The FDA has already cabled that a rapid emergency use authorization can be expected, and it could even go faster than the EUA for Pfizer last week – a quick process itself.
The Moderna vaccine is very similar to the vaccine from Pfizer and BioNTech. Both use a new approach with genetic material known as messenger RNA or mRNA.
“It’s based on the same technology,” said Dr. Elissa Malkin, co-investigator of the Moderna Clinical Trial at George Washington University in Washington, DC, at CNN.
“Really, they are quite similar,” added Malkin, who has studied both the Pfizer and Moderna data.
“I think they will very likely approve it soon.”
The technology doesn’t require the actual virus to make the vaccine – just the genetic code, which is used to trick the body into making little pieces that look like the virus’s external “spike” protein, triggering an immune response. .
Both have shown to be about 95% effective in preventing disease, both appear to be very safe, and both have been tested on tens of thousands of volunteers in the US and the world.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Wednesday that he hopes the FDA will issue an EUA on Thursday.
“Tomorrow, the FDA will hopefully make a decision on whether the Moderna messenger RNA vaccine will receive emergency clearance,” Fauci said on CNBC.
The FDA’s Advisory Committee on Vaccines and Related Biologicals, a group of experts unaffiliated with the vaccine maker, will meet Thursday to discuss whether the Moderna vaccine will be recommended, as they did with Pfizer’s vaccine last Thursday.
A discussion and vote is scheduled for 3:10 p.m. Eastern and it could all be over soon. FDA staff have already reviewed and confirmed Moderna’s safety and efficacy data and have not asked any major questions.
“It appears to be about 95% effective in preventing disease, including 100% effective in serious diseases, about 95% effective in preventing disease in people over the age of 65, of different ethnic and racial backgrounds,” said Dr. Paul Offit, a member of VRBPAC and director of the vaccination center at Philadelphia Children’s Hospital, told CNN Tuesday.
Moderna also says it can show his vaccine prevents asymptomatic infections – a plus, as health officials have said they weren’t sure whether Pfizer’s vaccine prevents infection in general or just symptomatic infection. A vaccine that stops all infections helps to better control the spread of the virus.
Moreover, there are no obstacles to discuss. Pfizer’s vaccine had been rolled out in Britain before the US EUA, and two allergic reactions were reported. That gave the committee members something to discuss last week. Moderna’s has not been used outside of clinical studies.
In addition, Pfizer’s vaccine had been tested in younger age groups, and the committee members discussed whether the EUA should also cover teens between the ages of 16 and 18. In the end they decided it should. Moderna’s vaccine application includes 30,000 volunteers aged 18 and over.
If the committee recommends an EUA, the FDA can decide whether to accept it, but it usually does and is expected. That can happen immediately.
Then it’s up to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) to recommend the vaccine to the public. ACIP recommended Pfizer’s vaccine last week and the CDC approved it. ACIP is scheduled to meet Saturday to discuss the Moderna vaccine – a meeting slated to await a swift FDA EUA decision.
The rollout could go just as fast as the rollout of the Pfizer vaccine this week.
Alex Azar, Secretary of Health and Human Services, says the federal government has nearly 5.9 million doses of Moderna vaccine ready to go to 3,300 locations next week. According to Operation Warp Speed chief advisor Moncef Slaoui, 20 million doses of Moderna’s vaccine could be delivered by the end of the month.
Health officials expect it will be easier to distribute Moderna’s vaccine. Pfizer’s vaccine should be stored at about minus 100 degrees Fahrenheit, a temperature that requires a special type of freezer. Modernas can tolerate temperatures manageable by a regular freezer.