J&J’s Covid-19 vaccine closes in on FDA’s nod
The US drugs regulator has virtually cleared the path for a third Covid-19 vaccine, confirming the efficacy and safety of the Johnson & Johnson shot on Wednesday.
J&J’s one-shot vaccine could join Pfizer and Moderna’s shots as early as this week in the battle against a pandemic that has killed more than half a million people in the United States, a grim milestone crossed earlier this week.
An advisory committee of experts appointed by the US Food and Drug Administration (FDA) will meet on Friday to evaluate the findings and grant emergency use authorisation.
According to papers submitted by Johnson & Johnson to the FDA seeking emergency use go-ahead, the vaccine has demonstrated an overall efficacy level of 66% - 72% in the United States and 57% in South Africa, a country that is dealing with a highly contagious strain of the coronavirus.
The vaccination was more effective, at 86%, against severe forms of Covid-19 in the United States, and 82% against severe disease in South Africa, reducing the risk of hospitalisation and death among those inoculated.
Unlike Pfizer-BioNTech and Moderna’s jabs, Johnson & Johnson’s one is a one-shot vaccine. It’s also known to be easier to store - it can be kept in refrigeration for three months - and transport. The vaccine does not require extremely cold conditions, which the Pfizer vaccine needs.
The Johnson & Johnson vaccine was tried out on more than 44,000 people, aged 18 and older, in multiple countries. The company applied for emergency use authorisation on February 4.
The pharma giant expects to roll out millions of doses of its vaccine the next week, pending authorisation, but it is likely to fall short of the expected 10 million by February end.
“We will have 20 million doses of the vaccine to be made available by the end of March and we’re prepared to ship, immediately upon emergency use authorisation, nearly 4 million doses of our vaccine, Richard Nettles, the company subsidiary Janssen’s vice-president of medical affairs, said on Tuesday.