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First COVID-19 vaccine could be approved by next week – Expert Reaction

Pfizer-BioNTech’s Covid jab could get the tick by New Zealand’s medicines regulator as early as next Wednesday, Prime Minister Jacinda Ardern said today.

The mRNA vaccine is one of four in the country’s COVID-19 vaccine portfolio. Next Tuesday, Medsafe will seek advice from the Medicines Assessment Advisory Committee about the vaccine. Depending on the committee’s feedback, MedSafe may be able to grant provisional approval as soon as the following day.

The SMC asked experts to comment on this announcement.

Dr Nikki Turner, Director Immunisation Advisory Centre, University of Auckland, comments:

“It’s very positive to see this progress. It is important to support the Medsafe process to ensure New Zealand has appropriately gone through a checking process for our own population and not just reliant on international licensure.

“Clearly, there is a good body of data now on the Pfizer vaccine, both from the pivotal clinical trials and real world experience on now millions of vaccinees in Europe, the UK and the USA. To date, the safety data in the real world is good and matches the experience in the trials. The limiting step now will be securing supplies, but New Zealand’s current need is initially quite small because the most urgent need is to protect border staff and MIQ facilities staff. Securing these smaller amounts of vaccine supplies is likely to be more feasible than expecting large quantities, as they are wanted urgently in countries who currently have high amounts of disease.

“It has been a considerable advantage to New Zealand that we have not been the first ‘cab off the rank’ and we now have not just clinical trial data but also real world information on vaccine safety. This is very helpful to support New Zealanders who have concerns about vaccine safety that we have good safety data now to proceed. How effective it is in the real world, time will tell.”

No conflict of interest.

NOTE: The Immunisation Advisory Centre (IMAC) has a contract with the Ministry of Health to delivery education and training to the healthcare sector for COVID-19 vaccines.