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The Centers for Disease Control and Prevention has cleared the reformatted Covid shots targeting the latest omicron sub-variants for the fall, making it possible for more people to get a booster shot within days.
The agency’s independent committee on vaccines voted 13 to 1 earlier on Thursday in favor of the shots after reviewing available safety and efficacy data during a meeting that lasted nearly seven hours. CDC Director Dr. Rochelle Walensky signed the shot a few hours later, clearing the way for pharmacies to start injecting it soon.
PfizerOmicron boosters are used for people 12 years of age and older, while ModernaUpdated photos have been licensed for those 18 years of age or older. Eligible age groups can receive boosters at least two months after completing their main series or their most recent booster with old shots.
Walensky said her decision follows “a comprehensive scientific review and strong scientific discussion.”
“If you’re eligible, there’s no bad time to buy a Covid-19 booster and I highly encourage you to get it,” she said in a statement.
Pfizer plans to require the Food and Drug Administration to also license new boosters for children ages 5 to 11 as early as October, company executives told the committee on Thursday.
The primary vaccines will no longer be used as boosters in people 12 years of age and older as the reformulated shots are about to be marketed.
Public health officials are expecting another wave of Covid-19 infections this fall as immunity to older vaccines wanes, sub-omicron bacteria are more contagious, and people spend more time indoors as the weather turns colder and families gather for the holiday.
The CDC and FDA hope the new boosters will provide longer-term protection against infections, mild illness, and severe illness. The footage has been reformatted targeting omicron BA.5, the dominant variant of Covid as well as the strain that appeared in China over two years ago.
To date, the US has secured 171 million doses of new boosters from Pfizer and Moderna. According to the CDC, more than 200 million people are eligible for the shot. Dr Sara Oliver, a CDC official, told the committee on Thursday that there should be enough vaccine supply to meet demand this fall.
There’s no data from human trials on the new BA.5 boosters, so it’s unclear how they will perform in the real world. The CDC and FDA have used human data from clinical trials for shots that target the original version of omicron, BA.1, which triggers a stronger immune response than older vaccines.
Pfizer and Moderna were initially developing omicron boosters to target BA.1, but the FDA asked the companies to shift gears in June and develop alternative BA.5 arrows after the auxiliary became active. should dominate. The decision to focus on BA.5 did not leave enough time to wait for data from human trials before deploying the vaccine in the fall.
The lack of human data for BA.5 injections has caused some controversy, but Dr. Peter Marks, a senior FDA official, said the agency had followed the same process as outlined by the FDA. used for many years with a strain change to the influenza vaccine. Marks said Wednesday that flu vaccine strains were also altered without human clinical data.
Dr Pablo Sanchez, the only committee member to vote against the shots, called the recommendation premature and said the US should wait for human data before proceeding with the boosters.
“There’s a lot of hesitancy about vaccines – we need data on people,” said Sanchez, a professor of pediatrics at Ohio State University. But Sanchez said he believes the new booster is safe and that he will likely get one himself.
Panel member Dr. Oliver Brooks, medical director of Watts HealthCare Corporation in Los Angeles, questioned why the FDA decided to use the BA.5 vaccine when clinical data were available for BA shots. .1 that vaccine manufacturers are initially developing. Brooks ultimately voted in favor of the photos.
But Dr Sarah Long, also a member of the committee, said there is no reason to expect the BA.5 boosters to be inferior to the older injections as they also include the original Covid strain, and they have the potential to reduce fall and winter hospitalizations and deaths. Long also voted in favor.
Officials at the FDA and CDC have said the omicron BA.1 and omicron BA.5 boosters are so similar that immune response data from a BA.1 injection will give a good indication of how they are working. of tip BA.5. According to Dr. Jacqueline Miller, who works on vaccine development at Moderna, Omicron BA.1 and BA.5 are closely related to the four-mutant difference.
Moderna completed registration for a clinical trial of the BA.5 shots last week and should have results by the end of the year, Miller told the CDC committee Thursday. Pfizer’s clinical trial is also ongoing, though the company hasn’t said when it expects results.
Health authorities also reviewed data on BA.5 scans from studies in rats. Moderna presented data showing that injections of BA.5 increased antibody levels in mice more than fourfold compared with older injections. The mice express the same cellular proteins as humans to which the virus attaches. Pfizer’s BA.5 booster increased antibody levels by 2.6-fold in mice compared with the original vaccine.
According to the FDA.
Oliver, the CDC official, told the committee that health officials do not expect any difference in the safety profile of the BA.1 and BA.5 shots because the secondary variables differ only by one few mutations.
But Oliver notes that the risk of myocarditis following injection of the BA.5 booster is unknown. There is a higher risk of myocarditis in men and adolescents after a second dose of Pfizer and Moderna, but a higher risk of myocarditis from a Covid infection, according to the CDC.
“We know that the risk of myocarditis is unknown, but we can expect a risk similar to that occurring after a monovalent vaccine,” says Oliver. Single-price vaccines are old shots that have been given to millions of people in the US over the past two years.
The original vaccines, first authorized in December 2020, no longer provide meaningful protection against infection because the virus has mutated so much in the past two years. These injections were developed against the strain of bacteria that first emerged in China, so they are no longer suitable to target the spreading omicron subtypes.
Infections, hospitalizations and deaths have fallen dramatically since the great wave of omicron infections last winter, but have continued to be high this summer. Omicron BA.5 is the most contagious and immune-evasive variant, and as a result, disruptive infections are becoming increasingly common.
The efficacy against hospitalization of the older vaccine also decreased after omicron BA.5 became dominant. The third dose was 77% effective at prophylactic hospitalization 4 months after injection, but protection decreased at 120 days to 34%, according to CDC data. The fourth dose in people 50 years of age and older was 56% effective at preventing hospitalization after four months.
According to Heather Scobie, a CDC epidemiologist who presented the data at Thursday’s meeting, the number of Covid deaths and hospitalizations among people 65 and older has increased since April. Scobie said the death toll had increased especially among people aged 75 and over.
The CDC has moved to a more targeted public health response with a focus on protecting the most vulnerable — the elderly, those with serious illnesses, and those with weakened immune systems. While there is no data on the real-world effectiveness of the new boosters, the US is rapidly deploying them in the hope that they will protect people this fall.