Doctors brace for questions with return of Johnson & Johnson vaccine

The small risk of a rare side effect didn't stop Breanna Valverde from getting a dose of the Johnson & Johnson COVID-19 vaccine last week.

The Maple Plain resident had discussed the single-dose shot with her doctor before federal regulators temporarily halted use of the vaccine last month amid safety questions and concerns. But after those same regulators called for a restart, Valverde checked back with her physician, then took action after hearing the news that a Minnesota first-grader died of COVID-19.

"My reason for getting it is not really for myself," said Valverde, a 44-year-old mother of two. "I don't want to be a part of unknowingly giving it to someone else."

Health care providers across Minnesota are anticipating a flood of questions from patients about COVID-19 immunizations in coming days as the Johnson & Johnson (J&J) vaccine returns to clinics. Doctors say the blood clot risk highlighted by the recent pause is more than offset by the benefits of vaccination, but it could prompt some patients — particularly women under 50 — to opt for two-dose vaccines from Moderna and Pfizer.

With the pace of vaccinations slowing across the state, health officials say the J&J vaccine is key to advancing population-level immunity against the virus, since vaccine holdouts might be more inclined to opt for a one-shot dose than two shots separated by several weeks.

"I think the Johnson & Johnson vaccine is critical to helping us close our community immunity gap right now, because of the one-and-done," said Patsy Stinchfield, a vaccine specialist at Children's Minnesota. "We need to make it convenient and we need to make it accessible and we need to do that soon, because those who are unvaccinated are vulnerable."

On Saturday, the state Department of Health reported 1,723 new coronavirus cases and 10 more deaths linked to COVID-19. The statewide tally of people who have received at least one vaccine dose increased to 2.55 million, including a 1,085-shot increase in total doses administered with the J&J vaccine.

Federal health officials recommended on April 13 that immunization clinics temporarily stop using the J&J vaccine after learning that six women out of nearly 7 million men and women who got that vaccine had developed a rare and dangerous problem with blood clots.

Additional data collected during the pause revealed nine more women who suffered from the side effect — a syndrome that includes blood clots and abnormally low platelet levels. By the time numbers were presented April 23 to the federal Advisory Committee on Immunization Practices (ACIP), three of the 15 patients had died. Seven were still hospitalized, including four who required intensive care.

Thirteen of the cases were found in women ages 18 to 49. That works out to a reporting rate of 7 cases per million recipients, federal officials say, since women in that age group received a total of 1.86 million doses.

A causal relationship between the vaccine and the problem is "plausible," according to an updated fact sheet from the manufacturer. Outside medical groups have stressed the rarity of the clotting syndrome plus the need for patients to know about the issue and options.

"I think that this risk trade-off is one that people have to individually measure for themselves," Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, told reporters last month. "What we are saying is that this should be, certainly, an option for women in that age category as one of the three vaccines that would be safely available to them for use."

Lynn Bahta, an ACIP member who voted to back resumed use the vaccine, said risk tolerance varies, so health care providers should talk with patients and tailor their guidance. But the risk with the J&J vaccine is "extremely low," said Bahta, who is the immunization program clinical consultant at the Minnesota Department of Health.

"If the woman were really nervous, I would say, 'What can I do to help you find the product you are comfortable with?' " Bahta said via e-mail. "If the person loves the convenience, I would say, 'Take the opportunity. If you have any of these symptoms call your health care provider right away, so you can get treated. The most important thing is to get vaccinated.' "

But some committee members, including Dr. Sarah Long, a professor of pediatrics at Drexel University College of Medicine, thought the recommendation should have been coupled with a warning for women ages 18 to 49.

"This is an age group that is most at risk, that is getting vaccine predominantly to save other people's lives and morbidity — not their own," Long told the committee. "And I think we have a responsibility to be certain that they know this."

In an interview, Long said that people should take the first COVID-19 vaccine available to them, whatever the brand. But if women under 50 have a choice, she'd recommend vaccines from Moderna or Pfizer.

"Why take that risk?" Long asked.

Yet the risk with the J&J vaccine is similar to the risk of side effects tolerated with some other vaccines, said Stinchfield, who is a nonvoting member of ACIP. There are some similarities between the very small vaccine risk and the risk for women who take oral contraceptives, she added, while acknowledging the comparison is "not an identical apples-to-apples."

The J&J vaccine also is seen as being critically important for reaching some populations, Stinchfield said, including people who resist shots due to fear of needles. The day after the ACIP vote, Stinchfield worked at a vaccine clinic where J&J shots weren't being offered, yet blood clots were "the question of the day."

"I think it's understandable," she said, "and I think that the public deserves those answers."

Allina Health System plans to reintroduce the vaccine soon. Dr. Kevin Best, the interim vice president of medical operations for primary care, said he's hearing more from patients who are interested in the convenience of it than from those who are worried about the blood clot issue.

It would be "very reasonable" for some patients to opt for Moderna or Pfizer, but that doesn't mean a woman under 50 would be wrong to select J&J, said Dr. Caitlin Eccles-Radtke, an infectious disease specialist at Hennepin Healthcare. The health system has found the one-shot vaccine helps immunize patients who can't easily get to the clinic for two shots, so a patient's access to health care can factor into the choice.

"Transparency and education are really critical in … letting people make a decision they feel comfortable with," she said.

The J&J vaccine not only brings faster protection, it seems to bring a lower chance of mild side effects such as fever and headaches that quickly go away after immunizations, said Dr. Elizabeth Baldwin, an obstetrician at HealthPartners.

"I think those reasons are valid," said Baldwin, who expects questions about the vaccine as her health system resumes providing it. "I would probably choose, myself — as a woman in this age group — I would choose the Pfizer or Moderna knowing this. But if the choice was Johnson & Johnson or nothing, I would take the Johnson & Johnson."

Medical groups say women can receive any of the three vaccines, noted Dr. Sarah Cross, a maternal fetal medicine physician at M Health Fairview. Having that choice, she said, is important.

"Women in this age group often have a lot of competing needs for their time," Cross said. "When I sit down and talk to my patients, you can talk about all of these things and help them make a decision."

Christopher Snowbeck • 612-673-4744