Coronavirus: Johnson & Johnson Covid jab given TGA tick of approval

The Therapeutic Goods Administration has given provisional approval to the Johnson & Johnson COVID-19 vaccine, making it the third coronavirus jab to receive regulatory approval in Australia.

A health workers prepares a syringe for administering the AstraZeneca Covid-19 coronavirus vaccine. Picture: Getty Images.

The Therapeutic Goods Administration has given provisional approval to the Johnson & Johnson COVID-19 vaccine, making it the third coronavirus jab to receive regulatory approval in Australia.

The federal government does not currently have a supply deal in place for the single-dose vaccine that has been shown to be up to 85 per cent effective against severe disease from COVID-19 in clinical trials.

The TGA said though the vaccine had been approved after a “rigorous” process it was conditional on its manufacturer Janssen-Cilag, known as Johnson & Johnson internationally, continuing to provide new data on its efficacy.

“This viral vector vaccine is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for the active immunisation for the prevention of (COVID-19) in adults greater than or equal to 18 years of age,” the TGA said.

“The official recommendation is for this vaccine to be given in a single dose.

“Provisional approval of this vaccine is subject to certain strict conditions, such as the requirement for Janssen-Cilag Pty Ltd to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment.”

Analysis by the FDA based on large clinical trials found that the vaccine was 85.9 per cent effective against severe disease in the US, 81.7 per cent effective in South Africa, and 87.6 per cent in Brazil.

The TGA said though the Johnson & Johnson vaccine has been shown to prevent Covid it was yet known whether it prevents transmission or asymptomatic disease.

A health worker administers the AstraZeneca Covid-19 coronavirus vaccine to a person at the mass vaccination site inside the Siam Paragon shopping mall in Bangkok, Thailand. Picture: Sirachai Arunrugstichai/Getty Images.

Unlike the Pfizer and Moderna jabs which are mRNA vaccines, for which Australia has supply deals, the Johnson & Johnson vaccine is a “viral vector vaccine” that uses human adenovirus viruses to create an immune response. It also does not require cold chain storage.

“Vector vaccines use a non-pathogenic, human adenovirus virus (known as the viral vector) that contains the genetic code for a protein unique to the coronavirus, the spike protein,” the TGA said.

“Once this enters the body, it instructs our cells to make the coronavirus spike protein. Our cells use these instructions to make copies of the protein.

“Our immune cells then recognise the spike protein as foreign and begin building an immune response against it.”

But a spokesperson for Health Minister Greg Hunt said the Janssen vaccine was an adenovirus vaccine, the same type of vaccine as the AstraZeneca vaccine.

“The government does not intend to purchase any further adenovirus vaccines at this time,” the spokesperson said.

The jab is the second adenovirus to be approved in Australia after the AstraZeneca vaccine.