US lifts pause on J&J’s Covid vaccine following safety review1 min read . Updated: 24 Apr 2021, 07:12 AM IST
- CDC and FDA said that the use of the Janssen COVID-19 Vaccine should be resumed in the United States.
U.S. health agencies lifted the pause on Johnson & Johnson’s Covid-19 vaccine on Friday. Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the US Food and Drug Administration and the US Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the US should be lifted and use of the vaccine should resume, the agencies said in a joint statement.
The two agencies said that the use of the Janssen COVID-19 Vaccine should be resumed in the United States. The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19. The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.
The pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine.
Health care providers administering the vaccine and vaccine recipients or caregivers should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers, which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine, they said.
Nearly 10 million doses of J&J’s vaccine are ready to be used across the U.S., according to CDC data, but just how quickly they will find their way into people’s arms is unclear.
Earlier this week, the European Union’s drug regulator suggested that the benefits of the J&J vaccine outweighed the risks. The European Medicines Agency said Tuesday that the clots should be listed as very rare side effects so that doctors and patients can look out for any danger signs.
Within hours, J&J resumed deliveries of the Covid-19 vaccine to the bloc. The EU deliberations, which moved more quickly than those in the U.S., set precedent for the Friday meeting of advisers to the CDC.
(With inputs from agencies)
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