Feds lift pause on Johnson & Johnson vaccine

Federal health agencies on Friday lifted the pause on using a COVID-19 vaccine from Johnson & Johnson after an advisory committee said the benefits more than offset the risks of a rare but serious blood clot problem.

The Centers for Disease Control and Prevention and Food and Drug Administration jointly called for the temporary pause earlier this month after detecting the safety issue in just a few patients. New data presented Friday to the Advisory Committee on Immunization Practices (ACIP) reinforced initial concerns that the risk seems to be greatest among women under 50.

A fact sheet about the vaccine that's given to patients has been revised to reflect the risk. Minnesota health officials said they expect immunizations with the vaccine will soon resume.

"Right before the pause was announced last week, the State of Minnesota had distributed 9,600 doses of Johnson & Johnson (J&J) vaccine to Minnesota providers," the Minnesota Department of Health said in a statement. "Those doses have been stored by the providers who received them and we expect them to be available in the coming days along with any updated information to provide to those getting the vaccine."

Modeling suggests that every 1 million doses of vaccine used will prevent 650 hospitalizations and 12 deaths among women age 18 to 49, said Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention. The usage also could prevent another 4,700 hospitalizations and nearly 600 deaths among women over 50, Walensky added.

"The administration of Johnson & Johnson's COVID vaccine can resume immediately," she said during a Friday evening news conference. "The risk is very low."

The J&J vaccine is unique among those being used in the U.S. because it's delivered in one dose, rather than vaccines from Moderna and Pfizer that require a second shot. The one-shot feature makes the vaccine an important tool for reaching people who otherwise might not get immunized, health officials say, either because they don't have easy access to clinics or they can't take off two days from work to get vaccinated.

"We are looking at a very rare risk, and the high benefit — and the need to make all vaccines available to all of us," said Lynn Bahta, an immunization program consultant at the Minnesota Department of Health who is a member of the ACIP. "We need that flexibility."

The J&J vaccine has shown success around the world in protecting patients against more infectious variants of the virus that causes COVID-19, Dr. Mathai Mammen, the global head of research and development at the company's vaccine division, told the advisory committee.

Variants increasingly are part of the COVID-19 problem in Minnesota, where the illness is sending young adults to the hospital, said Patsy Stinchfield, a nurse practitioner at Children's Minnesota who is a nonvoting member of the committee.

"What makes me nervous is the climbing incidence of COVID," Stinchfield said. "I have an urgency to move on this."

The vote was not unanimous, however, with some members saying more should be done to make sure that women under 50 are advised of the risk.

Health officials paused use of the J&J vaccine on April 13 after finding six cases of a rare blood clot in conjunction with a platelet condition, out of nearly 7 million people who received the vaccine. In subsequent days, they learned of nine more cases, bringing the total to 15 cases out of nearly 8 million doses administered, Dr. Tom Shimabukuro, a vaccine specialist at CDC, told the committee.

Three of the patients have died. Seven are still hospitalized, including four in intensive care, Shimabukuro said, while five patients had been discharged home.

The advisory committee considered issuing a statement that would have highlighted the problem but ultimately opted to back the vaccine's general use.

"I'm just surprised that there weren't more votes recommending that there be more information provided in the way of a warning," said Dr. Greg Poland, a vaccine immunology specialist at Mayo Clinic, after listening to Friday's proceedings.

"I think what would have been better for all involved in terms of the vaccine, in terms of the public, in terms of public trust, is to say: 'It's a great vaccine. It's one dose. The benefits far outweigh any risks — but here are the risks and benefits,' " Poland said.

Health officials have worried about the downstream effect of the pause because it came at a time of softening interest — and struck right at the safety issues that leave some people hesitant.

Minnesota has been among the fastest in the U.S. in vaccine administration. The state reported Friday that nearly 2.4 million people — or 54% of the eligible population — had received some vaccine and that more than 1.7 million people had completed the one- or two-dose series.

Vaccine appointments aren't getting filled as quickly at clinics, pharmacies and public health events, though.

The state reported 10 more COVID-19 deaths on Friday along with 2,167 — raising the state's totals to 7,064 deaths and 564,584 infections.

Minnesota hospitals also reported 689 COVID-19 cases in inpatient beds on Thursday, including the 202 patients needing intensive care, the highest total since late December. One-third of the 691 COVID-19 patients admitted to Allina Health hospitals this month have been age 50 to 64, and 85% of the patients in that age group have not received any vaccine.

While some pandemic indicators appear to be easing, state Health Commissioner Jan Malcolm urged people to seek vaccine and take other measures such as mask-wearing in public to limit viral transmission.

Hugo's Family Marketplace received its first vaccine doses on April 13 at three pharmacy locations in northwestern Minnesota, with two of the locations receiving the J&J version shortly before its use was paused.

As a result, the pharmacy chain appears artificially slow, providing only 7% of its doses within three days compared with the state goal of 90%. A spokesperson said some hesitancy is affecting the numbers as well.

"We became eligible to administer vaccines at a time when vaccine hesitancy was setting in," said spokesperson Lisa Mangino Swanson. "Those who were anxious to receive the vaccine had already gotten one elsewhere over the previous months. Our hope is that we can get more people on board with vaccination efforts and help us reach herd immunity in our communities."

Christopher Snowbeck • 612-673-4744

Jeremy Olson • 612-673-7744