Moderna to apply for emergency use authorization for COVID-19 vaccine candidate on Monday

Moderna announced that it will apply for emergency use authorization from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine candidate on Monday.

The company said in a statement that testing showed its vaccine candidate was 94.1 percent effective in preventing COVID-19 and was 100 percent effective against severe COVID-19.

It also said “no serious safety concerns” have been identified to date. Some trial participants have experienced reactions like pain at the site of the injection or fatigue.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” said Stéphane Bancel, chief executive officer of Moderna.

Moderna is set to submit its emergency use application with both the FDA and the European Medicines Agency. Similar reviews are already underway for regulatory bodies in Canada, Switzerland, the U.K., Israel and Singapore.

The FDA’s Vaccines and Related Biological Products Advisory Committee is likely to meet on Dec. 17 to review the Moderna vaccine candidate’s safety and efficacy data, according to the company. The drugmaker expects to have made about 20 million doses of the virus available in the U.S. by the end of the year.

Pfizer, meanwhile, has announced its own candidate is 95 percent effective, following interim data showing it was 90 percent effective against the virus.

The extremely high efficacy of two different vaccines is welcome news in the fight against the pandemic, but there are still several tough months before it will be available on a broad scale.

While the first high-priority Americans are expected to get doses of the vaccine in December, it will take several more months for the wider public to have access. Officials predict that people who do not fall into high-risk groups could start getting the vaccine sometime in the spring.

Health officials on Sunday warned of a surge in COVID-19 cases in the wake of Thanksgiving holiday travel.

“We have to be careful now because there almost certainly is going to be an uptick because of what has happened with the travel,” Anthony Fauci said on ABC’s “This Week.”

The nation’s leading infectious disease expert also said the U.S. may see a “surge upon a surge” in the next few weeks.

— Peter Sullivan contributed to this report, which was last updated at 7:54 a.m.