Vaccine providers across Juneau and the United States immediately halted distribution of the Johnson & Johnson vaccine Tuesday after the Center for Disease Control and Prevention recommended a pause, following six cases of blood clots developing following vaccination.
The risk is low, say Alaska state health experts, but all adverse reactions deserve thorough handling.
“I really want to underscore that these adverse events appear to be very rare. COVID vaccine safety is a top priority for all of us and we take all reports of adverse reactions seriously,” said Dr. Joe McLaughlin, state epidemiologist, in a news conference. “For people who got the vaccine more than a month ago, the risk is very low at this time.”
Six cases of the clots had occurred out of the 6.8 million doses of the J&J vaccine administered, all in women between 18 to 48. Symptoms began appearing 6-13 days after being vaccinated, according to the CDC. One of those patients has died, according to the Food and Drug Administration, and the others are under investigation.
“People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider,” said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, in a news release. “Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.”
All six of the known cases have occurred in the Lower 48, McLaughlin said. He emphasized that the effects had only appeared with the J&J vaccine, not the Moderna or Pfizer vaccines.
Cause for rational caution
“It doesn’t hurt to step back for a day and make sure we’re heading in the right direction,” said Scott Watts, owner and pharmacist at Ron’s Apothecary Shoppe. “Any time you get a group of that many people, the chances of side effects are out there. We don’t want to be that millionth person. We want to be safe and cautious.”
Watts said his entire stock of vaccines right now is the J&J variety. Ron’s will work with the state to get alternate vaccines to administer.
“Today, we had a clinic of 40 doses. We canceled that,” Watt said. “At this point it’s day by day. I don’t know how far out to cancel clinics. Like a lot of providers, we’re just monitoring the situation.”
A clinic scheduled with a local business on Friday, originally slated for the J&J vaccine, has switched over to the Moderna vaccine, said CBJ Emergency Operations Center planning section chief Robert Barr. Locally, the number of J&J vaccines administered is in the low hundreds, Barr said, with the majority of those at Bartlett Regional Hospital. A number of J&J vaccines were also distributed at a Department of Veterans Affairs clinic.
“We got fifty doses in March. They arrived March 22. We were giving about five doses a day in March. We gave all of those out pretty quickly,” said BRH infectious disease preventionist Charlee Gribbon in a phone interview.
BRH received about another 100 doses in April, Gribbon said, and have administered about half of those, mainly to patients in the hospital already. Many people like the idea of a one-and-done shot that doesn’t require a follow-up, Gribbon said.
“We’ve reached out to all of the providers to make sure they have other vaccines for their clinics,” said Kelsey Pistotnik, member of the Department of Health and Social Services’ Alaska Immunization Program, during the news conference. “We’re making sure they have stock.”
The situation would be drastically different if these side effects had appeared in the Pfizer or Moderna vaccines, which have been the bulk of all vaccines distributed. Alaska has received 35,000 doses of the J&J vaccine and administered it to 11,178 Alaska residents as of Tuesday morning, said Tessa Walker Linderman, co-lead of Alaska’s Vaccine Task Force, during the news conference. As of Tuesday afternoon, 258,687 people in Alaska had received at least one dose of total doses of vaccine, according to state data.
The VA has also stopped administering the J&J vaccine, said VA public affairs specialist Katie Yearley in an email. Veterans scheduled for vaccination will have the option to receive the Moderna vaccine instead. The VA has administered 685 doses of the J&J vaccine, Yearley said.
“The impact of this is a lot different than if it was Pfizer or Moderna. We have a lot more Pfizer and Moderna in stock than J&J,” Pistotnik said. “We had some (J&J vaccine) at our depot at Anchorage that we were getting ready to put out the door this morning. Obviously, that’s halted.”
Likelihood of side effects
While the side effects are serious, it’s not uncommon to have rare side effects in the mass rollouts of medicine, especially when the rollout is as huge and high-profile as this, said Dr. Coleman Cutchins, an Alaska state pharmacist, during the news conference. Testing a vaccine on hundreds or even thousands of people will not turn up the same set of rare circumstances as a vaccine that’s applied to millions of people a month.
“We don’t think of rare adverse events, 1 in 100,000, 1 in a million, until they make it to market,” Cutchins said. “This is commonly done in the FDA process. I could name out probably 15 examples of this in the last decade. We’ve seen this happen and it’s a common way and it shows us the FDA process works.”
Cutchins also pointed out that the CDC has to weigh the public good, using the example of statins, the most common type of prescribed cholesterol-lowering drug. Statins lower the chance of having a first or second cardiovascular trauma event for 500 or 1,000 people of every 10,000 people respectively who take them. But they also increase the risk of certain rare and serious conditions, such as increasing odds of a stroke in 10 of those 10,000, Cutchins said.
“Blood clots are scary. They can stop you from breathing. They can cause seizures or strokes. But COVID is scary, too. The threat of COVID is much greater than the threat of a blood clot,” Gribbon said. “With new medication and new vaccines or a new formulation of an old vaccine, we are all part of this together in a major real world study of millions of people getting the COVID vaccine. We’re going to see those side effects because it’s millions of people getting a dose rather than thousand.”
The clotting issue appears to be similar to issues being experienced in Europe with the AstraZeneca vaccine, Cutchins said, which underwent a similar hold in a number of countries. The issue with the vaccine may be related to a rare and abnormal immune response that also appears in those treated with Heparin, a blood thinner.
“They did a similar thing with the AstraZeneca vaccine. They paused, they evaluated. Some of them have started giving AstraZeneca again,” Cutchins said. “It’s difficult to say what will happen here. Our FDA process is a little more stringent.”
Johnson & Johnson said in a news release it was aware of the blood clots and the investigation and recommended anyone with the symptoms outlined to contact their healthcare provider. The pharmaceutical company also said they were halting their rollout of the vaccine in Europe for the time being.
• Contact reporter Michael S. Lockett at (757) 621-1197 or firstname.lastname@example.org.