The FDA has already telegraphed that a quick emergency use authorization can be expected and that this can happen even faster than the U.S. for Pfizer last week, a quick process.
The Modern vaccine is very similar to the Pfizer and BioNTech vaccine. Both use a new approach that includes genetic material known as messenger RNA or mRNA.
“It’s based on the same technology,” Dr. Elissa Malkin, co-researcher of the Modern Clinical Process at George Washington University in Washington, DC, told CNN.
“Really, they look pretty similar,” added Malkin, who has studied data from Pfizer and Moderna.
“I think it’s very likely that they’ll authorize it quickly.”
The technology does not require the actual virus to make the vaccine: simply the genetic code, which is used to trick the body into pieces that resemble the virus’s outer “ear” protein, causing an immune response.
Both have shown approximately 95% effectiveness in disease prevention, both appear very safe, and both have been tested on tens of thousands of volunteers worldwide and in the United States.
The director of the National Institute of Allergies and Infectious Diseases, Dr. Anthony Fauci said Wednesday he expects the FDA to issue the U.S. on Thursday.
“Tomorrow, the FDA expects it to make a decision on whether or not the Modern Messenger RNA vaccine will get an emergency use authorization,” Fauci told CNBC.
The FDA’s advisory committee on vaccines and related biological products, a group of experts unrelated to the vaccine maker, will meet Thursday to discuss whether Moderna’s vaccine is recommended, as they did with Pfizer on Thursday. past.
A discussion and vote is scheduled for 3:10 p.m. in the East and it could all end quickly. FDA staff has already reviewed and confirmed Moderna’s safety and efficacy data and has not raised any important questions.
“It appears to be approximately 95% effective in disease prevention, including 100% effective in serious disease, approximately 95% effective in disease prevention in people over 65, with different ethnic backgrounds and racial backgrounds,” he said. say Dr. Paul Offit, a member of VRBPAC and director of the Philadelphia Children’s Hospital’s Vaccine Education Center, told CNN Tuesday.
Modern also says she can prove her vaccine prevents asymptomatic infections, an advantage, because health officials have said they weren’t sure if the Pfizer vaccine prevents the infection in general or just the symptomatic infection. A vaccine that stops all infections will help better control the spread of the virus.
Also, there are no potholes on the road to discuss. The Pfizer vaccine had been deployed in Britain before the US, and two allergic reactions were reported. This gave committee members something to discuss last week. Moderna’s has not been used outside of clinical trials.
In addition, the Pfizer vaccine had been tested in younger age groups and committee members discussed whether the U.S. should cover teens between the ages of 16 and 18. They finally decided they should do it. Moderna’s vaccine application covers 30,000 volunteers over the age of 18.
If the committee recommends a U.S., the FDA can decide if it accepts it, but it usually does and is expected to do so. This could happen immediately.
It is then up to the Public Health Control and Prevention Advisory Committee (ACIP) to recommend the vaccine to the public. ACIP recommended the Pfizer vaccine last week and the CDC approved it. ACIP is scheduled to meet Saturday to discuss the Modern Vaccine, a meeting scheduled in anticipation of a quick FDA decision by the U.S.
The launch could be as fast as the launch of the Pfizer vaccine this week.
Health and Human Services Secretary Alex Azar says the federal government has about 5.9 million doses of the Modern vaccine ready to go to 3,300 places next week. According to Operation Warp Speed’s chief adviser Moncef Slaoui, 20 million doses of Moderna’s vaccine could be administered by the end of the month.
Health officials hope it will be easier to distribute Moderna’s vaccine. The Pfizer vaccine should be stored at about 100 degrees Fahrenheit, a temperature that requires a special type of freezer. Moderna can tolerate temperatures controllable by a normal freezer.