Doctors in Minnesota expect that they'll again be using a COVID-19 vaccine manufactured by Johnson & Johnson within a few weeks, so long as troubling new safety reports from recipients don't emerge in the coming days.
But even if it returns soon, the vaccine likely will face perception problems after it was temporarily pulled from circulation last week after several patients reportedly suffered side effects involving a rare and dangerous blood clot issue.
While exceedingly uncommon, the clotting is concerning because of the serious patient risk as well as its similarity to rare side effects that surfaced with a COVID-19 vaccine used in Europe. Health officials hope collecting better data on the risk will help rebuild confidence in the single-dose vaccine, which they've been counting on to quicken the pace of vaccinations and protect groups who otherwise might miss out on immunizations.
"Will we be using the vaccine again? Yes, I think certainly so," said Dr. Gregory Poland, a vaccine immunology specialist at Mayo Clinic. "It is an effective and it's an overall safe vaccine, and has the big value of a single dose."
The number of people who have experienced clots after receiving a Johnson & Johnson vaccine is so small — six people out of nearly 7 million vaccine recipients — that some might question whether the pause is necessary, said Poland, who supports it. Consequences from temporarily pulling the vaccine from use are limited, he added, because COVID-19 immunizations are continuing with vaccines in wider use from Moderna and Pfizer, products where safety questions haven't emerged.
"This is a demonstration that the vaccine safety surveillance system that we have in the U.S. picks up risks even this small — one in a million," Poland said.
State hits 7,000 deaths
Minnesota reported 2,429 new coronavirus cases and 10 more deaths linked to COVID-19 on Saturday, pushing the statewide pandemic death toll past 7,000.
The milestone comes as the rolling seven-day average for deaths declined last week, according to the Star Tribune's coronavirus tracker. The seven-day average for net new cases was up from one week earlier but down from the previous two days.
On Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration recommended the pause of the Johnson & Johnson vaccine "out of an abundance of caution," federal officials said. They called for a review of the matter by the 15-member Advisory Committee on Immunization Practices (ACIP).
The vaccine's manufacturer on Friday published a letter in the New England Journal of Medicine saying the "evidence is insufficient" to show a causal link between the vaccine and the rare clotting problem.
The clots, called cerebral venous sinus thrombosis (CVST), were found in women age 18 to 48 within six to 13 days of vaccination. They occur in the system of veins that drain blood from the brain, and they're so unusual that most doctors have never seen the problem in patients, said Dr. John Misa, chief medical officer for the Allina Health Group.
Data presented to ACIP last week showed that about 1.4 million doses of the Johnson & Johnson vaccine have been given to women ages 20 to 50. Standard incidence rates would lead doctors to expect anywhere from .39 to 1.58 clots to form in a group that size, Misa said, rather than the six clots that actually occurred.
Doctors on the watch
Health officials are asking doctors to watch for the problem so they can learn if others might be affected. The advisory committee is scheduled to meet again Friday.
Misa said he expects the vaccine will again be recommended for use, although "there may be some new recommendations [on] to whom we administer this vaccine."
The pause gives doctors time to understand that they shouldn't treat the clotting problem with a widely used drug that "could actually make the situation worse," said Dr. Abe Jacob, chief quality officer at M Health Fairview.
"My guess, just looking at the numbers now, is that they will un-pause the vaccine," Jacob said. "To me, as much anxiety and concern as there was about, 'Oh, they're developing these vaccines too fast, they got them out too quickly' — this, to me, is reassuring that we can ... raise a concern about safety and pause the vaccine to do more analysis."
Health officials recognize there are risks with temporarily halting use of the vaccine — particularly since it prevents a disease that often harms people through blood clots, said Patsy Stinchfield, a nurse practitioner at Children's Minnesota.
"You don't want to cause problems by being overly cautious," said Stinchfield, who is a nonvoting member of the ACIP.
High hopes for vaccine
Doctors at NorthPoint Health & Wellness hoped the easy-to-use Johnson & Johnson vaccine would help speed immunizations among communities of color that have experienced lower vaccination rates. Community vaccinations are easier to operate because staff and patients don't have to worry about scheduling a second dose, which is required with the Moderna and Pfizer products, said Stella Whitney-West, chief executive at the north Minneapolis clinic.
Latino patients at Southside Community Health Services also liked the convenience of the one-shot option, said Raul Noriega, medical operations director at the Minneapolis Clinic. Sawtooth Mountain Clinic in Grand Marais had plans for using the vaccine at pop-up events for resort workers who lack transportation for getting to clinics, said Kate Surbaugh, the clinic's chief executive.
Damage to the vaccine's reputation could discourage some patients, particularly in communities with distrust of the health care system rooted in historical inequities.
"I think the longer it takes before they bring it back online, it's going to be harder — it's going to be more suspect," said Whitney-West, whose clinic treats many patients who are Black, Indigenous and people of color. "People are going to feel like 'OK, what are you not telling us? Why did it take this long? Is there more to the story?' "
That issue is key for the ACIP. Lynn Bahta, a voting member of the committee and immunization specialist at the Minnesota Department of Health, said during the group's meeting last week that "the confidence for COVID vaccines is just right at a precipice — we've got people that can't wait to get it, and others who have been waiting and seeing."
Yet Bahta believes "uptake" will return close to previous levels, so long as patients are reassured by the committee's deep review of the issue and new troubling data doesn't emerge.
"We wouldn't allow this vaccine to continue to be given if we didn't believe it was safe to be given," she said in an interview. "I think people will need to hear that, and I think that we will see a return to pretty good use of the vaccine."
Christopher Snowbeck • 612-673-4744