Johnson & Johnson to resume Covid-19 vaccine roll-out in Europe after EMA review

Johnson & Johnson (J&J) will resume Covid-19 vaccine roll-out in Europe following the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed the overall benefit-risk profile being positive.

PRAC has provided updated guidance for use of J&J’s Covid-19 vaccine, which follows PRAC review of a few cases of a very rare adverse event giving rise to blood clots along with low platelet counts, which can occur within one to three weeks following the company’s Covid-19 vaccine jab.

Consequently, J&J will update its Covid-19 vaccine Summary of Product Characteristics and Package Leaflet to contain important information on the diagnosis and management of this rare and adverse event.

This will alert healthcare professionals to the signs and symptoms of thromboembolism with thrombocytopenia, while suggesting upon the right course of treatment.

Following recommendation by PRAC, J&J will resume shipment of the Janssen Covid-19 vaccine in the European Union (EU), Norway and Iceland.

The updated guidance for EMA and Healthcare Professionals will be accessible to national healthcare authorities.

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. 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.”

Global ENSEMBLE Phase 3 trial data showed that the Company’s single-dose vaccine gave enough protection against Covid-19 related hospitalisation and death across geographies and demographics, including those areas in the clutches of emerging variants.

Currently, the cases are being reviewed by the US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA).

The CDC convened a meeting of the Advisory Committee on Immunization Practices (ACIP) on 14 April 2021, to review these cases and assess their potential significance.

The ACIP plans to reconvene for further discussion on 23 April 2021.

Developed by the Janssen Pharmaceutical Companies of J&J, the J&J Covid-19 vaccine received Conditional Marketing Authorization from the European Commission on 11 March 2021.