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Dansk

The vaccine from Janssen (Johnson & Johnson) may cause rare but severe side effects

Last night, the European Medicines Agency (EMA) published the review by the Pharmacovigilance Risk Assessment Committee's (PRAC) on the safety of the COVID-19 vaccine from Janssen (Johnson & Johnson). The Danish Health Authority will consider this review when deciding on using the vaccine in the Danish vaccination programme.

21 APR 2021

EMA's Pharmacovigilance Risk Assessment Committee's (PRAC) has now completed its preliminary review of incidences of unusual blood clots combined with low blood platelets following vaccination with the COVID-19 vaccine from Janssen. The EMA has concluded that there is a possible link between the occurrence of these severe cases of blood clots and the COVID-19 vaccine from Janssen and will update the product information to include a warning of these side effects.

"Following the manufacturer's recommendation, the Danish Health Authority decided to hold off on using the COVID-19 vaccine from Janssen while the safety of the vaccine was assessed. We take note of EMA's conclusion that there is a possible link between the vaccine and the rare but severe side effects," says Søren Brostrøm, Director General of the Danish Health Authority.

On 9 April 2021, the European Medicines Agency (EMA) announced that it would assess the safety of the COVID-19 vaccine from Janssen. The EMA came to this decision following reports from the United States of severe blood clotting events in people who had received the vaccine. On 12 April 2021, federal health protection agencies chose to pause the rollout of the Janssen vaccine in the United States as they investigate the safety of the vaccine. Soon after, Johnson & Johnson voluntarily recommended delaying the rollout of the COVID-19 vaccine from Janssen in Europe.

The Danish Health Authority will now assess the consequences of EMA's conclusion based on its preliminary studies. The manufacturer wishes to recommence its rollout of the vaccine, but the results of the investigations carried out by the US health protection authorities have not yet been made public.

"In the coming week, the Danish Health Authority will discuss EMA's assessment with the expert team that was formed when the COVID-19 vaccine from AstraZeneca was paused. Their advice will be invaluable to us as we decide on whether to use the COVID-19 vaccine from Janssen in Denmark," says Søren Brostrøm.

The Danish Health Authority anticipates making its decision public next week.