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Mass. notifies state providers to halt Johnson & Johnson vaccine rollout

A nurse filled a syringe with the Johnson & Johnson COVID-19 vaccine in the Staten Island borough of New York.
A nurse filled a syringe with the Johnson & Johnson COVID-19 vaccine in the Staten Island borough of New York.Mary Altaffer/Associated Press

Massachusetts and several other states, including Maine and Rhode Island, on Tuesday swiftly announced pauses of the administration of the Johnson & Johnson vaccine, abiding by federal recommendations so officials can investigate reports of blood clots in six recipients out of the more than 6 million people who have received the single-dose shot.

The Massachusetts Department of Public Health and the state’s COVID-19 Command Center both confirmed the J&J pause in Massachusetts.

“This action is being taken out of an abundance of caution as the FDA and CDC review these 6 cases, none of which are known to be linked to Massachusetts,” the Command Center said in a statement. “The FDA has reported over 6.8M doses of J&J have been administered nationwide. Individuals who have received a J&J vaccine should contact their physician if they have concerns.”

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According to the Baker administration, 181,034 residents received the J&J vaccine by April 12 out of a total of 1.7 million people considered by the state to be fully vaccinated.

Massachusetts lawmakerss on Tuesday questioned public health experts about the J&J news, during an unrelated hearing on the spread of COVID-19 variants.

“If one of the three vaccines either is not in use or has to be restricted … it will necessarily slow down the vaccine process,” said Dr. Dan Barouch, head of the Center for Virology and Vaccine Research at Beth Israel and a leading vaccine developer, during the hearing. “But I think it’s currently an area of uncertainty.”

Dr. Benjamin Linas, a Boston University professor of epidemiology, told lawmakers that his biggest concern isn’t safety issues, but what the news could mean for the public’s confidence in getting vaccinated, since public health officials are already battling hesitancy.

“It’s the potential damage that can be done to public trust,” Linas said. “The fact that there is a brief pause here does not mean things are falling apart. It’s actually quite the opposite. This is the system working.”

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Rachael Piltch-Loeb, a fellow with the Emergency Preparedness Research, Evaluation & Practice Program at the Harvard T.H. Chan School of Public Health, said in an interview that out of the six known blood clot cases, one person died and another is hospitalized in critical condition.

“This particular type of blood clotting disorder is unusual,” she said.

It’s also “incredibly rare,” she said.

“What’s important to keep in mind is that this does not mean that the vaccine is going to be taken out of use” permanently, she said. “It’s an incredibly effective vaccine against COVID-19.”

Piltch-Loeb said she’d be “absolutely shocked if they didn’t start using the vaccine again. The utility of this vaccine is high and these adverse events are so rare. Hopefully, this investigation will happen quickly.”

Dr. David A. Rosman, president of the Massachusetts Medical Society, called the pause “entirely appropriate” in a separate statement.

“The commitment to patient safety must always come first,” Rosman said. “Ultimately, the agencies’ adherence to transparency, safety and the scientific process in response to a potential adverse reaction which fewer than one in a million patients have suffered should be reassuring to all those who have been vaccinated and those in line.”

Rosman stressed that COVID-19 remains a “present and dangerous” threat.

“The dramatic decline in hospitalizations and deaths among the at-risk populations that have been vaccinated illustrate the efficacy of the vaccines,” Rosman said, adding that anyone with questions should “connect with their physician.”

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Johnson & Johnson used vaccine technology licensed from Beth Israel’s Center for Virology and Vaccine Research.

As with the messenger RNA vaccines made by Pfizer-BioNTech and Moderna, Johnson & Johnson’s vaccine relies on a cutting-edge approach to stimulating immunity. It uses a harmless and relatively rare cold virus, adenovirus serotype 26 — or Ad26 — to deliver part of the distinctive spike protein on the surface of the coronavirus into cells to trigger an immune response without making people sick. Adenovirus-based vaccines have been investigated for about three decades but have yet to be licensed for use in the United States.

In January 2020, Chinese scientists posted the genetic sequence of the coronavirus online. Researchers in Barouch’s lab frantically began designing an Ad26 vaccine that would deliver part of the distinctive spike protein on the coronavirus into cells to trigger an immune response.

Two weeks later, Dr. Barouch contacted executives at Janssen to see if they were interested in collaborating with his lab, as they had on HIV, Zika, and Ebola. They were. Beth Israel soon signed an agreement with the company, which has licensed the technology from the hospital.

Researchers worked marathon days at Barouch’s lab designing multiple versions of the vaccine that were tested in mice, ferrets, hamsters, and rhesus monkeys.

“I think that it’s important to focus on safety — at this time, it seems that the J&J and Astra Zeneca vaccines, both of which are adenovirus-based delivery mechanisms, are noting some extremely rare but serious clotting complications that may be associated,” said Dr. Abraar Karan in a email, an internist at Brigham and Women’s Hospital and Harvard Medical School.

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He said investigation of the clotting is a necessary step.

“We need to investigate whether there is clear causality here given these are still very rare events — 6 cases out of greater than 6.8 million doses of the J&J administered,” Karan said. “As the CDC/FDA noted, the combination of clots with low platelets is what is drawing forth more attention. Here, we should continue to look to the CDC and FDA regarding safety; I am appreciative of their quick action, transparency, and diligence.”

Olivia Adams, a software developer for athenahealth who created the MA Covid Vaccine Appointments portal, on Tuesday urged the public to remain calm.

“If you got the J&J (my husband did just last week) please don’t panic,” Adams tweeted. “These cases are extremely rare. But I’m not looking forward to the resulting scarcity and increased vaccine hesitancy. I continue to work on @macovidvaccines and with @macovidvaxhelp to get shots in arms.”

