WASHINGTON – The United States yesterday authorised Johnson & Johnson’s (J&J) Covid-19 vaccine for emergency use, giving the nation a third shot to battle an outbreak that has killed more than 500,000 Americans.
The single-shot vaccine is highly effective in preventing severe Covid-19, including against newer variants, said the Food and Drug Administration before giving it the green light.
“The authorisation of this vaccine expands the availability of vaccines, the best medical prevention method for Covid-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the US,” said the regulator’s acting director, Janet Woodcock.
In large clinical trials, the J&J vaccine’s efficacy against the severe form of the disease is 85.9% in the US, 81.7% in South Africa, and 87.6% in Brazil.
Overall, among 39,321 participants across all regions, the efficacy against severe Covid-19 is 85.4%, but it fell to 66.1% 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.
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.
100 million doses by June
The J&J vaccine is the third to get the nod in the US after those by Pfizer and Moderna were provisionally approved last December.
Over 65 million people in the US have received at least one shot of either the Pfizer or Moderna vaccines, but unlike those, the J&J jab requires just one dose – and is stored at fridge temperatures, offering logistical and practical advantages.
The J&J shot is slightly less protective than Pfizer and Moderna’s two-shot regimens, both of which have an efficacy of around 95% against all forms of Covid-19 from the classic strain.
There is a hint, based on preliminary data, that the vaccine may be effective against asymptomatic infection – though J&J said it needs to do more research to confirm this.
The company has announced that it aims to deliver a total of 20 million doses by end-March, with 100 million by June – though the US is pushing to expedite the timeline.
The J&J vaccine uses a common-cold-causing adenovirus, which has been genetically modified so that it cannot replicate, to carry the gene for a key protein of the coronavirus into human cells. – AFP, February 28, 2021