An independent advisory committee recommended Moderna’s COVID-19 vaccine for emergency use Thursday, pushing it one step closer to becoming the second shot authorized by U.S. regulators.
In a 20-0 vote, with one abstention, the panel of outside experts endorsed the vaccine — developed in partnership with the National Institutes of Health — which clinical trials showed is 94.5 percent effective in preventing the virus, especially severe cases.
The Vaccine and Related Biological Products Advisory Committee voted to recommend Moderna’s shot for emergency use in Americans 18 and older. Pfizer’s was authorized for 16 and older last week.
Their recommendation is now in the hands of career Food and Drug Administration officials, who will make the final call on whether to authorize the vaccine as soon as this weekend. Last week, the FDA issued an emergency authorization for Pfizer’s vaccine Friday night, just over 24 hours later.
Health and Human Services Secretary Alex Azar told ABC's "Good Morning America" on Friday morning that the FDA has informed Moderna that emergency use authorization could come as early as Friday.
"The FDA has communicated to Moderna that we expect to grant their emergency-use authorization. That could come as soon as today," Azar told ABC News' George Stephanopoulos Friday on "Good Morning America."
"This is an exceptionally safe vaccine," he added. "It's a shockingly effective vaccine -– the Moderna vaccine as well as the Pfizer vaccine."
Azar promised that "trucks will roll, planes will fly this weekend," if the vaccine gets approved, with "5.9 million doses of Moderna vaccine allocated for next week."
The HHS secretary urged Americans to get the shot: "All of us have complete confidence in the independence and quality of the FDA’s review process. That's why you're seeing the vice president, the second lady, the surgeon general today getting vaccinated."
"I plan to get vaccinated next week as long as the White House physician says that it's appropriate to do so and do so on TV," Azar added. "We just want to make sure people know we have supreme confidence in the process and confidence in the safety and efficacy of the vaccine, and we wouldn't ask you to do something that we wouldn't do."
About six million doses of Moderna’s vaccine are ready to ship early next week if the vaccine is authorized, double the number of Pfizer doses sent out in the first wave. The distribution will be similar to Pfizer’s. UPS and FedEx will ship doses to hundreds of different sites per week, as requested by each individual state.
In Thursday’s meeting, the panel questioned FDA scientists and Moderna researchers about the vaccine’s efficacy, the company’s clinical trials and potential side effects of the vaccine. They also discussed the need for continued studies of the shot, since an Emergency Use Authorization (EUA) does not equal a full FDA approval.
Still, panel members decided that the benefits of Moderna’s vaccine outweigh its risks.
“This is a really opportune time for us to move science forward,” said Dr. Hayley Gans, a professor of pediatrics at Stanford University School of Medicine. “The science … highly outweighs any of the issues that we’ve seen.”
The Moderna vaccine requires two doses given 28 days apart, compared to 21 days for the Pfizer shot.
The six million doses set to go out next week are just the first wave of 200 million doses available to the U.S., enough to vaccinate 100 million people. Health officials purchased another 100 million doses last week and have the option to purchase more according to a contract with the company.
Participants in Moderna’s clinical trial were more likely to have a reaction than people who got the Pfizer vaccine, according to data released by the FDA. Nearly 70 percent reported fatigue and around 60 percent reported a headache and muscle pain, while others reported chills and joint pain.
Experts say that those reactions are a good sign, because they mean your body is reacting to the vaccine properly.
“They are actually side effects of your immune system fighting the virus,” said Dr. Paula Cannon, a virologist and Associate Professor of Microbiology at the University of Southern California’s medical school.
“[They] should be considered like an ‘Oh, good, I’ve got a little bit of a headache.’ That probably means the vaccine is working. It’s doing its job.”
On Friday morning, Vice President Mike Pence and Second Lady Karen Pence received the Pfizer vaccine publicly, along with Surgeon General Jerome Adams.
The three are the first members of the administration to get the vaccine, and the vaccinations were broadcast live on national TV.
“We feel highly confident having seen the data that it will be not only safe, but it will be incredibly effective,” the surgeon general said in an interview with Spectrum News. “And we want to set an example.”
When asked, Adams could not say when or if President Trump would get vaccinated, since he has recovered from the virus and received an antibody treatment.
“The science does suggest that you need to be especially cautious in someone who has been previously infected and gotten monoclonal antibodies as the President did,” Adams told Spectrum News.
The surgeon general said he’s concerned that some Americans are hesitant about the vaccine, but he encouraged people to ask questions and speak with their health provider about their doubts.
“This vaccine will be incredibly effective at preventing severe complications, keeping people alive,” Adams said. “So that's the main reason you should get a vaccine. Because it will help you.”
Both the Moderna and Pfizer vaccines use mRNA technology, which gives the body a recipe to make the spike proteins found on the outside of the coronavirus, thereby triggering an immune response. Experts consider the technology safe, especially since it doesn’t involve injecting a version of the virus itself.
With both Pfizer and Moderna’s vaccines authorized, U.S. officials expect to vaccinate 20 million people by the end of the year. Nearly six million Pfizer doses have already been allocated to states.
Moderna’s shot offers more flexibility to health care providers, since the vaccine is effective at room temperature for up to 12 hours, while Pfizer’s can only sit out for two. It also allows states to order a smaller amount of doses to certain sites and rural areas. Pfizer requires a 975 dose minimum order.
On Thursday, representatives for Moderna elaborated on the company’s future trials of the vaccine. They include continued studies in children as well as a closer look at possible serious reactions, including Bell’s palsy — a type of facial paralysis seen in three participants — and allergic reactions, which have been reported in a handful of people who have gotten the Pfizer vaccine.