Health

An FDA Panel Decides It’s Time for a New COVID-19 Booster


OOn June 28, an expert panel convened by the US Food and Drug Administration (FDA) voted 19 to 2 to change the vaccines that have been used since December 2018. 2020 to protect against COVID-19.

The change, which will only apply to the booster dose for those already vaccinated, includes the inclusion of a strain targeting the Omicron variant, which is currently responsible for nearly all COVID-19 infections- 19 in the United States and worldwide. But the committee stopped short of deciding exactly which strain of Omicron; Omicron has produced many different auxiliary variables, starting with BA.1 and now BA.4 and BA.5The latter two currently account for 50% of COVID-19 cases in the United States. Including an Omicron strain in the next boost is similar to how flu viruses are swapped out every year to give people the strongest immunity against any flu version. circulated at the time.

The committee’s decision was based on a number of pieces of evidence, including the fact that Omicron differs from the original version of the virus in currently approved vaccines. The initial COVID-19 vaccines, as well as booster doses that have been authorized in the US, target an earlier strain of the virus known as D614G, which public health experts refer to as the ancestral strain.

Experts have also heard from scientists at the US Centers for Disease Control and Prevention (CDC), who have provided data showing that these original vaccines are no longer effective. in protecting people from infection with the Omicron variant and its subvariants as against ancestry. stress. Vaccines continue to provide good protection against severe illness with COVID-19, and without hospitalization or death from the disease, but public health experts have provided evidence. convinced that that protection could be even stronger if subsequent booster shots come from a new version of the vaccine specifically targeting Omicron.

Why is a new vaccine needed now?

The FDA committee decided that it was time to update the COVID-19 vaccine and that continuing to strengthen it with the existing shot would not provide the long-term protection that people need. The experts looked at data on the dominance of the Omicron variant, which has been circulating in the US since December 2021 and has spawned several different subvariants, including BA.1, BA.2.12.1BA.4 and BA.5.

The same FDA committee has see you in april discussed the criteria for changing the COVID-19 vaccine and concluded that the advice of the World Health Organization Technical Advisory Group on COVID-19 Vaccine Composition (TAG-Co-VAC) would be considered. , which analyzes data on COVID-19 vaccine effectiveness and makes recommendations on when to change vaccines if effectiveness shows signs of decline, like a similar WHO group for flu vaccines annual. That group conclusion in June, although currently available vaccines made by Moderna and Pfizer-BioNTech continue to protect against severe COVID-19 disease — even if people are infected with Omicron variants — immunity A stronger anti-Omicron solution may be accompanied by a booster dose containing the new Omicron vaccine. Dr Kanta Subbarao, director of the WHO Collaborating Center for Influenza Reference and Research, explained to the committee the rationale behind the group’s advice, noting that the addition of the Omicron-specific ingredient to the substance The next booster will increase the amount of protection people can get from vaccinations. “It doesn’t quite fit what [virus strain] potentially circulating, but more about achieving broader immunity [against the existing variants]’ she told the committee.

Subbarao presented data showing that people who were vaccinated and subsequently infected with Omicron produced a range of antibodies that could neutralize more SARS-CoV-2 variants, including the parent strain and Omicron. , compared with those who were unvaccinated and infected with Omicrons, who primarily produced immune responses specific to Omicrons only.

However, WHO has not recommended switching to the Omicron-specific vaccine to immunize unvaccinated people, as there are still no data to demonstrate whether such immunity is strong enough.

The FDA committee also considered a number of other evidences, including the fact that currently circulating versions of SARS-CoV-2, primarily from the Omicron strain, are sufficiently different from the original virus that the vaccine targets. and currently available vaccines are less effective at protecting against Omicron infection than they are against other variants. The committee reviewed data showing that although current vaccines continue to protect against severe illness, levels of antibodies against the virus in vaccinated people, including those who have already been vaccinated. repeated injections, which will decrease over time.

Considering all available data, the FDA panel decided that there was sufficient evidence to justify altering the COVID-19 booster vaccine to better target the Omicron variant currently responsible. responsible for nearly all infections.

Which version of Omicron will the next vaccine target?

