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US panel recommends Pfizer COVID-19 vaccine for younger children

Issam Ahmed - Agence France-Presse
US panel recommends Pfizer COVID-19 vaccine for younger children
(FILES) In this file photo taken on May 13, 2021, Aiden Arthurs receives the Pfizer-BioNTech Covid-19 Vaccine from Pharmacist Andrew Mac (R) in Bloomfield Hills, Michigan. A high level medical panel of US government advisors was meeting on October 26, 2021, to decide whether to authorize the Pfizer Covid-19 vaccine in five-to-11-year-olds, likely paving the way for younger children to get their shots within weeks. If, as expected, the independent experts convened by the Food and Drug Administration (FDA) vote in favor, it will set in motion actions leading to 28 million more Americans becoming eligible for immunization.
AFP / JEFF KOWALSKY

WASHINGTON, United States — A medical panel of US government advisors endorsed the Pfizer Covid-19 vaccine in five-to-11-year-olds Tuesday, paving the way for younger children to get their shots within weeks.

The independent experts concluded the known benefits — both directly to kids' health but also in ending school and other disruptions — outweighed the known risks.

After a day of presentations and debate, the final vote was 17 in favor and one abstention.

The Food and Drug Administration, which convened the meeting, is expected to give its formal green light soon, making 28 million young Americans eligible for the shot by mid-November.

"It is pretty clear to me that the benefits do outweigh the risk when I hear about children who are being put in the ICU, who are having long term outcomes after their COVID, and children are dying," said Amanda Cohn of the Centers of Disease Control and Prevention (CDC), who voted yes.

"It's never when you know everything — the question is when you know enough," said Paul Offit, a pediatrician at the Children's Hospital of Philadelphia, who also voted yes but reflected on the fact that more complete safety data would become available over time.

He added that many children who are at high risk stand to benefit, and that the theoretical risk of myocarditis, the most worrisome side-effect, would probably be very low, given the lowered dose of 10 micrograms, compared to 30 micrograms in older ages.

Nevertheless, several experts partly caveated their votes by saying they would not favor broad vaccine mandates in schools and the shot should remain a personal decision for families.

Earlier, top FDA vaccine scientist Peter Marks said younger children were "far from being spared harm of Covid-19," adding that, in this group, there had been 1.9 million infections and 8,300 hospitalizations, roughly a third of which required intensive care.

There have also been around 100 deaths, making it a top 10 leading cause of death, he added.

Rare side-effects

An analysis by Pfizer posted by the FDA before the meeting showed the vaccine was 90.7 percent effective at preventing symptomatic Covid-19.

FDA scientist Hong Yang presented a risk-benefit model that showed at current infection rates, the vaccine would prevent far more hospitalizations from Covid than they might cause from myocarditis.

If community transmission was brought down to very low levels, this may change -- but even then vaccination might be worthwhile because of long term risks linked to non-hospitalized cases, she added.

These include multisystem inflammatory syndrome in children (MIS-C), a rare but highly serious post-viral complication, which has affected more than 5,000 children of all ages and claimed 46 lives.

In its clinical trial, Pfizer evaluated safety data from a total of 3,000 vaccinated participants, with the most common side-effects mild or moderate, including injection site pain, fatigue, headache, muscle pain and chills.

There were no cases of myocarditis or pericarditis (inflammation around the heart), but experts agreed there were not enough study volunteers to be able to detect highly rare side-effects.

Matthew Oster, a CDC researcher, gave a presentation on what is known so far about these side-effects among groups already eligible for vaccines.

Of 877 vaccine-induced myocarditis cases in under 29s, 829 were hospitalized, according to official data. The vast majority were discharged but five remain in intensive care.

The rate will probably be lower in the five-to-11 age group than among adolescent males, because it is thought to be linked to testosterone.

The panel weighed this theoretical risk against preventing Covid, which may cause more frequent and severe myocarditis.

The meeting comes as the United States is emerging from its latest wave driven by the Delta variant.

Overall, 57 percent of the total population is now fully vaccinated. 

Vaccine confidence has risen in recent months, but the United States remains behind every other G7 nation in percent of population fully vaccinated.

COVID-19 VACCINES

PFIZER

UNITED STATES

As It Happens
LATEST UPDATE: June 16, 2022 - 8:48am

Pharma giants Sanofi and GSK said on July 29, 2020, that they have agreed to supply Britain with up to 60 million doses of a potential COVID-19 vaccine. The agreement covers a vaccine candidate developed by France's Sanofi in partnership with the UK's GSK and is subject to a "final contract."

This thread collects some of the major developments in the search for a vaccine to ease the new coronavirus pandemic. (Main photo by AFP/Joel Saget)

June 16, 2022 - 8:48am

A panel of experts convened by the US Food and Drug Administration unanimously recommends Covid-19 vaccines  for children under five, the final age group awaiting immunization in most countries.

Formal authorizations should follow soon, with the first shots in arms expected early next week, just over a year-and-a-half after the first Covid vaccines were greenlighted for the elderly in December 2020.

"This recommendation does fill a significant unmet need for a really ignored younger population," says Michael Nelson, a professor of medicine at the University of Virginia, one of the 21 experts asked to vote for the milestone meeting. — AFP

June 15, 2022 - 9:24am

A panel of US medical experts recommends the Moderna COVID-19 vaccine for use in children aged six through 17.

Formal authorization should soon follow, at which point families will have a second option against the coronavirus, as Pfizer's vaccine was given the greenlight for teens and younger children last year.

After weighing available data, 22 experts convened by the US Food and Drug Administration unanimously agreed that the known benefits outweighed the known risks when Moderna's vaccine was administered as two shots at the adult dose of 100 micrograms to those aged 12-17, and half of that for children 6-11. — AFP

June 8, 2022 - 10:16am

A panel of experts convened by the US drug regulator recommends the Novavax COVID-19 shot, a late runner in the fight against the virus that could nonetheless play a role in overcoming vaccine hesitancy.

Three vaccines are currently approved in the United States: Pfizer and Moderna, which are based on messenger RNA, and Johnson and Johnson, which recently received a recommendation against broad use becase of links to a serious form of clotting.

Experts voted 21 in favor of the Novavax vaccine, with none against, and one abstention, despite some concerns it may be linked to rare cases of heart inflammation. — AFP

June 4, 2022 - 6:04pm

The Food and Drug Administration voices concern about myocarditis being potentially linked to the Novavax COVID-19 vaccine, just as experts are to weigh its use in the United States. 

The Novavax vaccine is already authorized in other countries, particularly in Europe. In the United States, an independent committee convened at the request of the FDA is to meet Tuesday to evaluate data from the clinical trials of Novavax and give its recommendation. 

In advance of that, the agency published a lengthy document on Friday analyzing these results, as it had done for the three other vaccines already authorized in the country. — AFP

April 14, 2022 - 9:19am

The head of US pharmaceutical giant Pfizer says a COVID-19 vaccine effective against multiple variants is possible before the end of 2022.

Chairman Albert Bourla says the firm was also working on producing a vaccine that could provide good protection for a whole year, meaning people would come back annually for boosters, as with influenza shots.

"I hope, clearly by autumn... that we could have a vaccine" that worked against not only the dominant Omicron but all known variants, he says. — AFP 

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