An influential Food and Drug Administration advisory panel on Thursday overwhelmingly supported Moderna’s coronavirus vaccine, an important step paving the way for distribution of the second Covid-19 vaccine in the United States next week.
The non-binding decision, passed 20 to 0 with one abstention, from the FDA’s Vaccines and Related Biological Products Advisory Committee came exactly one week after the external group of vaccines and infectious diseases experts voted to approve the vaccine. Pfizer and BioNTech for an Emergency Use Permit or EUA. The agency awarded Pfizer’s EUA the next day, and the first vaccinations in the US were given on Monday.
The FDA Advisory Committee plays a key role in the approval of flu and other vaccines in the US and checks that the injections are safe for public use. While the FDA does not have to follow the advisory committee’s recommendation, it often does. The US plans to ship just under 6 million doses next week, pending agency approval, General Gustave Perna, who oversees logistics for the Operation Warp Speed vaccination project, told reporters Monday.
An EUA means the FDA will allow some people to receive the vaccine while the agency continues to evaluate data. It is not the same as full approval, which requires more data and can usually take several months longer. Moderna has only submitted two months of follow-up safety data. The agency usually takes six months for full approval. The committee recommended urgent authorization of the vaccine for people 18 and older.
Initial doses will be limited as production increases, and officials predict it will take months to immunize anyone in the US who wants to be vaccinated. The Centers for Disease Control and Prevention has provided states with an overview 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 is a new approach to vaccines that uses genetic material to elicit an immune response. Data from late-stage clinical trials show that the vaccine is more than 94% effective in preventing Covid, is safe and appears to ward off serious illness. To achieve maximum effectiveness, the vaccine requires two doses four weeks apart.
The FDA has indicated it would approve a Covid-19 vaccine that is safe and at least 50% effective. The flu vaccine, by comparison, generally reduces people’s risk of getting the flu by 40% to 60% compared to people who have not been 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 the recommendations outlined in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19.”
The FDA said 13 deaths had been reported on Dec. 3, with six in the vaccine group. Two deaths in the vaccine group were those over 75 with pre-existing conditions, the agency said. One case involved 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 pain are the most common side effects of Moderna’s vaccine, along with some rare symptoms such as persistent nausea or vomiting and facial swelling likely caused by the shots, according to the FDA. Some of the side effects were difficult to shake, 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 in Alaskan health workers who used Pfizer’s vaccine. Doran Fink, deputy director of the FDA division of vaccines and related product applications, said the agency would continue to investigate the cases.
“As we continue to examine and evaluate the data, we will consider whether additional recommendations need to be made,” he said. “At this point, we don’t have enough data to somehow make a definitive recommendation.”
There are limited data on the safety of the vaccine in pregnant women and children. Thirteen pregnancies were reported in the Moderna trial through Dec. 2, with 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 immunized but did not know, the agency said.
Dr. David Martin, vice president for drug safety at Moderna, told the committee on Thursday that the company will set up a “pregnancy registry” to track how the vaccine is performing in pregnant women.
“With regard to safety in case of vaccine exposure during pregnancy, a developmental and reproductive study was completed in December 2020 with no adverse findings,” said Martin. “Given the limited human exposure to date in the phase three study, we will establish a pregnancy registry with a cohort recruited from the general population.”
While not necessarily a side effect, the FDA said it recommends monitoring people who receive Pfizer or Moderna’s vaccine shots for possible cases of Bell’s palsy, a condition that causes sudden frostbite or weakness in the facial muscles. The agency also found a higher prevalence of lymphadenopathy, a disease that can cause swollen or enlarged lymph nodes, in the Pfizer and Moderna studies in the vaccine group compared to the placebo groups.
Moderna has said the vaccine will remain stable for up to 30 days at 36 to 46 degrees Fahrenheit, the temperature of a standard home or medicine refrigerator. It can be stored at a temperature of 4 degrees Fahrenheit for up to six months. In comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit.
The federal government announced last week that it will purchase an additional 100 million doses of Moderna vaccine. The US entered into an agreement with Moderna in August to acquire 100 million doses for approximately $ 1.5 billion. Moderna said it charged $ 32 to $ 37 per dose that month for its vaccine for some customers, under cheaper “pandemic prices.” The company said it was in discussion for larger volume deals that will have a lower price.
CNBC’s Noah Higgins-Dunn contributed to this article.
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