4:13 PM, Feb 27, 2020


Pfizer and BioNTech request that FDA expand emergency use of their COVID-19 vaccine to adolescents

Posted at 5:29 PM, Apr 09, 2021
and last updated 2021-04-09 17:29:42-04

(WSYM) — Pfizer has formally requested that the FDA expand its Emergency Use Authorization to include children between the ages of 12 and 15. If granted, the drugmaker’s vaccine would be open to the widest age range as it’s already been approved for those 16 and up.

This is such great news. It’s so important for us to start immunizing kids. Especially for us here in Michigan because kids are getting infected and spreading the virus. We see this with all the outbreaks that have been linked to schools and youth sports. Now, Pfizer did not provide any new information. Their request to expand its COVID-19 vaccine is based on their Phase 3 adolescent trials. Those trials found that the vaccine revved up the kid's immune systems and produced strong antibodies. It was well tolerated and side effects were consistent with what we’ve already seen in adults. Most importantly, its efficacy for adolescents aged 12 to 15 was 100%.

Experts have estimated that kids in this age bracket would start to get immunized around the start of the school year.

In my opinion, I think Pfizer could get its Emergency Use Authorization amended by the end of this month, or in early May. Which would then open the door to adolescents getting shots in their arms not long after that. You know I’m a parent. And I’m very excited about this even though my three boys are not in this age group. But Pfizer has kicked off another trial for kids 6 months to 11 years of age. Once that’s a go I plan to have my boys vaccinated. Yes, I know they’re young and not at high risk of getting severe COVID. But, we need kids of all ages to get the shots. Otherwise, we won’t reach herd immunity. We’ll just continue to wrestle with this virus especially as more variants continue to pop up.

Switching topics slightly, we’re expecting AstraZeneca to apply for Emergency Use Authorization. Not for children but for adults. AstraZeneca’s vaccine may not be offered to Americans if it’s approved.

There is concern that AstraZeneca’s vaccine causes rare blood clots. The European Medicines Agency recently said it should be listed as a side effect.

They came to this conclusion after analyzing 18 deaths. I stress the word rare. Because 25 million people in European countries have received AstraZeneca’s shot. As for it not being used here, first of all, if the FDA grants emergency use authorization, that means the clinical data has been scrutinized. The shot would have been deemed safe overall for the age group it’s approved for. Safety right now is not the reason why it might not be used here in the US. According to Dr. Anthony Fauci, it has to do with the other three vaccines – Pfizer, Moderna, and Johnson & Johnson. The US has already contracted enough vaccines for the American public from these three companies. So at this moment, a fourth vaccine is not really needed here.