The Food and Drug Administration announced Friday night that they have granted emergency use authorization to Moderna's COVID-19 vaccine for use in individuals 18 and older, the second vaccination against the coronavirus in the United States.

What You Need To Know

  • The FDA granted emergency use authorization to Moderna's COVID-19 vaccine for use in individuals 18 and older

  • Moderna's vaccine is the second in the US; the US is the first country to authorize Moderna's vaccine

  • The coronavirus has claimed more than 312,000 U.S. lives and killed 1.7 million people worldwide

  • 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

The much-needed doses are set to arrive Monday to help combat the latest outbreak of the virus; the country is regularly recording more than 3,000 deaths a day.

“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen M. Hahn, M.D. said in a statement.

President Trump wrote to Twitter following the emergency authorization: "Congratulations, the Moderna vaccine is now available!"

In a statement released late Friday following the FDA granting emergency use authorization to Moderna's COVID-19 vaccine, President-elect Biden said that while both vaccines are a promising milestone, "the fight against COVID-19 is not yet over."

"We know the immense challenges ahead, including scaling up manufacturing, distribution, and the monumental task of vaccinating hundreds of millions of Americans," Biden said. "We need to make sure we have the resources to do all of this and to do it quickly. And, we need a coronavirus and economic relief package passed immediately."

Biden expressed gratitude for "the scientists, medical experts, and trial participants who helped to deliver these vaccines and evaluated their safety and efficacy free from political influence."

The president-elect noted that he would be receiving a COVID-19 vaccine on Monday, following Vice President Mike Pence, House Speaker Nancy Pelosi, and Senate Majority Leader Mitch McConnell receiving it on Friday. 

"This is about more than politics," he added. "This is about saving lives. I look forward to receiving the vaccine publicly on Monday and continuing to build confidence in the scientific process. Vaccines don’t save lives, vaccinations do. I believe we can administer 100 million vaccine shots in the first 100 days of my administration. My administration will focus on the science and managing a robust and aggressive plan to contain the virus on day one. It will take all of us, continuing to do our part, to slow the spread of the virus including mask wearing and social distancing."

“Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA," he added. "These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”

This is the first such authorization of the Moderna vaccine in the world; a number of other countries have authorized the COVID-19 vaccine from Pfizer and BioNTech.

“I want to thank the thousands of participants in our clinical trials and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. I want to thank the NIH and NIAID for their scientific leadership and our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point. I also want to thank the Moderna team, our suppliers and our partners for their tireless work across research, development and manufacturing of our vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna.

“I am proud of what the Moderna team has achieved in collaboration with our partners," Bancel added. "We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants. It has been a 10-year scientific, entrepreneurial and medical journey and I am thankful to all those who have helped us get here today. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease.”

“Today’s authorization demonstrates our steadfast commitment to the health of the American people, with the assurance that our scientific standards and the integrity of our review process have been maintained," added Peter Marks, M.D., Ph.D., the Director of the FDA’s Center for Biologics Evaluation and Research. "This achievement is yet another testament to the dedication of FDA’s career scientists and physicians, who have been working urgently to conduct comprehensive and rigorous evaluations of the data submitted for vaccines to prevent COVID-19."

The vaccine is very similar to the Pfizer-BioNTech that is now being dispensed to millions of health care workers and nursing home residents as the biggest vaccination drive in U.S. history starts to ramp up.

The two work “better than we almost dared to hope,” NIH Director Dr. Francis Collins told The Associated Press. “Science is working here, science has done something amazing.”

Early results of large, still unfinished studies show both vaccines appear safe and strongly protective although Moderna’s is easier to handle since it doesn’t need to be stored at ultra-frozen temperatures.

A second vaccine represents a ray of hope amid despair as the virus continues to spread unabated even before holiday gatherings that are certain to further fuel the outbreak.

The authorization comes at a dire time for the nation as it battles the pandemic, which has claimed more than 312,000 U.S. lives and killed 1.7 million people worldwide. 

New cases in the U.S. are running at over 216,000 per day on average. Deaths per day have hit all-time highs, eclipsing 3,600 on Wednesday.

California has emerged as one of the most lethal hot spots, with hospitals running out of intensive care beds and ambulances lining up outside emergency rooms in scenes reminiscent of the calamity around New York City last spring. California on Friday reported over 41,000 new cases and 300 more deaths.

The move follows a vote Thursday by an independent advisory committee, which recommended Moderna’s COVID-19 vaccine for emergency use.

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.

About six million doses of Moderna’s vaccine are ready to ship early next week following the vaccine's authorization, 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 examplws.

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.

The Associated Press contributed to this report.