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‘One and done’ – Johnson & Johnson’s single-shot vaccine recommended by EU regulator

Written by on 11/03/2021

Johnson & Johnson’s single-shot COVID vaccine has been recommended for approval by the EU drugs regulator.

Authorisation for the vaccine – referred to by some as “one and done” – will follow shortly, said the EU Commission.

The European Medicines Agency (EMA) is recommending that it should only be used by adults.

The bloc has had a slow start in rolling out vaccines, with its president criticised for not acting fast enough.

The Johnson & Johnson jab is the fourth to be endorsed for use in the European Union after those from Pfizer, AstraZeneca and Moderna.

Some 200 million shots have been ordered by the EU, with an option for more, but it’s unclear at the moment exactly when they will be delivered.

America, Canada and Bahrain have also signed the J&J jab while South Africa is doing an expedited review.

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The UK has ordered 30 million doses, pending approval by the Medicines and Healthcare products Regulatory Agency (MHRA), with the option of millions more.

In a 44,000-person trial by Johnson & Johnson, the vaccine was found to be 66% effective overall at preventing moderate-to-severe COVID-19 four weeks after inoculation.

For preventing serious illness only, it was 85% effective.

As well as being one shot, it also only needs to be kept at fridge temperature, making its storage, distribution and handling much easier.

And costing as little as $10 (£7) a dose, it is cheaper than most vaccines – coming in at about the same as two shots of the Oxford/AstraZeneca option.

Johnson & Johnson said it worked across multiple variants of coronavirus, including some effectiveness against the South African variant.

The European regulator said in a statement on Thursday that the vaccine was about 67% effective.

It said most side effects were usually mild or moderate and stopped within a couple of days. The most were pain at the injection site, tiredness, muscle pain, headache and nausea.

It’s also hoped that having a one-shot vaccine can help speed up vaccination in poorer countries.

Johnson & Johnson is hoping to make about one billion doses this year but has had production delays in the the US and Europe.

 Sky News

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