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EMA panel starts review of J&J’s single-shot vaccine for blood clots

The European Medicines Agency’s vaccine safety panel has started its review reports of cases of blood clots being formed among people who received the Johnson & Johnson’s single dose covid-19 vaccine.

Four serious cases of unusual blood clots with low blood platelets have been reported post-vaccination with the covid-19 vaccine, an issue that was similar to those seen in vaccinees who were given the AstraZeneca’s covid-19 vaccine. Of the four cases, one occurred in a clinical trial while the remaining three occurred during the vaccine rollout in the US. One of the four was fatal.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has started the review of the two cases even though vaccinations with the single-shot vaccine has not yet started in any European Union member state.

“These reports point to a ‘safety signal’, but it is currently not clear whether there is a causal association between vaccination with COVID-19 Vaccine Janssen and these conditions. PRAC is investigating these cases and will decide whether regulatory action may be necessary, which usually consists of an update to the product information,” the EMA said in a statement on Friday.

To be sure, a side effect that occurs after vaccination is not necessarily caused by the vaccine, and sometimes could be triggered by underlying causes for the vaccinees themselves.

The PRAC’s review comes two days after European and UK regulators spoke of a possible link between the AstraZeneca vaccine and some rare occurrences of blood clots, adding that it should be listed as a “very rare” side effect of the jabs.

The EMA’s safety committee carried out an in-depth review of 62 cases of cerebral venous sinus thrombosis—blood clot in the brain—and 24 cases of splanchnic vein thrombosis—blood clot in the abdomen—reported in the European Union drug safety database as of 22 March. Of these cases, 18 were fatal. The cases were reported from the European Economic Area and the UK. Most of the cases reported have occurred in women under 60 years of age within two weeks of vaccination.

The PRAC’s review is also significant as a spokesperson for Johnson & Johnson today said that the company planning to soon start a bridging study in India for its single-dose covid-19 vaccine and is in discussion with the Indian government for it.

A bridging study involves conducting human trials to determine the safety and immune response of the vaccine among the local population and is necessary because vaccines often differ in safety and effectiveness among varying demographics.

The Indian regulator has also stressed on the importance of such studies and had refused to give a waiver to Pfizer when it sought an import license for its messenger RNA vaccine in India.

In India, J&J is in a pact with Hyderabad-based Biological E to manufacture around 1 billion doses of the single-dose vaccine.

However, Mint could not ascertain whether J&J will be applying for the trial in India through Biological E or will be doing the trial alone. Spokesperson for both J&J and Biological E declined to comment on the matter.

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