UVA Today

Enter into this equation that the omicron variant that has led to record numbers of children under age 5 hospitalized with COVID-19, suggesting that omicron may not be as mild in these younger children as it is on adults. The FDA asked Pfizer to apply for emergency use authorization prior to the results of the three-dose study are complete. ... Pfizer has followed through with an [emergency use authorization] request. The FDA announced Monday that it is convening its Vaccine and Related Biologic Products Advisory Committee on Feb. 15 to discuss the request for emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age. The data that the committee will be evaluating will be released to the public no less than two days prior to the meeting, and the meeting itself will be live-streamed on YouTube.

My take on this is that this is a good thing to move forward with evaluation of the safety and efficacy of the two-dose vaccine in the 6-month to 4-year-old children. The review will be conducted in public so that everyone can see the data, and if the Vaccine Advisory Committee judges that EUA should be granted, there are still independent reviews of the vaccine by the full FDA, the independent Advisory Committee on Immunization Practices and, finally, the CDC. So there are a lot of checks and balances to ensure the correct decision is reached.

Q. Can you walk us through how these vaccines were tested for safety? 

A. Safety data will be released by the FDA in advance of the Feb. 15 Vaccine Advisory Committee meeting, so we will all see the safety data then. What has already been published in the New England Journal of Medicine on Jan. 6 is the safety data for the same vaccine (at the higher dose of 10 µg) in children 5 to 11 years of age. ... The vaccine was approximately 95% effective at preventing COVID-19, which at the time, was predominantly the delta variant.

Q. Many parents are struggling with frequent day care closures due to COVID outbreaks. Will CDC guidelines mandating these closures likely change once children under 5 are fully vaccinated?

A. If vaccination is required for staff and children in day care, then one would anticipate that closures due to COVID-19 will be a thing of the past.

Q. What is the efficacy for this vaccine? And how quickly will a child begin showing immunity against COVID after becoming fully vaccinated?

A. With older children, we know, seven days after receiving the second dose, that the vaccine was approximately 95% effective at preventing COVID-19 from the delta variant. With two doses in children 2 to 5 years of age where the immune response is less, and with the omicron variant, one would anticipate that the vaccine will be less effective, with some unpublished estimates of 50% to 60% effective.

The thought of the FDA, I believe, is that the clinical trial testing of the third dose will be completed in time for the children to receive that third dose, should it be proven safe and effective.

Q. Will young children also need booster shots in the future, roughly five to six months after full vaccination?

A. The mRNA vaccines are moving to a three-dose set of primary vaccinations or shots for all age groups, so, yes, most likely a third dose will be needed.

Q. Do children need to be vaccinated if they’ve already had COVID-19?

A. The degree to which vaccination will enhance naturally acquired immunity from omicron is not known, athough for prior variants, there was added protection by vaccination. Booster vaccinations will, in all likelihood, become part of the landscape of childhood vaccinations in any case, as immunity to coronavirus is short-lived and not lifelong.  

Q. Can COVID vaccines be given to children along with their regularly scheduled vaccinations?

A. Yes, the COVID vaccine will become incorporated into the schedule of childhood vaccinations.

Q. After authorization, how quickly do you expect this vaccine to be readily available in Charlottesville? 

A. There should be little in the way of delay, as although the dose is different than the currently used vaccines, there is no shortage overall of the Pfizer BioNTech vaccine in the U.S.