“An abundance of caution.” That’s the phrase state and federal officials have repeatedly used to describe the reasoning behind the temporary suspension of Johnson & Johnson Covid-19 vaccinations.
Vermont paused Johnson & Johnson vaccine clinics within hours of a recommendation by federal health agencies Tuesday morning.
Six people out of the roughly 6.8 million recipients of the vaccine experienced a rare blood clotting issue after their shots, according to a joint statement by officials from the Food and Drug Administration and the Centers for Disease Control and Prevention.
The agencies are now investigating a potential link between the vaccine and the clotting issue, the statement said.
The delay has raised questions for Vermonters who have recently received the J&J vaccine, have scheduled future J&J appointments or are generally concerned about vaccine side effects. VTDigger compiled responses to frequently asked questions about the J&J suspension based on information from Tuesday’s state press conference, global news reports and emails with medical experts. This information is subject to change.
I have a J&J appointment scheduled. What should I do?
If that appointment is between now and Friday, plan on rescheduling.
If you registered through the Health Department, the state will reach out to you, said Mike Smith, secretary of the Agency of Human Services. You will be invited to reschedule an appointment for a Pfizer or Moderna dose — or, you may reschedule an appointment for a Johnson & Johnson dose at a later date, “if and when the precaution is lifted.”
If you registered through CVS or Walgreens, expect to hear directly from the pharmacy. Both chains confirmed they are also suspending J&J vaccinations but will reschedule for Pfizer or Moderna doses as supply allows.
As of Tuesday afternoon, the state had suspended J&J vaccine clinics only through Friday. Gov. Phil Scott said the administration was waiting for further guidance from federal agencies, which is expected later this week.
I’ve already received the J&J vaccine. Should I be concerned?
There have been no reported cases of blood clots after vaccinations in Vermont, Health Commissioner Mark Levine said Tuesday, calling the issue “rare and unusual.”
Levine said people experiencing the syndrome reported by the CDC would have extreme symptoms, including a severe headache or abdominal pain, within about two weeks after receiving the J&J vaccine. (The CDC said the six patients in question, all women between the ages of 18 and 48, experienced symptoms between six and 13 days after their shots.)
Those experiencing mild symptoms — such as headache, fever or chills — in the days after receiving the shot are likely experiencing the normal side effects of any vaccine dose, Levine said. Those who received the J&J vaccine more than a month ago are also at minimal risk.
Why did the FDA and CDC make this decision? What will it take to restart J&J distribution?
In their joint statement, agency representatives said the blood clotting issue found in the six patients was rare but severe. The typical treatment for blood clots may be dangerous in these types of cases, they warned. Pausing use of the J&J vaccine will give the agencies time to prepare health providers to properly identify and treat similar cases.
The CDC’s Advisory Committee on Immunization Practices plans to hold an emergency meeting on Wednesday to review the known cases and make further recommendations.
Levine said the advisory committee will discuss whether the vaccine should not be used for certain populations, citing women of childbearing age or women who are on birth control pills as possible examples. However, no such determinations have yet been made.
Scott said Tuesday that, based on information from the federal government, the pause was likely to be “days, not weeks.”
What happens with the doses that have already been delivered to the vaccination sites?
No doses are being disposed of at this time, Gov. Phil Scott said Tuesday. The Johnson & Johnson vaccine, unlike the Pfizer and Moderna vaccines, can be stored under proper refrigerator conditions, so there is no danger of spoilage in the short term.
Didn’t this already happen with AstraZeneca? What did we learn from that situation?
Yes — several countries paused distribution of the Oxford/AstraZeneca vaccine after similar concerns with blood clotting. About 220 cases of severe clotting, 30 of them fatal, have been reported among 34 million recipients in Europe, according to Science. Some countries have restored access to the vaccine but limited it to older age groups.
Tim Lahey, an infectious disease physician at the University of Vermont Medical Center, said the AstraZeneca experience illustrated the balance between managing vaccine-related safety concerns and delaying access to a lifesaving vaccine.
“We know nearly all effective drugs have side effects of some sort, some of them rarely serious, and we need to approach vaccines similarly,” Lahey said. “If the benefits massively outweigh the risks, those risks are OK to take.”
If the J&J vaccine is allowed again, why should recipients be confident that all of its potential risks have been addressed?
Some small risk of side effects accompanies nearly every kind of effective medication, Lahey said, including the Johnson & Johnson and AstraZeneca vaccines. “But since overall they protect people from a life-threatening infection, I still think they are a public health miracle.”
Lahey said the pause recommended by the FDA and CDC indicates how seriously the federal government is taking any potential risks.
“Our scientists and regulators are being extremely, extremely careful about vaccine safety,” he said. “They are bending over backwards to get this right because they know it is critically important for the general public to trust the science behind these vaccines.”
The “exceedingly low” risk of a blood clotting issue from the J&J vaccine should be weighed against other common risky behaviors like driving or flying, said Mary Cushman, a hematologist at UVM. “Taking birth control pills might be more risky, which also causes clots.”
“The benefits of preventing Covid are likely to be much much greater,” Cushman said, adding that the virus itself also carries a risk of blood clotting.
Are the Pfizer and Moderna vaccines still considered safe?
Yes. The Pfizer and Moderna vaccines were developed using a different method from the J&J and AstraZeneca vaccines. Both use mRNA, a type of genetic material, to help the body fight the coronavirus.
“There is no sign of added clotting in recipients of the mRNA vaccines,” Lahey said.
Before gaining emergency use authorization from the FDA, clinical trials found the Pfizer and Moderna vaccines to be extremely effective at preventing illness and death with minimal side effects.
How could the J&J suspension affect Vermont’s drive for herd immunity?
Scott said Tuesday that the delay was not likely to slow the overall pace of vaccinations. While the state will not receive new Johnson & Johnson doses this week, the allocation of Pfizer and Moderna doses will increase slightly.
Asked whether the suspension could cause some people to lose trust in the vaccine, Levine said he hoped the transparency about the potential safety issues would instill confidence in the process for reporting and reviewing adverse reactions.
Levine added that the chances of a blood clot were far less than the chances that a person might contract Covid and potentially develop chronic, “long haul” symptoms. “Those are all statistics that are much more alarming than a one-in-a-million occurrence that we’ve learned about today,” he said.
How common is this type of ‘pause’ or recall?
There are precedents for vaccine recalls, said Beth Kirkpatrick, director of the UVM Vaccine Testing Center. In the late 1990s, a licensed rotavirus vaccine, which was thought to cause an intestinal problem in babies, was paused and eventually taken off the market. The move showed the importance of “phase four” trials, the practice of responding to vaccine effects after they move from controlled trials to real-world applications.
“It doesn’t happen very often, but the systems are in place that it can be picked up and grabbed and addressed as soon as possible,” Kirkpatrick said.
Lahey said the unusual circumstances of the Covid-19 pandemic make it difficult to draw comparisons to past recalls.
“Sure, before a viral pandemic killed nearly 3 million human beings, it was uncommon for a country to suspend distribution of a widely used medication,” Lahey said, “but it is also unprecedented for me to wear a mask to visit the grocery store, so all bets are off.”
Correction, Apr. 14: A previous version of this post misstated the storage temperature requirements for the J&J vaccine.
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