Elsewhere around the country, authorities are pumping the brakes on J&J as well.

“We are advising all Ohio vaccine providers to temporarily pause using the Johnson and Johnson (Janssen) vaccine,” Ohio Governor Mike DeWine tweeted.

Closer to home, Maine, Rhode Island, New Hampshire, and Vermont are following suit.

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“Maine CDC is not aware of any reports of these cases in Maine residents,” said a joint statement from Maine Governor Janet Mills, state Health and Human Services Commissioner Jeanne Lambrew, and Dr. Nirav D. Shah, director of the Maine CDC. “Given this recommendation, the State of Maine is advising that providers pause administration of the Johnson & Johnson vaccine until the U.S. CDC’s scientific advisory committee has further reviewed the safety data.”

In Rhode Island Tuesday, the state vaccine subcommittee said it was still figuring out how the news would impact the allocations to Rhode Island, as well as upcoming clinics and appointments. But “due to this information, we are going to pause” the use of the Johnson & Johnson vaccine in the state, the panel said.

“This news will not slow down New Hampshire,” said Granite State Governor Chris Sununu in a statement confirming his state’s pause. “While the federal government has directed a brief pause in the J&J vaccine, the state is already working with our partners to ensure that they have an alternative supply of Pfizer or Moderna to help continue their efforts today.”

Dr. Mark Levine, Vermont’s health commissioner, discussed his state’s pause in a separate statement.

“We understand this news may be unsettling, but people should not be alarmed about overall vaccine safety, and hopefully the pause will be brief,” Levine said. “The extreme caution being taken in this case by the CDC and FDA is entirely consistent with their and Vermont’s commitment to vaccine safety and transparency every step of the way.”

The news also had an immediate impact on vaccine distribution at pharmacies and hospitals, as well as on regional vaccine collaboratives operating clinics.

Tufts Medical Center said “We have paused administration of the Johnson & Johnson COVID-19 vaccine and are working through a plan while we await further state and federal guidance,” spokesman Jeremy Lechan wrote in an e-mail.

A spokesman for CVS pharmacies said the company would not be providing the J&J vaccine at all of its stores.

“We are immediately implementing a pause in the use of the Johnson and Johnson’s COVID-19 vaccine per the recommendation from federal health agencies,” Matt Blanchette said.

The company hasn’t yet determined the full impact on its vaccination efforts.

“We are working through details now and will provide more information when we have it,” Blanchette said, adding in a follow-up statement that in light of the pause, “we are emailing all customers who have a scheduled appointment to receive a Johnson & Johnson COVID-19 vaccine at CVS Pharmacy to inform them that their appointment is being cancelled.”

Blanchette added that CVS regrets “any inconvenience and will follow up with affected customers to reschedule their appointments as soon as possible.”

Walgreens was on a similar wavelength.

“Out of an abundance of caution, we are immediately suspending the administration of the J&J vaccine at our stores and off-site clinics and are awaiting further guidance,” said Walgreens spokeswoman Erin Loverher in a statement. “We are reaching out to patients with scheduled appointments and rescheduling vaccinations from other manufacturers, as supply allows.”

The Lower Merrimack Valley Regional Collaborative, which runs vaccine locations in Amesbury and West Newbury, said in a statement that about 2,000 people have received the J&J shot at its clinics, and that the collaborative’s expecting guidance from authorities on what may need to be communicated to those patients.

“This is an unfortunate situation, but as always we will abide by the guidance and information we receive from our state and federal health partners,” said Amesbury Fire Chief and Health Director Ken Berkenbush in the statement from the collaborative. “We are pleased that we will be able to hold our patients faultless and ensure that all patients who would have received a Janssen vaccine this week will have the chance to receive a first dose of the Pfizer vaccine.”

Dr. Ashish K. Jha, dean of the Brown University School of Public Health, tweeted that the public health authorities are making the right call.

“US govt calling for a pause of the J&J vaccine after a small number of people develop a very rare blood clot. While unfortunate, it’s the right step,” Jha tweeted. “Central to vaccination success is ensuring people have confidence they are safe.”

Jha added that the reported clotting is far from a common occurrence.

“These events (central venous thrombosis) are VERY rare,” Jha tweeted. “6 out of 7 million. No vaccine (or drug) is perfect. But confidence is built on having a system that takes adverse events seriously, investigates them, makes data-driven decisions. [That’s] what FDA/CDC doing. And it’s right.”

Dr. Megan Ranney, an emergency room physician who directs the Brown-Lifespan Center for Digital Health in Providence, also referenced the prior issues with the AstraZeneca vaccine in a separate Twitter thread.

“Reporting 6 cases of cerebral venous sinus thrombosis plus low platelets- the same complication observed w/ AstraZeneca - among 7 million doses administered,” she wrote, adding that “the same complication has been reported as a very rare [side effect] of [AstraZeneca].”

Ranney also noted that someone who becomes infected by COVID-19 has a much higher chance of getting a blood clot, with one study putting the odds at about 20 percent.

“Science and medicine, like life, is full of weighing risks vs benefits,” Ranney wrote. “Right now, the risk of catching #covid19 & getting a bad complication is much higher than this very rare adverse effect. BUT - for some groups (women? Young women?) that assumption may not be true.”

Material from prior Globe stories was used in this report. Travis Andersen and Felicia Gans of the Globe Staff contributed.


John R. Ellement can be reached at john.ellement@globe.com. Follow him on Twitter @JREbosglobe. Emily Sweeney can be reached at emily.sweeney@globe.com. Follow her on Twitter @emilysweeney. Jonathan Saltzman can be reached at jonathan.saltzman@globe.com. Matt Stout can be reached at matt.stout@globe.com. Follow him on Twitter @mattpstout.