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.
"The safety and well-being of the people who use our products is our number one priority. We appreciate the rigorous review of the PRAC and share the goal of raising awareness of the signs and symptoms of this very rare event to ensure the correct diagnosis and appropriate treatment," said Paul Stoffels, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson.
"We strongly believe in the positive benefits of our single-shot, easily transportable COVID-19 vaccine to help protect the health of people everywhere and reach communities in need globally. We are committed to equitable access and to bringing an affordable COVID-19 vaccine to the public on a not-for-profit basis for emergency pandemic use,” he added.
In the US, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) are currently reviewing the same blood clot cases.
Following an initial meeting of the CDC’s Advisory Committee on Immunisation Practices (ACIP), another meeting has been scheduled for 23 April for further discussion of the blood clot cases.