FDA advisory panel endorses Moderna COVID-19 vaccine for emergency use

COVID-19 vaccine
Source FDA

Another vaccine for the novel coronavirus is one step closer to be given the green light. This is after a U.S. Food and Drug Administration advisory panel on Thursday voted to recommend the authorization of the Moderna COVID-19 vaccine for emergency use.

FDA vaccine advisers, who comprise the Vaccines and Related Biological Products Advisory Committee, voted 20-0 with one abstention in favor of the vaccine.

The U.S. Centers for Disease Control and Prevention would need to give its thumbs-up for the Moderna COVID-19 vaccine before vaccine shots can be rolled out. A CDC advisory panel is reportedly meeting this weekend to discuss its next steps.

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The FDA, meanwhile, is poised to authorize emergency use of the Moderna vaccine as the country continues to grapple with a surge in COVID-19 cases. Moderna vaccines could start to be administered as early as next week.

“To go from having a sequence of a virus in January to having two vaccines available in December is a remarkable achievement,” said Dr. James Hildreth, president, and CEO of Meharry Medical College in Nashville, Tennessee, a member of the panel.

Moderna COVID-19 vaccine 94.5 percent effective

The Moderna COVID-19 vaccine is reported to have an efficacy of 94.5 percent, similar to the BioNTech and Pfizer’s vaccine. More than 30,000 participants in the U.S. enrolled in the biotechnology company’s Phase 3 study, known as the COVE study.

In a statement, Moderna CEO Stéphane Bancel said, “We have been working with the U.S. Centers for Disease Control and Prevention and Operation Warp Speed to prepare for the distribution of mRNA-1273, if the FDA chooses to grant an Emergency Use Authorization. We look forward to getting our vaccine to people in the U.S. to help address this ongoing public health emergency.”

Unlike the Pfizer vaccine, however, the Moderna vaccines can be stored at standard freezer temperatures.

U.S. officials earlier witnessed unexpected hitches during the first week of the BioNTech-Pfizer COVID-19 vaccine distribution. These include some vaccines being stored at extremely cold temperatures.

At least two trays of COVID-19 vaccine doses that were delivered in California had to be replaced after their storage temperatures dropped below minus 80 Celsius (minus 112 Fahrenheit).

The BioNTech-Pfizer COVID-19 vaccines must be kept at around negative 70C.

Both vaccines require two doses. The second dose of the Pfizer vaccine should be given 21 days after the first, while Moderna’s must be given 28 days later.

Officials said the country has already contracted for 300 million vaccine doses between the BioNTech-Pfizer shot and one from Moderna in the first half of 2021, and 900 million doses in total from drugmakers developing COVID-19 vaccines.


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