EMA Calls for Blood Clot Warning on J&J Vaccine Label, U.S. May Follow Suit

In a move that clears the way for EU member states to resume inoculations with the Johnson & Johnson (J&J) vaccine, the European Medicines Agency (EMA) concluded yesterday that the vaccine’s labeling should include a warning about the risk of blood clots and the company said vaccine deliveries in Europe will resume.

Expert advisers to the Centers for Disease Control and Prevention (CDC) are scheduled to meet Friday to discuss the issue and are likely to arrive at a similar recommendation, according to Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases.

The European Commission granted a conditional authorization to the single-dose J&J vaccine on March 11 and the EU was anticipating that the vaccination would help jump-start its sluggish vaccine rollout, but no vaccinations with the J&J shot have been given in Europe.

The EMA’s safety committee reviewed eight U.S. reports of blood clots — including one fatality — where nearly 8 million people have already received the shot. J&J vaccine deliveries are currently halted in the U.S., pending investigations by the FDA and the CDC (DID, April 19).

The EMA noted the cases have mainly occurred in women younger than 60 within three weeks of vaccination. The reviewers speculated that the blood clots combined with low blood platelets may be caused by an immune response sometimes found in patients receiving the blood thinner heparin.

Earlier this month, the EMA reached a similar conclusion over blood clots linked to the AstraZeneca vaccine and called for a warning label recommendation (DID, April 8), following its review of 62 cases associated with that shot.

The EMA panel concluded that the risks of hospitalization or death associated with COVID-19 infections far outweighs the very rare risks of blood clots from receiving the J&J vaccine.

In related findings from Oxford University last week, the authors concluded that the risk of rare blood clots in the brain are much higher for unvaccinated COVID-19 patients than for those who have been vaccinated.

J&J’s COVID-19 vaccine sales reportedly reached $100 million in the quarter just ended, but the U.S. and European pauses make future revenue projections uncertain. It is unclear whether the drugmaker can make good on its pledge to deliver 100 million doses to the U.S. before the end of next month provided the hold is lifted.

The N.J.-based drugmaker has delivered 17.6 million doses in the U.S. to date, according to CDC data. — Jason Scott