The North Carolina Department of Health and Human Services is telling all providers administering the Johnson & Johnson one-shot COVID-19 vaccine in North Carolina to pause.
In a briefing this afternoon, Health Secretary Dr. Mandy Cohen said it's a precaution and that the occurrences that have prompted concern are "literally one in a million."
Top takeaways from @ncdhhs about pausing the J&J vaccine:
— WUNC (@wunc) April 13, 2021
📌 If you received the J&J shot in last 3 weeks and within 3 days had a severe headache, leg pain, or difficultly breathing, consult your doctor.
📌 @SecMandyCohen confirmed this is our vaccine safety system working.
The state's decision comes after the Centers for Disease Control and Prevention and the Food and Drug Administration announced that they were investigating unusual clots in six women between the ages of 18 and 48 that may be linked to the Johnson & Johnson shot. One person has died.
The acting FDA commissioner expected the pause to last only a matter of days.
Impact In NC
Duke Hospitals and UNC Healthcare are among the providers that have paused their use of the Johnson & Johnson COVID-19 vaccine. Dr. David Wohl, an epidemiologist at UNC Health, says anyone who has an appointment to get the Johnson & Johnson vaccine at UNC Health should still show up.
"If you have a J&J appointment come anyhow, and we will give you either a Moderna or Pfizer vaccine, we don't want you to delay. People who are walking in today, we're explaining things to them, we are offering them a Pfizer or Moderna vaccine. It's gone really smoothly," said Wohl.
Officials with Novant Health said they're not aware of any safety issues impacting Novant patients who've received the Johnson & Johnson vaccine. Dr. Jerome Williams of Novant Health said this pause means the health care system will have to alter its distribution strategy.
"As long as we have an abundance of Pfizer and Moderna we're able to meet the needs of the community. However, it does change our strategy and tactics because Johnson & Johnson is a little bit easier to administer from the community standpoint," said Williams.
Other providers that have paused distribution of the Johnson & Johnson vaccine include the Durham County Public Health Department and UNC-Chapel Hill, which has suspended its student vaccine clinic.
Patients who had appointments to get the Johnson & Johnson vaccine today are instead being offered the Pfizer or Moderna vaccines, or an opportunity to reschedule.
Most North Carolinians who've been vaccinated to date have received the Pfizer or Moderna shots. State health officials say this pause affecting the least-used of the three vaccines shouldn't significantly slow the vaccination effort across the state.
Impact Across US
More than 6.8 million doses of the J&J vaccine have been given in the U.S., the vast majority with no or mild side effects.
The FDA said the cases under investigation appear similar to the clots that European authorities say are possibly linked to the AstraZeneca vaccine, which is not yet cleared in the U.S. European regulators have stressed that the AstraZeneca risk appears to be lower than the possibility of developing clots from birth control pills.
Federally run mass vaccination sites will pause the use of the J&J shot. Authorities stressed they have found no signals of clot problems with the most widely used COVID-19 vaccines in the U.S. — from Moderna and Pfizer.
“I’d like to stress these events appear to be extremely rare. However COVID-19 vaccine safety is a top priority,” acting FDA Commissioner Janet Woodcock said at a news conference.
Speaking at the White House, Dr. Anthony Fauci, the nation’s top expert on infectious disease, said the pause would allow the FDA and the CDC to investigate the clotting cases “to try and understand some of the mechanisms” and “to make physicians more aware of this.”
A CDC committee will meet Wednesday to discuss the cases, and the FDA has also launched an investigation into the cause of the clots.
FDA officials emphasized that Tuesday’s action was not a mandate. Doctors and patients could still use J&J’s vaccine if they decide its benefits outweigh its risks for individual cases, said Dr. Peter Marks of the FDA.
The agencies recommend that people who were given the J&J vaccine should contact their doctor if they experience severe headache, abdominal pain, leg pain, or shortness of breath within three weeks.
