US Health Agency recommends first shot of Omicron booster

In two votes, 13-1 each, the immunization committee of the US Centers for Disease Control and Prevention (CDC) recommends that Americans receive Specific Omicron Enhancement dose of the COVID-19 vaccine. After a day-long discussion of available data on September 1, the panel recommended boosters from two manufacturers – Pfizer-BioNTech and Moderna, both of which produce mRNA-based vaccines; new boosters made by Pfizer-BioNTech for adults 12 years of age and older and Moderna injections for adults 18 years of age and older. The team also recommends that people wait at least two months after their previous dose before getting one of the two new boosters. Within hours of the vote, CDC director Dr. Rochelle Walensky accepted the committee’s advice to propose a new type of booster.

The Omicron booster could “help restore protection that has weakened since a previous vaccination and is designed to provide broader protection against newer variants,” she said in a statement. a statement announcing its decision. “This recommendation follows a comprehensive scientific review and robust scientific discussion. If you’re eligible, there’s no bad time to get a COVID-19 booster and I highly encourage you to get it. “

CDC guidance comes a day after Authorized by the United States Food and Drug Administration (FDA) Omicron-specific snapshots of both companies.

The booster is the first to target a variant of the SARS-CoV-2 virus. All vaccines approved by the FDA and recommended by the CDC to date, as well as the booster doses that the agencies have authorized, target the virus that originally emerged in 2019. Latest Omicron boosters target BA.4 and BA. 5 subtypes of the virus, now account for nearly all new COVID-19 infections in the US

The Omicron BA.4/5 booster represents a dramatic change in the way that health officials are hoping to protect the public. Instead of recommending booster doses every few months, as they have advised since the vaccine became available in late 2020, they are hoping to switch to a vaccination schedule similar to that for the flu, with one injection every year. The newly authorized Omicron booster will replace the existing boosters of the original COVID-19 vaccine. All people 12 years of age and older will be eligible to receive a single dose, regardless of how many previous booster doses they have received to date.

In recommending booster shots, the CDC’s independent panel of vaccine experts acknowledged that although it had previously authorized booster vaccinations, the vaccine differs in several ways. Not only was it the first to target a variant of the virus, it was also the first to contain genetic material against two versions of the virus — the parent or ancestral strain, and Omicron BA.4 and BA. 5, thus- is called a bivalent vaccine. In the case of both Pfizer-BioNTech’s and Moderna’s boosters, the same dosage as the previous enhancers were allowed, but split between the parent strain and Omicron BA.4/5.

Perhaps most disturbing to committee members, both companies’ boosters have yet to be tested on humans, which means there’s no direct evidence that these injections actually work. the protection of people from becoming seriously ill with COVID-19. Both Pfizer-BioNTech and Moderna developed the Omicron booster after FDA Expert Panel Meeting in June and requires vaccine manufacturers to target the subvariables BA.4 and BA.5. The companies have developed a booster that combines the original strain and an earlier version of Omicron, BA.1, and has shown that it helps increase the level of virus-fighting antibodies against Omicron. But because BA.4 and BA.5 quickly surpassed BA.1 in causing infections, the FDA required a dual-value vaccine that included BA.4 and BA.5. Both companies submitted data to the FDA in August from animal studies showing that their enhancers increased antibody levels in mice.

The FDA and CDC scientists stress that the animal data are sufficient to recommend the latest booster, based on all the evidence supporting the safety and effectiveness of previous versions of the vaccine for now. They point to real-world data involving millions of people who have been immunized and boosted up to two times with the original vaccine, as well as data on the bivalent BA.1 booster that has never been released. market. Dr. Doran Fink, associate clinical director of vaccine and related products applications at FDA, opened the discussion by telling members, “The FDA as authorized reviewed it. full evidence base, mainly consisting of extrapolation based on data from clinical trials with similar bivalent vaccine formulations including the original Omicron BA.1 and Omicron sublineage components, as well as experience extensive experience in the use of monovalent vaccines in both primary series and booster forms. In addition, the FDA reviewed supporting data from several animal studies to provide additional reassurance about our extrapolation method.”

