FDA Scientists Endorse Moderna's COVID-19 Vaccine for Emergency Use

Scientists from the U.S. Food and Drug Administration (FDA) endorsed biotech company Moderna's COVID-19 vaccine for emergency use on Tuesday.

According to Stat News, FDA scientists found that Moderna's vaccine is safe and effective a day after the company's competitor Pfizer started shipments across the U.S.

The agency's experts were upbeat about Moderna's shot and said there were "no specific safety concerns identified." They also confirmed the vaccine's efficacy of 94.1 percent, reported CBS News.

A panel of outside experts will also examine the vaccine's data on Thursday, with a final approval decision shortly after.

The FDA endorsement is one step towards formal clearance for the vaccine to be administered to the public, which will likely happen next week, reported CNBC.

A similar group of medical advisors also reviewed Pfizer's vaccine for emergency use last Thursday, and the FDA gave the green light for widespread use the following day.

The FDA doesn't have to follow the outside committee's recommendation, but it often does.

The report will serve as a brief for FDA's Vaccines and Related Biological Products Advisory Committee, which will evaluate the request for emergency use.

If it also approves Moderna's shot, it will be the second vaccine to be distributed in the U.S., following Pfizer's distribution recently.

FDA Reviewers Say Moderna Vaccine Prevents Symptomatic COVID-19

According to the FDA reviewers, Moderna's two-dose vaccine was "highly effective" in preventing the symptomatic spread of COVID-19 from occurring "at least 14 days after the receipt of the second dose."

Some of its side effects, such as aches and pains, were seen as "more severe" than the Pfizer vaccine, but these differences are not expected to impact the vaccine's clearance significantly.

Impressively, data also showed that the vaccine might have some level of efficacy after one dose, preventing asymptomatic COVID-19 cases, said Stat News.

Like the reviewers' findings, Moderna also claimed its vaccine was 94 percent effective against symptomatic COVID-19 while also preventing severe disease cases.

Who Can Get the Moderna Vaccine?

Moderna asked for authorization in people over 18, while Pfizer's vaccine was authorized for people over 16 years old.

As per the FDA report, the vaccine was equally effective for people of different age groups, genders, and racial and ethnic groups.

It also worked well among people with medical conditions that put them at high risk for severe COVID-19.

During the vaccine's clinical trials, only a small number of people contracted the coronavirus, and none of their cases were severe.

This data suggests that the Moderna vaccine helps prevent serious illness or even death from the virus.

Moderna's vaccine trial has 30,000 volunteers. Half of the group was given a placebo, while the other half was injected with the vaccine.

In a previously disclosed data from Moderna, it was revealed that 185 people from the trial's placebo group contracted COVID-19. Only 11 cases occurred in volunteers who received the vaccine.

Thirty cases of severe COVID-19 were recorded in the placebo group, while none were found in the vaccine group.

Of all the Moderna's trial volunteers, 10 percent were Black, 20 percent were Hispanic or Latino, five percent were Asian, and just less than one percent were Native American.