Moderna to Seek Quick Approval of Coronavirus Vaccine in US, Europe
By Ken Bredemeier
WASHINGTON – Drugmaker Moderna said Monday it is seeking emergency authorization in the United States and Europe to distribute its coronavirus vaccine after tests showed it is 94% effective.
The U.S. biotechnology company’s request could mean that health workers will be able to inoculate patients against the virus as soon as mid-December with either of two coronavirus preventatives — Moderna’s or another equally successful test drug produced by the corporate tandem of Pfizer-BioNTech — if the companies win approval from drug regulators.
Moderna said it conducted a 30,000-person clinical trial, and its results were on a par with the best pediatric vaccines.
The drugmaker said that of the 196 volunteers who contracted COVID-19, 185 had received a placebo versus 11 who received the vaccine. Moderna reported 30 severe cases — all in the placebo group — including one COVID-19-related death.
The Moderna and Pfizer requests for emergency use of their vaccines come as the number of coronavirus cases is surging in the U.S., where tens of thousands of new cases are being recorded daily.
Health officials say they are especially worried about an even further spread of the virus because millions of people ignored warnings against traveling for last week’s Thanksgiving holiday and could travel again over the upcoming Christmas and New Year’s holiday weekends.
The U.S. has 4% of the world’s population but nearly a fifth of its recorded coronavirus deaths — more than 266,000 — the most in any country, according to Johns Hopkins University. Worldwide, the death toll has topped 1.46 million.
Top U.S. health experts say 20 million Americans could get vaccine shots in the latter half of December, possibly with front-line health care workers targeted initially, followed by elderly people living in nursing homes. An advisory committee at the Centers for Disease Control and Prevention is meeting Tuesday to lay out the order in which Americans will be able to get vaccinated.
Millions of people will likely be able to get one of the vaccines in the first months of 2021, although polls show that about four in 10 Americans say they will refuse to get a shot, either because they are opposed to vaccinations in general or are particularly wary of coronavirus inoculations.
The U.S. Food and Drug Administration is considering the Pfizer vaccine on December 10, with consideration of Moderna’s a week later. In addition to seeking U.S. approval, Moderna said it would apply for conditional approval from the European Medicines Agency.