In addition, the FDA cleared third doses of the vaccine for some children ages 5 to 11 who have weakened immune systems because of solid organ transplants or other medical conditions.
The FDA actions are expected to be reviewed by the Centers for Disease Control and Prevention and its panel of outside vaccine advisers this week. Assuming the Advisory Committee on Immunization Practices, which is scheduled to meet Wednesday, signs off on the additional shots, CDC director Rochelle Walensky is expected to officially recommend them later that day.
The bid to make extra shots available to younger adolescents comes as the omicron variant spreads rapidly, driving up the number of cases, upending travel plans and sending education officials scrambling to decide whether and how to reopen schools.
Some schools are making painful decisions to revert, at least temporarily, to remote teaching. But many large districts are forging ahead with a resumption of in-person learning — although some are imposing strict rules involving coronavirus testing. Public schools in the District, which are scheduled to reopen later this week, are requiring proof of a negative test result for all returning students and teachers. Other school systems are beefing up mask mandates.
FDA officials, on a call with reporters, said the agency moved to broaden access to boosters because data from real-world experience and laboratory tests indicate the shots significantly bolster protection against the omicron variant while posing minimal risk of side effects.
The agency cited Israeli data involving more than 6,300 12- to 15-year-olds that showed there were no new safety issues among those who received a third dose of the Pfizer-BioNTech shot. Specifically, the FDA officials said, there were no new cases of rare heart-related side effects — called myocarditis and pericarditis — that previously had been linked to the vaccine.
The agency also relied on information from Israel in deciding to shorten the interval between second and third doses of the vaccine for adolescents and adults. Scientists reported recently that no new safety concerns arose among more than 4 million people who received boosters at least five months after getting the second shot of the Pfizer-BioNTech vaccine.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the interval was changed for the Pfizer-BioNTech vaccine because there was data to support such a move.
The intervals between initial shots and boosters for the Moderna and Johnson & Johnson vaccines remain unchanged — they are a minimum of six months and two months, respectively. But Marks said the FDA would be receptive to shortening the Moderna interval, if given the appropriate data.
Regarding immunocompromised children, the FDA said it authorized a third dose for 5- to 11-year-olds who have undergone organ transplants or have impaired immune systems for some other reason because these patients may not respond adequately to the initial vaccine series. The agency previously cleared a third dose for immunocompromised individuals 12 years and older. The doses can be administered 28 days after the second shot, the agency said.
The FDA said 5- to 11-year-olds who are not immunocompromised do not need boosters at this time — they were cleared for initial shots in late October. Officials said they are closely following that age group.
“We certainly understand the pressing need in that age range,” Marks said, adding that the agency will move “with the appropriate speed” if boosters are necessary. Until then, he said, it is critical for parents to get young children vaccinated, noting that vaccinations have lagged in that age group.
For months, public health officials have urged eligible individuals to get booster shots, pointing to data suggesting vaccine-induced immunity wanes. That effort has taken on increased urgency in recent weeks as the highly transmissible omicron variant has fueled a sharp rise in infections — an average of about 400,000 per day — in the United States.
Some studies on omicron offer hope that the variant is less likely to result in severe illness and hospitalizations than delta, the last dominant variant. But officials have noted that the number of children being hospitalized across the country is creeping up and caution that the impact of the virus can be unpredictable.
Asked by reporters whether the FDA was considering a vaccine that specifically targeted omicron, Marks said the agency does not know whether that will be needed. For one thing, he said, it isn’t clear whether the omicron surge will be a very quick wave or persist.
Acting FDA commissioner Janet Woodcock agreed.
“The last thing we want to do is just be going through, and doing this and that, if the current boosters will really do the job against omicron,” Woodcock said.
Vaccine manufacturers are developing and testing omicron-specific shots in case they are needed, the officials said.
Business - Latest - Google News
January 04, 2022 at 02:31AM
https://ift.tt/3pRNx4Q
FDA authorizes coronavirus vaccine boosters for 12- to 15-year-olds as schools reopen amid omicron surge - The Washington Post
Business - Latest - Google News
https://ift.tt/2Rx7A4Y
Bagikan Berita Ini
0 Response to "FDA authorizes coronavirus vaccine boosters for 12- to 15-year-olds as schools reopen amid omicron surge - The Washington Post"
Post a Comment