(WXYZ) — Pfizer has announced positive results regarding its COVID-19 trial for children aged 5 to 11. The biopharmaceutical company says its data shows its vaccine is not only safe but very protective.
I’m really happy to share some good news. It directly affects my family, as three of my kids are not vaccinated. That’s because they’re not yet eligible.
Right now, only 12 and up are authorized to get Pfizer's COVID vaccine. But that could change very soon. Pfizer’s data from their phase 2/3 clinical trial included just over 2,200 participants between the ages of 5 and 11. The dosage administered was one-third the strength of what’s used for those aged 12 and up. So instead of a 30-microgram dose, it was a 10-microgram dose.
The children were still given two doses, three weeks apart. One month after the second dose, the vaccine generated a strong immune response - meaning that it created coronavirus fighting neutralizing antibodies - and the levels matched what Pfizer has seen in teenagers and young adults. Also, the safety profile was also quite similar as well.
There have been no confirmed cases of myocarditis, that’s inflammation of the heart muscle. The vaccine was well-tolerated with less fever and chills compared to trial participants aged 16 to 25.
Other temporary side effects included sore arms near the injection site and achiness. As for COVID cases, Pfizer’s clinical trial was not designed to compare the number of cases in the vaccine group vs the placebo group. However, the company did say that there haven’t been enough infections anyway, so they can’t compare groups. That of course could change down the road as the study is ongoing.
It’s possible that Pfizer could file sooner for Emergency Use Authorization since the data has come earlier than expected. If so, then it’s also possible that we could have a vaccine for this younger age group by Halloween. Of course, that would all depend on both the FDA and the CDC.
The FDA has said it would do its best to review the data as thoroughly and quickly as possible. But it could take four weeks or it could take six weeks to comb through the research.
Partha Nandi, MD FACP
CEO & Creator
Ask Dr Nandi, Emmy award winning television show
International Best Selling Author, Ask Dr Nandi: 5 Steps to Becoming Your Own #HealthHero for Longevity, Well-Being, and a Joyful Life
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