Washington state Tuesday paused the administration of single-dose Johnson & Johnson COVID-19 vaccines, following federal guidance after six of the 6.8 million people to receive the shot in the U.S. developed rare blood clots.
“This action is being taken out of extreme caution,” said Dr. Umair Shah, the state’s health secretary, adding that he expected the measure would be temporary.
The state and vaccine providers will continue to administer the two other vaccines approved for emergency use, Pfizer-BioNTech and Moderna, which require two doses for full protection.
Federal health agencies on Tuesday morning called for an immediate pause in administration of the vaccine after six women who had received it developed a rare condition involving blood clots and that is linked to low platelet counts. The women were between 18 and 48. One woman died.
“… These events appear to be extremely rare,” Food and Drug Administration Acting Commissioner Janet Woodcock said at a news conference. “We expect it to be a matter of days for this pause.”
The pause — just two days before Washington opens eligibility to everyone age 16 and over — comes at a critical time in Washington’s vaccination campaign.
Some 34% of Washingtonians have received at least one dose of vaccine, but concerning coronavirus variants are to blame for an increasing proportion of the state’s cases, and hospitalizations from COVID-19, the illness caused by the coronavirus, are on the rise.
State officials had hoped a major boost in vaccine supply promised by the Biden administration would arrive by “Vax Day” — as they’ve taken to calling April 15’s eligibility milestone — allowing them to hasten the pace of vaccination. But those prospects dimmed earlier this month because manufacturing problems with the Johnson & Johnson vaccine already had slowed new supply to a trickle.
“We don’t think this is going to have much of an impact,” Shah said.
It’s not yet clear the vaccines’ role in the clotting events.
“It may not be cause and effect. It may be a rare association,” said Dr. Scott Lindquist, state epidemiologist, during a news briefing.
Washington officials aren’t aware of any instances of blood clots associated with the Johnson & Johnson vaccines here, according to Gov. Jay Inslee’s office.
Federal regulators now will review reports of adverse events.
“We’re recommending a pause in the use of the J&J COVID-19 vaccine in order to prepare the health care system to recognize and treat patients appropriately and report severe events they may be seeing in people,” said Dr. Anne Schuchat, principal deputy director of the Centers for Disease Control and Prevention.
Shah said state leaders agreed to the pause even though early data suggests these complications are “one in a million” because they want to receive more information, allow for more people to come forward if they are experiencing recent symptoms and because the most common treatment for blood clots can be harmful for this rare condition.
“It’s cerebral venous sinus thrombosis — which means a clot in the brain. We don’t want to minimize that because the common treatment for clots, if we use it, heparin, can be devastating for the patient,” Lindquist said, referring to a blood thinner.
Schuchat said the pause will also allow for the CDC’s advisory committee of independent experts to review safety data on Wednesday and help determine next steps.
The AstraZeneca vaccine, which relies on the same basic platform for its vaccine but has not received emergency use authorization from the FDA, also has seen reports about blood clots.
Dr. Deborah Fuller, a microbiologist and vaccinologist with UW School of Medicine, said the discovery of rare risk events, such as the blood clots reported in young women vaccinated with doses of both Johnson & Johnson and AstraZeneca, is not unexpected.
New vaccines undergo trials involving tens of thousands of people, but when they are administered to millions, the very rare risks can emerge.
“It’s a numbers game and in a pandemic, when you are vaccinating millions, you’re going to see it quicker. That is the case with every medicine out there,” Fuller said.
“They [researchers] will figure this out and be able to determine who is at risk and label it, ‘If you are in this group, you should not take this medicine.’ “
Fuller said it’s interesting that Johnson & Johnson’s and AstraZeneca’s vaccines both use adenovirus-based vectors to deliver the virus code to cells, and that the answer to the clot issue could lie within that delivery platform.
“We are very, very lucky we have vaccine choices,” she said. “Over the next year we are going to see which are the safest and best vaccine choices for each demographic.”
State and federal officials are recommending that people given the Johnson & Johnson vaccine monitor their symptoms and contact their health care provider if they experience severe headache, abdominal pain, leg pain or shortness of breath within three weeks of receiving the shot.
“For those who have received the vaccine more than several weeks ago, or a month ago, the risk for complication … is very low,” Shah said.
As the state approaches “Vax Day,” officials said they don’t expect a significant impact on the state’s overall vaccination campaign.
“The vaccine is such a small proportion of our supply,” Shah said, adding that the state ultimately expects Johnson & Johnson “back in the mix.”
The health department said 160,000 doses of Johnson & Johnson vaccine have been administered in Washington so far, about half of what has been delivered to Washington state through state and federal allocations. About 650 facilities throughout Washington received doses, according to Michele Roberts, the acting assistant secretary of health in charge of the vaccination program.
According to the state’s April 8 update on vaccine distribution, the state was forecast to receive 12,900 doses of the Johnson & Johnson vaccine this week and 4,300 for each of the following two weeks. By comparison, the state was forecast to receive 386,810 doses of all vaccines this week.
Seattle Mayor Jenny Durkan said Tuesday that people who have scheduled appointments for the Johnson & Johnson vaccine with the city would instead be given the Pfizer vaccine.
Snohomish County suspended vaccinations at its downtown Everett mass-vaccination location at the Angel of the Winds Arena. The county’s mobile vaccination team was also using Johnson & Johnson and will, for now, be using Moderna.
People who were scheduled to receive one of the 2,500 doses of Johnson & Johnson could be rescheduled for a later date or moved to other mass-vaccination sites offering either Pfizer or Moderna, said Jason Biermann, Snohomish County’s emergency management director, during a regular press briefing Tuesday.
Public Health – Seattle & King County said it had about 1,500 Johnson & Johnson appointments scheduled this week at its Auburn mass-vaccination site and another 400 doses slated for use in mobile clinics run by the health department and its emergency medical services partners. The agency switched to Moderna for those appointments.
Health care providers who had been gearing up to vaccinate homeless people who live in encampments were grappling with the implications of the pause Tuesday.
The relative ease of storing Johnson & Johnson doses, and the fact that immunization only required one shot, made it easier to bring the vaccines to people in hard-to-reach places, such as people who are homeless and living outside or in their vehicles.
Seattle homeless health care nonprofit Hepatitis Education Project had planned to wait until more Johnson & Johnson doses were available to vaccinate people without shelter. Many of the people the organization serves don’t have a way to follow up with a health care provider for a second shot.
“I think we’re going to have to rethink that a lot,” said Hepatitis Education Project director of programs Sarah Deutsch, who worried the pause would deter people from seeking vaccine altogether. “The more times people are told they’ll need to come back, the less they’ll come in the first place.”
Several Washingtonians recently vaccinated with the Johnson & Johnson vaccine said they were not fazed by the news of the blood clots, but worried over implications for the broader community.
“I’m not concerned for my own health. Obviously, I’m going to educate myself about what the symptoms are for developing a blood clot and be aware of it,” said Lia Chiarelli, 45, who received a vaccine on Monday.
Chiarelli said she viewed contracting the coronavirus as a much greater risk to her health than this rarely reported potential side effect.
“I’m aware and very grateful to be aware. I’m also still feeling better about my own health today than I was yesterday before receiving the Johnson & Johnson,” Chiarelli said.
Carrie Krueger, 60, who got a Johnson & Johnson shot at a pharmacy last week, said she viewed the pause as an overreaction and worried it would slow down the pace of the vaccine rollout.
“Blood clots can be a side effect of birth control. This is something most women are aware of — still these medications are widely available and used,” Krueger said, adding that she was concerned the interruption would bolster fear and vaccine hesitancy.