The FDA panel recommends emergency clearance

An influential advisory body to the Food and Drug Administration overwhelmingly endorsed Moderna’s coronavirus vaccine on Thursday. This is an important step that paves the way for the distribution of the second Covid-19 vaccine in the US next week.

The non-binding decision, approved 20-0 with one abstention from the FDA’s Advisory Committee on Vaccines and Related Biological Products, came exactly one week after the external panel of vaccines and infectious diseases approved the vaccine from Pfizer and BioNTech recommended for an emergency permit or EUA. The agency granted Pfizer EUA the next day, and the first vaccinations in the US were given on Monday.

The FDA advisory panel plays a key role in approving flu 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 advisory board’s recommendation, it often does. The US plans to ship nearly 6 million cans next week pending the agency’s OK, General Gustave Perna, who oversees logistics for the Operation Warp Speed ​​vaccination project, told reporters on Monday.

Prior to the vote, some committee members stressed that their approval of Moderna’s vaccine was not a full FDA approval and reiterated that the agency needed to review further safety and efficacy data.

“I don’t want people to interpret this as an approved vaccine,” said Dr. Cody Meissner, voting committee member and infectious disease expert at Tufts University School of Medicine. The confirmation is “based on the evidence available, but that is limited”.

An EEA 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 several months longer. Moderna only submitted security data for two months. The agency typically takes six months for full approval. The committee recommended emergency approval of the vaccine for people aged 18 and over.

Member Dr. Michael Kurilla, an infectious disease expert at the National Institutes of Health, was the only member who disagreed with the vote. He said he had decided to abstain because he was “uncomfortable” in advocating the vaccine for anyone over the age of 18.

“In the midst of a pandemic and with limited vaccine supplies, a blanket statement for anyone aged 18 and over is just too broad,” Kurilla said. “I am not convinced by all of these age groups that the benefits actually outweigh the risks.”

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.

Moderna’s vaccine uses messenger RNA or mRNA technology. It’s a new approach to vaccines that uses genetic material to trigger an immune response. Late-stage clinical trial data shows the Covid vaccine is more than 94% effective at preventing, safe, and appears to ward off serious illness. For maximum effectiveness, the vaccine requires two doses four weeks apart.

The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.

FDA officials on Tuesday endorsed Moderna’s vaccine, saying in documents that the clinical trial results and safety data “are in line with recommendations in FDA guidelines on approving the emergency use of vaccines to prevent COVID-19.”

The FDA said 13 deaths were reported in the study as of December 3, including six in the vaccine group. Two deaths in the vaccine group were people over 75 with pre-existing medical 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 kidney failure.

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.

During the meeting on Thursday, medical experts also asked the agency about allergic reactions after two cases occurred among Alaskan health workers who took Pfizers’ vaccine. Doran Fink, deputy director of the FDA’s vaccines and related product applications division, said the agency will investigate the cases further.

“As we continue to examine 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 is little data on the safety of the vaccine in pregnant women and children. Thirteen pregnancies were reported in Moderna’s study as of December 2, six in the vaccine group, according to the FDA. 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.

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

“Regarding the safety of vaccine exposure during pregnancy, a development and reproduction study was completed in December 2020 with no adverse results,” Martin told the committee. “Given the limited human exposure to date in the Phase 3 trial, we will establish a pregnancy registry that includes a cohort recruited from the general population.”

While not necessarily a side effect, the FDA recommends monitoring people receiving Pfizer’s or Moderna’s vaccination shots 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.

According to Moderna, the vaccine will stay stable for up to 30 days at 36 to 46 degrees Fahrenheit, the temperature of a normal household or medical refrigerator. It can be stored at minus 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 it would buy another 100 million doses of Moderna’s vaccine. The US reached an agreement with Moderna in August to purchase 100 million cans for about $ 1.5 billion. Moderna said it charged some customers $ 32 to $ 37 per dose for its vaccine at lower “pandemic prices” this month. The company said it was under discussion for larger volume agreements that will have a lower price.

– CNBC’s Noah Higgins-Dunn contributed to this report.

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