The FDA and U.S. Centers for Disease Control and Prevention (CDC) jointly issued a statement to recommend a temporary pause in the use of
J&J’s ( JNJ Quick Quote JNJ - Free Report) vaccine in the United States as they review reports of “rare and severe” blood clots in a few individuals who had taken the J&J one-shot COVID-19 vaccine.
FDA/CDC said that six cases of rare and severe blood clots, called cerebral venous sinus thrombosis, accompanied by low levels of blood platelets (thrombocytopenia) have been identified. All the cases occurred in women between 18-48 years of age. Symptoms emerged 6 to 13 days after the shot was given.
While CDC will conduct a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday, the FDA is also reviewing these cases. Until the review process is complete, the pause has been recommended as a measure of caution, the statement said
It is important to note that such blood clot issues are “extremely rare” as six cases have been reported out of 6.8 million Americans who have received the J&J single-shot jab.
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.
J&J’s shares were down 1.3% on Apr 13 after the FDA/CDC’s joint statement was issued. This year so far, J&J’s shares have risen 1.3% against a decrease of 0.3% for the
Earlier this week, The European Medicines Agency (“EMA”) safety committee, Pharmacovigilance Risk Assessment Committee (“PRAC”) began a review to assess reports of blood clots in some people who had taken the J&J 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. 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 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 ( AZN Quick Quote AZN - Free Report) 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. Some countries have restricted use of AstraZeneca’s in younger people.
Please note that J&J and AstraZeneca’s vaccines have been developed using adenovirus technologies while the other two vaccines, which have been launched,
Pfizer ( PFE Quick Quote PFE - Free Report) -BioNTech’s BNT162b2 and Moderna’s ( MRNA Quick Quote MRNA - Free Report) mRNA-1273 vaccines are mRNA-based vaccines.
Shares of BioNTech and Moderna were up 6.7% and 7.4%, respectively on Tuesday after the FDA/CDC recommendation for pausing use of J&J’s vaccine. 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. No clot cases have been reported in people who have received either the Pfizer or Moderna vaccine.
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