Pfizer has announced some big news in their efforts to make the COVID-19 vaccine available for kids ages 5-11. In a press release, Pfizer said results from a Phase 2/3 trial showed “a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen.”
This is especially important as delta is impacting children to a much greater degree than earlier variants. What exactly does this mean for parents and kids? Dr. Tiffany Kimbrough, pediatrician and mom of two kids age 5 and under, answers some questions to help ease fears and provide clear, evidence-based information.
Vaccines must go through several stages of testing before they can be made available to the public. Phase 1 tests safety and assesses if the vaccine induces a proper immune response by giving it to healthy volunteers. In Phase 2, the vaccine is given to people with the characteristics similar to those for whom the vaccine is intended (in this case ages 5-11). Phase 3 involves giving the vaccine to thousands of people in the targeted group to test for safety and efficacy.
Pfizer’s announcement is exciting because it means that they’re well through their studies with great results.
These phases of the trial included 2,268 children ages 5-11.
Trial participants were given two doses of the vaccine, 21 days apart. Each dose was 10 micrograms, which is smaller than the 30-microgram doses given to people 12 and older. This smaller dose was selected with careful thought to safety, tolerability and immunogenicity – or ability to cause an immune response – in children in this age group.
The children’s immune responses to these doses were comparable to the responses seen in people ages 12 and older with the larger doses.
Yes, Pfizer confirmed that side effects were similar to those observed in individuals ages 16-25 – generally mild and short-lived. There were no instances of myocarditis, a type of heart inflammation, which is excellent news.
This is the first time results are being released for this age group. More detailed data will be available when it is peer-reviewed and published, which will occur before emergency use authorization is granted.
Pfizer has said it plans to submit for EUA by the U.S. Food and Drug Administration soon. It could be just a matter of weeks from the time of submission to when EUA is granted. Studies continue on kids ages 6 months to 5 years as well, with doses of 3 micrograms for each injection in this age group. We’ll be keeping a close eye on it, with hopes of safely vaccinating many more patients in the coming months.
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