Moderna’s COVID-19 vaccine likely to clear last hurdle within the week

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Moderna’s COVID-19 vaccine likely to clear last hurdle within the week

By Sandra Levy - 12/15/2020

The Food and Drug Administration staff endorsed Moderna's COVID-19 vaccine as safe and effective in documents released Tuesdaysetting up the vaccine for emergency use authorization by the Food and Drug Administration by the end of this week. This would mean Americans may soon have two vaccines in the fight the fight against the virus.

The FDA on Saturday granted emergency use authorization to Pfizer and BioNTech’s COVID-19 vaccine for use in individuals 16 years old and older.

A committee independent of the FDA, the Vaccines and Related Biological Products Advisory Committee, will meet Thursday to decide whether to recommend that the agency approve Moderna’s COVID-19 vaccine.  The meeting follows the meeting last Thursday, when the panel recommended that the FDA authorize Pfizer's vaccine.

Moderna’s vaccine could be administered to the public as early as next week if it wins emergency use authorization from the FDA. Moderna is asking the FDA to approve the use in people age 18 and over, while Pfizer’s vaccine was cleared for use in people age 16 and older.

Moderna's COVID-19 vaccine has been found to be 94% effective at preventing symptomatic illness and appears to prevent the spread of COVID-19

The high efficacy of the Moderna vaccine was noted after two doses given 28 days apart. There also is evidence that just one dose of Moderna's may stop the virus's spread.

A second document published on the FDA website shows asymptomatic infection was reduced by 63% after the first shot, but it is anticipated that two doses of the vaccine will be required for maximum protection.