An influential Food and Drug Administration advisory panel on Thursday overwhelmingly supported Moderna’s coronavirus vaccine, a key step in paving the way for the distribution of the second Covid-19 vaccine in the United States next week.
The non-binding decision, made between 20 and 0 with one abstention, from the FDA’s advisory committee on vaccines and related biological products, came exactly one week after the external panel of vaccine and disease experts infectious voters voted to recommend the Pfizer vaccine and BioNTech for an emergency use authorization. , the USA. The agency granted Pfizer the U.S. the next day and the first inoculations were made in the U.S. on Monday.
The FDA advisory committee plays a key role in approving the flu vaccine and other vaccines in the U.S., in verifying that vaccines are safe for public use. While the FDA should not 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 acceptance, General Gustave Perna, who oversees the logistics of Operation Warp Speed’s vaccine project, said Monday to reporters.
A U.S. means the FDA will allow some people to receive the vaccine while the agency continues to evaluate the data. It’s not the same as full approval, which requires more data and can usually take a few more months. Modern has submitted only two months of security tracking data. The agency usually requires six months for full approval. The committee recommended emergency authorization of the vaccine for people over 18 years of age.
Initial doses will be limited as manufacturing increases, and officials predict it will take months to vaccinate all U.S. who want to be vaccinated. The Centers for Disease Control and Prevention has provided states with a scheme that recommends prioritizing health care workers and residences, but states can distribute the vaccine as they see fit.
The Moderna vaccine uses messenger RNA or mRNA technology. It is a new approach to vaccines that uses genetic material to elicit an immune response. Data from end-stage clinical trials show that the vaccine is more than 94% effective in preventing covidism, which is safe and appears to defend against serious disease. To achieve maximum effectiveness, the vaccine requires two separate doses for four weeks.
The FDA has indicated that it would authorize a vaccine against Covid-19 that is safe and has a minimum efficacy of 50%. In comparison, the flu vaccine generally reduces the risk of getting the flu by 40% to 60% compared to people who are not inoculated, according to the CDC.
FDA staff supported the Modern vaccine on Tuesday, saying in documents that the results of the clinical trials and safety data were “consistent with the recommendations set forth in the FDA Guidance on Authorization to Use ’emergency for vaccines to prevent COVID-19 “.
The FDA said 13 deaths were reported on Dec. 3, with six in the vaccine group. Two deaths in the vaccine group were 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 for thrombocytopenia and acute renal failure.
Fatigue, headaches, and muscle aches are the most common side effects of Moderna’s vaccine, along with some uncommon symptoms like intractable nausea or vomiting and facial swelling that are likely to be triggered by shots, according to the FDA. Some side effects were difficult to shake, although they resolved within a week, the FDA said.
Ahead of the vote Thursday, medical experts also asked the agency about allergic reactions after two cases in Alaska health workers who took the Pfizer vaccine. Doran Fink, deputy director of the vaccine and applications division of FDA-related products, said the agency would continue to investigate the cases.
“As we continue to research and evaluate the data, we will consider whether additional recommendations need to be made,” he said. “Right now, we don’t have enough data to make a definitive recommendation one way or another.”
There are few data on vaccine safety in pregnant women and children. The Moderna test through Dec. 2 reported thirteen pregnancies, with six in the vaccine group, the FDA reported. The company tracks all women who became pregnant after receiving the vaccine or who were pregnant when they were immunized but did not know it, according to the agency.
Dr. David Martin, vice president of drug safety at Moderna, told the committee Thursday that the company will establish a “pregnancy registry” to monitor the performance of its vaccine on pregnant women.
“In terms of safety in the event of exposure to the vaccine during pregnancy, a study on development and reproduction was completed in December 2020, with no adverse results,” Martin told the committee. “Given the limited human exposure so far in the phase three trial, we will establish a pregnancy registry that includes a cohort recruited from the general population.”
While not necessarily a side effect, the FDA said it recommends monitoring people receiving Pfizer or Moderna vaccines for possible cases of Bell’s palsy, a condition that causes sudden freezing or weakness in the facial muscles. The agency also noted a higher prevalence of lymphadenopathy, a disease that can cause swollen or enlarged lymph nodes, in the Pfizer and Moderna trials in the vaccine group compared to the placebo groups.
Modern has said its vaccine remains stable between 36 and 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 4 degrees Fahrenheit negative. In comparison, the Pfizer vaccine requires a storage temperature of minus 94 degrees Fahrenheit.
The federal government announced last week that it would buy an additional 100 million doses of Modern vaccine. The United States signed an agreement with Moderna in August to acquire 100 million doses for about $ 1.5 billion. Moderna said that month she charged between $ 32 and $ 37 per dose for her vaccine for some clients, under a cheaper “pandemic price.” The company said it was in discussions to get higher-volume deals that would have a lower price.
CNBC’s Noah Higgins-Dunn contributed to this article.
This is a developing story. Please check for updates again.