SA scientists welcome US approval of J&J vaccine

The approval by one of the world’s most stringent regulators of the Johnson & Johnson (J&J) coronavirus vaccine has been welcomed by SA’s top scientists.

On Saturday, the US Food and Drug Administration (FDA) issued an emergency-use authorisation for the third vaccine for the prevention of Covid19 caused by severe acute respiratory syndrome coronavirus.

The emergency-use authorisation allows the Janssen Covid19 vaccine to be distributed in the US for use in individuals 18 years and older, the FDA said in a statement.

Linda-Gail Bekker, co-principal investigator on the Sisonke implementation study, said on Sunday in an interview that the approval by the FDA was a “huge milestone”.

“It’s a very important milestone to show that regulators are confident about the data. They feel that this is an important vaccine to add to the Sars CoV-2 response and we concur.”

The Sisonke study is administering J&J’s shot to health-care workers, and was devised as a bridging mechanism until other vaccines are available.

Until the FDA’s decision on Saturday, J&J’s vaccine had been authorised by regulators, including by the SA Health Products Regulatory Authority (Sahpra), for research but was not yet licensed for commercial production.

The FDA said the available safety data to support the emergency-use authorisation included an analysis of a study of 43,783 participants enrolled in an ongoing randomised, placebo-controlled study being conducted in SA, certain countries in South America, Mexico and US.

In terms of effectiveness, the FDA said the data that supports it included an analysis of 39,321 participants in the ongoing randomised, placebo-controlled study who did not have evidence of Sars-CoV-2 infection before receiving the vaccine.

Among these participants, 19,630 received the vaccine and 19,691 received saline placebo.

“Overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical Covid-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical Covid-19 occurring at least 28 days after vaccination,” the FDA said.

It added that the vaccine was about 77% effective in preventing severe/critical Covid-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical Covid-19 occurring at least 28 days after vaccination.

Silverani Padayachee, senior manager of pharmaceutical evaluation at Sahpra, said in a written response on Sunday that the FDA’s emergency-use authorisation did not affect Sahpra’s rolling review of the vaccine as the FDA approval was an emergency-use authorisation and not a full marketing authorisation.