FDA panel recommends emergency approval

On Thursday, an influential Food and Drug Administration advisory group overwhelmingly supported Moderna’s coronavirus vaccine, a key milestone paving the way for the distribution of the second Covid-19 vaccine in the United States next week.

The non-binding decision, which was passed 20-0 with one abstention, by the FDA’s Advisory Committee on Vaccines and Related Biologics came exactly one week after the external group of experts on vaccines and infectious diseases voted to recommend the Pfizer vaccine and BioNTech for emergency use authorization. , or EUA. The agency granted Pfizer’s EUA the next day and the first vaccinations in the United States were administered on Monday.

The FDA advisory committee plays a key role in approving influenza and other vaccines in the United States, verifying that vaccines are safe for public use. While the FDA doesn’t have to follow the advisory committee’s recommendation, it often does. The United States plans to ship just under 6 million doses next week, pending the agency’s agreement, General Gustav Perna, who oversees the logistics of the Operation Warp vaccine project, told reporters on Monday. Speed.

An EUA means that the FDA will allow certain people to receive the vaccine while the agency continues to assess the data. This is not the same as full approval, which requires more data and can usually take several months longer. Moderna only submitted two months of tracking safety data. The agency typically needs six months for full approval. The committee recommended emergency authorization of the vaccine for people 18 years of age and older.

Initial doses will be limited as manufacturing increases, with officials predicting that it will take months to vaccinate everyone in the United States who wish to be vaccinated. The Centers for Disease Control and Prevention has provided states with a plan that recommends prioritizing health workers and nursing homes, but states can distribute the vaccine as they see fit.

Moderna’s vaccine uses messenger RNA, or mRNA, technology. It’s a new approach to vaccines that uses genetic material to elicit an immune response. Data from advanced clinical trials shows the vaccine is over 94% effective in preventing Covid, is safe, and appears to fend off serious disease. To achieve maximum effectiveness, the vaccine requires two doses four weeks apart.

The FDA has said it will allow a Covid-19 vaccine that is at least 50% safe and effective. The flu shot, by comparison, typically reduces the risk of getting the flu by 40% to 60% compared to people who are not vaccinated, according to the CDC.

FDA staff approved Moderna’s vaccine on Tuesday, saying in documents that clinical trial results and safety data were “in line with recommendations set out in the FDA’s guidelines on emergency use authorization. vaccines to prevent COVID-19 “.

The FDA said 13 deaths had been reported as of Dec. 3, including six in the vaccinated group. Two deaths in the vaccinated group were in people over 75 with pre-existing conditions, the agency said. One case was a 72-year-old vaccine recipient with Crohn’s disease and short bowel syndrome who was hospitalized with thrombocytopenia and acute renal failure.

Fatigue, headaches and muscle aches are the most common side effects of Moderna’s vaccine, along with some rare symptoms such as insoluble nausea or vomiting and facial swelling likely triggered by the injections, according to the FDA. . Some side effects were hard to shake off, although most resolved within a week, the FDA said.

At Thursday’s meeting, medical experts also asked the agency about allergic reactions after two cases occurred among health workers in Alaska who took Pfizer’s vaccine. Doran Fink, deputy director of the FDA’s vaccines and related products division, said the agency would continue to investigate the cases.

“As we continue to investigate and assess the data, we will consider whether any further recommendations need to be made,” he said. “At this point, we don’t have enough data to make a definitive recommendation one way or the other.”

There is little data on the safety of the vaccine in pregnant women and children. Thirteen pregnancies were reported in Moderna’s trial through Dec. 2, including six in the vaccine group, the FDA said. The company is tracking all women who became pregnant after receiving the vaccine or who were pregnant when they were vaccinated but did not know it, according to the agency.

Dr David Martin, vice president for drug safety at Moderna, told the committee on Thursday that the company would establish a “pregnancy registry” to track the performance of its vaccine in pregnant women.

“Regarding safety from vaccine exposure during pregnancy, a developmental and reproductive study was completed in December 2020, with no adverse results,” Martin told the committee. “Given the limited human exposure to date in the phase three trial, we will be establishing a pregnancy registry that includes a cohort recruited from the general population.”

While this isn’t necessarily a side effect, the FDA has said it recommends monitoring people who receive Pfizer or Moderna vaccines for possible cases of Bell’s palsy, a condition that causes sudden freezing or freezing. weakness of facial muscles. The agency also noted a higher prevalence of lymphadenopathy, a disease that can produce swollen or enlarged lymph nodes, in Pfizer and Moderna’s trials in the vaccine group compared to the placebo groups.

Moderna said her vaccine remained stable at 36 to 46 degrees Fahrenheit, the temperature of a standard home or medical refrigerator, for up to 30 days. It can be stored for up to six months at less than 4 degrees Fahrenheit. In comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit.

The federal government announced last week that it would purchase an additional 100 million doses of the Moderna vaccine. The United States struck a deal with Moderna in August to acquire 100 million doses for around $ 1.5 billion. Moderna said that month he was charging some customers between $ 32 and $ 37 per dose for his vaccine, under a cheaper “pandemic price.” The company said it was in talks for larger volume deals that will have a lower price.

CNBC’s Noah Higgins-Dunn contributed to this article.

This is a developing story. Please come back for updates.