J&J Vaccine Rollout To Resume In Europe, With Warning Label

Welcome

BUFFALO, WV - MARCH 26: A Premise Health healthcare worker loads a syringe with the Covid-19 Johnson & Johnson Janssen vaccine. (Photo by Stephen Zenner/Getty Images)

Johnson & Johnson’s COVID-19 vaccine is back in play — in Europe, at least.

The company announced it will resume shipping its vaccine overseas after European Union health officials gave the OK to do so, provided that J&J add a warning label indicating potential risk of rare blood clots. We’re still waiting for a decision on when the single-dose vaccine will be available again in the U.S., but White House chief medical advisor Dr. Anthony Fauci said he expects a decision on that could come as soon as Friday.

Fauci added that he expects U.S. regulators to require some kind of warning label for the J&J vaccine that mentions the possible connection to the blood clots.

The endorsement from the EU clears a major hurdle for the company not just to make its single-dose vaccine available in Europe, but also to combat public perception over concerns about possible side effects. Distribution of J&J’s vaccine was paused in the U.S., after six cases showed signs of a rare blood clot in six women. Six-point-eight million people had received the J&J vaccine up to that point, leading some medical experts to say the decision to halt distribution of the vaccine was an overreaction.

Dr. Paul A. Offit, a vaccine expert at Children’s Hospital of Philadelphia, said the decision to pull J&J from the vaccine rotation that includes Pfizer and Moderna’s doses, only added fuel to the fire of vaccine hesitancy that threatens to impede the U.S. vaccination program.

“You’ve put a scarlet letter on the Johnson & Johnson vaccine.”

Dr. Paul offit

Dr. Offit also suggested that tarnishing the J&J vaccine in the public eye could undermine efforts to get the shot in the arms of people who are on the fence about vaccination. Johnson & Johnson’s dose is easier to store and because it’s a single shot, requires less time commitment.

“There is no doubt in my mind that there are groups for whom this vaccine is of benefit,” Dr. Offit told the New York Times, “meaning that they’re more likely to get this vaccine than the other vaccines, whether it’s because of where they live, or because they’re homebound, or it’s hard to get a second dose.”