4 Things to Know About the J&J Covid Vaccine Pause

By Phil Galewitz APRIL 14, 2021

Four months into the largest U.S. vaccine rollout in decades, it’s become clear that the messaging surrounding covid-19 vaccination efforts is as important as the science behind them.

That was true when the first covid vaccines were introduced in December at hospitals and nursing homes and even more so after the federal government on Tuesday paused the Johnson & Johnson vaccine after reports of extremely rare but very serious — in one case, fatal — side effects emerged.

Most health experts largely applauded the government for its decision, saying it showed regulators making vaccine safety their top priority. They said regulators need to strike a balance between addressing small but serious risks while encouraging millions to get inoculated to quickly end the pandemic.

“The pause is a good decision and shows the public health system is working,” said Noel Brewer, a professor in the health behavior department at the University of North Carolina-Chapel Hill.

1. What exactly happened with the J&J single shot anyway?

The Centers for Disease Control and Prevention and the Food and Drug Administration recommended Tuesday that health providers and states temporarily stop the use of J&J’s covid vaccine after reports emerged that six women in the U.S. who got the single-shot preventive developed a rare but serious blood clot. One of the women died and another is in critical condition.

All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination, FDA and CDC officials said.

It’s the latest in a series of messaging challenges.

This pause comes less than a week after three vaccine clinics in Georgia, North Carolina and Colorado temporarily stopped using the vaccine when several people fainted or became dizzy immediately following their shots. Fainting is a known risk from all vaccines, affecting about 1 in 1,000 people, health experts say. In response to these cases, some health experts questioned whether even the short-term halt was necessary.

In addition, federal regulators are concerned that the blood clotting seen with the J&J vaccine is the same type as seen globally with AstraZeneca’s vaccine. The AstraZeneca vaccine isn’t in use in the United States but has been authorized in more than 70 countries. The European Medicines Agency recently concluded that unusual blood clots with low blood platelets should be listed as “very rare side effects” on the AstraZeneca vaccine label. While advising the public to look out for signs of clots, the European regulators said the benefits of the shot were still worth the risk.

It also comes on the heels of questions faced by J&J regarding its rollout after a Baltimore subcontractor who was making its vaccine accidentally spoiled 15 million doses earlier in April. The problems at the facility were contributing to a drop in J&J doses this month.

2. But what does all this mean in terms of my risk?

More than 560,000 Americans have died of covid in the past year — or 1 in 586 people. An individual’s risk of dying of or being hospitalized with covid is far higher than the risk of getting a rare blood clot from the J&J vaccine.

Meanwhile, the risk of getting a blood clot is also far higher if you have covid.

To put the less-than-1-in-a-million risk of getting a severe blood clot from the J&J vaccine in perspective, people face a 1-in-500,000 chance each year of being struck by lightning.

“It’s important to keep these numbers in context,” Jonathan Watanabe, a pharmacist and an associate dean in the College of Health and Sciences at the University of California-Irvine, said of the rare blood clots. “While frightening, it’s a rare event.” The risk of blood clots associated with covid infection is actually greater, he added.

The pause, which FDA officials said they expect will be a few days, will give regulators time to alert doctors to the added risk and show them how to recognize and treat the clots and make reports to the government.

The CDC will convene a meeting of the Advisory Committee on Immunization Practices today to further review these cases and assess their potential significance. The committee could recommend adding the blood clot risk to the list of warnings about the vaccine or could recommend that certain populations avoid the vaccine.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Leave a Comment

%d bloggers like this: