Tracking the FDA advisory panel meeting on Covid-19 vaccines for kids

The second some dad and mom have been anxiously awaiting for months is sort of right here: The Pfizer-BioNTech Covid-19 vaccine for kids aged 5 to 11 will probably be licensed to be used within the subsequent week, after completion of a four-step course of that begins in the present day.

It’s also a second some portion of fogeys has been dreading for months. And over the weekend, they made their issues identified to specialists on the Meals and Drug Administration’s vaccines advisory committee, which meets in the present day to overview the proof on the Pfizer vaccine’s security and efficacy in children ages 5 to 11. Members of the the Vaccines and Associated Organic Merchandise Advisory Committee (VRBPAC) have been deluged by an organized e mail marketing campaign urging them to not advocate the vaccine.

“Over the weekend I used to be getting about one e mail each minute,” mentioned VRBPAC member Paul Offit, a vaccines knowledgeable at Kids’s Hospital of Philadelphia, who mentioned by the point the weekend was over he had acquired “lots of and lots of.”

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Offit and colleagues on VRBPAC will meet all day to overview the information and are scheduled to vote on the finish of the day on whether or not, of their estimation, the advantages of the vaccine outweigh the dangers for this group of kids. If licensed, the Pfizer vaccine would be the first pediatric Covid vaccine.

The FDA isn’t sure to comply with VRBPAC’s recommendation, although it usually does, and disregarding it on a problem as delicate as authorizing a Covid vaccine for kids would make for a problematic launch of this system to vaccinate 5- to 11-year-olds. Whereas the committee’s vote will not be unanimous, it’s unlikely to vote in opposition to authorizing this vaccine for kids.

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A day or so after VRBPAC votes, the FDA is anticipated to subject an emergency use authorization for the Pfizer vaccine. Step three of this course of is having advisers to the Facilities for Illness Management and Prevention overview the vaccine’s security and efficacy and vote on whether or not CDC Director Rochelle Walensky ought to advocate its use. The Advisory Committee on Immunization Practices meets subsequent Tuesday, Nov. 2. If it advises Walensky to advocate the vaccine, the CDC director is probably going to try this inside hours, permitting the vaccination of 5- to 11-year-olds to start as early as Nov. 3. There are already 16 million doses of the pediatric vaccine obtainable — with extra to return — for states to order and so they have been ordering it, although transport received’t start till the FDA points the authorization.

Matthew Herper and I will probably be live-blogging in the present day’s VRBPAC assembly, which begins at 8:30 a.m. ET. You’ll be able to watch it here. We will probably be posting our updates and evaluation beneath in reverse chronological order; verify again usually.

— Helen Branswell

Some context for in the present day’s discussions

7 a.m.: The Pfizer-BioNTech vaccine is the one one of many U.S.-deployed Covid vaccines that can be utilized by folks right down to the age of 12. Anybody 12 and older will get the identical dose of vaccine, on the identical routine — two 30 microgram pictures given 21 days aside.

However for youthful kids, the FDA required the corporate to conduct further checks to find out the security and efficacy of the vaccine in kids. Pfizer examined three doses: 10 micrograms, 20 micrograms and 30 micrograms. It’s in search of emergency authorization for the 10-microgram dose, which is one-third as a lot vaccine as is given to adults. The corporate mentioned Friday that the youngsters’s dose was 91% efficient at stopping symptomatic Covid-19 on this age group.

Uncomfortable side effects have been usually much like these reported by adults who received the Pfizer vaccine — issues like complications and fevers.

One of many hallmarks of an FDA overview is that the company doesn’t simply take the phrase of a would-be producer of a vaccine or drug; its workers reanalyze the unique information to make sure the FDA agrees with the claims the corporate in search of a license or emergency authorization is making.

Matt reviewed the FDA’s evaluation, which was launched Friday night time. The company’s scientists concluded the safety supplied by the vaccine would positively outweigh any threat of myocarditis — irritation of coronary heart muscle — that the vaccine seems to set off not often in some teenagers and younger adults, largely males. The circumstances seen after use of the vaccine seem like milder than common myocarditis and of shorter period. Not less than in teenagers and younger adults, Covid an infection is way extra more likely to set off myocarditis than the vaccine is, in keeping with research from Israel.

The Pfizer examine in contrast 1,518 kids who acquired the vaccine to 750 kids who acquired a placebo. There have been three circumstances of symptomatic Covid among the many former and 16 among the many latter. The vaccinated kids who contracted Covid had very gentle signs; none had fever. However 10 of the 16 unvaccinated kids had fevers and signs have been extra pronounced general within the placebo group.

The FDA analysts used mathematical modeling to estimate what number of hospitalizations can be prevented by vaccinating one million boys within the 5 to 11 age vary at six totally different factors within the pandemic in america. At most factors, the vaccine would stop 200 to 250 hospitalizations per a million vaccinated boys. However when transmission of the SARS-CoV-2 virus was low, because it was in June 2021 — earlier than the unfold of the Delta variant — the vaccine would solely have prevented solely 21 hospitalizations per a million boys, the company’s mannequin recommended.

That meant, the FDA mentioned, that at occasions of low transmission the vaccine would possibly set off barely extra myocarditis-related hospitalizations in boys than Covid-related hospitalizations it prevents. However even then, it mentioned, the advantages should still outweigh the dangers, as a result of the myocarditis circumstances are primarily gentle and the Covid circumstances that require hospitalization are extra extreme.

The necessity to steadiness the vaccine’s advantages versus the dangers of myocarditis is more likely to be the important thing subject of in the present day’s discussions. Not less than one VRBPAC member, Tufts Medical Middle pediatrician Cody Meissner, has been indicating for months that he has severe issues about utilizing the vaccine in people who find themselves at decrease threat of creating extreme illness in the event that they contract Covid. Children positively fall into that class, so Meissner will probably be vocal in the present day.

— Helen Branswell