This question led to the most division between invited speakers and committee members. While Subbarao from WHO suggested including BA.1 in the next vaccine, because of its genetic difference from the original SARS-CoV-2 strain in current vaccines, Dr. Peter Marks from the FDA did not agree, he prefers to focus on BA.4 and BA.5 instead. “Current vaccines appear to be the least effective against them,” he said.

Both Moderna and Pfizer-BioNTech provide data on the new vaccine they developed containing two strains of SARS-CoV-2: the parent strain and the strain targeting the first Omicron variant, BA.1, in the so-called vaccine Please two values. This approach is similar to that used in the flu shot, which typically targets three different strains of flu.

The companies also develop and research vaccines targeting only the BA.1 Omicron variant, but have found that combining Omicron and the original strains provides a broader immune response against more than just the original strains. strain Omicron.

The committee was not tasked with deciding which versions of Omicron should be included in the new enhanced footage, although committee members were inclined to target BA.4 and BA.5, because of these versions. increasingly popular in the US. However, there is little data regarding the effectiveness of vaccines containing BA.4 and BA.5, and committee members urged the companies to continue working on these versions, which even Moderna does. and Pfizer-BioNTech are both doing.

Will the new vaccine provide better protection against Omicron?

That is the hope, although there is still little data from the real world on how much stronger protection against Omicron will actually be. The companies tested their dual-value vaccines for their ability to generate antibodies against the virus, against Omicron in the lab, and the committee extrapolated from those studies that antibody levels enough to protect against infection and disease.

It is not clear whether people receiving bivalent vaccines that target BA.1 produce the same levels of antibodies against the newer Omicron subvariables, including BA.4 and BA.5, as against BA.1. are not. Moderna is studying how the immune response to BA.4 and BA.5 produced by the BA.1 dual vaccine compares to the response against BA.1, and Pfizer-BioNTech has provided initial data from a mouse study. That data showed that its bivalent vaccine produced antibodies against strains BA.4 and BA.5, although to a lesser extent than against BA.1 or the original virus strain. Both companies are continuing to work on their new vaccines against newer Omicron sub-variants, which are likely to become more common in the coming months.

Are vaccines safe?

Some members of the committee raised questions about whether the dual-value vaccine, which targets two different strains of SARS-CoV-2, produces more side effects, including myocarditis, Inflammation of the heart tissue affects most adolescent males or not. In short-term data provided by Moderna and Pfizer-BioNTech and reviewed by the FDA, adverse events and adverse reactions to new vaccines measured approximately one month after vaccination occurred at similar rates to initial dose, but longer follow-up is necessary.

Will other new vaccines be out later this year?

The committee also looked at data from Novavax, the company that makes the COVID-19 vaccine, using technology different from the mRNA platform behind Moderna’s and Pfizer-BioNTech’s vaccines. The FDA is still reviewing the company’s emergency use authorization request and has not made a decision. But many committee members were impressed with the data from Novavax’s original vaccine candidate, which targeted the original strain of SARS-CoV-2 but generated a strong immune response with a wide variety of variants. , including against Omicron. Dr. Glenn Gregory, the company’s president of research and development, argues that the data is a good case for deploying Novavax’s vaccine, with two doses, to combat current Omicron cases. But because that vaccine isn’t authorized and the data hasn’t been reviewed by the FDA, it’s unclear how valid that evidence is.

When will new boosters be available?

Both Moderna and Pfizer-BioNTech have already begun production of dual-value vaccines targeting BA.1, and Moderna said that if the US government decides to ramp up that injection, they could have hundreds of millions of doses by May. 7 or August.

However, if regulators decide on a chemotherapy vaccine containing strains of BA.4 or BA.5, both companies will need about three months to produce those shots and pass evaluation. FDA pricing, so those vaccines won’t be available until October or November if FDA and CDC authorize them.

Now that the FDA advisory committee recommends that some version of Omicron be included in the next booster shot, the FDA will review the available data or request additional data from vaccine manufacturers. , to decide what type of Omicron should be included and when people should be promoted. The panel’s decision is just the first in a long series of steps — and many more studies — required before anyone receives a new COVID-19 vaccine in the fall. “What I would like to see is additional data and a better understanding of the clinical implications for the impact on health outcomes,” said Adam Berger, director of healthcare and clinical research policy at the National Institutes of Health. serious outcomes and illness. “I would like more data on the long-term durability of any kind of change to the actual vaccine composition.”

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