J&J’s Covid Vaccine Remains Paused as CDC Advisers Seek Data

(Bloomberg) -- U.S. public health advisers concluded a meeting on Johnson & Johnson’s Covid-19 vaccine without a vote, effectively extending a pause on its use while they seek more data on a rare clotting side effect.

After scrutinizing evidence related to the blood clots during an hours-long emergency meeting Wednesday, advisers to the U.S. Centers for Disease Control and Prevention said they lacked adequate information to make recommendations on how to respond to reports of the rare blood clots. The CDC’s Advisory Committee on Immunization Practices didn’t give a precise date for when they’ll reconvene to reconsider the vaccine.

That leaves J&J’s shot in limbo. The delay isn’t expected to slow the U.S. vaccination campaign much, the Biden administration has said, with shots from Pfizer Inc. and Moderna Inc. flowing. Still, an extended pause could cast doubt about the shot that’s helping vaccinate rural communities and other hard-to-reach populations.

After six women who received the J&J vaccine developed a rare and severe form of blood clotting, the CDC and the Food and Drug Administration jointly recommended Tuesday to pause its use. Members of the panel, who are independent of the agency, carefully considered data from those cases alongside similar incidents tied to AstraZeneca Plc’s Covid-19 shot in Europe.

“I want to be able to feel comfortable with my family members and with myself for that matter to receive this vaccine,” said Beth Bell, a panelist and clinical professor of global health at the University of Washington.

They weighed concerns about J&J’s shot with risks from contracting Covid-19, which has killed 564,275 people in the U.S., according to the latest count from Johns Hopkins University. The stakes are high, with variants spreading in the U.S. -- especially in the Midwest -- and threatening to erase the gains the U.S. has made against the virus with vaccination.

Unusual Syndrome

J&J supports efforts to raise awareness of the rare side effect and will continue to collaborate with health officials on battling the pandemic, Chief Scientific Officer Paul Stoffels said late Wednesday in a statement.

“We continue to believe in the positive benefit-risk profile of our vaccine,” he said in the statement.

Six women between the ages of 18 and 48 who received the shot developed brain blood clots called cerebral venous sinus thrombosis. More than 6.8 million J&J shots have been administered in the U.S. At the meeting, a seventh case of an “adverse event” was mentioned that J&J is investigating -- the details of it were not discussed.

Lynn Bahta, a panelist and an official with the Minnesota Department of Health, said having more information would give officials more confidence in touting the safety of J&J’s vaccine.

“Right now the confidence for other vaccines is just right at a precipice,” she said. “We’ve got people that can’t wait to get it and others who have been waiting and seeing, and this I think contributes to that confidence people have.”

Yet Jeff Weitz, a professor at McMaster University in Canada and president of the International Society on Thrombosis and Haemostasis, said he’s not sure what the panel is waiting for.

“The most important thing worldwide is we vaccinate as many people as possible to put this pandemic behind us, and with variants taking over, caseloads are just ramping up like crazy. So we’ve got to get people vaccinated and these very rare, one-in-a-million events shouldn’t be stopping us from doing that,” Weitz said.

States Following

States and pharmacies signaled they would follow the pause advisory, halting the rollout of J&J’s vaccine in the U.S. six weeks after it began. ACIP’s decision could pave the way for resumption, with possible restrictions on certain populations, as some EU countries have done with AstraZeneca’s Covid vaccine that has also been associated with clotting.

The clotting syndrome is highly unusual in that it involves low levels of platelets, the blood component mainly responsible for coagulation, and has been seen only at low rates in vaccine recipients. One common treatment for clots, the blood-thinner heparin, could potentially worsen the condition and increase the risk of death, a worry federal health officials say played a key role in their decision to issue the advisory.

Cerebral venous thrombosis occurs in women at three times the rate as men, a CDC official said Wednesday. Patients tend to be younger, with a median age of 37. In the cases linked to the J&J shot, all six patients were female. The median age was 33. The U.S. is ramping up vaccination of younger people as seniors were prioritized earlier in the immunization campaign.

The cases in the U.S. with J&J’s shot mirror those observed in Europe with AstraZeneca’s. Both vaccines program a harmless cold virus, called an adenovirus, to make coronavirus proteins, thus preparing the immune system to battle future infections. AstraZeneca has not yet applied for U.S. clearance of its vaccine, which has been shown to be effective in clinical trials.

The two other Covid-19 vaccines being used in the U.S., from Moderna and partners Pfizer and BioNTech, use messenger RNA technology rather than an adenovirus vector. The mRNA is a piece of genetic material that instructs human cells to make coronavirus proteins, triggering an immune response.

Helen Keipp Talbot, a panelist and associate professor at Vanderbilt University, said the U.S. is fortunate to have two other vaccines at its disposal and should use these alternatives to take the time to carefully consider the clotting cases.

©2021 Bloomberg L.P.