Cambridge-Based Moderna's Coronavirus Vaccine Gets Emergency OK

CAMBRIDGE, MA — Another 6 million doses of coronavirus vaccine is expected to be shipped across the country within the next few days after the U.S. Food and Drug Administration issued an emergency-use approval for Cambridge-based Moderna's vaccine for those 18 years old or older.

The second vaccine approval — coming on the heels of the Pfizer vaccine's emergency approval last week and distribution to front-line health care workers this week — will allow Massachusetts to expand vaccinations into venues outside of hospitals because the Moderna vaccine does not have to be shipped and stored at the extremely low temperatures of the Pfizer vaccine.

Massachusetts Gov. Charlie Baker said on Friday that nursing home workers and residents — the next priority group of people after hospital emergency workers scheduled for the vaccine — should start getting their shots on Dec. 28.

"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," FDA Commissioner Stephen Hahn said in announcing Moderna's emergency approval.

As was the case with the Pfizer vaccine last week, health officials are seeking to assure any areas of the public skeptical about the vaccines, and their rapid approvals, that the Moderna vaccine is safe for the vast majority of people. Those with known severe allergic reactions to vaccines and certain other medications are not advised to take the Moderna vaccine, under the emergency authorization.

"Through the FDA's open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited time frame 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," Hahn said. "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."

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The Moderna vaccine is a two-shot vaccine where the second shot is prescribed for 28 days after the initial dose. The Pfizer vaccine has a 21-day interval between doses.

Both have shown in trials to be up to 94 percent effect in preventing severe coronavirus symptoms, according to research released through the respective companies.

Hospitals across New England, including UMass Memorial in Worcester, MelroseWakefield Hospital and North Shore Medical Center in Salem, began vaccinating front line health care workers this week in what has been often described as the first "light at the end of the tunnel" amid a coronavirus case spike regionally and nationwide.

Both Rhode Island and Massachusetts did get a surprise late in the week when the federal government informed them less of the Pfizer vaccine will be shipped in upcoming weeks than originally projected.

But Gov. Baker said on Friday that he does not believe the delay will have a significant effect on the state's timeline to vaccinate the most vulnerable front line workers and nursing home residents by the end of January, along with home health care workers and those living and working in congregate settings sets as shelters and prisons in phase one, before moving to a second phase in February that will include those with significant underlying conditions, teachers and essential workers in some industries, and eventually all those over age 65 by the end of the second phase in March.

According to Gov. Baker's timeline, the general population should be eligible to get a vaccine starting around April.

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