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J&J's (JNJ) COVID-19 Jab Under EU Review for Rare Blood Clots

The European Medicines Agency (“EMA”) safety committee, Pharmacovigilance Risk Assessment Committee (“PRAC”) began a review to assess reports of blood clots in a few individuals who had taken the J&J JNJ one-shot COVID-19 vaccine. 

The EMA’s report stated that four cases of rare clots accompanied by low blood platelets have been identified after vaccination with J&J’s jab. One of the cases was fatal.

J&J’s single-shot COVID-19 vaccine is presently approved for emergency use in the United States and was granted Conditional Marketing Authorization (CMA) by the European Commission last month. However, the vaccine has not yet been rolled out in European countries. Though such blood clot reports raise safety issues, a causal link between J&J’s vaccine and these rare events has not been established.  PRAC is studying the cases and will give its decision of whether regulatory action is needed.

J&J’s shares were down 1% on Apr 9 after the blood clot reports emerged. This year so far, J&J’s shares have risen 2.4% against a decrease of 0.1% for the industry.

 

 

J&J is the second company whose COVID-19 vaccine is being investigated for rare blood clot events.

Last week, The UK’s Medicines and Healthcare products Regulatory Agency and EMAfound a “possible link” between AstraZeneca’s COVID-19 vaccine and extremely rare blood clot events. The World Health Organization also said that a “causal relationship” between the vaccine and blood clot risk factors events is probable. However, all these regulatory bodies maintained that that the vaccine’s benefits outweigh the risks. The PRAC recommended to list the unusual blood clots with low blood platelets as a rare side effect of the vaccine. The PRAC has also started a review to assess five reported cases of a rare disorder called capillary leak syndrome in people who were inoculated with the AstraZeneca jab. However, the PRAC states it was not clear whether these events were linked to the vaccine.

Meanwhile, U.K’s Joint Committee on Vaccination and Immunisation recommended that individuals below 30 years of age should opt for an alternative vaccine available in the country.

Some countries have restricted use of AstraZeneca’s in younger people after the review results were published.

Please note that J&J and AstraZeneca’s vaccines have been developed using adenovirus technologieswhile the other two vaccines, which have been launched, Pfizer PFE-BioNTech’s BNTX BNT162b2 and Moderna’s MRNA mRNA-1273 vaccines are mRNA-based vaccines. Some investors are of the opinion that Moderna and Pfizer/BioNTech may benefit from safety issues related with J&J and AstraZeneca’s COVID-19 vaccines.

J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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