Regulators in the US and EU have lifted a pause on the use Johnson & Johnson’s COVID-19 vaccine, following reports of six cases of a rare and severe type of blood clot.
J&J’s vaccine is important to the US immunisation programme as it is administered in a single shot, unlike approved rivals from BioNTech/Pfizer and Moderna, which require two jabs for a full effect.
The experts from the US Centers for Disease Control and Prevention (CDC) and FDA examined available data to assess the risk of thrombosis involving the cerebral venous sinuses – large blood vessels to the brain and other sites in the body.
Experts were looking to assess the risk of clots forming in people with low platelet counts, also known as thrombosis-thrombocytopenia syndrome (TTS).
The FDA and CDC ruled that use of the vaccine developed by J&J’s Janssen unit should be resumed in the US, adding that they have confidence it is safe and effective in preventing COVID-19.
They said available data suggest the chance of TTS occurring is very low, although experts will continue to monitor the situation.
In a statement, J&J noted the decision and said it had updated vaccine fact sheets to reflect the findings.
European regulators last week also ended restrictions on the J&J vaccine that had been imposed during a safety review, following approval last month.
The European Medicines Agency’s safety committee also considered the data from the US and came to a similar conclusion – that the chance of blood clots forming was very low and that the vaccine’s benefits continued to outweigh any risks.
Similar problems have also been linked with AstraZeneca’s COVID-19 vaccine and the EMA has also ruled its benefits outweigh any risks.
AZ’s vaccine, which like J&J’s shot is based on a viral vector, has not yet been approved in the US although a filing for an emergency approval with the FDA is expected soon.
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