Pfizer and BioNTech announced today that they have completed a phase 3 study of their COVID-19 vaccine in children aged 12 to 15 and that it appears to be 100% effective so far in this age group. If the FDA agrees the vaccine is safe and effective, it may be available for ages 12 and over starting this summer.
At what age can the vaccine be used?
The Pfizer vaccine is currently approved for ages 16 and up, and the other two US vaccines (Moderna and Johnson & Johnson) for ages 18 and up. All three companies said They are testing or planning to test their vaccine in children. (Typically, a company will conduct trials on adults, then teenagers and younger children.)
The most recent study was carried out on 2,260 adolescents, half of whom received the vaccine and half of whom received a placebo. There were 18 cases of COVID-19 in the placebo group and none in the vaccine group, which means that the effectiveness was 100% perfect. In practice, that number might turn out to be lower, but seeing this result is encouraging.
The researchers also tested the children’s antibody levels one month after receiving their second dose and found that they were as good as the antibody levels of vaccinated adults. The side effects were similar to those seen in older age groups.
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What’s next?
So far we only have Pfizer’s press release, but the company plans to publish the results in a peer-reviewed journal and also to submit it to the FDA. For its part, the FDA could change the Emergency Use Authorization (EUA) for the vaccine to make it available to people 12 years and older instead of the current 16 years and older. (None of the vaccines are fully approved, however The EEA allows them to be legally administered during the pandemic.)
The company says it has already started a study in five to eleven year olds and will begin giving doses to two to five year olds next week. Approval for these age groups will probably not be possible until the end of this year or the beginning of next year.
