A key Food and Drug Administration advisory body is due to vote Thursday on whether to recommend Moderna’s emergency approval of Moderna’s Cova-19 vaccine to pave the way for a second preventative treatment to be distributed in the US
The non-binding decision of the FDA’s Advisory Committee on Vaccines and Related Biological Products is due exactly one week after the external group of vaccines and infectious disease experts overwhelmingly voted to recommend Pfizer-BioNTech’s emergency vaccine approval. The FDA approved this vaccine a day later.
A positive vote from the committee will likely pave the way for the FDA to approve Moderna’s emergency vaccine. The committee plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not need to follow the committee’s recommendation, it often does.
It is about the potentially life-saving doses needed to end the pandemic that killed more than 300,000 Americans in less than a year. Public health officials say the US will likely need more than one vaccine as starting doses will be limited. Approximately 75% of the US population must be vaccinated to achieve herd immunity that protects enough people so that the virus cannot spread and be contained, US officials say.
Here’s what you can expect:
1.) When do you vote?
According to a draft agenda, the meeting should take place from 9 a.m. to 5:15 p.m. The vote usually takes place towards the end.
Prior to voting, medical experts will evaluate Moderna clinical trial data and provide their opinion on the vaccine, including whether the benefits outweigh the risks for an emergency approval. Moderna is asking the FDA to approve the use of the vaccine in people 18 years and older. Pfizer’s has been approved for use in people aged 16 and over. The low data in younger teenagers was a sticking point for the few advisory board members who last week voted against approving the Pfizer vaccine.
2.) What happens next?
The FDA will decide whether to clear Moderna’s vaccine for emergency use. In Pfizer’s case, the agency’s final decision came a day after the meeting.
Such approval means that the FDA will allow some people to receive the vaccine as the agency continues to analyze data. This is not the same as a full approval, which requires more data and can typically take months longer. Moderna only submitted security data for two months. The agency typically takes six months for full approval.
3.) When will I get the vaccine?
The US plans to ship close to 6 million doses of Moderna’s vaccine once the FDA clears the EUA. This was announced by General Gustave Perna, who oversees the logistics for the Operation Warp Speed vaccination project, to reporters on Monday. Medical supply company McKesson will package the cans and distribute them to 3,285 locations across the country, he said.
The initial doses will be limited as production increases. Officials predict it will be months before everyone in the US who wants to be vaccinated is vaccinated. The Centers for Disease Control and Prevention has provided states with an outline recommending that priority be given to healthcare workers and nursing homes. However, states may distribute the vaccine at their own discretion.
Moncef Slaoui, who heads the White House’s Operation Warp Speed, said Monday officials expect 20 million Americans to get their first shot of Modernas or Pfizer’s vaccine this month. He added that by the end of February, 100 million “gun vaccine shots” will be administered between the first dose and the booster shots. By the end of March, around 100 million Americans could be fully vaccinated, nearly a third of the population, he said.
4.) Should I get the vaccine if I have Covid?
The FDA has stated that patients with Covid-19 may still be at risk of re-infection and could benefit from the vaccine. Researchers are still trying to determine how long immunity lasts after being infected with the virus. An Oxford study suggests that protection lasts at least six months.
Little data is available on the safety of the vaccine in pregnant women and children, according to documents released Tuesday by the FDA. Although children and younger teenagers are not considered for Moderna emergency clearance, pregnant women are likely to be included.
Pregnant women were not excluded from Pfizer’s emergency clearance last week, leaving patients to consult their doctor. It is likely that the FDA will do the same for Moderna’s vaccine.
Thirteen pregnancies were reported in Moderna’s study as of December 2, six in the vaccine group, the FDA said. The company is tracking all women who became pregnant after receiving the vaccine or were pregnant when they were vaccinated but didn’t know it, according to the agency.
5.) What are the side effects?
Fatigue, headaches, and muscle aches are the most common side effects of Moderna’s vaccine, along with some rare symptoms such as persistent nausea or vomiting and facial swelling, which the FDA says are likely caused by the gunfire. Some side effects were tough to shake, although most were resolved within a week, the FDA said.
While not necessarily a side effect, the FDA recommends monitoring people receiving Pfizer or Moderna vaccinations for possible cases of Bell’s palsy, which leads to sudden freezing or weakness of facial muscles. The agency also found a higher prevalence of lymphadenopathy, a disease that can cause swollen or enlarged lymph nodes, in the vaccine group compared to the placebo groups in Pfizer and Moderna studies.
Dr. Peter Marks, director of the FDA’s Center for the Evaluation and Research of Biologics, said in an interview with JAMA on Monday that once the vaccines have been administered, the agency can easily and quickly access data on Bell palsy cases.
Dr. Paul Offit, a voting member of the advisory board, agreed that Bell’s paralysis in the launch of the vaccine is worth monitoring. He voted last week to recommend Pfizer’s vaccine. “I’m not rejecting this yet,” he said in an interview with CNBC.
CNBC’s Will Feuer and Noah Higgins-Dunn contributed to this report.
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