EU regulator gives green light for J&J to resume vaccine shipments
Johnson & Johnson (J&J) will restart deliveries of its Covid-19 vaccine to the EU after the bloc’s drug regulator said the benefits of the shot outweigh the risks of a possible link with cases of rare blood clots.
The European Medicines Agency assessment on Tuesday echoed its review of the vaccine from AstraZeneca, which has also been linked with the rare clot. In both cases, the regulator noted that Covid-19 can be fatal and the use of vaccines is crucial to fighting the virus.
“The global death toll has surpassed 3-million people, and there are still thousands dying every day,” EMA executive director Emer Cooke said. “There is untold suffering behind all of these cases, and these vaccines play an immensely important role in combating this pandemic.”
In its decision, the EMA said the clots should be listed as very rare side effects so that doctors and patients can look out for any danger signs. That allows EU governments to make their own decisions on whether to restrict use to certain age or patient groups, as many have done with the similar shot from Astra.
J&J will also seek to raise awareness of the symptoms of the rare clots to ensure they’re correctly diagnosed and treated, the company’s Chief Scientific Officer, Paul Stoffels, said in a statement. Doctors are being advised not to use the anticoagulant heparin.
The EMA said its own independent investigation will continue, including research on the blood clots associated with different vaccines. Additionally, the regulator will issue an update on its research into AstraZeneca’s vaccine by the end of the week.
The issues with J&J, which halted deliveries of the vaccine in Europe last week, were a further blow to the bloc’s immunisation programme. The rollout had been starting to pick up after a sluggish start due to delays in Astra shipments as well as safety concerns. Both shots had been pitched as linchpins of the drive to inoculate 70% of the bloc’s adult population by the end of the summer.
Shares in J&J rose as much as 2.9% on Tuesday. The company earlier reported stronger-than-expected first-quarter sales.
US authorities are expected to follow with their own ruling on the Covid-19 vaccine by Friday, after they paused use of the J&J shot last week. One possibility would be to allow use of the shot with some form of restriction or warning, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said on Sunday.
There have been eight reports in the US — out of more than 7-million people who got the shot — of a severe form of blood clot combined with low platelet levels within three weeks after immunisation. The cases were in people between the ages of 18 and 49 years old, with a median age of 33, and most were in women.
The EMA said there had been more than 300 cases worldwide of rare blood clotting incidents combined with low platelet counts. There were 287 occurrences with the AstraZeneca vaccine, eight with J&J’s shot, 25 for Pfizer and five for Moderna, said Peter Arlett, head of data analytics at the EMA.
The single-dose J&J shot, like the two-injection one developed by AstraZeneca and the University of Oxford, uses an adenovirus to deliver genetic material into the body to spur a defence against Covid-19.
The 27-nation EU is unlikely to renew contracts with both AstraZeneca and J&J, instead prioritising the messenger-RNA vaccines made by the Pfizer-BioNTech alliance and Moderna, France’s industry minister said last week.
With booster shots likely to be necessary, the European Commission is already in talks with Pfizer and BioNTech for as many as 1.8-billion additional doses through 2023.
Bloomberg News. For more articles like this please visit Bbloomberg.com
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