Three doses of Pfizer-BioNTech's COVID vaccine for the youngest kids were 80 percent effective against the omicron variant of the coronavirus, according to early data the company released on Monday, May 23.
The long-awaited results bring Pfizer's vaccine one step closer to a reality for parents of children ages six months to four years, the only age group in the United States that remains ineligible for vaccination.
BusinessWire reported that results from Pfizer's Phase 2/3 clinical trial also found that the COVID-19 vaccine, which uses a dosage one-tenth the level used for adults, generated a robust immune response in young children and that it was safe.
Efficacy figure may still change as Pfizer gathers more data
Dr. Uğur Şahin, the CEO and a co-founder of BioNTech, issued a statement about the new data, saying, "The findings suggest that the low-dose vaccine provides young children with a high level of protection against the recent Covid-19 strains. We are preparing the relevant documents and expect completing the submission process to the FDA this week."
The 80 percent efficacy figure may change as Pfizer-BioNTech gathers more data. The findings are based on ten symptomatic cases of COVID that transpired seven days after the third dose of the vaccine was administered on April 29.
A formal analysis will be performed by the company once at least 21 positive cases are recorded in the clinical trial. The company said that the safety and immune response data are finalized.
The first two doses of the COVID vaccine are given three weeks apart, followed by a third dose that is provided at least two months later. The company's findings were announced in a news release, and the complete data have not been made available for outside experts to review.
Dr. Isaac Bogoch, an infectious disease specialist at the University of Toronto, told NBC News that while the findings are helpful, more vaccine data in young children is still needed.
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COVID cases on the rise across the U.S., including among children
Bogoch said that in the omicron era, it does not appear that vaccine protection against infection is long-lasting. He added that it would be helpful to power studies to see the protective benefit from two versus three COVID vaccine doses against severe infection, which Bogoch said is less common in this age cohort but can still happen.
Dr. William Schaffner, an infectious diseases expert at the Vanderbilt University Medical Center, said that the trial data of Pfizer may be too small to detect myocarditis, although he does not expect the inflammatory heart condition to be a problem for this particular age group. The mRNA Covid vaccines, from both Moderna and Pfizer, have been linked to a small but increased risk of the side effect in young adults and older teens.
COVID cases are again on the rise across the United States, including among kids. The American Academy of Pediatrics reported 93,000 new cases in children during the week that ended on May 12, a 76 percent increase from two weeks before.
