Another Step Toward Covid Shots For Kids: Pfizer Submits Data To FDA
Pfizer and BioNTech provided the Food and Drug Administration with clinical trial data for kids between 5 and 11. The companies say that the tests showed that their covid vaccine is safe and effective for those ages and plans to request approval "in the coming weeks." FDA OK may not come until November though, the Wall Street Journal reports.
NPR:
Pfizer Submits Favorable Initial Data To The FDA On Kids' COVID-19 Vaccine Trial
Pfizer and BioNTech are another step closer to seeking authorization for young children to receive the COVID-19 coronavirus vaccine, submitting data to the Food and Drug Administration that shows a "robust" antibody response and "favorable" safety outcomes in kids ages 5 to 11 who received the two-dose regimen in clinical trials. The companies plan to submit a formal request for emergency-use authorization of the vaccine for that age range "in the coming weeks," they said Tuesday. (Chappell, 9/28)
The New York Times:
Pfizer And BioNTech Submit Data On Vaccine For Kids 5 To 11
Pfizer and BioNTech announced on Tuesday that they had submitted data to the Food and Drug Administration that the companies said showed their coronavirus vaccine is safe and effective in children ages 5 to 11. The companies said they would submit a formal request to regulators to allow a pediatric dose of their vaccine to be administered in the United States in the coming weeks. Similar requests will be filed with European regulators and in other countries. (LaFraniere, Bengali and Weiland, 9/28)
But the timing is still in question —
The Wall Street Journal:
Pfizer’s Covid-19 Vaccine For Kids May Not Be FDA Authorized Before November
Regulatory clearance of the Pfizer Inc. and BioNTech vaccine for young children may not come until November, according to a person familiar with the matter, after the companies said they won’t ask for the green light for a few weeks. The companies said Tuesday they provided U.S. health regulators with data from a recent study of their vaccine in children 5 to 11 years old. They said they would file an application asking the Food and Drug Administration to authorize use in the coming weeks, though they had previously targeted submitting the application as early as the end of September. (Hopkins and Armour, 9/28)
The Atlantic:
Vaccine Data for Kids Under 5 Are Coming ‘Before the End of the Year’
The vaccine timeline for young kids is looking a little more solid. This morning, Pfizer submitted data to the FDA showing that its COVID-19 vaccine is effective and safe for children ages 5 to 11. And this afternoon, the company’s CEO, Albert Bourla, said that trial results for even younger kids, aged 2 to 4, will be available in a couple months’ time. “Before the end of the year,” he confirmed in an interview with Craig Melvin, the Today news anchor and MSNBC anchor, at The Atlantic Festival. Submission to the FDA will follow soon thereafter, Bourla said. (Zhang, 9/28)
Also —
Philadelphia Inquirer:
COVID-19 Vaccine Eligibility For Kids 5-11 Could Help All, If Enough Families Get The Shots
More than 23,000 children in Pennsylvania contracted the coronavirus in the first three weeks of September, part of a national increase over the last month that has closed schools, worried parents, and heightened urgency for the authorization of vaccination for younger children. The expansion of vaccine eligibility to about 28 million U.S. kids appears closer than ever — expected within weeks, possibly before October’s end — and it could improve the pandemic outlook for everyone. (McCarthy and McDaniel, 9/28)
Axios:
Axios-Ipsos Poll: Parents May Not Want Vaccine For Young Kids
While the U.S. is inching toward expanding COVID-19 vaccines to kids younger than 11, many parents may not be eager to take advantage of them, according to the latest installment of the Axios/Ipsos Coronavirus Index. 44% of parents with kids between ages 5 and 11 said they are likely or somewhat likely to get their children vaccinated, compared with 42% who said they're unlikely to. 56% of parents with kids ages 12 to 17 said their kids were already vaccinated or likely to get the shot, while 41% said they were not likely to get the shot for their child. (Reed, 9/29)
And vaccines have proved effective in teens —
CIDRAP:
COVID Vaccine Protection Stayed Strong In Teens During Delta, Data Show
Vaccine effectiveness (VE) for the two-dose Pfizer/BioNTech COVID-19 vaccine was up to 91.5% in Israeli teens 12 to 15 years old during the Delta (B1617.2) variant outbreak, according to a study published yesterday in Emerging Infectious Diseases. Israel made the Pfizer vaccine available for teens starting Jun 2, and by Aug 26, 46.1% of those who were eligible were partially vaccinated and 31.2% were fully vaccinated. To estimate VE, the researchers looked at those who received their second dose between Jul 1 and Jul 24, excluding those who had a history of COVID-19 infection. (9/28)
