J&J resumes roll-out of COVID-19 vaccine in EU
Johnson & Johnson (J&J) is planning to resume the roll-out of its COVID-19 vaccine in the EU following updated guidance from the European Medicines Agency’s (EMA) safety committee.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed a small number of cases of very rare blood clots in combination with low platelet counts in individuals who have received the J&J vaccine.
According to J&J, these very rare adverse events can occur within approximately one to three weeks following injection with its COVID-19 vaccine.
The PRAC has confirmed the overall benefit-risk profile of J&J’s COVID-19 vaccine, although J&J must update the product information for the jab to include information on the diagnosis and management of this type of rare adverse event.
J&J will now resume shipments of its COVID-19 vaccine in the European Union, Norway and Iceland, with updated EMA and Healthcare Professionals guidance to become available to national healthcare authorities.
Read more: http://www.pharmatimes.com/news/j_and_j_resumes_roll-out_of_covid-19_vaccine_in_eu_1367702
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed a small number of cases of very rare blood clots in combination with low platelet counts in individuals who have received the J&J vaccine.
According to J&J, these very rare adverse events can occur within approximately one to three weeks following injection with its COVID-19 vaccine.
The PRAC has confirmed the overall benefit-risk profile of J&J’s COVID-19 vaccine, although J&J must update the product information for the jab to include information on the diagnosis and management of this type of rare adverse event.
J&J will now resume shipments of its COVID-19 vaccine in the European Union, Norway and Iceland, with updated EMA and Healthcare Professionals guidance to become available to national healthcare authorities.
Read more: http://www.pharmatimes.com/news/j_and_j_resumes_roll-out_of_covid-19_vaccine_in_eu_1367702
