When Will the Moderna Vaccine Be Approved?

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The COVID-19 vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) is expected to be approved by the Food and Drug Administration (FDA) for emergency use, following a review by a panel of outside experts on Thursday.

The FDA said: "On December 17, 2020, the Center for Biologics Evaluation and Research's (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Moderna, Inc., COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years and older."

The FDA usually follows the advice of the expert panel, but is not required to do so.

Emergency use of Moderna's mRNA-1273 vaccine is expected to be granted on Friday, according to people familiar with the agency's plans speaking to The New York Times.

In an FDA briefing for the Thursday VRBPAC meeting released on Tuesday, the vaccine was described to be "highly effective in preventing PCR-confirmed COVID-19 occurring at least 14 days after receipt of the second dose," with an overall efficacy of 94.1 percent.

The briefing added the vaccine had "no specific safety concerns identified that would preclude issuance of an EUA."

"FDA may issue an EUA after determining that certain statutory requirements are met.

"If these criteria are met, under an EUA, FDA can allow unapproved medical products (or unapproved uses of approved medical products) to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by threat agents.

"In the event an EUA is issued for this product, it would still be considered unapproved and would continue under further investigation," the briefing stated.

Dr. Anthony Fauci, the director of NIAID and member of the White House COVID-19 task force, said during an interview with Vox he is hoping to be inoculated within the next few days.

"I'm not going to be getting it today. Likely, I hope, within the next few days," he told Vox's Sean Rameswaram.

"We just rolled it out yesterday. There were 2.9 million doses that were distributed to about 145 sites, so we're going to try and do it really as a symbol to get people to appreciate that we're confident that it's safe and that it is certainly very efficacious," Fauci added, referring to the efficacy of the Moderna/NIAID vaccine as well as the one developed by Pfizer and BioNTech.

Speaking to Newsweek earlier this month, Fauci said: "If people take the vaccine, we could go a long way to really diminishing dramatically [in cases] as we get into the second and third quarter of 2021. Then I think you'll start to see a dramatic diminishing of cases.
"I think the decreases are going to start as we get into April and as more of the general population gets vaccinated."
Moderna logo COVID-10 vaccine December 2020
A syringe with a needle seen in front of a Moderna logo in Dortmund, Germany on December 10. The COVID-19 vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases is expected... Alex Gottschalk/DeFodi Images via Getty Images

The wider picture

The novel coronavirus has infected more than 73.5 million people, including over 16.7 million in the U.S., since it was first reported in Wuhan, China.

More than 1.6 million people have died worldwide and over 41.6 million have recovered as of Wednesday, according to John Hopkins University.

The graphic below, provided by Statista, shows the percentage of adults in the U.S. who would or would not get a COVID-19 vaccine.

COVID vaccine hesitancy in U.S.
STATISTA

The graphic below, provided by Statista, shows the countries with the highest COVID-19 death tolls.

coronavirus death toll us december 13
Statista

The graphic below, provided by Statista, shows the spread of COVID-19 cases in the U.S.

COVID-19 cases across U.S.
STATISTA

About the writer

Soo Kim is a Newsweek reporter based in London, U.K. She covers various lifestyle stories, specializing in travel, health, home/interior design and property/real estate. Soo covered the COVID-19 pandemic extensively from 2020 to 2022, including several interviews with the chief medical advisor to the president, Dr. Anthony Fauci. Soo has reported on various major news events, including the Black Lives Matter movement, the U.S. Capitol riots, the war in Afghanistan, the U.S. and Canadian elections, and the 2020 Tokyo Olympics. Soo is also a South Korea expert, covering the latest K-dramas—including the breakout hit Squid Game, which she has covered extensively, including from Seoul, the South Korean capital—as well as Korean films, such as the Golden Globe and Oscar-nominated Past Lives, and K-pop news, to interviews with the biggest Korean actors, such as Lee Jung-jae from Squid Game and Star Wars, and Korean directors, such as Golden Globe and Oscar nominee Celine Song. Soo is the author of the book How to Live Korean, which is available in 11 languages, and co-author of the book Hello, South Korea: Meet the Country Behind Hallyu. Before Newsweek, Soo was a travel reporter and commissioning editor for the award-winning travel section of The Daily Telegraph (a leading U.K. national newspaper) for nearly a decade from 2010, reporting on the latest in the travel industry, from travel news, consumer travel and aviation issues to major new openings and emerging destinations. Soo is a graduate of Binghamton University in New York and the journalism school of City University in London, where she earned a Masters in international journalism. You can get in touch with Soo by emailing s.kim@newsweek.com . Follow her on Instagram at @miss.soo.kim or X, formerly Twitter, at @MissSooKim .Languages spoken: English and Korean


Soo Kim is a Newsweek reporter based in London, U.K. She covers various lifestyle stories, specializing in Read more