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US authorises J&J’s single-dose Covid vaccine for emergency use

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US President Joe Biden speaks after visiting a Federal Emergency Management Agency (FEMA) Covid-19 vaccination facility at NRG Stadium in Houston, Texas, on Friday. AFP

US authorises J&J’s single-dose Covid vaccine for emergency use

The US on February 27 authorised Johnson & Johnson’s (J&J) Covid-19 vaccine for emergency use, giving the nation a third shot to battle the outbreak that has killed more than 500,000 people in the country.

The single-shot vaccine is highly effective in preventing severe Covid-19, including against newer variants, the Food and Drug Administration (FDA) said before giving it a green light.

US President Joe Biden said in a statement: “This is exciting news for all Americans, and an encouraging development in our efforts to bring an end to the crisis.”

But he urged the populace to remain vigilant with anti-virus curbs such as social distancing, warning that new variants of the virus still posed a threat.

“But we cannot let our guard down now or assume that victory is inevitable,” Biden said.

A third vaccine is seen as a vital means to ramp up the immunisation rate in the US, where more than 500,000 people have lost their lives to the coronavirus.

In large clinical trials, the J&J vaccine’s efficacy against severe disease was 85.9 per cent in the US, 81.7 per cent in South Africa, and 87.6 per cent in Brazil.

Overall, among 39,321 participants across all regions, the efficacy against severe Covid-19 was 85.4 per cent, but it fell to 66.1 per cent when including moderate forms of the disease.

Crucially, analyses of various demographic groups revealed no marked differences across age, race, or people with underlying conditions.

100 million doses by June

The J&J vaccine is the third to be greenlighted in the US after Pfizer’s and Moderna’s were provisionally approved in December.

Over 65 million people in the US have so far received at least one shot of either the Pfizer or Moderna vaccines – but unlike those, the J&J vaccine requires just one dose, and is stored at fridge temperatures, offering logistical and practical advantages.

The J&J shot appears less protective than Pfizer and Moderna’s two-shot regimens, which both have an efficacy of around 95 per cent against all forms of Covid-19 from the classic coronavirus strain.

All three have been shown to fully protect against hospitalisations and death, however.

Maine Center for Disease Control and Prevention director Nirav Shah told The Washington Post the two earlier vaccines were tested months before the emergence of “variants of concern” that could affect the efficacy, meaning the Pfizer and Moderna results were not an “apples to apples” comparison with the J&J shot.

There was a hint, based on preliminary data, that the J&J vaccine might be effective against asymptomatic infection – though the company said it needs to do more research.

The company has announced it aims to deliver 20 million doses by the end of March, with 100 million by June – though the US is pushing to expedite that timeline.

The J&J vaccine uses a common-cold causing adenovirus, which has been genetically modified so that it can’t replicate, to carry the gene for a key protein of the coronavirus into human cells.

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