J&J COVID-19 vaccine pause: How the company and government should have communicated about it

Pulling the vaccine may unnecessarily make it the choice of last resort if it’s reintroduced back into the market, says a former FDA communications pro.

J&J COVID-19 vaccine pause: How the company and government should have communicated about it

Pausing Johnson & Johnson’s COVID-19 injections may spur vaccination hesitancy, according to a former supervisor for the U.S. Food and Drug Administration’s office of public affairs.

On Tuesday, the Centers for Disease Control and Prevention and the FDA issued a statement calling for a pause on the use of the vaccine due to blood clotting in six people after receiving the jab, including one who died. The hold is expected to last seven to 10 days, according to The New York Times.

The FDA and Centers for Disease Control and Prevention’s communications were to let people understand why a pause was being placed on the J&J vaccine, said Peter Pitts, a former FDA associate commissioner and current cofounder of the Center for Medicine in the Public Interest.

Although the messaging was clear, he noted it had an unintended consequence of conveying that the vaccine was a bad product.

To announce the pause, J&J released a statement, repeating the CDC and FDA warning. It advised people who developed severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the vaccine to contact their health care providers.

The FDA and CDC posted the news on Twitter. They held a joint media call that was also live-streamed on YouTube, the morning that the pause went into effect. Janet Woodcock, the acting FDA commissioner, moderated the talk with Peter Marks, director of the FDA Center for Biologics Evaluation and Research, and Anne Schuchat, the CDC’s principal deputy director.

The CDC’s independent advisory committee on immunization practices met on Wednesday to review data to make recommendations regarding the vaccine. On Tuesday’s call, the speakers explained that the pause will allow careful deliberation to consider the next steps, weighing risks and benefits, given the context of the pandemic.

The government physicians emphasized that the actions were taken in an “abundance of caution” and that the adverse events were “extremely rare.”

The duration of the pause will depend upon the review of the scientific information but is expected it to be a matter of days.

Marks noted that with the over 180 million injections of the Pfizer and Moderna vaccines, there have been no reports of similar blood clotting problems. Bloomberg pointed out that these two companies have handled the vast majority of the U.S. vaccinations, amounting to 95% of the shots this week.

Pitts stressed that 6.8 million people in the U.S. have received the J&J vaccination, with six adverse events, including one death. Looking at these statistics, he assessed that having the vaccine available far outweighs the risks--acknowledging every vaccine or medical product entails some risk. 

“I think a pause for the entire American population was probably not the right decision,” said Pitts. “Taking the vaccination out of circulation has the potential to make the J&J vaccine the vaccine of last resort.”

Right now, the governmental priority is getting Americans vaccinated. 

As an alternative, Pitts suggested they could have continued the J&J vaccinations but limited the patient pool or recommended that women in a specified age group opt for another vaccine. 

J&J’s communications department and CCO Michael Sneed declined to comment to PRWeek, beyond the company statement.

Pitts observed although there was a correlation, scientists have not determined that the J&J vaccine caused the blood clots. But he nonetheless commented, “Eating crow is never tasty. So, sometimes it’s better not to order it.” 

As for J&J, Pitts suggested that the company should have posted a statement that said: “We’re working with the FDA. We believe our product remains safe and effective and is an important tool in the fight against COVID-19. Full stop.”

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