Medsafe to seek 'additional data' before approving Johnson & Johnson Covid-19 vaccine

Source: 1News

Medsafe today announced it will seek "additional data" before approving the Johnson & Johnson Covid-19 vaccine.

It comes after the vaccine has been paused in both the US and Europe over fears it can cause blood clots in some recipients.

"After receiving information from the US Food and Drug Administration (FDA) related to cases of blood clots reported in the US, Medsafe has issued a number of additional requests for data from Janssen," Medsafe says in a statement.

"The pause of the rollout in the US and Europe has also been discussed with Janssen."

Medsafe group manager Chris James says Medsafe expects to provide an update on the Janssen approval process in the next two to three weeks.

“This will allow us time to investigate the data we receive so that when we do make a decision, we can reassure the New Zealand public about the safety and efficacy of the vaccine.

“We continue to receive information from our regulatory colleagues, which includes the FDA in the US and Therapeutic Goods Administration in Australia, who are also assessing the Janssen vaccine.

“Medsafe has a robust system in place for evaluating the safety and quality of medicines and vaccines for use in New Zealand, and will continue to make decisions based on the most up to date information,” James says.

The Government has previously stated it has secured enough doses of the Pfizer vaccine for every New Zealander. This is the vaccine which is currently being used to vaccinate border workers before a wider rollout.