The PRAC recommendation enables J&J to resume the supply of its Covid-19 vaccine in the European Union (EU), Norway and Iceland
J&J resumes Covid-19 vaccine roll out in Europe. (Credit: Myriams-Fotos from Pixabay.)
The European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) has updated the guidelines for use of Johnson & Johnson (J&J)’s Covid-19 vaccine.
The PRAC review follows a very rare adverse event involving blood clots in combination with low platelet counts, which resulted in a temporary halt in the use of the vaccine.
The review committee confirmed that the J&J Covid-19 vaccine showed a positive overall benefit-risk profile.
With the PRAC recommendation, J&J will resume the supply of its Covid-19 vaccine in the European Union (EU), Norway and Iceland.
Johnson & Johnson chief scientific officer and executive committee vice-chairman Paul Stoffels said: “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.”
The company will update the Summary of Product Characteristics and Package Leaflet of its vaccine to include information about diagnosis and management of the rare adverse event.
With the updated label, healthcare professionals will be alerted to the signs and symptoms of thromboembolism with thrombocytopenia, along with a proper course of treatment.
Developed by J&J’s pharmaceuticals business unit Janssen, the vaccine offered superior protection against Covid-19 related hospitalisation and death.
Janssen Covid-19 vaccine received the European Commission (EC) Conditional Marketing Authorisation last month, for use in people aged 18 years and above.
The EC authorisation was based on data from the Phase 3 ENSEMBLE study, which showed that the vaccine was 85% effective in preventing severe Covid-19.
Furthermore, the US Centres for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) are currently reviewing the rare adverse reaction cases.
Stoffels added: “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.”