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Vaccine shipments to begin as new coronavirus restrictions take effect in Mass.

The Food and Drug Administration cleared the two-dose COVID-19 vaccine developed by Pfizer and its German partner, BioNTech, for emergency use on Friday, and the US Centers for Disease Control and Prevention issued a final clearance on Saturday.
The Food and Drug Administration cleared the two-dose COVID-19 vaccine developed by Pfizer and its German partner, BioNTech, for emergency use on Friday, and the US Centers for Disease Control and Prevention issued a final clearance on Saturday.JEFF KOWALSKY/AFP via Getty Images

As Pfizer plans to begin shipping doses of the first COVID-19 vaccine approved by American regulators for emergency use Sunday, a host of new restrictions on business activities go into effect in Massachusetts, where the death toll has passed 11,000.

Massachusetts expects to receive 59,475 doses in its first shipment, which could land in the state Monday or Tuesday, according to Dr. Paul Biddinger, who led the state’s vaccine advisory group.

“The vaccine is the most important intervention that will help us bring COVID under control and get us back to normal,” Biddinger, medical director for emergency preparedness at Mass General Brigham, said Saturday in a phone interview.

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The Food and Drug Administration cleared the two-dose vaccine, developed by Pfizer and its German partner, BioNTech, for emergency use on Friday, and the US Centers for Disease Control and Prevention issued a final clearance on Saturday.

A broadcast of the first doses departing from Pfizer’s manufacturing facility in Kalamazoo, Mich., is scheduled to begin airing at about 6:45 a.m. Sunday.

A spokeswoman for the state’s COVID-19 Response Command Center on Saturday welcomed news of the emergency use authorization, but didn’t provide new details about the distribution plan or specify when the first doses will arrive in Massachusetts.

The state announced 4,968 new COVID-19 cases and 47 additional deaths on Saturday.

Biddinger said a significant portion of the first doses will be delivered to hospitals. The state has said 21 hospitals have the ultra-cold storage capacity required to store Pfizer’s vaccine.

Massachusetts expects to receive a total of 300,000 doses by the end of the month, including 120,000 manufactured by Cambridge-based Moderna. The FDA plans to consider Moderna’s vaccine for emergency use on Thursday.

UMass Memorial Health Care has been told by the state to expect its first shipment of 1,950 doses on Tuesday, said Dr. Andrew Karson. Those doses are being prioritized for workers treating patients with confirmed or probable cases of COVID-19, including doctors, nurses, and employees who clean patients’ rooms, said Karson, chief medical officer at UMass Memorial Medical Center.

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“The top priority for us was safety for our caregivers, and equitability,” said Karson, who expects inoculations to begin Thursday.

The virus has infected about 700 employees so far, including approximately 220 workers who are currently out of work because they have COVID-19, Karson said.

“Our biggest worry right now is getting the vaccine in our hands as fast as we can to protect our workers, and therefore, our patients,” he said.

The vaccine distribution plan in Massachusetts calls for the initial doses to be distributed among health care workers providing COVID-19 care and to long-term care facilities, rest homes, and assisted living facilities. About 266,000 residents fall into those categories.

Biddinger said Mass General Brigham plans to launch its vaccination efforts by administering doses to about 20 employees at potentially two sites starting either the same day the shipment is received, or early the following day.

That effort will be followed by a soft-launch of employee vaccination clinics at locations across the hospital system, he said. By the third day, Mass General Brigham expects to have a fully operational vaccination effort at 12 sites with the goal of vaccinating about 1,000 workers daily.

Dr. David Hamer, a physician at Boston Medical Center and a Boston University epidemiologist, said he is watching to see whether large hospitals will get enough doses to immunize health care workers quickly enough.

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He said he is also concerned about the possibility that some health care workers may experience adverse side effects from the vaccination that would keep them out of work .

The most significant adverse reactions attributed to Pfizer’s vaccine were fatigue and headache, and they typically disappeared soon. Older adults tended to report fewer and milder side effects, according to the companies.

”My worry is that some of them may be moderate enough that they may interfere with individuals’ desire or capacity to work,” Hamer said. “There may be need for short-term sick leave for some employees.”

On Friday, the VA Bedford Healthcare System announced that it is among 37 sites operated by the US Department of Veterans Affairs that will receive initial doses of the vaccine and administer them to its health care workers and veterans in long-term care facilities.

The Bedford VA said it was selected to receive the initial doses because it can accommodate the ultra-cold storage requirements for Pfizer’s vaccine and has the capacity to vaccinate many people.

There have been 38 coronavirus deaths at the Bedford facility, according to federal figures. On Tuesday, the Bedford VA announced it was suspending in-person visitation and reintroducing other restrictions at its Community Living Centers due to a rise in COVID-19 cases at the facility and in surrounding communities. As of Saturday, there were 42 veterans and workers with active COVID-19 cases, federal figures show.

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The rollout of the vaccine at other long-term care facilities, rest homes, and assisted living facilities is planned to begin the week of Dec. 21 and will be carried out by clinical staff from CVS and Walgreens, said Tara Gregorio, president of the Massachusetts Senior Care Association. More than 60 percent of people who have died of COVID-19 in Massachusetts were patients at long-term care facilities.

CVS will vaccinate residents and staff at 1,800 senior sites in Massachusetts. Walgreens said it plans to provide vaccinations at 35,000 sites nationwide, but didn’t specify how many will take place locally.

The pharmacies have told senior facilities that, under federal guidelines, they will be making three visits to each site, bringing the vaccines and setting up clinics to administer injections. Each resident and staffer will need to receive two doses, four weeks apart for the Pfizer vaccine and three weeks apart for the Moderna vaccine.

Dr. Richard Feifer, chief medical officer for Genesis Healthcare, said in a statement that it is partnering with CVS to administer the vaccine and plans to participate in a program run by the Brown University School of Public Health to monitor patients for “any potential adverse health impacts” linked to inoculation.

Genesis Healthcare runs the country’s largest nursing home chain, including 26 sites in Massachusetts. An outbreak of COVID-19 at the company’s Courtyard Nursing Care Center in Medford claimed the lives of 72 patients.

Meanwhile, the state returns Sunday to an earlier stage of business restrictions designed to slow the spread of coronavirus. Governor Charlie Baker announced the measures on Tuesday.

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Theaters, other indoor performance venues, and some high-contact indoor recreational facilities will close. Capacity at virtually every other type of business, including retail outlets, gyms, libraries, museums, houses of worship, and movie theaters, will be reduced to 40 percent of capacity as all cities and towns revert to Phase 3 Step 1 in the state’s four-phase reopening plan.

Outdoor gatherings will be capped at 50 people, down from 100 currently, and anyone who plans to host more than 25 people at an outdoor event will be required to alert their local board of health.

People dining indoors at restaurants will have to abide by a 90-minute time limit, must wear masks when they are not actively eating or drinking, and cannot sit with a group larger than six patrons, down from 10.




Laura Crimaldi can be reached at laura.crimaldi@globe.com. Follow her on Twitter @lauracrimaldi. John Hilliard can be reached at john.hilliard@globe.com.