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Expect a quicker authorization of Moderna's coronavirus vaccine

The FDA has already telegraphed that a quick emergency use authorization can be expected and this one could go through even faster than the EUA for Pfizer last week — itself a speedy process.
The Moderna vaccine is very similar to Pfizer’s and BioNTech’s vaccine. Both use a new approach involving genetic material known as messenger RNA or mRNA.
Key committee meets Thursday to consider FDA authorization for Pfizer/BioNTech Covid-19 vaccine

“It’s based on the same technology,” Dr. Elissa Malkin, co-investigator for the Moderna Clinical Trial at the George Washington University in Washington, DC, told CNN.
“Really, they do seem quite similar,” added Malkin, who has studied both the Pfizer and the Moderna data.
“I think they are very likely to 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 making little bits that look like the outside “spike” protein of the virus, prompting an immune response.
Both have shown about 95% efficacy in preventing disease, both appear very safe and both have been tested in tens of thousands of volunteers across the US and the world.
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National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci said Wednesday he hopes the FDA will issue an EUA Thursday.
“Tomorrow, the FDA will hopefully make a decision regarding whether or not the Moderna messenger RNA vaccine will get an emergency use authorization,” Fauci said on CNBC.
The FDA’s Vaccines and Related Biological Products Advisory Committee, a group of experts with no ties to the vaccine maker, will meet Thursday to discuss whether to recommend Moderna’s vaccine, as they did with Pfizer’s last Thursday.
A discussion and vote is scheduled for 3.10 pm Eastern and it could all be over quickly. FDA staff have already reviewed and confirmed Moderna’s safety and efficacy data and have raised no major questions.
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“It looks to be roughly 95% effective at preventing disease, including 100% effective at severe disease, about 95% effective in preventing disease in people who are over 65, across different ethnic backgrounds, racial backgrounds,” Dr. Paul Offit, a member of VRBPAC and is director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told CNN Tuesday.
Moderna also says it can show its vaccine prevents asymptomatic infections — a plus, because health officials have said they were not sure if Pfizer’s vaccine prevents infection overall, or merely symptomatic infection. A vaccine that stops all infections will better help control the spread of the virus.
In addition, there are no bumps in the road to discuss. Pfizer’s vaccine had been rolled out in Britain ahead of the US EUA, and two allergic reactions were reported. That gave committee members something to discuss last week. Moderna’s has not been used outside clinical trials.
Alaska healthcare worker suffers allergic reaction to Covid-19 vaccine

Alaska healthcare worker suffers allergic reaction to Covid-19 vaccine

Plus Pfizer’s vaccine had been tested in younger age groups and committee members discussed whether the EUA should cover teens between 16 and 18. They eventually decided it should. Moderna’s vaccine application covers 30,000 volunteers 18 and older.
If the committee recommends an EUA, then the FDA can decide whether to accept it, but usually does and is expected to. That could happen immediately.
Then it’s up to the Centers fro Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) to recommend the vaccine for the public. ACIP recommended Pfizer’s vaccine last week and the CDC endorsed it. ACIP is scheduled to meet Saturday to discuss the Moderna vaccine — a meeting scheduled in anticipation of a quick FDA EUA decision.
The rollout could be just as quick as the rollout for Pfizer’s vaccine was this week.
Health and Human Services Secretary Alex Azar says the federal government has nearly 5.9 million doses of Moderna’s vaccine ready to go to 3,300 sites next week. According to Operation Warp Speed Chief Adviser Moncef Slaoui, 20 million doses of Moderna’s vaccine can be delivered by the end of the month.
Health officials expect it will be easier to distribute Moderna’s vaccine. Pfizer’s vaccine must be stored at around minus 100 degrees Fahrenheit, a temperature that requires a special type of freezer. Moderna’s can tolerate temperatures manageable by an ordinary freezer.

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