Moderna greenlights FDA for COVID-19 booster targeting Omicron variant

The company announced Wednesday that it has received an emergency use authorization from the Food and Drug Administration (FDA) for Moderna’s COVID-19 booster injection specific to Omicron.

Jab is the first reformulated injection to receive the green light in the United States. Approved for all adults 18 years and older. Pfizer, Moderna’s main competitor in launching COVID-19 footage, is expected to receive similar confirmation 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 injection were adapted to the original Wuhan Covid strain, and the virus mutated to circumvent the protection they provided.

Regulators have aimed to finish filming by September until they expect another potential spike in cases as the weather cools. However, some experts disagree with the approval of the injection, saying that current vaccines are of little value as they are still effective against hospitalization and death caused by the virus.

5 variant currently accounts for 89% of active COVID-19 cases in the United States, according to the latest CDC data.

“FDA approval of our elevated bivalent enhancer, mRNA-1273,222, gives Americans access to broader protection against Omicron derivatives,” Moderna CEO Stéphane Bancel said in a statement.

“Getting a booster that specifically targets the Omicron BA.4/5 variant, currently the most common strain of SARS-CoV-2, is an important public health measure people can take to protect themselves, especially as we enter a season. closed event meetings”.

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 to date, and has deleted almost all previous versions.

The Moderna test for shots involved 800 participants, and multiple formulations were tested initially.

The company reported that the second formulation of a specific injection of Omicron produced approximately 70 percent more antibodies against BA.5 than the previous version one month after taking the dose.

This could potentially be the most effective vaccine formulation to date against the new variant, but more data on infections, hospitalizations and deaths are needed before such a conclusion can be reached.

Just because Covid antibodies have diminishing returns over time, having 70% more antibodies doesn’t necessarily mean the injection 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 evade vaccine immunity has largely taken the unvaccinated population by surprise. many developed countries.

The number of cases in the United States spread rapidly, reaching 800,000 per day.

This has led to the demand for COVID-19 boosters that can specifically target the mutant strain and prevent infection.

The FDA is eager to release these images and has already begun setting launch targets before they are authorized.

Dr. Peter Marks, director of the Center for Biological Evaluation and Research at the agency’s main vaccine regulator, FDA, said in June that the goal is to make vaccines specific to Omicron available by September.

The move will increase the financial advantage of Covid withdrawals for Moderna to date.

The Cambridge, Massachusetts-based company was relatively unknown prior to the COVID-19 pandemic. Since early 2020, the stock price has risen by $19, peaking at $430 in September 2021. It’s currently $134.79 on Wednesday afternoon.

Dr. Marty Makary (left), a public health expert at Johns Hopkins University, wrote that the endorsement was “bad medicine” and “bad policy.” Dr. VRBPAC member Paul Offit (right) votes against approval of Omicron’s special boosters because he doubts they offer value

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

Current injections may not provide much protection against infections, but can still reliably prevent a person from being hospitalized or dying from the virus.

Dr. Marty Makary, a public health expert at Johns Hopkins University, wrote last week that there is little evidence that these additional vaccines are necessary.

‘Where is the data to support such a broad recommendation? There are no public clinical trial results of the new mRNA vaccines, which are expected to be approved next month. We actually don’t know anything about them,” Makary wrote.

“Forcing the American public to blindly comply with the purchase of a new mRNA vaccine is not only bad medicine, it is also bad policy. And it certainly does not follow science.

Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and member of the FDA’s Advisory Committee on Vaccines and Related Biologicals (VRBPAC), wrote in a STAT News editorial in June that he wanted to see more data. The government has invested heavily in it.

Offit notes that in data submitted by both companies, Omicron’s supplement booster doubled antibody levels, although he doubts it would provide greater efficacy overall.

“For example, such a double difference is comparable to the slightly larger peak in neutralizing antibodies caused by the first two doses of the Moderna vaccine compared to the Pfizer vaccine,” he explained, noting that the protection offered was comparable.

“These two vaccines offered almost the same protection against mild and severe Covid-19, but the benefits of the Pfizer vaccine diminished slightly more quickly over time.”

He was one of two VRBPAC members who voted against launching versions of the recording tailored for the Omicron variant.