FDA panel approves COVID-19 vaccine slated for Vero

PHOTO PROVIDED BY WASHINGTON POST

Friday update: The U.S. FDA Friday issued an emergency use authorization for Moderna’s COVID-19 vaccine, clearing the way for the drug to be distributed across the country. Moderna is the second vaccine to be approved by the FDA.

 

Earlier story

If the U.S. Food and Drug Administration heeds the overwhelming endorsement of its vaccine advisory committee, doses of the ModernaTX Covid-19 vaccine should be heading to Vero early next week. 

The FDA Vaccines and Related Biological Products Advisory Committee voted 20-0 on Thursday afternoon that the benefits of the ModernaTX vaccine outweigh the risks for individuals age 18 and older. 

The FDA agency leadership must still sign off on an Emergency Use Authorization (EUA), as it did late last Friday night for the Pfizer-BioNTech vaccine before it can be shipped to locations around the country. The Pfizer vaccine received a 17-4 vote for use in people age 16 and older because some members were leery about giving the vaccine to minors.

On Wednesday, Gov. Ron DeSantis announced a plan to distribute the ModernaTX vaccine in Florida once the FDA moves on the EUA. Cleveland Clinic Indian River was listed among the hospitals slated to receive the ModernaTX vaccine. 

Doses of the Moderna vaccine will be distributed to 173 hospital locations that did not receive doses in the first allocation of the Pfizer COVID-19 vaccine. These hospital locations span 43 counties,” a press release from DeSantis’ office said. “The state is able to distribute this vaccine to a large number of hospitals as the Moderna vaccine does not require ultra-cold storage.”

Should the FDA approve the ModernaTX vaccine, DeSantis said he expects Florida hospitals to receive nearly 370,000 doses in December. The top priority groups to get the vaccine are front-line healthcare workers and residents of nursing homes and assisted-living facilities. 

Moderna is a United States-based company, headquartered in Massachusetts, and the development and mass-production of the vaccine was partially underwritten by the U.S. government as part of Operation Warp Speed.

In clinical trials involving more than 30,000 participants ages 18 to 95, initial data from the first few months of the study seem to indicate that the ModernaTX vaccine is nearly 95 percent effective in protecting those who receive two vaccinations from getting the COVID-19 disease. The study clinical trial did not enroll children, pregnant and lactating women or people with autoimmune conditions. 

DeSantis announced on Wednesday that production issues with the Pfizer-BioNTech vaccine would likely delay shipments to Florida over the next two weeks after the first 174,900 doses landed at five regional “hub” hospitals on Monday and Tuesday. 

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