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FDA advisory panel reviews Johnson & Johnson’s Covid-19 vaccine

A panel of experts will review whether the US Food and Drug Administration should grant emergency authorisation to Johnson & Johnson’s single-dose Covid-19 vaccine, which could bolster vaccination efforts in the US and around the world.

If the panel recommends authorisation, as it is expected to do, the vaccine will be the third to be authorised in the US, and the first to require only one jab instead of two. The regulator is set to make a final decision as soon as this weekend, and the company has said it is ready to ship 4m doses immediately.

Authorisation of the J&J shot will help reinforce US supplies as the Biden administration races to distribute vaccinations as quickly as possible. The FDA has already granted emergency authorisation to the vaccines made by BioNTech/Pfizer and Moderna, nearly 70m doses of which have so far been administered.

Friday’s vote follows a report earlier this week from FDA staff confirming the J&J jab was up to 88 per cent effective at preventing severe or critical disease, though only up to 78 per cent effective at preventing moderate to severe illness.

Significantly, it also shows signs of working against the more transmissible 501.V2 variant now prevalent in South Africa. The trials showed the jab to be 82 per cent effective at preventing severe or critical disease at the site in South Africa and 64 per cent effective at stopping moderate to severe illness.

The FDA’s scientists said the vaccine did not show signs of causing side effects that would stop them from authorising it. The main complaints from recipients were pain at the injection site, headaches and fatigue, as have been reported with the Moderna and BioNTech/Pfizer vaccines.

This week the number of coronavirus deaths in the US passed 500,000 — by far the highest death toll in the world in absolute terms — underscoring the urgent need to ramp up vaccinations to prevent a fresh surge in infections, especially from emerging variants.

As the first single-shot vaccine, J&J’s jab will be an important contribution to the global race to inoculate people around the world. The vaccine is easy to transport and store, and is being produced on a non-profit basis, making it more likely to be widely adopted in the developing world.


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