What we know so far about COVID-19 vaccinations for kids

Pfizer says its COVID-19 vaccine is secure and efficient in youngsters ages 5 to 11, and that it plans to file for emergency-use authorization “within the coming weeks.”

The query on quite a lot of mother and father’ minds proper now: When can my child get one?

Tens of millions of kids have examined optimistic for COVID-19. Not less than 460 have died. Circumstances in youngsters have accelerated in the course of the Delta variant wave: As of Sept. 2, youngsters made up 15.1% of reported circumstances over the period of the pandemic; in simply the week ending Sept. 2, they made up 26.8% of the entire, in keeping with the American Academy of Pediatrics. That represents a 250% enhance in youngster circumstances for the reason that week of July 22-29.

In accordance with a report within the Atlantic, some mother and father have fudged their children’ delivery dates to get ones simply shy of turning 12-years outdated their pictures. (The FDA doesn’t suggest this.) Others have sought medical doctors who’re keen to vaccinate youthful youngsters through off-label use. (Additionally not advisable.) If the shot is accepted for teenagers 5 to 11, these sorts of work-arounds can be moot.

Right here’s what we all know proper now in regards to the timeline to getting children beneath 12 vaccinated.

How shut are we to a COVID-19 vaccine for teenagers?

On Sept. 20, Pfizer introduced it can search emergency-use authorization for its COVID-19 vaccine for youngsters ages 5 to 11.

On Tuesday, the corporate supplied an replace, saying it has given the FDA the information on the part 2 and three trials it carried out with youngsters, though it hasn’t filed the emergency use software but. Pfizer has mentioned it plans to file for that authorization earlier than the top of this month; a information launch the corporate issued Tuesday mentioned to count on the formal submission “within the coming weeks.”

There isn’t any timetable for a way lengthy the approval course of might take. For comparability, Pfizer submitted the vaccine for emergency-use authorization for adults on Nov. 20, 2020, and acquired that authorization three weeks in a while Dec. 11. Full FDA approval was granted on Aug. 23, 2021. The AP reported that an individual aware of the matter however not approved to debate it publicly mentioned pictures could possibly be out there round Thanksgiving or presumably earlier in November, relying on how rapidly the FDA strikes to evaluate the applying and information.

On Monday morning, Facilities for Illness Management and Prevention Director Dr. Rochelle Walensky advised ABC the company was “enthusiastically awaiting” that data.

“As quickly as [the vaccine data] get submitted to the FDA, I do know the FDA is urgently planning to evaluate these information, it can go from the FDA to the CDC, and we’ll evaluate it with comparable urgency,” Walensky mentioned on ABC’s “Good Morning America.” “And I’m hoping within the order of weeks.”

The FDA’s vaccine chief mentioned earlier this month that he’s “very, very hopeful” that vaccines can be approved and rolled out for youngsters ages 5 to 11 by the top of this 12 months. In the identical interview, he mentioned as soon as the FDA receives information from Pfizer, “we’re going to do an intensive job on that as rapidly as we will” and make a decision “hopefully inside a matter of weeks quite than a matter of months.”

What about Moderna and Johnson & Johnson?

The Moderna medical trials for teenagers 6 to 11 are underway. In July, the New York Instances reported that the Pfizer trials had been transferring sooner than its mRNA vaccine competitor’s.

The Johnson & Johnson vaccine has emergency-use authorization for folks 18 and older. As of this month, the drugmaker is in Section 3 of medical trials to check its vaccine on adolescents ages 12 to 17.

When will children beneath 5 have the ability to be vaccinated?

Pfizer had mentioned in July that it anticipated to have outcomes for the trials on children 5 to 11 by September, youngsters ages 2 to five quickly after that, and infants and toddlers 6 months to 2 years outdated in October or November. It has come by way of on these first outcomes, with no reported delays in trials for any of the youthful age teams. Moderna mentioned it additionally plans to run trials for youngsters as younger as 6 months.

So the reply is: These trials are ongoing. We must always know extra within the subsequent month or two.