Pfizer-BioNTech announced Monday that the vaccine against coronavirus was safe and produced a promising immune response during a trial with children aged five to 11.
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Pfizer and BioNTech stated that they will submit the data to the Food and Drug Administration and international drug regulators as soon as possible. This could allow them to make the COVID-19 shot for children younger than ten years old.
Two-dose vaccinations are currently approved for children under 12 years old in the United States. Numerous parents and public-health officials have been calling for vaccines to be expanded into younger populations. This is especially true as COVID-19 cases have increased in recent weeks.
Pfizer and BioNTech are continuing research in younger children. They expect to see results for infants as young as 6 months old by the end of this year.
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Albert Bourla, CEO of Pfizer, stated that since July, the number of pediatric cases with COVID-19 has risen by approximately 240% in the US. This underlines the need for vaccination.
The FDA will be under pressure to quickly act once BioNTech and Pfizer submit their data. Although drug and vaccine reviews can take 9-12 months, the FDA has given priority to assessing COVID-19 vaccines. For example, the FDA took one month to expand Pfizer’s vaccine to 12-year-olds to 15-year olds in May.
It is not clear how fast the FDA will act to allow this expansion into younger children. Pfizer previously stated that it believes the FDA will allow the shot to be administered to younger children before October ends.
Pfizer and BioNTech want to offer the vaccine in two 10-microgram doses for younger children. The vaccine is available in two 30-microgram doses for adults and children aged 12 and over.
Pfizer and BioNTech tried the smaller dose on 2,268 children aged 5-11 years. The vaccine's immune response was measured using the levels of virus-fighting antibodies found in their blood. This result was comparable to that of a group of 16-to-25-year-olds who were given the 30-microgram dose.
These antibodies are believed to indicate that the vaccine will be effective in protecting children against the virus. They didn't offer any evidence to prove that the vaccine prevents COVID-19 in this age group.
Side effects are comparable in age between 5-to-11-year-olds and 16 to-25-year olds, according to the companies. The companies did not give any further details on the severity and frequency of side effects in this younger age group. The release does not contain any peer-reviewed medical journal results.
