Covid-19 Latest News: Omicron, Boosters and Case Updates

Credit…Saul Martinez for The New York Times

Federal regulators authorized booster shots of the Pfizer-BioNTech coronavirus vaccine for 16- and 17-year-olds on Thursday, at least six months after they received their second injection of that vaccine. The measure paves the way for several million teens to receive an additional injection.

All adults have been eligible since November 19 to receive a booster six months after their second injection of the Pfizer or Moderna vaccines, or two months after a Johnson & Johnson vaccination. Nearly 50 million Americans, or a quarter of those who are fully vaccinated, have received the additional vaccines.

The Food and Drug Administration expanded Pfizer’s authorization to cover the youngest age group in an emergency. The other two coronavirus vaccines, Moderna and Johnson & Johnson, are licensed for use in adults only.

The agency’s decision, which was expected, comes as an initial series of laboratory tests suggested that the new fast-spreading variant, Omicron, appeared to attenuate the power of two doses of the Pfizer vaccine.

“Since we first licensed the vaccine, new evidence indicates that the effectiveness of the Covid-19 vaccine is declining after the second dose of the vaccine for all adults and for those in the age group of 16 and 17. years, ”said Dr. Peter Marks, who oversees the FDA’s vaccine division. A booster “will help provide continued protection against Covid-19 in this and older age groups,” he added.

Dr. Rochelle P. Walensky, director of the Centers for Disease Control and Prevention, was quick to agree to the move, saying the agency was encouraging teens to get a booster dose.

“Although we do not have all the answers on the Omicron variant, initial data suggests that Covid-19 enhancers help to extend and strengthen protection against Omicron and other variants,” he said in a statement.

The CDC, which sets vaccine policy for the federal government, and the FDA acted without the involvement of their expert vaccine advisory panels, which have generally met publicly before eligibility for vaccines is authorized and expanded.

Those meetings reportedly provided regulators and experts with an opportunity to publicly discuss the merits of the measure, including a review of safety data collected on adolescents who had received the Pfizer-BioNTech vaccine.

Pfizer and BioNTech said Wednesday that tests on blood samples from people who had received just two doses showed much lower levels of antibodies that fight the virus against Omicron than against an earlier version of the virus. Antibodies are the immune system’s first line of defense against the virus, and the results suggest that two doses may not be enough to protect against infection. the companies said.

With a boost, the level of antibodies that work to neutralize the Omicron variant was comparable to those that fight the original variant after two doses, the companies said.

Senior administration health officials have said that Omicron, which contains dozens of never-before-seen mutations, is an even more reason for everyone eligible for a booster to receive it. More than 200 million Americans, more than 60 percent of the population, have been fully vaccinated.

Although the vaccination rate in the US overall is still well below that of some other countries, Omicron’s discovery has prompted many people to get vaccinated – even the variant is still unknown.

Support for the boosters has been growing among public health experts for the Omicron variant; some who previously opposed them now support a broad campaign. The FDA expert committee rejected Pfizer-BioNTech’s request in September to authorize a booster vaccine for 16- and 17-year-olds, in part due to concerns about what they saw as insufficient data on a rare heart condition related to the Pfizer-BioNTech and Moderna injections, especially in younger men.

That condition, myocarditis or inflammation of the heart muscle, can also be caused by the virus. Federal scientists have said that cases tend to be mild and resolve quickly.

According to federal data, about 5.5 million teens ages 16 to 17, two-thirds of that age group, have received at least one dose of the Pfizer vaccine. More than 4.7 million have received two doses. About three million got their second chance at least six months ago and would be eligible for a third injection this month.

Dr Ugur Sahin, CEO of BioNTech, Pfizer’s German partner, said: “In the current situation, it is important to give everyone a boost, particularly in the context of emerging variants like Omicron.” Pfizer CEO Dr. Albert Bourla called the booster injection expansion “a critical milestone.”

Pfizer is supplying booster doses to the US government under a deal negotiated months ago.

“Companies do not expect today’s news to affect existing supply agreements with governments and international health organizations,” said a statement released Thursday by Pfizer.

Leave a Comment