Medsafe could give its go-ahead to Pfizer-BioNtech vaccine Tuesday

February 01, 2021 01:25 PM AEDT | By Team Kalkine Media
 Medsafe could give its go-ahead to Pfizer-BioNtech vaccine Tuesday

Summary

  • Medicines Assessment Advisory Committee (MAAC) is slated to meet on 2 February to review clinical data from Pfizer vaccine trials and its use for the world.
  • Medsafe will decide whether to authorise the Pfizer vaccine in NZ or not after taking MAAC’s advice.
  • If the provisional approval is granted, NZ still may have to wait to get the vaccine.

On 26 January 2021, NZ government declared that Medicines regulator Medsafe would take a decision on the approval of Pfizer and BioNTech vaccine after taking advice and recommendations from the Medicines Assessment Advisory Committee (MAAC). MAAC will meet on 2 February to take a decision on the vaccine’s approval.

Prime Minister Jacinda Ardern, while addressing a press conference, stated that Medsafe would consider MAAC’s suggestions and might seek to give conditional permission.

The provisional consent is likely to include restrictions for the pharmaceutical firm to give data and information within a negotiated timeline. This requires further evidence from clinical trials and manufacturing as it becomes available.

Source: Shutterstock

Further, Medsafe's benefit-risk evaluation of the pharmaceutical company's data may be checked by the Ministerial Expert Advisory Committee. The Medicines regulator will be prepared to obtain and oversee vaccines as soon as Pfizer is in a spot to send them, as per the government. 

NZ will have to wait even if the approval is granted

COVID-19 Response Minister Chris Hipkins said vaccination for COVID-19 would play a vital role in protecting the health and well-being of New Zealanders and would be the major step back to a normal life over the course of time.

He also stated that if Medsafe decided that further assurances were needed before the approval, its decision would be considered apt for the safety of Kiwis, as per the NZ government.

ALSO READ: What is NZ COVID-19 vaccination schedule? Who will be given priority?

However, if the approval is granted, it would imply that Medsafe has enough data and confidence on the safety and effectiveness of the vaccine to begin the vaccination process. However, there will be repeated monitoring of the vaccine in NZ and abroad.

Over the past year, these courageous people have been defending NZ from the global pandemic and thus, it is the duty of the country to protect them and those who share their homes, he added.

DO READ: Is New Zealand ready for COVID-19 vaccine rollout or is it rushing?

Moreover, in order to get the vaccine, New Zealand will have to wait in line.

The first vaccines are scheduled to arrive in the country by the end of March. It would first vaccinate border employees and their nearby contacts. It is estimated that completion of vaccinating this group would take 2 or 3 weeks, once the vaccine arrives in NZ.


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