FDA's expected approval of Pfizer's COVID vaccine for adolescents: Yahoo News Explains

The U.S. Food and Drug Administration is preparing to authorize use of Pfizer’s COVID-19 vaccine for children aged 12 to 15 years old. Yahoo News Medical Contributor Dr. Kavita Patel explains what to expect in terms of the vaccine’s efficacy, side effects and when Americans can expect the vaccine to become available to younger age groups.

Video Transcript


KAVITA PATEL: Pfizer submitted an application for an amendment to their current Emergency Use Authorization to allow for 12 to 15-year-olds to be added to the current indications. That translates to-- probably within the next week or so-- being able to fully vaccinate anyone above the age of 12 with the Pfizer vaccine. And we think that we have enough supply in the country to get the majority of 12 to 15-year-olds vaccinated, with Pfizer also agreeing to manufacture additional doses if necessary.


They found it in the 12 to 15 cohort that it was almost 100% effective. It was 100% effective in reducing the risk of death and reducing the risk of severe hospitalization, and close to 100% for reducing the mild to moderate categories. So an incredibly effective vaccine with also very similar safety profiles for the adult. The data for asymptomatic transmission will lag once they have already deployed and injected more people with the vaccine. So we expect to see data on asymptomatic transmission in the months following.


Now, we haven't seen the full data that the FDA has seen. So this is all from the press release. So we are hoping we will see much more explicit detail about this in the detailed data for the FDA, which should become public as well.

But the side effects should be similar to what we see in adults. That is people who might experience some local injection site pain or discomfort, some muscle aches. And then for some people, they might experience some of the other additional side effects. Anything from headaches to nausea to vomiting, or mimicking flu-like symptoms. So I do think we will need to see the full data to have confidence in what that looks like.


Pfizer has completed trials in some of the younger age populations but they're going through data analysis. So we would hope to see the next age group, which would be 5 to 12. We hope that we can start to see some of that data after they've had at least an average of two months of follow up of those trial participants. So that's-- we do think that that could come as early as the fall of this year, 2021.

All three manufacturers are in trials of different stages, with Pfizer having completed more of the trials than the earlier age groups. But Moderna is in the field, so we should see data from that once they're wrapped up with enrollment. Johnson & Johnson has also been in the field with six months and older, and that's something that had a pause because of the temporary pause, but has resumed.

So we do hope we will see some initial data from those sets of age groups. But it will likely be kind of in a rolling basis. So Pfizer-- just like it was with the adult emergency authorizations-- first, and then weeks later, Moderna, and then months later, Johnson & Johnson.

We might start to see kind of a similar pattern where we see weeks to months between the manufacturers, as long as the independent Data Safety and Monitoring Board finds that indeed the vaccines are safe and effective for an emergency use.