Moderna Receives FDA Green Light for COVID-19 Booster Targeting Omicron Variant

Moderna has received emergency use authorization from the Food and Drug Administration (FDA) for its Omicron-specific COVID-19 booster shot, the company said Wednesday.

The jab is the first reformulated shot to receive the regulatory green light in the United States. It was approved for all adults over the age of 18. Pfizer, Moderna’s main competitor in rolling out COVID-19 vaccines, is expected to receive similar approval soon.

The new vaccinations increase antibody protection against the Omicron variant – which includes all of the most contagious virus strains to date. Previous versions of the shot were tailored for the original Wuhan Covid strain and the virus has since mutated to elude the protection they offered.

Regulators are aiming to release the footage by September ahead of another potential spike if the weather turns colder. But some experts disagree with the shot’s approval, saying it’s of little value as the current crop of vaccines is still effective against hospitalizations and deaths caused by the virus.

Moderna Received Emergency Use Authorization from the FDA for its Omicron-Specific COVID-19 Vaccines (File Photo)

Moderna Received Emergency Use Authorization from the FDA for its Omicron-Specific COVID-19 Vaccines (File Photo)

“FDA approval of our updated bivalent booster, mRNA-1273.222, provides Americans with access to broader protection against Omicron variants,” Moderna CEO Stéphane Bancel said in a statement.

“Obtaining a booster shot specifically targeting the Omicron BA.4/.5 variant, currently the most prevalent strain of SARS-CoV-2, is an important public health action people can take to protect themselves to protect themselves, especially as we head into a season filled with indoor gatherings.’

The BA.5 variant now accounts for 89 percent of COVID-19 infections, reports the Centers for Disease Control and Prevention. It’s the most contagious strain of the virus yet, and has wiped out nearly every version that came before it.

Moderna’s trial for the recordings included 800 participants and several formulations were initially tested.

The company reported that its second formulation of an Omicron-specific injection produced nearly 70 percent more antibodies effective against BA.5 than a previous version one month after receiving the dose.

This could potentially be the most effective formulation of vaccine against the new variant to date, although more data on infections, hospitalizations and deaths will need to be collected before that determination can be made.

Because Covid antibodies have a diminishing return over time, 70 per cent more antibodies doesn’t necessarily mean vaccination is that much more effective.

The Omicron variant emerged in late 2021 and took the world by storm: it was the most mutated version of the virus yet, and its ability to bypass vaccine immunity caught the largely vaccinated population of many developed countries unprepared.

It spread quickly, causing case numbers to hit 800,000 daily in the US.

This sparked demand for COVID-19 boosters that could specifically target the mutated strain and prevent infection.

The FDA is eager to get these shots out and has already set targets for launch before they’ve even been approved.

dr Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, the agency’s chief vaccine regulator, said in June the goal is to have Omicron-specific vaccines available by September.

dr Marty Makary (pictured), a public health expert from Johns Hopkins University, wrote that the permit was

dr Paul Offit (pictured), a member of VRBPAC, voted against allowing the Omicron-specific boosters, doubting they would add value

dr Marty Makary (left), a public health expert from Johns Hopkins University, wrote that the permit was “bad medicine” and “bad politics”. dr Paul Offit (right), a member of VRBPAC, voted against allowing the Omicron-specific boosters, doubting that they add value

However, not all experts agree that these jabs are necessary.

While current vaccinations no longer offer much protection against infection, they can still reliably prevent a person from having to be hospitalized or dying from the virus.

dr Marty Makary, a public health expert at Johns Hopkins University, wrote last week that there was little evidence the extra shots were necessary.

“Where is the data to support such a comprehensive recommendation? The new mRNA vaccines, which are expected to be approved next month, have no clinical trial results that are public. In fact, we don’t know anything about them,” Makary wrote.

“Urging the American people to blindly obey to take a novel mRNA vaccine is not just bad medicine, it’s bad politics. And it certainly doesn’t follow science.”

dr Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), wrote in a STAT News comment in June that he would like to see more data in favor of the shots, before the government invested heavily in them.

Offit notes that in the data submitted by both companies, the additional Omicron booster increased antibody levels two-fold, although he doubts they’ll provide much potency overall.

“This type of two-fold difference is similar to, for example, the slightly larger peak in neutralization of antibodies elicited by the first two doses of the Moderna vaccine compared to the Pfizer vaccine,” he explained, noting that the protection provided was similar .

“These two vaccines provided almost identical protection against mild and severe Covid-19, although the benefits of the Pfizer vaccine wore off at a slightly faster rate over time.”

He was one of two members of VRBPAC who voted against introducing versions of the shot specifically tailored for the Omicron variant.

https://www.dailymail.co.uk/health/article-11165135/Moderna-receives-FDA-green-light-COVID-19-booster-targeting-Omicron-variant.html?ns_mchannel=rss&ns_campaign=1490&ito=1490 Moderna Receives FDA Green Light for COVID-19 Booster Targeting Omicron Variant

Andrew Kugle

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