It’s a different approach from .’s approach UK and Canadian health authorities who decided to allow the divalent enhancer administered by Moderna against the BA.1 auxiliary variable.

That has some public health experts in the US concerned about recommending the Omicron BA.4/BA.5 booster. Dr Pablo Sanchez, a professor of pediatrics at Ohio State University and the sole opponent to the vote against the proposal of the new Omicron booster, said: “I feel we really need the data. human material. It’s a new vaccine, a new platform, and there’s a lot of uncertainty about vaccines, so we need human data. I really feel this is too early and wish we had seen human data.”

However, Sanchez admits he will probably still get the booster shot, as he is convinced by the FDA’s argument that the existing evidence, even if it’s indirect, shows that the new injection is both safe. both potentially effective. There is also the fact that every year the annual flu shot is approved without data demonstrating effectiveness against the latest flu strains in circulation, making vaccination a gamble. , although pre-computed. “I want to remind the committee that every year, we recommend it,” said Dr. Melinda Wharton, from the CDC’s National Center for Immunization and Respiratory Diseases and executive secretary of the CDC committee. use of influenza vaccines based on new strains for which no clinical studies are available. “In many ways, this is similar to that.”

In support of their recommendation to change the booster, CDC researchers noted that people vaccinated with the parent vaccine and booster were weakened and, in some cases, less able to protect themselves. protected from contamination with sub-bacteria Omicron BA./BA.5. While early vaccines and boosters are protecting people from illnesses that require hospitalization, even that protection appears to be dwindling, as more fully vaccinated people are getting sick. moderate after infection with BA.4/BA.5. The model presented by the CDC scientists also suggests that if health authorities have to wait a few more months, until November, for the human studies to be completed on the BA.4/5 boosters. , about 137,000 people will be hospitalized and nearly 10,000 people will die from COVID-19.

That’s the reasoning behind the government’s push to license new enhancers, but it’s unclear if the public will follow the advice of health officials and rush for boosters – especially during a environment where people are tired of repetitive enhancers and increasingly skeptical of their effectiveness. As more and more people become infected with the highly contagious variant of Omicron BA.4/5, they believe their immunity to illness outweighs the need for a boost. And some health officials don’t believe the BA.4/5 booster provides additional protection from disease compared to the original vaccine, which becomes all the more questionable when it comes to people. vaccinated and boosted, and who have recently been infected with Omicron BA.4/5, as many Americans have recently had. Dr. Paul Offit, a professor at Children’s Hospital of Philadelphia and a member of the FDA’s vaccine expert committee, did not feel there was enough data to support the recommendation of a new and potentially potent booster. will not queue for this injection. “The CDC’s permission and recommendation doesn’t change the data, which is very little offensive,” he told TIME. “We still do not have human data on this vaccine. I don’t plan on getting this vaccine, mainly because I don’t think I need it. I had three previous injections and one had a mild natural infection.”

Some of the data presented to CDC committee members addressed this question about how much most people, who are vaccinated and boosted, would benefit from the specific booster. Omicron brand. Although it is biologically significant to compare the booster shot with circulating virus, currently the Omicron BA.4/5 subvariable, studies have not been completed. Early animal data are encouraging, suggesting that fortification by injection of the specific drug Omicron can help people build broader immunity to not only the original strain, but also to many variables. include Alpha, Beta, Delta and Omicron, but rat data may not substitute for human trials.

Both companies are conducting human studies and expect to have that information in the next few months, but in the meantime, people will have to decide for themselves how comfortable they feel. how to use the latest booster dose. “I think this is a big step towards simplification,” Wharton told the committee. “I hope we are moving towards something simpler and will not require such frequent changes in the future. Obviously we’re not there yet, but I think this is a big step forward.”

The U.S. government purchased 170 million doses of Omicron BA.4/5 booster from two manufacturers, and Pfizer-BioNTech shipped 100,000 doses to 62 destinations on September 1. After Labor Day weekend , the company plans to deliver 3 million doses to more than 3,000 locations. Moderna is producing 66 million doses of the drug to fulfill government orders, but there are no reports of how many have been shipped so far.

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