On Monday, Pfizer and BioNTech declared their two-dose COVID-19 vaccine safe for children aged 5 to 11. With scientists describing it as “safe and well-tolerated” in children under the age of 12.
This declaration was based on data collected in trials that involved more than 2,000 children in nearly 100 clinical trial sites in 26 U.S. states, Finland, Poland and Spain. Children in the trial were given smaller doses compared to the doses given to 12-year-olds and older. And according to the two Pharma companies, their vaccines were well tolerated and showed “robust” neutralizing antibody responses in children in the 5 to 11 age group.
According to Pfizer and BioNTech, the immune response and side effects were seen among children between 5-11 years were quite similar to that of 16-to25 year-olds. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower does are consistent with those we have observed with our vaccine in other older populations a higher dose,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech, in a statement.
Based on these results, Pfizer and its German Partner BioNTech will be applying for an emergency use authorization with the U.S Food and Drug Administration (FDA) this month. The giant Pharma will also be seeking authorization in Europe.
“We intend to submit the data by the end of the month and then, of course, it will be up for the FDA to review that data and determine whether the vaccine can be released for broad use,” said Dr. Bill Gruber, Pfizer’s senior vice president of vaccine and clinical research and development as well a pediatrician said, in an interview with NBC “TODAY” show.
While Pfizer and BioNTech submit data to the FDA for vaccine use for children under 12, they say that they are currently testing their vaccine in children under five. The result from these trials will be released by the end of the year.
It will not be the first time Pfizer has applied for an emergency use authorization from the FDA. The company first applied for emergency use authorization use in November last year for its adult vaccine. Pfizer jumped this hurdle with the FDA granting them full approval for their two-dose COVID-19 vaccine for 16-year-olds and older. The vaccine is currently being administered to 12 to 15-year-olds, also under the FDA’s emergency use authorization.
Half of the 5- to 11-year-olds were given two doses of the vaccine 21 one day apart in the clinical trial for this vaccine. The other half were given placebo shots. However, a lower dose of the vaccine was given to the first half, 11hg dose, while those aged 12 and above got 30hg. Unlike those of adults, these pediatric trials were not based on efficacy but rather the number of antibodies induced by the vaccine in the children. Therefore, the vaccine’s efficacy cannot be disclosed, that according to a Pfizer spokesperson.
The announcement made by Pfizer couldn’t come at a better time as hospitalizations and deaths have recently gone up in the U.S. due to the highly contagious variant. With pediatric cases trending up as well, 71,726 per week at the beginning of August and 243,000 just last week, parents in a poll were split in half-50/50 about the Pfizer vaccine.