FDA Preparing To OK Pfizer Covid Vaccine For Kids Ages 12 To 15
The Food and Drug Administration is expected early next week to expand emergency use authorization of the Pfizer vaccine to all Americans aged 12 or older. Pfizer is also preparing to file an application for full FDA approval by the end of May.
The New York Times:
FDA Set To Authorize Pfizer Vaccine For Adolescents By Early Next Week
The Food and Drug Administration is preparing to authorize use of the Pfizer-BioNTech coronavirus vaccine in adolescents 12 to 15 years old by early next week, according to federal officials familiar with the agency’s plans, opening up the U.S. vaccination campaign to millions more people. ... The clearance, in the form of an amendment to the existing emergency use authorization for the Pfizer vaccine, could come as early as late this week. If it is granted, the Centers for Disease Control and Prevention’s vaccine advisory panel is likely to meet the following day to review the clinical trial data and make recommendations for the vaccine’s use in adolescents. (Weiland, Mandavilli and LaFraniere, 5/3)
FDA Expected To OK Pfizer Vaccine For Teens Within Week
The FDA action will be followed by a meeting of a federal vaccine advisory committee to discuss whether to recommend the shot for 12- to 15-year-olds. Shots could begin after the Centers for Disease Control and Prevention adopts the committee’s recommendation. Those steps could be completed in a matter of days. The New York Times first reported on the expected timing for the authorization. (Miller and Lemire, 5/3)
Pfizer Plans To File For Full FDA Approval Of Covid Vaccine At The End Of This Month
Pfizer said Tuesday it plans to file for full U.S. approval of its Covid-19 vaccine with German drugmaker BioNTech at the end of this month. If the FDA signs off, the company will be able to market the shot directly to consumers. In releasing its first-quarter financial results, the company also reported $3.5 billion in first-quarter sales of its Covid-19 vaccine and reported earnings and revenue that beat Wall Street’s expectations. (Lovelace Jr., 5/4)
In related news about children and covid —
Here’s What To Know About The Pfizer Vaccine And Teens
An infectious disease expert at Boston Medical Center says the data from Pfizer on its coronavirus vaccine is promising when it comes to children ages 12 to 15. "For all of us to get back to a new normal, we’re going to need to vaccinate as much of the population (as possible) and we know that children make up about 20% of the U.S. population," Dr. Sabrina Assoumou said. "So vaccinating children is going to be an important piece of our strategy." (5/4)
Children Now Account For 22% Of New U.S. COVID Cases. Why Is That?
The number of children contracting COVID-19 in the U.S. is much lower than the record highs set at the start of the new year, but children now account for more than a fifth of new coronavirus cases in states that release data by age, according to the American Academy of Pediatrics. It's a statistic that may surprise many: Just one year ago, child COVID-19 cases made up only around 3% of the U.S. total. On Monday, the AAP said children represented 22.4% of new cases reported in the past week, accounting for 71,649 out of 319,601 cases. The latest report, drawn from data collected through April 29, illustrates how children's share of coronavirus infections has grown in recent weeks. (Chappell, 5/3)
Covid ‘Doesn’t Discriminate By Age’: Serious Cases On The Rise In Younger Adults
After spending much of the past year tending to elderly patients, doctors are seeing a clear demographic shift: young and middle-aged adults make up a growing share of the patients in covid-19 hospital wards. It’s both a sign of the country’s success in protecting the elderly through vaccination and an urgent reminder that younger generations will pay a heavy price if the outbreak is allowed to simmer in communities across the country. (Stone, 5/4)