Eu Agency Links J&J Shot To Rare Clots, Says Odds Favour Use

LONDON: The European Union's drug regulatory agency said Tuesday that it found a

possible link between Johnson & Johnson's COVID-19 vaccine and extremely rare blood clots and that a warning should be added to the label.

But experts at the agency reiterated that the vaccine's benefits outweigh the risks.

The European Medicines Agency made those determinations after a very small number of blood clot cases in people who had gotten the vaccine were reported in the United States.

The agency said a warning about the blood clots should be added to labels for the Johnson & Johnson's vaccine and that these rare blood disorders should be considered very rare side effects of the vaccine.

The EMA also recommended a label change for the AstraZeneca COVID-19 vaccine after finding a link between it and rare blood clots.

In both cases, the agency said the benefits of being immunized against COVID-19 still outweighed the very small risks of recipients developing the unusual clots.

Last week, Johnson & Johnson halted its European roll-out of the vaccine after US officials recommended a pause in the vaccine, when they detected six very rare blood clot cases among nearly 7 million people who had been vaccinated.

European officials said they considered all currently available evidence from the U.S., which consisted of eight reports of serious cases of rare blood clots associated with low blood platelets, including one death.

All of the cases occurred in people under age 60, but the EMA said that it hadn't been able to identify any specific risk factors.

Last week, J&J halted its European rollout of its one-dose vaccine after the US Food and Drug Administration recommended officials pause its use while the rare blood clot cases are examined.

Officials identified six cases of the highly unusual blood clots among nearly 7 million people who were immunized with the shot in the US.

Johnson & Johnson advised European governments to store their doses until the EU drug regulator issued guidance on their use; widespread use of the shot in Europe has not yet started.

The delay was a further blow to vaccination efforts in the European Union, which have been plagued by supply shortages, logistical problems and concerns over unusual blood clots also in a small number of people who received the AstraZeneca COVID-19 vaccine.

Experts worry the temporary halt on J&J's shot could further shake vaccine confidence and complicate worldwide COVID-19 immunization efforts.

Last week, South Africa suspended its use of the vaccine in the wake of the US pause, and countries including Italy, Romania, the Netherlands, Denmark and Croatia put their J&J doses into storage.

The blood clots linked to the J&J vaccine are occurring in unusual parts of the body, such as veins that drain blood from the brain.

Those patients also have abnormally low levels of blood platelets, a condition normally linked to bleeding, not clotting.

In its statement, the EMA said the cases it reviewed of unusual blood clots in people who received the J&J shot were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca.