Wednesday 27 October 2021

Vax for kids

The FDA's decision on vaccines for 5-12 year olds should be up today. The workings from their meeting of 26 October are here.

I expect that kids in the US will be able to be vaccinated in November.

Last week, I emailed MedSafe to ask where things were in the process here. I'd hoped that they'd have been asking Pfizer to get its data to them at the same time, so that MedSafe might consider things in parallel with the US. We'd then be able to hit the ground running.

Ever the optimist. 

Their reply:

Here is our response attributable to Chris James - Group Manager, Medsafe:

In order for Medsafe to consider granting provisional approval for the Pfizer vaccine for 5 to 11-year-olds, Pfizer must submit an application to Medsafe, which has not yet been received.

We understand Pfizer has submitted an application to the US FDA for Emergency Use Authorisation of their COVID-19 vaccine for use for children aged 5 to 11.

Pfizer does not carve up its data for different countries. Regulators have harmonised requirements on the format and supply of data for applications. It is Pfizer’s decision who and when to submit applications to. We recommend you direct any further questions in this area to Pfizer.

If, and when Pfizer does submit an application, Medsafe will prioritise the assessment of the data for this age group. If Medsafe provisionally approves this, further clinical and scientific advice will be sought from the COVID-19 Vaccine Technical Advisory Group before it goes to Cabinet for a “decision to use”.

And if there is a decision to use, please rest assured, we will have enough vaccines for everyone. We will provide updates on progress.
So when Pfizer gets around to getting an application in to a small country at the far end of the world, Medsafe will start thinking about it. It may go over summer break. Then the Technical Advisory Group has to weigh in. Then Cabinet has to decide. It's a political decision, after all, about whether I should continue to be banned from having my daughter vaccinated.

It would be nice if drugs approved elsewhere were also just here available, without having to jump through Medsafe, then the Technical Advisory Group, then Cabinet. 

In the absence of being able to have my 11 year old vaccinated, it would be great to have a stock of rapid antigen tests around the house. If any of us develop any symptoms, we'd be off for a Covid test. But it can take a while to get results back. A rapid test could help while waiting. 

Alas, those are also still banned. 

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