J&J COVID-19 vaccine to resume Europe rollout
pharmafile | April 21, 2021 | News story | Research and Development | COVID-19, COVID-19 vaccine, J&J, J&J vaccine, JJ, pharma, pharma news
The Johnson & Johnson COVID-19 vaccine will continue its rollout in Europe, following a review from the EMA.
It was confirmed yesterday that the Pharmacovigilance Risk Assessment Committee (PRAC) has provided updated guidance for use of J&J’s vaccine, and confirmed the overall benefit-risk profile remains positive.
The advice comes after a review of a small number of cases of blood clots in combination with low platelet counts, that can occur within around one to three weeks following injection with the J&J jab.
J&J will now update their vaccine package leaflet to include information on diagnosis and management of the possible side effect – thromboembolism with thrombocytopenia – while healthcare professionals will be made aware of the symptoms and treatment as well.
The vaccine will continue to be used throughout Europe, with shipments to the EU, Norway and Iceland now set to resume.
In the US, the FDA and CDC are continuing to review the same cases of blood clots. It is expected that the CDC will convene a meeting of the Advisory Committee on Immunization Practices on Friday to discuss the matter further.
Dr Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at J&J, 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.”
Jack Goddard
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