June 13, 2022 — The FDA is gearing up for a busy week – after a busy weekend releasing details about the effectiveness and security of each the Pfizer/BioNTech COVID-19 vaccine in youngsters beneath 5 years outdated and the Moderna vaccine in youngsters 6 months to 17 years of age.
This information comes simply earlier than two FDA advisory panels are scheduled to satisfy Tuesday and Wednesday to advocate whether or not or to not authorize one or each vaccines in these youngest of People. The FDA doesn’t should comply with its panels’ suggestions however typically does so.
Early briefing paperwork launched Friday and Saturday by the FDA reveals each two-dose vaccines secure and efficient in these age teams.
The Pfizer information reveals their vaccine to be 75.6% efficient in stopping symptomatic COVID-19 in youngsters 6 months to 23 months outdated, in addition to 82.4% efficient for kids 2- 4- years-old.
The Moderna information reveals the vaccine to be 51% efficient in youngsters 6 months to 2 years outdated and 37% efficient in youngsters 2 years to five years outdated.
FDA paperwork additionally present that the Moderna vaccine seems secure and efficient in 6- to 17-year-old youngsters and teenagers. The company famous two doses of the Moderna vaccine set off an immune response on this age much like the effectiveness seen in adults.
Requested to touch upon the early information on the Pfizer and Moderna vaccines and their authorizations, Matthew Harris, MD, medical director for the New Hyde Park primarily based Northwell Well being COVID-19 vaccination program mentioned “I will surely advocate the vaccine as soon as it turns into accessible.”
Nothing is definite till the FDA decides, although. And if the vote is sure for a number of of those vaccines/age teams, the CDC must log off as properly, which may come later this week after the company hears from two of its personal advisory panels..
Harris emphasised the importance of vaccinating youngsters in opposition to COVID-19, and the continued problem to persuade dad and mom to get the pictures for each their youthful and older youngsters. “We nonetheless have a protracted strategy to go for main vaccines and boosters for kids 5 years and above,” he says.
If a number of of those COVID-19 vaccines receives FDA authorization, it’s anticipated that oldsters can begin getting their youngsters and/or youngsters vaccinated the week of June 20. In accordance with Harris, healthcare professionals expect a “surge” of COVID-19 instances within the fall season, saying that the “timing of the vaccine is essential.”