Parents of children under 5, who are still waiting for a Covid vaccine, have had their hopes raised and then dashed already this year. With the announcement that Pfizer will seek approval for a 3-dose vaccine series for children ages 6 months to 4 years old, it now appears likely that the FDA will approve a vaccine for the youngest children sometime in June.
Pfizer’s announcement comes as welcome news as the U.S. experiences yet another surge in infections, inducing the Philadelphia School District to reinstate its mask mandate.
Pfizer and BioNTech announced that in a subset of participants in their clinical trial of 1,678 children ages 6 months-4 years, a 3-dose series of the vaccine proved to be 80% effective in preventing symptomatic Covid infection.
Dr. Albert Bourla, chief executive of Pfizer, said in a statement: “We are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response.”
This data is preliminary, as only ten Covid cases were reported in subjects enrolled in the study thus far. The data will be analyzed and finalized once there have been 21 cases, as per the clinical trial’s protocol.
“We are preparing the relevant documents and expect completing the submission process to the FDA this week,” said Prof. Ugur Sahin, M.D., CEO and co-founder of BioNTech.
Pfizer had first reported that it was seeking approval of its vaccine for children under 5 in late January, but in February they paused this request, saying that they were awaiting data from the clinical trial of the 3-dose vaccine. Initial approval had been sought for a 2-dose vaccine.
Moderna asked the FDA to approve their vaccine for children under 6 in April and they continue to wait for approval. The Moderna vaccine is given in two doses, at one quarter of the adult dose. Moderna reported that its vaccine series was 51% effective in preventing symptomatic infection in children under 2, and 37% effective in ages 2-5 — meaning that if Pfizer’s preliminary data from their 3-dose vaccine holds up, it offers stronger protection that the Moderna vaccine. It is also possible that Moderna will request approval for a booster dose of their vaccine.
A committee of outside advisors will examine the data and make a recommendation to the FDA, likely in mid-June. The committee might recommend authorization of the Pfizer, Moderna, or both vaccinations.
The FDA has recently approved a booster shot of the Pfizer vaccine for ages 5-11. Data released at the end of February found that the vaccine’s effectiveness declined rapidly over time when faced with the highly infectious omicron variant. Pfizer is the only vaccine currently approved for this age group, although Moderna is also seeking approval for its vaccine for children ages 6-11 and 12-17.
While Covid infections in children are generally mild, many parents are eager to vaccinate their kids to protect against the possibility of long Covid, which does occur in children, as well as to help slow the spread of disease. Data also show that the vaccine offers protection against hospitalization and death, although both are uncommon in children.
Yet only 28% of children ages 5-11 were fully vaccinated by this April, according to the CDC, indicating a significant amount of parental reluctance. The Pfizer vaccine was approved for this age group in late October. CDC data shows that approximately 75% of children have already had Covid.