Lauren Dempsey, MS in Biomedicine and Law, RN, FISM News
The FDA has accepted Pfizer BioNTech’s application for an emergency use authorization (EUA) of their COVID-19 vaccine that would allow infants and young children to receive COVID-19 vaccines.
If granted authorization, children ages 6 months to 5 years old will become eligible for vaccination by the end of June. Pfizer-BioNTech’s clinical trials found that three doses of the vaccine for children 6 months to under 5 years were 80% effective against Omicron. The dose for children in this age group is 3-micrograms, which is one-tenth of the adult dose.
In a press briefing last week, the White House COVID-19 response coordinator Dr. Ashish Jha spoke about this development saying “We know that many, many parents are eager to vaccinate their youngest kids and it’s important to do this right. And that’s what this process has been all about.”
Some, however, have questioned the need for vaccination in this age group.
Time and data have proven that Pfizer BioNTech’s vaccines have provided limited protection for a short duration in adults, causing many to wonder if the lack of durability warrants any risks, even if minimal, that the vaccine may pose for children.
Data from Pfizer-BioNTech’s clinical trial revealed that “efficacy peaked at 96.2% during the interval from 7 days to less than 2 months after the second dose and declined gradually to 83.7% from 4 months after the second dose to the data cutoff date — an average decline of approximately 6% every 2 months.” This implies that parents will eventually need to take children for COVID-19 boosters every few months to maintain effectiveness of the vaccine, similar to boosters that are recommended for adults.
Statistically children have the lowest risk of death or serious illness from COVID-19, while those aged 75 and older are facing the greatest risk. Under the EUA, vaccines were rushed to market and in many cases mandated, but deaths from COVID-19 are lower now than they have been over the last 2 years, raising the question of the relevancy of an EUA.
An EUA implies that America is still in a public health emergency which requires government protection and intervention. Current data would suggest that the U.S. is no longer in a public health emergency, voiding the need for an EUA.
Last fall the FDA’s vaccine advisory panel recommended approval of the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 even with a lack of data. FDA member Dr. Eric Rubin, said at that time, “We’re never going to learn about how safe the vaccine is unless we start giving it – that’s just the way it goes.”
In April, Moderna applied for authorization of its two-dose vaccine for children under 6 years old with the pharmaceutical company saying the vaccine was 51% effective against symptomatic infection for children ages 6 months to 2 years and 37% effective for children aged 2 to 5 years old. Moderna’s 25-microgram two dose series is one-quarter of its adult dose.
Moderna also just released information on a new “bivalent” COVID-10 booster, which targets the original SARS-CoV-2 virus and Omicron variant. The booster produced 1.75 times more neutralizing antibodies, however, Moderna has not yet released clinical trial data and there is no evidence that the durability has improved.
The FDA’s advisory group, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet June 14 and 15 to review the data submitted by both pharmaceutical companies. If approval is granted the CDC will then make a final recommendation.
The vaccines are available for purchase and states can begin placing orders this week. There will be 10 million doses available, and if the FDA grants an EUA the government will start to ship the vaccines across the country.
According to a new survey by the Kaiser Family Foundation, only 1 in 5 parents plan to get their children under 5 years old vaccinated. 27% of those polled say they will “definitely not” get their child vaccinated and 11% said they would only do so if a vaccine is required.