Tuesday, 30 November, 2021
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FDA committee endorses Pfizer-BioNTech vaccine for 5- to 11-year-olds

On Tuesday this week, the US Food and Drug Administration's vaccine advisory committee overwhelmingly endorsed a smaller dose of the Pfizer COVID-19 vaccine for children aged 5-11, a key step in getting shots to the 28m children in the age group.

The CDC had reported that the Pfizer-BioNTech vaccine is 93% effective against hospitalisation for COVID-19 among 12- to 18-year-olds, the strongest evidence yet of the vaccine’s ability to keep young people out of the hospital, and the committee decided that the benefits far outweigh the risks for the age group. US News reports that most committee members believed the shot would be important to continuing in-person learning for children, although others cited concern about the increased risk of myocarditis, a rare condition of heart inflammation that has been linked to the Pfizer and Moderna shots. Others expressed worry that authorisation of the vaccine in this age group could lead to vaccine mandates from schools.

Although the FDA doesn’t have to follow the committee’s recommendations, it usually does. The CDC’s vaccine advisory committee meets next week to consider the shot. If the CDC director accepts the recommendations, the vaccinations can begin.

The New York Times reports that the study offers additional signs that vaccinating more young people could not only reduce the spread of the virus in the US, but also protect those children from the rare cases in which they become severely ill.

“This evaluation demonstrated that two doses of Pfizer-BioNTech vaccine are highly effective at preventing COVID-19 hospitalisation in 12-18-year-olds”, the agency’s scientists wrote, “and reinforces the importance of vaccination to protect the youths against severe COVID-19.”

The CDC studied young people who were hospitalised at 19 paediatric hospitals across 16 states from June to September. It compared the odds of vaccination among young patients with COVID and children in hospital with other illnesses.

Among the 179 patients in the study with COVID, 3% were vaccinated and 97% were unvaccinated. Twenty-nine of the young COVID patients needed life support, and two died; all were unvaccinated, the agency said. Vaccinated children with COVID also tended to have shorter hospital stays than unvaccinated children.

Nearly three-quarters of the COVID patients in the study had at least one underlying health condition, adds The New York Times, including obesity, diabetes, asthma or respiratory disorders, putting them at higher risk of severe illness.

Since last Monday, 46% of children aged 12 to 15 had been fully vaccinated across America, as were 54% of 16- and 17-year-olds. The Pfizer-BioNTech vaccine is authorised for emergency use in children aged 12 to 15, and fully approved in those over 16. Booster shots have not been authorised for anyone in the US under 18 years old.

Paediatric hospitalisations rose as the Delta variant spread across the United States, reaching their highest level during the pandemic in September, the CDC said.

A clinical trial of the Pfizer-BioNTech vaccine had earlier shown that the shots were highly effective at preventing COVID in children, but had not examined effectiveness against hospitalisation in that group.

US News article – FDA Committee Endorses Pfizer COVID-19 Vaccine for Kids 5-11 (Open access)

 

New York Times article – Pfizer-BioNTech’s vaccine is highly effective against hospitalization for those 12 to 18, a study shows. (Restricted access)

 

See more from MedicalBrief archives:

 

Phaahla’s move on jabs for 12-year-olds without parental consent ruffles feathers

 

CDC investigates 'relatively few' reports of myocarditis from Pfizer vaccination

 

Pfizer vaccination ‘highly effective’ against Delta in adolescents — Israel study

 

NICD: SA should consider vaccinating adolescents against COVID

 

 

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