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J&J vaccine pause was right move, but creates big challenge

Health officials at the Food and Drug Administration faced a no-win choice when confronted with information that a handful of women who had received the Johnson & Johnson coronavirus vaccine had developed rare and dangerous blood clots.

With only six such cases out of 7 million vaccines delivered, FDA officials could have opted to continue vaccinations while investigators dug deeper for evidence of causation between the vaccine and the blood-clot issue. Revealing the medical problems and suspending the vaccine, they had to know, would reduce public confidence in the inoculation program.

But failing to pause could have fueled the narrative that public health officials were willing to lie to the public about the safety of the vaccines and to coverup problems. And what if others, subsequently vaccinated, suffered illness or death due to blood clotting because the FDA failed to urge a pause?

In the end, federal health officials made the right choice, and really the only choice — they recommended a pause while the experts try to get a better handle on the situation. The FDA was joined by the Centers for Disease Control and Prevention in making the decision.

There will be fallout. Straddlers, who remained undecided about getting a coronavirus-prevention vaccine for fear it might cause health problems, will be unlikely to trust the J&J vaccine, even if health experts later give the OK and resume vaccinations. Some may be sufficiently spooked that they won’t get the Moderna or Pfizer vaccines either.

On social media, conspiracy theorists and anti-vaxxers will utilize the reports of blood clots to undermine public trust in the vaccination program. Yet the handling of the matter should do the opposite, it should bolster trust in the vaccination efforts. Public health officials are exercising extreme caution and putting safety first in pausing the entire program to better understand a few, isolated cases.

The six cases were found in women aged 18 to 44, including one fatal case. The problems occurred within two weeks of the women receiving the J&J vaccine. Adding to the mystery, the women had low levels of platelets, which help form clots. And they all had clotting in the brain, which can cause stroke or death.

On Wednesday, the Advisory Committee on Immunization Practices, a panel of experts who advise the CDC on vaccine policies and protocols, was meeting to try to better understand the issue. Outcomes could range from a conclusion that the clots and vaccine were unrelated, to recommendations that people of certain ages, gender or underlying medical conditions avoid the J&J vaccine, to an outright stoppage.

Most likely, the J&J vaccinations will resume in some fashion. If so, public health officials will face a major challenge in rebuilding trust in the vaccine’s efficacy. The vaccine’s big advantage is that it only has to be administered once, unlike the two-shot Moderna and Pfizer versions. The J&J vaccine has been used extensively to bring coronavirus protection to inner city and under-vaccinated minority groups, its one-shot nature eliminating the logistical challenge of assuring folks get follow-up shots. Yet these same populations have proved the most skeptical, due to past experience, about trusting those bearing promised cures. This news about the J&J vaccine will only feed such skepticism.

It would be a terrible irony if, in stopping to evaluate a few extremely rare cases, federal health officials end up increasing vaccine reluctance, leading to far more people being sickened and dying due to coronavirus than would ever have faced this blood-clotting issue.

Therein lies the challenge state and local public health officials will face, however this turns out. It will be up to them to make the case that the government’s prudent actions show the experts and the vaccines can be trusted, that nothing is being hidden, and that the virus poses the far greater threat. This argument also has the advantage of being true.

The Day editorial board meets regularly with political, business and community leaders and convenes weekly to formulate editorial viewpoints. It is composed of President and Publisher Tim Dwyer, Editorial Page Editor Paul Choiniere, Managing Editor Izaskun E. Larrañeta, staff writer Erica Moser and retired deputy managing editor Lisa McGinley. However, only the publisher and editorial page editor are responsible for developing the editorial opinions. The board operates independently from the Day newsroom.


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