The Pfizer/BioNTech vaccine is also safe and effective in 5- to 11-year-olds. This is evident from phase 2/3 research, both companies reported in a press release on Monday. The companies will share the research results with the American and European medicines agencies in order to obtain market authorization as soon as possible.
The Pfizer/BioNTech vaccine is currently only approved for people over the age of twelve. Research on 2,268 children between the ages of five and eleven now shows that the vaccine – in a lighter dose – is also effective and does not show any major side effects. For example, the number of antibodies generated is comparable to that in people aged 16 to 25 years, and the side effects are also largely similar.
“These research results provide a strong foundation for applying for marketing authorization for children between the ages of 5 and 11,” said Albert Bourla, CEO of Pfizer. “We will urgently submit the data to the FDA and the other agencies.”
As with people over the age of twelve, children between the ages of five and eleven will need to receive two doses of the corona vaccine, 21 days apart. At 10 µg, the dose is three times lower than that previously administered to people over the age of 12.
Both companies also have two other sub-studies underway: with children between two and five years old and children between six months and two years. Those results are expected by the last quarter.
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