Federal authorities on Tuesday recommended that states stop using Johnson & Johnson’s Covid-19 vaccine while an investigation is conducted into six serious cases of clotting problems that were reported among women who received the vaccine, one of them fatal.
The clotting problem, which appears to be extraordinarily rare, is similar to the one reported after use of AstraZeneca’s Covid-19 vaccine, which has not been authorized for use in the United States to date. And it is similar to an event that occurred during Johnson & Johnson’s U.S.-based clinical trial, an event that led to a temporary pause in that trial.
The Centers for Disease Control and Prevention and the Food and Drug Administration jointly announced the recommendation, which falls short of an order not to use the vaccine. The statement said a special meeting of CDC’s Advisory Committee on Immunization Practices will be held Wednesday to review the data around the issue.
“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” the statement said. “This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.” Related:
In a statement, Johnson & Johnson said it is working closely with health authorities and medical experts to investigate the issue. It also announced it would delay the rollout of its vaccine in Europe.
The blood clots reported in the six cases are known as cerebral venous sinus thrombosis (CVST); in all cases, the clots were seen in combination with low levels of blood platelets, a condition known as thrombocytopenia. All occurred among women between the ages of 18 and 48, the statement from the CDC and FDA said, and symptoms occurred between six and 13 days after vaccination. In addition to the fatal case, one of the women is in critical condition.
As of Monday, more than 6.8 million doses of the Johnson and Johnson vaccine have been administered in this country. The vaccine is given as a single dose.
“You have a greater chance of being in a car accident on the way to getting this vaccine than you have of having a problem from this vaccine. But that’s not how people view risk,” said Paul Offit, a vaccine expert at Philadelphia Children’s Hospital.
Still, he suggested the clotting problem may spell the end of the use of Johnson & Johnson’s vaccine in the United States.
“In this country, you have two other vaccines, which are likely going to be produced in a quantity that enables everyone to be vaccinated,” he said. “So I think as we get more and more of the Moderna and Pfizer vaccine out there … I think it would not be surprising if … this vaccine would not come back onto the market.”
Offit was on the advisory panel that recommended the FDA authorize use of Johnson & Johnson’s vaccine.Newsletters
The statement from the CDC and FDA did not say what the background rate for such events is — the number of cases you would expect to see among people had not been vaccinated. That figure is needed to help authorities figure out whether an adverse event reported after vaccination might be linked to the vaccine or just a chance occurrence.
Johns Hopkins School of Medicine estimates CVST events occur at a rate of about five per million people per year.
The CDC and FDA said people who have received the Johnson & Johnson vaccine who develop certain symptoms within three weeks of receiving the vaccine should contact their health care provider. The symptoms were listed as severe headache, abdominal pain, leg pain, or shortness of breath.
The investigation into the Johnson & Johnson vaccine comes at a critical time for the Covid-19 vaccine rollout. Vaccine supplies that were scarce earlier in the year are starting to swell; rather than long lines, some jurisdictions are starting to report having unclaimed shots.
That had been expected. It has been known that behind the hordes desperate to be vaccinated was some significant portion of people who were worried about getting newly developed vaccines as well as some who will refuse vaccine under all circumstances. Persuading the former to get vaccinated in the face of a reports of a potential link between some of the Covid vaccines and a serious side effect will increase the challenge.
That said, vaccination with the AstraZeneca vaccine continues in many countries, though a number have placed limits on who can receive the vaccine — reserving its use for older adults, in whom these events have not been reported.
In Europe, where the AstraZeneca vaccine is being widely used, at least 222 suspected cases have been reported among 34 million people who have received the vaccine, according to a news report in the journal Science.