Pause on J&J Covid Vaccine Signals U.S. Safety System Is Working

April 13, 2021, 7:13 PM

U.S. officials’ call to pause use of Johnson & Johnson’s Covid-19 vaccine is reasonable and a sign the government’s safety monitoring system is working, health professionals say.

The pandemic has given the general public a taste of the rigorous and cautious processes used to develop and test medications. It’s also shone a light on the sometimes messy aspects of science when it moves at a fast pace—things change quickly as more and more data is collected.

“While a pause may appear surprising, it is actually a sign that the surveillance process and monitoring of these events, which is routine for drugs and therapies, is working as it should,” Vineet Arora, a physician and researcher at the University of Chicago, said.

“It is critical that we not lose sight of the huge benefit of the vaccine,” she said.

The Food and Drug Administration and the Centers for Disease Control and Prevention announced Tuesday that health professionals should temporarily stop administering Covid-19 shots made by J&J. The recommendation follows six reported cases of blood clots in combination with low platelet levels that developed a week or two after getting that vaccine.

U.S. health officials say the pause is only expected to last a few days.

Almost 7 million Americans have gotten the J&J vaccine so far, making these six cases extremely rare. It’s not clear what caused the clots, but state leaders should pause J&J vaccine administration “out of an abundance of caution” while experts analyze the data, Janet Woodcock, acting commissioner for the FDA told reporters Tuesday.

The standard treatment for clots is the blood thinner heparin, but the rare combination of clots and low platelets makes that typical treatment hazardous, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said.

The pause is not only for researchers to examine the potential connection between the shot and blood clots, but also to inform health providers that they need to be on the lookout for this specific combination and treat it in a special way, he said.

See: One Dose and Variant-Tested: The J&J Covid-19 Shot Explained

Getting the Word Out

Almost immediately after the announcement, state leaders and doctors across the country sought to tamp down fears about Covid-19 vaccine safety. Similar sentiment poured out from doctors across Twitter, calling the short pause “pretty reasonable” and “appropriate to get more info.

Health officials say the agencies’ recommendation isn’t meant to insinuate the vaccine is unsafe, but that they’re merely being as cautious and transparent as possible.

“When we saw this pattern and were aware that treatment needed to be individualized for this condition it was of the utmost importance to us to get the word out,” Anne Schuchat, principal deputy director of the CDC, said. “That being said, the pandemic is quite severe and cases are increasing in a lot of places and vaccination is critical.”

This is not the first time health officials have been quick to stop administering new Covid-19 vaccines as they assess safety concerns.

Concerns have emerged in recent months over AstraZeneca’s shot and whether it causes a similar combination of blood clots and low platelet counts. European drug regulators and the World Health Organization said they believe there’s a possible link between the AstraZeneca vaccine and the clots, but that the benefit of getting the shot outweighed the risks.

In September 2020, AstraZeneca paused clinical trials for its coronavirus vaccine after someone participating in the study got sick. The trial resumed six weeks later and the vaccine was eventually approved in multiple countries.

J&J also paused trials in October 2020 because someone fell ill, but it resumed those trials over a week later.

“After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified,” the company said in a statement at the time. “Based on the information gathered to date and the input of independent experts, the Company has found no evidence that the vaccine candidate caused the event.”

Johnson & Johnson said in a Tuesday statement on the blood clots that it’s working closely with health authorities and strongly supports “the open communication of this information to healthcare professionals and the public.”

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Alexis Kramer at akramer@bloomberglaw.com

To read more articles log in.

Learn more about a Bloomberg Law subscription.