Medsafe asks Janssen to provide additional COVID-19 Vaccine data

Medsafe asks Janssen to provide additional COVID-19 Vaccine data

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Medsafe is seeking additional data from Janssen after deciding whether to approve their pharmaceutical COVID-19 Vaccines for New Zealand.

Information from the Food and Drug Administration has uncovered a number of cases that have resulted in blood clots being reported within the United States.

Requests were issued from Medsafe to Janssen, which follows a pause in the United States and Europe’s rollout.

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Source: CC/ Sam Hudson [Wgtn]

Medsafe Group Manager Chris James says an update is expected and will be provided to the public on the approval process that is scheduled to happen within two to three weeks time.

“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,” he said.

“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.”

Vaccine processes’ quality of medicines and safety go through a review process before they can be approved for use in New Zealand.

Mr James says Medsafe will make decisions on the most up to date information regarding Vaccines being rolled out around the country.

Source: CC/ Sam Hudson

On February 3, Director-General of Health Dr Ashley Bloomfield mentioned in a press briefing that the Ministry of Health is focusing on ‘giving access’ to a Vaccine and that over time, people may gradually wish to take it.

“I have great confidence in the process that Medsafe has undertaken. Just emphasising, as Chris said, no corners have been cut here. We have gone through a robust process,” said Dr Bloomfield.

“Every day, every week, we are getting more data from around the world as millions more by this Vaccine [Pfizer], and other Vaccines are administered. There is nothing out of the ordinary from what we are seeing from a safety guard coming through. It is very assuring.”

Image: SUPPLIED/CC/ Sam Hudson [Wgtn]

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