Federal regulators recommended the pause out of an abundance of caution after learning that six women developed “rare and severe” blood clots after receiving the vaccine, according to a joint statement by the FDA and the Centers for Disease Control and Prevention.
It’s unclear whether the Johnson & Johnson vaccine is connected to the blood clots, and acting state Health Secretary Alison Beam said that a federal panel will meet Wednesday to discuss their next steps for reviewing the cases.
But Beam emphasized that the reported incidents have affected fewer than one in one million Johnson & Johnson vaccine recipients. To date, 6.8 million people across the country – including 262,739 in Pennsylvania – have received the one-dose vaccine.
Beam told reporters during a Tuesday briefing that the announcement should not deter Pennsylvanians from seeking COVID-19 vaccines, which have proven in clinical trials to be safe and effective.
“We have said these vaccines would be the most scrutinized in history, and this [pause] reflects that,” Beam said.
Pennsylvania’s announcement came the same day that the state opened vaccine eligibility to all adults over the age of 16. Anyone who has an appointment with a health care provider to receive the Johnson & Johnson vaccine should ask those providers whether they can receive a COVID-19 vaccine made by Pfizer or Moderna instead, Beam said.
She also said that anyone who has received the Johnson & Johnson vaccine in the last three weeks should contact their doctor if they develop a severe headache, abdominal pain, leg pain or shortness of breath.
The FDA authorized the Johnson & Johnson vaccine for emergency use in February. Health officials said it would fill a critical gap in their vaccination arsenal, since it required only one dose and had less stringent storage requirements than the other approved vaccines.
Pennsylvania set aside its first 200,000 Johnson & Johnson shots for educators and child care workers. In March, it completed a statewide mission to vaccinate those workers so children could return to school and daycare.
Beam said that Johnson & Johnson shots were then made available to firefighters, grocers and food safety workers. The state also distributed the Johnson & Johnson doses to regional vaccine authorities, who stocked it at mass vaccination clinics or distributed it to healthcare providers along with Moderna and Pfizer shots.
A Centre County mass vaccination clinic that administered Johnson & Johnson doses said it would suspend operations following the state’s announcement Tuesday. Another clinic in western Pennsylvania said it would offer different vaccinations instead.
Pharmacies at the central Pennsylvania grocery chain Giant were also offering the shot, and have begun canceling those appointments until further notice, a spokesperson said.
Krys Johnson, an epidemiologist at Temple University in Philadelphia, told the Capital-Star in an email that the move was “responsible,” comparing it to European nations pausing their use of the Astra-Zeneca vaccine, which has not yet been approved for emergency use in the United States.
For both COVID-19 vaccines, blood clots following the vaccine are rare, Johnson said, and far lower than the risk of the same for such activities as smoking or using oral contraceptives.
“It is likely that J&J will be back in use in a short period of time, likely with extra safety and screening measures in place to determine whether people are already more susceptible to blood clots based on other exposures,” she added.
As of Tuesday, almost 2.5 million Pennsylvanians are fully vaccinated, either by the Johnson & Johnson single dose or with two shots of the Pfizer or Moderna vaccines, according to the Pennsylvania Department of Health.
Another 4 million people are partially vaccinated and awaiting a final dose of the two-dose vaccines.
New daily case counts have been on the rise since mid March, according to state data. All told, more than 25,000 Pennsylvanians have died due to COVID-19 since the pandemic started in March 2020.
Stephen Caruso is a reporter with the Pennsylvania Capital-Star where this story first appeared.