Moderna has received emergency use authorization from the FDA for its Omicron-specific COVID-19 vaccines (file photo)

Moderna receives FDA green light for COVID-19 recall targeting Omicron variant

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

The jab is the first reformulated shot to receive the regulatory green light in the United States. It has been approved for all adults aged 18 and over. Pfizer, Moderna’s main competitor in rolling out COVID-19 plans, is also expected to receive similar approval soon.

The new vaccines will increase antibody protection against the Omicron variant – which includes all of the most infectious strains of the virus to date. Previous versions of the shot were tailored to the original strain of Wuhan Covid, and the virus has since mutated to evade the protection they offered.

Regulators aim to get the vaccines out by September ahead of another potential spike in cases as the weather cools. However, some experts disagree with the approval of the vaccine, saying it provides little value because the current crop of vaccines are still effective against hospitalizations and deaths caused by the virus.

Moderna has received emergency use authorization from the FDA for its Omicron-specific COVID-19 vaccines (file photo)

The BA.5 variant now accounts for 89% of active COVID-19 cases in the United States, according to the most recent data from the CDC

The BA.5 variant now accounts for 89% of active COVID-19 cases in the United States, according to the most recent data from the CDC

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

“Receiving a booster that specifically targets the Omicron BA.4/.5 variant, currently the most prevalent strain of SARS-CoV-2, is an important public health measure people can take to protect themselves, especially while we are heading into a season filled with indoor gatherings.

The BA.5 variant now accounts for 89% of COVID-19 infections, the Centers for Disease Control and Prevention reports. It is the most infectious strain of the virus to date and has extinguished almost all versions that have come before it.

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

The company reported that its second formulation of an Omicron-specific jab generated almost 70% more effective antibodies against BA.5 than a previous version one month after receiving the dose.

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

Because Covid antibodies have diminishing returns over time, having 70% more antibodies doesn’t particularly mean the vaccine is 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 to date, and its ability to circumvent vaccine immunity caught the widely vaccinated population of many developed countries.

It spread rapidly, causing the number of cases in the United States to reach 800,000 a day.

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

The FDA is eager to roll out these vaccines, already setting deployment goals even before they’ve been cleared.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, the agency’s lead vaccine regulator, said in June that the goal was to make Omicron-specific jabs available by September. .

This decision will add to the financial advantage that the Covid blows have been for Moderna so far.

The Cambridge, Mass.-based company was relatively unknown before the COVID-19 pandemic. Since the start of 2020, its stock price has risen from $19 to $430 in September 2021. It is currently at $134.79 as of Wednesday noon.

Dr Marty Makary (pictured), a public health expert from Johns Hopkins University, wrote that the endorsement is 'bad medicine' and 'bad politics'

VRBPAC member Dr Paul Offit (pictured) voted against approving Omicron-specific boosters, doubting they would add value

Dr Marty Makary (left), a public health expert from Johns Hopkins University, wrote that the endorsement is ‘bad medicine’ and ‘bad politics’. VRBPAC member Dr Paul Offit (right) voted against approving Omicron-specific boosters, doubting they would add value

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

Current vaccines may no longer offer much protection against infection, but they can still reliably prevent a person from requiring hospitalization or dying from the virus.

Dr Marty Makary, a public health expert at Johns Hopkins University, wrote last week that there was little evidence these extra injections were needed.

“Where is the data to support such a drastic recommendation?” New mRNA vaccines expected to be licensed next month do not have public clinical trial results. In fact, we know nothing about them,” Makary wrote.

“To urge the American people to blindly obey to take a new mRNA vaccine is not just bad medicine, it’s bad politics. And it’s certainly not in accordance with 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 Biologicals Advisory Committee (VRBPAC), wrote in a STAT News op-ed in June that he would like to see more data in favor of the shootings before the government invests heavily in it.

Offit notes that in data submitted by both companies, the supplemental Omicron booster doubled antibody levels, though he doubts they provide much overall efficacy.

“This type of double difference is, for example, similar to the slightly higher peak of neutralizing antibodies triggered by the first two doses of the Moderna vaccine compared to the Pfizer vaccine,” he explained, noting that the protections provided were similar.

“These two vaccines provided almost identical protection against mild and severe Covid-19, although the benefits of the Pfizer vaccine waned somewhat more rapidly over time.”

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

Moderna receives FDA green light for COVID-19 recall targeting Omicron variant

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