Months of Work Hang in the Balance as Moderna’s COVID-19 Vaccine Awaits AdComm Vote
A critical vote is set to take place today amongst those on a U.S. Food and Drug Administration (FDA) advisory panel in regard to the COVID-19 vaccine from Moderna. The Vaccines and Related Biological Products Advisory Committee will be determining whether the product should be authorized for emergency use, according to CNBC.
This move comes one week after an outside group of authorities on the matter voted to recommend the approval of Pfizer and BioNTech’s COVID-19 vaccine for emergency use.
The meeting is slated to run from 9 a.m. ET to 5:15 p.m. ET, according to a draft of the agenda. The vote itself is not slated to take place until after 3 p.m. ET. Throughout the day, various presentations will be given by medical experts pertaining to Emergency Use Authorization (EUA).
If the vaccine receives the designation, the FDA will allow some people to receive the product as the agency continues to look at the data. It is worth noting that this is not the same as a full approval, which requires additional information. To this point, Moderna has only submitted two months of follow-up safety data, and the FDA typically requires six months for a full approval.
The U.S. intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA. Gen. Gustave Perna, who oversees the logistics for Operation Warp Speed, told reporters earlier this week that McKesson will package and distribute the vaccine to more than 3,000 sites across the country. Initial doses are expected to be limited as manufacturing ramps up.
The Moderna vaccine is similar to Pfizer and BioNTech’s vaccine in the sense that they both use an approach utilizing messenger RNA (mRNA). The technology leveraged to create the vaccine does not require the actual virus, according to CNN. Instead, it uses a genetic code, which tricks the body into developing an immune response to the virus. Both vaccines have shown about 95% efficacy in preventing novel coronavirus infections.
Moderna has stated that it can also demonstrate that its vaccine prevents asymptomatic infections. This gives it a slight edge over Pfizer and BioNTech’s vaccine, which experts are unsure of in regards to its level of protection.
Moderna’s vaccine has not been used outside of clinical trials, while Pfizer and BioNTech’s vaccine has already been rolled out in Britain. However, two allergic reactions were reported overseas, giving committee members something else to consider as they look to approve emergency use for Moderna’s vaccine.
An efficacy analysis of a Phase III trial of the vaccine was made available at the end of November by Moderna. The data showed that the vaccine was generally well-tolerated with no serious safety concerns identified to date. Based on prior analysis, the most common adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache and erythema/redness at the injection site.
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease,” said Stéphane Bancel, chief executive officer of Moderna, at the time of the announcement. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death.”
The company submitted for emergency use authorization with the FDA upon the release of the Phase III analysis in November.
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