Drug regulatory bodies in the United States have been urging the pharma giant Pfizer to apply for Emergency Use Authorization (EUA) for its two-dose COVID-19 vaccine for children 6 months to 5 years old, a source told The Associated Press yesterday.
The company is expected to submit for the EUA by today.
Earlier, trials have shown that Pfizer’s COVID vaccine, which is administered to younger children at one-tenth the dose of the adult shot, is safe and produces an immune response. However, last year, the company announced the two-dose vaccine proved to be less effective at preventing COVID in children ages between 2 and 5.
The regulatory bodies encouraged Pfizer to add a third dose to the study, believing that another dose would enhance the vaccine’s efficacy much like the booster dose does in adults.
The Food and Drug Administration (FDA) is pushing the company to submit its EUA application based on the two-dose data for potential approval this month, and then to return for additional approval once it has the data from the third dose study, which is expected by the next month.
The two-step approval process could mean that younger children could be vaccinated a month earlier than previous estimates, assuming the FDA and the Centers for Disease Control and Prevention (CDC) authorize the shots.
The source, who spoke on the condition of anonymity to discuss sensitive regulatory issues, said the decreased efficacy of the two-dose COVID vaccine was not unexpected due to the emergence of Omicron, the highly transmissible variant of COVID-19.
“Allowing young kids to be vaccinated with a two-dose shot earlier would ultimately accelerate when they could get the expected stronger protection from a third dose,” per the news outlet. “That would be welcome news for parents of young children, the last remaining age group without approval of COVID-19 shots.”
Compared to adults, young children are far less likely to develop serious complications or to die from COVID-19. However, the number of cases in children has increased amid the nationwide spike in Omicron cases. Most cases, hospitalizations, and deaths have occurred in older people, especially the unvaccinated.
The Biden administration has been bolstering the approval of pediatric vaccines against COVID-19, which could help reopen and keep open schools and daycare centers.
The FDA and CDC approved the use of vaccines among children aged between 5 and 12 in November. However, the rate of vaccination in that group has been slower than officials hoped.
Pfizer’s two-dose COVID vaccine in children ages 5-12 is administered three weeks apart. The company is studying the efficacy of the third dose for young children. The news was published in The Washington Post and The Associated Press.
