Coronavirus: Janssen COVID-19 vaccine receives provisional approval by New Zealand's Medsafe

Medsafe has granted provisional approval to the Janssen COVID-19 vaccine for people over the age of 18, Chris Hipkins says. 

"New Zealand secured two million doses of the Janssen vaccine through an advance purchase agreement last year," the COVID-19 Response Minister says. "We purchased a portfolio of vaccine options to provide us with flexibility, and the approval of a second COVID-19 vaccine is welcome news."

"Medsafe follows a rigorous assessment process informed by the most up to date medical and scientific data. Approval has been very carefully considered with safety the key priority.

"The medical evidence shows Janssen is a very safe and effective vaccine. It is a great addition to our vaccine options."

The Government's plan continues to be to use the Pfizer vaccine primarily, but having the Janssen vaccine "increases our choices and provides us with flexibility if we need it". 

"As a single dose vaccine, it may be useful in hard to reach locations or emergencies, or for those who cannot get the Pfizer vaccine."

Hipkins says New Zealand has secured enough doses of the Pfizer vaccine for all Kiwis and our Pacific neighbours in 2021. The vaccine rollout will be extended to the general public from the end of July.

Getting provisional approval means the pharmaceutical company must meet certain conditions, including supplying more data from its clinical trials around the world as they progress. This will happen at the same time as the vaccine can be used.

"Provisional approval is the first step in the process. Cabinet will weigh up the options on the best use of the Janssen vaccine following advice from officials. A Cabinet 'decision to use' can be expected sometime in August,” Hipkins says.

The Janssen vaccine has received emergency or provisional approval in Canada, USA, and Australia.