FDA authorizes Moderna vaccine for emergency shipment

Moderna COVID Vaccine Is Shown to Be Safe, Will Likely Be Approved. New data released on Tuesday supports Moderna's own findings about the efficacy of the vaccine. The Moderna trial was conducted among 30,000 people and showed an efficacy of 94.1 percent. The review from the Food and Drug Administration (FDA) means that the drug is eligible for emergency use. As with the Pfizer vaccine, an advisory panel will meet on Thursday to offer an assessment on whether the vaccine should be approved. Sources say that the FDA will likely approve the vaccine on Friday. Nearly six million doses could potentially be ready for distribution once it is approved. On Monday, the U.S. surpassed 300,000 total deaths due to COVD-19, more than any other country by far

The Food and Drug Administration has granted emergency distribution of the Moderna vaccine Friday evening.

The news comes after the FDA advisory panel voted to approve Moderna’s highly effective coronavirus vaccine.

Earlier, Health and Human Services Secretary Alex Azar said shipments of Moderna’s coronavirus vaccine, which has been shown to be safe and nearly 95% effective in trials, will begin this weekend if the FDA grants emergency use authorization as expected Friday.

“Trucks will roll, planes will fly this weekend, 5.9 million doses of Moderna vaccine allocated for next week,” Azar told ABC’s “Good Morning America” on Friday.

Azar said the Moderna vaccine is “shockingly effective” and he expected to get vaccinated next week, if the White House physician cleared him to do so. Azar’s wife has tested positive for COVID-19, and he is quarantining now.

The drug known as mRNA-1273 was developed by the National Institutes of Health in cooperation with the biotechnology company based in Cambridge, Massachusetts.

»PREVIOUS COVERAGE: U.S. vaccinations ramp up as second COVID-19 shot nears

The Moderna vaccine can’t come soon enough as the country’s death toll has surpassed 310,000 amid more than 210,000 new cases daily, based on weekly averages of data compiled by Johns Hopkins University. The devastating toll is expected to only grow in coming weeks, fueled by holiday travel, family gatherings and lax adherence to basic public health measures.

The Vaccines and Related Biological Products Advisory Committee voted unanimously to approve the vaccine, saying the benefits outweighed its risks for individuals 18 and older. The vote was 20-0 with one abstention.

Preliminary studies before now have confirmed the effectiveness and safety of the Moderna vaccine, bringing it to the cusp of being used on the frontlines of the pandemic.

The positive news comes as the nation’s largest vaccination campaign got underway last week with the emergency approval and distribution of a vaccine made by Pfizer and BioNTech, with hospitals and nursing homes ramping up inoculations.

The Moderna vaccine will be approved for adults only. Pregnant women and women who are nursing were not included in the study of more than 30,000 individuals.

People with severe health conditions also were not included in the study group. Some people reported side effects such as arm pain, fatigue and muscle aches, but no one experienced any real health emergency.

Recipients also tend to experience temporary flu-like side effects that can include fever, fatigue and aches, especially after the second dose as the vaccine revs up their immune system.

The first vaccine deliveries have provided a measure of encouragement to exhausted doctors, nurses and hospital staffers around the country who hail the new vaccine as a “remarkable scientific achievement.”

“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, a committee member, immunologist, and president and CEO of Meharry Medical College in Nashville, Tennessee, according to USA Today.

Information provided by The Associated Press was used to supplement this report.