Three Pfizer Shots 80% Effective Against Omicron in Toddlers, Trial Data Show
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Pfizer-BioNTech made an announcement on Monday that their new three-dose COVID-19 vaccine for children under the age of 5 is 80% effective in preventing infections, including those caused by the Omicron variant. This is a significant improvement in efficacy compared to Moderna, which stated in March that their two-dose vaccine is 51% effective in children aged 6 months to 2 years, and 37% effective in children aged 3 to 6 years. Researchers believe that both vaccines provide strong protection against severe illness and hospitalization in this age group.
The U.S. Food and Drug Administration (FDA) has scheduled a meeting on June 15 for its vaccine advisory committee to review emergency use authorization requests from Moderna and Pfizer-BioNTech for children aged 6 months to 5 years and 6 months to 4 years, respectively. While Pfizer and BioNTech have not yet submitted their request, they plan to do so by the end of the week, according to a press release from BioNTech CEO Ugur Sahin.
The advisory committee will provide a recommendation on the approval of the vaccines at the end of the meeting, which is typically followed by the FDA. Many experts are hopeful that the shots will be approved shortly after the mid-June meeting. Peter Hotez, co-director of Texas Children’s Hospital’s Center for Vaccine Development, expressed optimism that immunization for children under 5 could begin as early as next month.
Children under the age of 5 are currently the only Americans without access to COVID vaccines, and parents are eager to protect their children, particularly as cases are once again on the rise, stated Dr. Jennifer Shu, a pediatrician based in Atlanta. When news about Pfizer’s vaccine was announced on Monday, several parents inquired about adding their children to a waiting list for the upcoming vaccines. Dr. Shu assured them that there will be availability for everyone who wants the shots, as her practice has consistently received an adequate supply of pediatric vaccines.
The news from Pfizer and BioNTech comes after a prolonged saga that repeatedly raised hopes for vaccinating toddlers against COVID, only to later disappoint. In late February, Pfizer-BioNTech initially requested emergency authorization from the FDA for a two-dose vaccine for children aged 6 months to 4 years, but withdrew the application just five days later. In April, when Moderna was preparing to submit their application for emergency use authorization, it was reported that the FDA might delay the review process until Pfizer’s vaccine was also ready. This sparked anger and led to a congressional letter demanding an explanation from the agency. The announcement of the June 15 committee meeting seems to confirm these speculations of a simultaneous review.
The trial results released on Monday clarified what experts had suggested since February, that Pfizer’s two-dose vaccine did not provide full protection for young children. According to Hotez, it was always intended to be a three-dose vaccine.
This news comes at a time when reported COVID-19 cases in the U.S. have increased by 53% in the past two weeks, with youth infections also on the rise, albeit at a slower rate. However, these numbers may not capture the complete extent of new cases due to increased at-home testing, as explained by Dr. Shu.
A recent study by the Centers for Disease Control and Prevention (CDC) revealed that during the winter’s Omicron surge, children under the age of 5 were hospitalized with the virus at a rate five times higher than during the Delta surge. In February, CDC data showed that 3 out of 4 children under 18 had been infected with the virus. Repeat infections remain a concern and can occur within a few months of each other. Dr. Shu explained that unvaccinated children are more likely to become ill and experience severe outcomes compared to their vaccinated peers, emphasizing that many hospitalized children have not received the vaccine.
In addition to suggesting that children get vaccinated as soon as they are eligible, the pediatrician proposes that schools should consider implementing mandatory mask-wearing policies as cases of infection increase. While a small number of schools and districts have already taken this step, the majority still allow masks to be optional, although some have strengthened their language in recommending their use.
However, Shu is aware of some children who have chosen to wear masks at school after witnessing their peers falling ill. With prom and graduation season underway, these young individuals do not want to miss out on these important events.
"It is not possible to replace or recreate these experiences if you miss them," Shu emphasized.