4:13 PM, Feb 27, 2020


FDA authorizes second coronavirus vaccine

APTOPIX Virus Outbreak Vaccine Race
Posted at 7:44 PM, Dec 18, 2020

The FDA announced on Friday that it has issued an emergency use authorization for a second coronavirus vaccine.

Its approval comes just one week after the FDA gave an emergency use authorization for a similar vaccine by Pfizer. That vaccine began distribution earlier this week.

Moderna’s vaccine has been hailed as a medical breakthrough. The vaccine has been considered 94.1% effective against the virus. According to Moderna, none of the thousands who were given two shots of the vaccine had severe COVID-19 symptoms. That is compared to 30 patients who were given a placebo who had symptoms.

In order to obtain an emergency use authorization, the FDA weighed the vaccine’s benefits against possible side effects. An emergency use authorization is not a full FDA approval, but it allows those outside of a clinical or hospital setting to obtain the vaccine.

“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” FDA Commissioner Stephen M. Hahn said in a statement. “Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA. These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”

According to Moderna, approximately 20 million doses will be delivered to the U.S. government by the end of December 2020. Moderna said it expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those available in the U.S.

While the vaccine could nearly eliminate the number of hospitalizations and deaths associated with the virus, the shot might result in some symptoms.

In an interview with CNN last month, Operation Warp Speed chief scientific adviser Moncef Slaoui said that 10 to 15% of those immunized had noticeable side effects.

“Most people will have much less noticeable side effects. That frankly -- in comparison to a 95% protection against an infection that can be deadly or significantly debilitating -- I think is an appropriate balance," he told CNN.