FDA Grants Moderna’s Coronavirus Vaccine Emergency Authorization

The FDA approved Moderna’s coronavirus vaccine for emergency use Friday, making the United States the first country to have approved two safe and effective vaccines against COVID-19.

Its approval follows a key FDA panel’s overwhelming vote Thursday to endorse the vaccine’s safety and efficacy. The Moderna vaccine’s approval means that its distribution could begin within hours, providing hospitals and long-term care facilities across the country thousands of much-needed doses.

Moderna said that it was prepared to distribute nearly six million doses once its vaccine was given approval, more than twice the amount initially distributed by Pfizer last weekend.

The Moderna vaccine’s path to FDA emergency authorization mirrored that of Pfizer’s vaccine, which was granted emergency approval last Friday. The same advisory panel voted to recommend Pfizer’s vaccine a day earlier, and the FDA released data reaffirming both vaccines’ safety and effectiveness exactly a week apart.

Though the United States followed several allies in approving the Pfizer vaccine, it is the first country to approve Moderna’s vaccine. Both are mRNA vaccines and have proved remarkably effective in halting coronavirus cases and completely effective in preventing severe cases.

Moderna released its Phase III trial results showing 95% effectiveness on Nov. 16, and applied for emergency use authorization two weeks later. Pfizer released the results from its Phase III trials a week earlier, showing that its vaccine was over 90% effective in combating the virus.

Both vaccines were developed and approved in fewer than 11 months, shattering every preexisting record relating to vaccine creation, authorization and distribution.

Pfizer’s authorization was granted as public confidence in a coronavirus vaccine rose for the third straight month after hitting a low point in late summer. Sixty-three percent of Americans said that they were willing to receive a vaccine when given the opportunity, according to Gallup’s latest poll.

The two vaccines will be distributed as the United States faces the most challenging weeks of the pandemic to date. The country has seen record cases, hospitalizations and deaths in recent days, and the virus has infected over 17.2 million Americans and killed over 311,000, according to a Johns Hopkins University database.