 

Males were much more likely to report heart inflammation after receiving a second dose than women.

As of June 11th, there were 9.1 per million reported cases of myocarditis/pericarditis in females ages 12-to-17 compared to 66.7 per million in males of that age group.

What’s more, rates among females ages 18-to-24 and ages 25-to-29 were 5.5 per million and 2.6 per million respectively.

Ang [among] males, rates were 56.3 per million for the 18-to-24 age group and 20.4 per million in the 25-to-29 group.

In Australia, the AstraZeneca Covid vaccine is facing further criticism over its links to a variety of side effects. The vaccine will have been almost completely phased out of the country’s roll-out by October.

Worth reading in full.

FDA Tells People to Throw Innova Lateral Flow Tests in the Bin

The American Food and Drug Agency (FDA) says the performance of the Innova-manufactured lateral flow test – the one in use across Britain, including in schools – has not been proven to be reliable and, for that reason, the test should either be returned to the manufacturer or thrown in the bin. The Guardian has more.

The FDA has raised significant concerns about the rapid Covid test on which the U.K. Government has based its multibillion-pound mass testing programme.

In a scathing review, the US health agency suggested the performance of the test had not been established, presenting a risk to health, and that the tests should be thrown in the bin or returned to the California-based manufacturer Innova.

In the UK, these lateral flow Innova tests form the cornerstone of Operation Moonshot, the mass-testing scheme championed by the prime minister’s former chief adviser. The idea was that the ability to deliver results within 30 minutes – without the need for processing in a laboratory – provided a cheap, pragmatic and efficient way to identify people who had caught the virus but not fallen ill. But critics have raised concerns about accuracy.

Given the tests have been offered free to millions in England, for use at home or at test centres, workplaces and schools, with the aim of detecting more cases, breaking chains of transmission and saving lives since April, the FDA announcement is particularly damning.

The US agency has not authorised the use of the Innova test in the US, although the manufacturer has submitted a request for authorisation. But when the FDA discovered the Innova test was being distributed for US use regardless, it conducted an inspection of Innova’s medical device operations between March and April 2021.

In its report, the agency accused the company of “false or misleading” estimates of the clinical performance of certain configurations of the test, saying the estimates did not accurately reflect the performance of the diagnostic devices during clinical studies.

The FDA also highlighted that the clinical study data submitted by Innova as part of its request for US authorisation was identical to data previously provided by other manufacturers in separate requests.

Worth reading in full.

Moderna Hopes Its Covid Vaccine Will Be the Second to Be Authorised for Use in American Children

Moderna has asked the U.S. Food and Drug Administration (FDA) to extend the emergency use of its Covid vaccine to American children aged 12 and over. The FDA approved the use of the Pfizer Covid vaccine in children a month ago on Thursday, and earlier this month the U.K.’s medicines regulator did the same for British children. The MailOnline has more.

When the [Moderna] vaccine was originally authorised for use by the FDA in December 2020, it was only for those aged 18 and older. 

However, recent Phase Three clinical trial data showed no children who were given the immunisation fell ill with the virus within 14 days of their second dose, while four children given the placebo later tested positive.

According to Moderna, this is “consistent with a vaccine efficacy of 100%”.

It comes exactly four weeks after Pfizer received approval from the FDA to administer its vaccine to children between ages 12 and 15. 

As of Thursday, more than seven million U.S. children between ages 12 and 17 have received at least one dose of the vaccine.

Still, only about one in three parents said they would immunise their children right away.

Although children can contract Covid and pass the disease on to others, they tend to not get very ill and make up about 0.1% of deaths.

“We are pleased to announce that we have submitted for an emergency use authorization for our Covid vaccine with the FDA for use in adolescents in the United States,” said Moderna CEO Stéphane Bancel in a statement

“We are encouraged that the Moderna Covid vaccine was highly effective at preventing Covid and SARS-CoV-2 infection in adolescents.”…

Moderna’s study included 3,732 adolescents from ages 12 to 17 enrolled at sites across the U.S….

Side effects were mild or moderate with the most common being pain at the site of injection, similar to adults in the clinical trial last year.

Other common symptoms were fatigue, headache, muscle pain and chills, but no serious side effects were reported. 

Worth reading in full.