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FDA set to approve Moderna vaccine for emergency use

Once approved, California could initially receive 672,000 doses of the Moderna vaccine to supplement the Pfizer doses already shipped out

SAN DIEGO COUNTY, Calif — As coronavirus vaccine supplies still remain in scarce supply, health leaders took a major step forward Thursday in helping provide hundreds of thousands more doses in the coming weeks. 

In a 20-1 vote, an independent advisory panel gave its endorsement to Moderna's COVID vaccine, a key step in the FDA's official approval for emergency use, meaning that the FDA is likely to approve it as early as Friday.

"The vaccine efficacy rate for symptomatic COVID-19 infection was 94.1%," said Dr. Tal Zaks, Moderna's Chief Medical Officer. "We also observed a dramatic reduction in severe cases."

Unlike Pfizer's vaccine, Moderna's does not require ultra-cold storage, and has a longer shelf life.

However, research shows that Moderna's vaccine has a slightly higher rate of less serious, common side effects, such as rash and itching.

County health leaders made it clear that they would get the message out when those vaccines will be available in the coming months.

"Just as we have announced when people can get tested for COVID, we will announce when people can get vaccinated," said Dr. Wilma Wooten, the county's public health officer.

Another issue is keeping track of everyone who gets the vaccine and ensuring they get the second dose as well.

With Moderna's vaccine, a four-week wait is required, compared to Pfizer's three week wait.

County leaders said that San Diego County's immunization registry will be critical in keeping track locally "both for making sure that no one got unnecessary repeated vaccinations that they shouldn't be getting, and also got their second vaccine on time," said Dr. Eric McDonald, Medical Director of the county's Epidemiology & Immunizations Services.

Dr. Mark Sawyer of Rady Children's Hospital, who sits on the FDA's independent advisory panel, raised the issue of inadvertently giving someone one dose of Pfizer's vaccine, then administering the Moderna vaccine for the second dose.

"That mistake is going to happen a lot as soon as we start to disseminate the vaccine around the country," Sawyer said during Thursday's review meeting.

The interim guidance in that case for now is not o administer a third dose.

"In other words, to assume that even though you are mixing products that  you are going to get an adequate  immune response," Dr. Sawyer added. "So at some point it would be nice to know if that's really true.

After Thursday's unanimous approval, it  is now up to the FDA to give Moderna its official approval for emergency use. 

After that, California could receive 672,000 doses of the Moderna vaccine before the end of the year, to supplement the Pfizer doses already received.

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