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FDA's Independent Vaccine Committee Meets Today to Discuss Pfizer Vaccine for Children

2021-10-26T13:19:41.775Z


The vaccine committee will listen to and discuss presentations from the US CDC on the impact of COVID-19 on children and will also discuss any potential vaccine safety issues.


Vaccinate children, vital to put a positive spin on the pandemic 2:34

(CNN) -

The US Food and Drug Administration (FDA) independent vaccine advisory committee meets Tuesday to debate whether the Pfizer / BioNTech covid-19 vaccine should be licensed for children ages 5 to 11. years.

Pfizer's vaccine is already licensed under emergency use for children 12-15 years of age and is approved for individuals 16 years of age and older.

The committee will listen to and discuss presentations from the US Centers for Disease Control and Prevention (CDC) on the impact of COVID-19 on children and will also discuss any potential vaccine safety issues.

Pfizer / BioNTech will also discuss trials it has conducted using a one-third the adult dose vaccine in children ages 5 to 11.

In a new document released ahead of Friday's FDA meeting, Pfizer said its vaccine is safe and 90.7% effective against symptomatic COVID-19 in children ages 5 to 11.

  • Pfizer says its vaccine is 90.7% effective against symptomatic COVID-19 in children ages 5 to 11

In an evaluation released late Friday night, the FDA said the benefits of Pfizer / BioNTech's covid-19 vaccine outweigh the risks to children under current pandemic conditions.

The FDA noted that the vaccine carries a theoretical risk of myocarditis, an inflammation of the heart muscle, or pericarditis, an inflammation of the outer lining of the heart, which could require treatment and even hospitalization.

But the risk of covid-19 is higher if enough virus circulates.

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Children are still less likely to be hospitalized or die from COVID-19 compared to adults, but 745 children 18 and younger have died from COVID-19 in the United States since the start of the pandemic, according to the CDC.

Almost 6.3 million children have tested positive for COVID-19 since the start of the pandemic.

In the week ending October 21, children accounted for a disproportionate number of COVID-19 cases, constituting more than a quarter of all cases in the United States.

Children make up 22% of the US population.

  • Children could be eligible for the COVID-19 vaccine in early November, says Fauci

If the FDA committee votes in favor of the emergency use authorization of the vaccine, the FDA will then make the final decision on its authorization.

The committee will consider the evidence presented by Pfizer that shows that the vaccine is safe and that it works to protect this age group.

Next, CDC's independent vaccine advisory committee will meet on November 2-3 and vote on whether to recommend the vaccine for this age group.

Ultimately, CDC Director Dr. Rochelle Walensky will decide whether to accept or modify the committee's recommendation.

Once Walensky gives his go-ahead, some 28 million children will be able to receive the covid-19 vaccine and the injections could be immediately available.

PfizerVaccinesCovid-19 vaccines

Source: cnnespanol

All news articles on 2021-10-26

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