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Baker says future Johnson & Johnson shipments to Massachusetts are ‘under review’ by federal government

Mishap at a Baltimore plant could slow expected supply surge

La Colaborativa executive director Gladys Vega spoke Thursday at the East Boston Neighborhood Health Center vaccine clinic in Chelsea.Craig F. Walker/Globe Staff/The Boston Globe

A day after heralding a windfall of Johnson & Johnson vaccine doses, state officials said Thursday that future shipments of the drug maker’s coveted one-shot COVID-19 vaccine are “under review” due to a mistake by a contractor that ruined millions of doses at a Maryland plant.

The mishap won’t jeopardize the 100,000 doses of J&J’s vaccine coming to Massachusetts next week, which officials described as a “one-time bonus” allotment that will dwarf previous weekly shipments of the vaccine.

But the federal review of J&J’s production threatens what was expected to be a surge of vaccine supply in the coming weeks, just as the general public becomes eligible for shots.


The pace of deliveries is now “the big open question,” Governor Charlie Baker said at a briefing. He said he expects to learn more from federal officials next week.

For weeks, Baker has trumpeted J&J as key to accelerating the state’s vaccination push and returning to “the normal that we left behind,” though it has accounted for a small fraction of the state’s vaccine supply until now. J&J’s one-and-done formula is considered ideal for reaching rural parts of the state and urban sites lacking the ultracold refrigeration required by the two-dose vaccines.

It is also thought to be a more practical option for groups such as homebound residents who can’t get to clinics or college students less inclined to show up for a second shot.

“We were really excited about the fact that, after a bunch of weeks of hearing that it was coming, there was finally this really significant move upward,” Baker said. But after the next J&J shipment, he said, “we don’t know what’s happening.”

The state’s vaccination program has grown steadily since February, including 448,045 doses administered in the past week, and 1.3 million residents fully vaccinated since mid-December. J&J’s vaccine only became available here in late March, but the Baker administration had hoped that it would become a growing part of the supply in coming weeks, with the general public set to become eligible for shots on April 19.


White House officials acknowledged Thursday that they have known about J&J’s production problem since last week, but they don’t expect it to slow down their vaccination drive.

On Tuesday, The New York Times reported that up to 15 million J&J doses were spoiled last month when workers at a pair of Baltimore plants operated by Emergent BioSolutions, a contractor that was making both J&J and AstraZeneca vaccines, mixed up their ingredients. The mistake delayed regulatory authorization of production at the sites.

Speeding up the national vaccination campaign has become increasingly urgent in recent weeks as new, highly transmissible coronavirus variants have been circulating in the United States, pushing up infection rates in Massachusetts and other states.

Baker, who repeated his daily warnings Thursday against large gatherings for the Easter and Passover holidays, said the state can ill afford any vaccine supply delays.

“It’s a shame to have 15 million vaccines, when you’re in a race against variants, go down the drain,” the governor said.

J&J issued a statement that gave few details of what happened at the contractor’s plants. It said J&J’s quality control process identified the problem before contaminated vaccine was sent to the final production and packaging stages known as filling and finishing. The drug giant said it had met its commitment to deliver 20 million doses to the United States by the end of March.


Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, who helped develop the J&J vaccine, said it’s being manufactured at multiple sites around the world.

Doses earmarked for Massachusetts next week are part of an 11 million-dose distribution to the United States this week from a J&J-operated plant in the Netherlands, he said.

Emergent’s plant in Baltimore, which had yet to be cleared for operation by the Food and Drug Administration, had planned to handle future US production. Now, until the FDA certifies it’s fixed its problem, J&J doses will have to come from elsewhere.

“This is an unfortunate event with the first batch of doses,” Barouche said. “But at the end of the day, this is going to be just a speed bump. I would call this a minor setback.”

Barouche said he remains confident that J&J will be able to deliver the 100 million doses the US government has purchased by the end of June. “They had hoped to accelerate that if they could,” he said. “But over the next month or two, there will still be a dramatic increase in J&J doses.”

With production of the two-dose vaccines from Pfizer-BioNTech and Cambridge-based Moderna also ramping up, the United States should remain on track to have enough supply to vaccinate about 320 million Americans by the summer, said Jen Kates, a senior vice president and global health policy director at the Kaiser Family Foundation in Washington.


But as public health officials press their efforts to persuade unvaccinated populations to get injections, she said, any delay in J&J’s timetable could deprive them of an important tool.

“To the extent that some individuals are more comfortable with one dose, if the one-dose vaccine isn’t available for a time, that adds to the challenge of reaching everyone,” Kates said.

J&J vaccines arriving in Massachusetts next week will be sent to CVS and Walgreens pharmacies, including 20 to 30 outlets opening for vaccinations just to handle the J&J supply. Others doses will go to regional vaccine collaboratives, community health centers, low-income senior housing, and mobile units that inoculate homebound residents.

The aim is “to take our existing channels and pump it out,” said Health and Human Services Secretary Marylou Sudders.

State and federal officials plan to redouble their outreach to the hardest-hit communities in the coming weeks, with education campaigns and “pop-up” vaccination sites operated by the Federal Emergency Management Agency nationwide.

The mass vaccination site at the Hynes Convention Center, jointly operated by CIC Health and FEMA, had planned to use J&J vaccines next month not only at the Hynes but in mobile units sent to pop-up clinics in Boston neighborhoods as well as Chelsea, Revere, and other high-risk communities.

Baker administration officials have already begun working to dispel misinformation and overcome vaccine hesitancy in those communities, where mistrust of the medical profession has historic roots. The governor on Thursday said he doesn’t see the J&J stumble further undermining confidence in vaccination.


Baker noted that the error was detected at the Baltimore plant before the tainted vaccines were released to the public.

“People screwed up, people recognized, people ditched it,” Baker said. “Right? I mean, the message to me is, whatever the [quality] control process was, it was in place there. It worked.”

Robert Weisman can be reached at robert.weisman@globe.com. Travis Andersen can be reached at travis.andersen@globe.com.