FDA Vaccine Advisory Committee Recommends Moderna and Pfizer-BioNTech Vaccines for Everyone 6 Months and Older

Today, the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to discuss approving the Pfizer-BioNTech and Moderna mRNA COVID-19 vaccinations for young children.

The committee unanimously voted to recommend Emergency Use Authorization (EUA) of the Pfizer-BioNTech vaccine for children 6 months-4 years of age, and the Moderna vaccine for children 6 months-23 months of age and 2 years-5 years of age.

With this vote, and yesterday’s VRBPAC decision to recommend expanding Moderna’s EUA to children 6-17 years, all Americans 6 months and older have access to mRNA COVID-19 vaccination.

Before the 2 VRBPAC meetings this week, the Pfizer-BioNTech vaccine was approved for Americans as young as 5 years of age, while the Moderna vaccine was only available to people 18 yeara and older.

Now, the FDA and US Centers for Disease Control and Prevention (CDC) will review the data and decide whether to acquiesce to VRBPAC’s recommendations. Historically, however, FDA and CDC COVID-19 vaccine authorizations have followed VRBPAC endorsements.

Since the beginning of the pandemic, there have been misconceptions that children cannot get sick or die of COVID-19. However, approximately 25% of children 0-4 years old require intensive care unit (ICU) admission after being hospitalized with COVID-19. In the US, there have been a total of 442 COVID-19 deaths in children 0-4 years.

VRBPAC voted on the following questions:

• Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine when administered as a 2-dose series (25 μg each dose) outweigh its risks for use in infants and children 6 months through 5 years of age?
• Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 3-dose series (3 μg each dose) outweigh its risks for use in infants and children 6 months through 4 years of age?

There has been criticism of the FDA for waiting this long to approve COVID-19 vaccination for these youngest children, despite having access to trial data for these age groups. The emergence of the Omicron variant caused unprecedented rates of severe and fatal infections in children. As COVID-19 vaccines were approved and mask mandates were lifted, young children were left behind.

However, several members of the committee noted that the number of children dying of fatal COVID-19 infection is relatively low, with one VRBPAC expert comparing the figure to the number of people struck by lightning each year.

After the votes, many VRBPAC members explained that COVID-19 vaccination may not be necessary for each child. Rather, VRBPAC is recommending both mRNA vaccines so that parents can choose whether to vaccinate their youngest children against COVID-19.

There was considerable debate surrounding the Pfizer-BioNTech and Moderna dosages to recommend for these youngest children. Given that young children are slated to receive a significantly lower dose of vaccine than adults, the committee discussed how many doses should be considered a primary series.

They noted that over time, especially among immunocompromised children, as many as 4 or 5 vaccine doses may be required to ensure adequate protection.