Medsafe delenda est

The solution is still really really obvious. If two trustworthy regulators have approved a medicine or vaccine, have it automatically approved in New Zealand. Let Medsafe have a veto lever it can pull in extraordinary cases, but don't let them pull it very often. It has to be for extraordinary cases, not just because they hate the loss of control.

FDA processes already mean that vaccines run behind the curve, trying to catch up to variants. Layering more on top of that just means that government can and will always blame the pharmaceutical companies for not getting applications in, when there's little point for any of them to prioritise doing paperwork for a tiny country at the far end of the world when there are bigger markets to serve first. 

From Newsroom today ($):

Astrid Koornneef, the director of the National Immunisation Programme at Health NZ/Te Whatu Ora, told Newsroom on Friday that Pfizer has yet to apply for either its BA.1 or BA.5 vaccine to be used in New Zealand.

"Medsafe is working with Pfizer on their plans to submit data to New Zealand on variant vaccines. This is expected to happen over the coming months," she said.

"Medsafe will be assessing this data as a priority once received."

Koornneef didn't answer questions about whether the Government's existing contracts with Pfizer cover these new vaccines or whether another agreement would have to be inked.

"Our agreements with Pfizer remain commercially sensitive and confidential, as are all our purchase agreements for Covid-19 vaccines. However, we have well-developed relationships in place with a range of vaccine manufacturers and continue to monitor progress in this space, including the development of potential new versions of vaccines as they emerge."

Pfizer did submit an application to Medsafe in August for its Covid-19 vaccine to be approved for children aged six months to four years. Currently, the vaccine is only authorised for those aged five and up.

The application is being assessed as a priority, Koornneef said, but there are many steps before a decision to use is made by Cabinet.

"Provisional approval by MedSafe is only the first step in the process. Subsequent steps include seeking Covid-19 Vaccine Technical Advisory Group science and technical advice, followed by a recommendation for consideration by the Director-General of Health."