CDC panel greenlights new COVID-19 boosters ahead of fall booster campaign

An independent panel of advisors from the Centers for Disease Control and Prevention voted in favor of deploying the newly updated COVID-19 booster shots, paving the way for CDC Director Rochelle Walensky to give final approval for the boosters on Thursday night. rice field. Or Friday, and for a dosed shot soon.

The new Booster Shot has been updated to target two different COVID strains in one shot. The current Omicron subvariants, BA.4 and BA.5, account for his 99% of new cases in the US and are the original strains of COVID. 19.

This is the first time the current COVID-19 vaccine has been significantly upgraded. In the future, experts expect vaccines may be updated regularly to match current strains.

Public health officials have directed vaccine companies to create a bivalent vaccine (a vaccine that targets two different strains). This is in hopes that the compilation will offer her broader protection against COVID this fall and winter, as infections can increase in flu season, cold weather. Weather and more time indoors.

“It’s consistent with what’s currently in circulation. And the hope here is that by boosting the amount of antibodies to that particular variant, we first saw these vaccines launched in the late It’s about regaining the kind of protection that we had at times.In early 2020, early 2021, we had very good protection against symptomatic disease,” said the FDA biologics evaluation study. The center’s director, Dr. Peter Marks, told reporters at a news conference Wednesday morning.

“I don’t know yet if we can get to the same level, but that’s the goal here, and that’s what I believe the evidence we’ve seen helps point to,” Marks said. Told.

Marks also stressed that it’s important not only to boost your antibodies for immediate protection, but also to work towards an annual shot, rather than a booster every few months.

He says that deploying bivalent boosters now will curb the incoming winter wave and “provide needed protection by October, November and December to provide another window to shut down vacation plans and such.” I hope you can prevent the method.

The FDA issued an updated Emergency Use Authorization for Booster Shots Wednesday morning. On Thursday, a panel of CDC advisors publicly reviewed the data before voting at approximately 4:30 p.m.

Booster doses will ship as soon as the FDA issues approval, but Warrenski’s recommendation is due Thursday or Friday, the last step before the shot becomes a weapon. Bookings can really pick up after the holiday weekend.

The U.S. government purchased approximately 171 million shots during the Pfizer-Moderna contract.

Pfizer’s latest vaccine is for ages 12 and up, and Moderna’s is for ages 18 and up. Both bivalent vaccines are permitted 2 months after receiving either the primary vaccine series or the last booster shot.

Moderna vials have dark blue caps and labels with gray edging, and Pfizer vials have gray caps and labels with gray edging.

Marks was hesitant to give an exact timeline for when people under the age of 12 will be allowed to be vaccinated, but he expects more data in the coming months. said.

“We can’t promise exact timing, but we expect to see a drop in the younger age groups within the next month or two,” Marks said.

“Therefore, as soon as we receive submissions from companies, we will take them very seriously because we know that some children, especially those in the slightly older age group, are going through a booster period. Because I know,” he said.

All people over the age of 5 are now eligible for a booster dose 5 months after the first dose. A person over 50 or immunocompromised can get her second booster dose four months after her first booster dose.

If the CDC director approves, anyone under the age of 50 who gets their first booster can now get a second booster. However, those who haven’t received any booster shots can also get a bivalent booster as their first booster.

“Unfortunately, only about half of eligible Americans get their first booster dose,” FDA Commissioner Dr. Bob Calif told reporters at the same news conference.

“CDC data show that people who have the latest vaccine have a 13 times lower risk of dying from COVID than those who have not been vaccinated and who have had only one booster. It has been shown to have a three times lower mortality rate.2.Therefore, this is a great opportunity to improve our life expectancy and reduce the mortality rate in our population,” said the Caliph.

Unlike the original vaccines and boosters, these new shots do not go through a lengthy clinical trial process in which thousands of Americans are vaccinated to test their safety and long-term efficacy. But federal health officials stress that these new shots are just as safe as the original vaccine because the underlying vaccine platform, the mRNA, is the same and has undergone many different clinical trials. .

Part of that review was an evaluation of another updated boostershot clinical study conducted by the vaccine company during the previous Omicron wave. A clinical trial of booster shots was considered relevant enough for a bivalent vaccine targeting the BA.4/BA.5 variant and the original strain of Omicron.

Officials also said the decision not to use time-consuming clinical trials for each new shot was a strategic move to keep vaccines up to date with rapidly evolving variants. Change every year.

“Had we waited for all the evidence, the wave would have already passed us and the damage would have been done,” Caliph said.

“People are right to ask questions, but the best consensus among experts is that this is the best way to go,” he added.

Marks also repeatedly defended the data the FDA used to make this approval. Clinical trial data for a bivalent vaccine targeting another Omicron subvariant and the original He COVID-19 strain, along with BA.4 and the original COVID-19 strain 5 subvariants -mRNA vaccine worldwide and real-world data of millions of people who got boosters.

“I think what we have is very similar to what we’ve done in the past with modified influenza strains that haven’t undergone clinical studies in the United States,” Marks said.

“We know how vaccines will work, and from the data that we have, we can predict how well our vaccines will work,” Marks said.

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