Several U.S. states said they would halt the use of the Johnson & Johnson coronavirus vaccine while regulators investigate cases of rare but severe blood clots in recipients of the shot.
Officials in New York, Connecticut, Massachusetts, New Hampshire, Rhode Island, Maryland, Virginia, Missouri, Georgia, Michigan and Ohio said they would follow a recommendation by the Disease Control and Prevention and the Food and Drug Administration to temporarily pause Johnson & Johnson distribution after six reports of unusual clotting.
The CDC and FDA said in a joint statement the recommendation was made “out of an abundance of caution,” noting there have been nearly 7 million doses administered with mild or no side effects.
On a call with reporters following the announcement, Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research, said a provider and patient can make a determination to receive the Johnson & Johnson vaccine “on an individual basis.”
All of the blood clot cases occurred in women between the ages of 18 and 48, with symptoms occurring 6 to 13 days after vaccination.
The CDC is scheduled to hold an emergency meeting Wednesday to review the cases, and the FDA will review that analysis as part of its own investigation into the clots and low blood platelets.
The agencies said it is important for health care providers to be aware of the “unique treatment required with this type of blood clot,” which differs from the usual treatment for blood clots.
The concerns about the Johnson & Johnson vaccine in the U.S. echo those of AstraZeneca in Europe, where many countries have restricted shots to older people. The inconsistent and, at times, contradictory handling of the issue by regulators has been criticized for damaging already fragile confidence in the vaccines and many of the regulators restricting its use continue to emphasize the benefits outweigh the possible risks. The European Medicines Regulator also opened an investigation into the Johnson & Johnson vaccine this week, though it is under the name of the company’s European subsidiary, Janssen. The drug regulator has stressed that there is no clear causal link between vaccine and blood clots at present.
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It is unclear how the pause will impact the U.S. vaccination campaign under the Biden administration, which has made more substantial use of Covid-19 vaccines from Moderna and Pfizer.
Australia has said it would not be purchasing Johnson & Johnson’s vaccine due to similarities between it and the AstraZeneca shot. Both make use of the same virus vector.
Six. The agencies emphasized how “extremely rare” the adverse events appear to be, with six reported cases from nearly 7 million doses administered. European regulators emphasized similar rarity with the AstraZeneca vaccine, with one number putting a risk at one in 250,000.