U.S. FDA Discussing COVID-19 Vaccinations for Infants

The U.S. Food and Drug Administration (FDA) announced a virtual meeting will take place on February 15, 2022, to discuss the request for emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.

Previously, the FDA authorized this mRNA vaccine for use in children 5 through 11 years of age in October 2021 and recently authorized the use of a single booster dose in individuals 12 through 15 years of age and older.

The Pfizer-BioNTech COVID-19 Vaccine, known internationally as Comirnaty, is a global leader in COVID-19 vaccinations.

According to the U.S. Centers for Disease Control and Prevention (CDC), there are approximately 18 million children less than 5 years of age in the U.S. 

Since the COVID-19 pandemic began in January 2020, the CDC has confirmed 287 children in this age cohort have died from COVID-19 related illnesses, as of February 2, 2022.

“The need for a safe and effective vaccine for our youngest children is significant, particularly given the rapid spread of the omicron variant, the notable rise in the number of hospitalizations in young children with severe disease, and the possibility that future variants could cause severe disease in those who are unvaccinated,” commented Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press statement issued on February 1, 2022.

“As we have done for other COVID-19 vaccine authorizations, this meeting will help ensure that the public has a clear understanding of the data and information the FDA will evaluate as it considers whether to authorize the vaccine.”

“We are committed to a transparent process, which will include input from our external advisors.”

The FDA intends to make the Vaccines and Related Biological Products Advisory Committee (VRBPAC) background material available to the public, including the meeting agenda and committee roster, no later than two business days before the meeting.

The CDC recently published an Original Investigation in the peer-reviewed journal the JAMA Network on January 25, 2022.

This CDC investigation found 1,991 cases of myocarditis (0.00004%) were reported to the Vaccine Adverse Event Reporting System, with 1,626 (0.000008%) meeting the case definition.

Of all patients with myocarditis, the median age was 21 years, 82% were male, with a median time to symptom onset was two days, generally after a second mRNA dose.

And on January 20, 2022, the European Medicines Agency (EMA) confirmed about 545,000,000 Comirnaty doses were given to people in the EU/EEA, and 522,530 side effects have been reported. 

The EMA also stated the outcome of reviews confirmed the risk of myocarditis and pericarditis, which is already reflected in the product information for Comirnaty. 

Based on the reviewed data, the EMA's committee determined that the overall risk for both heart conditions is overall 'very rare', meaning that up to 1 in 10,000. 

However, the EMA’s data shows that the increased risk of myocarditis after vaccination is highest in younger males.

Additionally, Pfizer disclosed on February 1, 2022, these may not be all the possible side effects of the mRNA vaccine. Serious and unexpected side effects may occur. 

The possible side effects of this mRNA vaccine are still being studied in clinical trials.

Moreover, data on the administration of this vaccine at the same time as other vaccines have not yet been submitted to FDA. Individuals considering receiving this vaccine with other vaccines, should discuss their options with their healthcare provider, stated Pfizer in a press release.

In general, the FDA’s VRBPAC vaccine committee includes a Chair, members with scientific, medical, and public health expertise, and a consumer and industry representative.

The FDA is an agency within the U.S. Department of Health and Human Services, that protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices.

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