Tuesday, 21 April 2026

Medsafe Delenda Est

Excellent news out of the UK. Abrysvo, a vaccine for RSV administered to pregnant women, reduces infant hospitalisation by 80%. 

From the BBC:

A vaccine during pregnancy which protects newborns against nasty chest infections is cutting hospital admissions of babies by more than 80%, UK health officials say.

A virus, called RSV, affects many babies in the first few months of life and can leave them gasping for breath and struggling to feed, with more than 20,000 babies ending up seriously ill in hospital in the UK every year.

Since 2024, women have been offered a vaccine from 28 weeks of pregnancy to protect their newborns.

A new study analysing the impact of the vaccine shows it gives "excellent protection" to babies when they are most vulnerable to RSV, the UK Health Security Agency (UKHSA) says.

RSV (respiratory syncytial virus) is one of the main reasons young babies are admitted to hospital before the age of one.

The UK govt website provides a few more details (alas, the link to the paper is broken).

The vaccine here is going to have been Abrysvo; it's the one that England rolled out against RSV.

Last year, I noted Abrysvo in a Post column on the proposed Medicines Amendment Bill. 

I'd written:

New medicines are slow to be authorised for the New Zealand market.

Even if it a medicine has already been approved by many other trustworthy overseas regulators like those in Canada, the UK, Australia and the EU, Medsafe can take a very long time to evaluate a medicine.

But pharmaceutical companies are not quick to get their medicines into our approval process. New Zealand is a tiny market. We are not at the top of anyone’s priority list. Medsafe will not assess a medicine without an application.

Consider RSV – the respiratory virus whose name is utterly unpronounceable when it isn’t an acronym. It is highly contagious. Pregnant women, infants, and some young children are more at risk from it – at least according to the Immunisation Advisory Centre.

Vaccination against RSV is available for New Zealand’s elderly. But while 40 other countries allow access to Abrysvo, a vaccine administered to pregnant women to protect their infants, Medsafe’s database shows no evidence that its manufacturer has applied for New Zealand approval.

New Zealand researchers helped with the clinical trials that proved its safety and effectiveness. But the vaccine is not available here. Simply being good enough for 40 other countries and tested here isn’t sufficient.

I noted that the Bill's proposed fast-track approval process for medicines wasn't what had been promised in the Coalition agreements. Those promised automatic approval if at least two trusted overseas regulators had approved a medicine - regardless of whether anyone got around to applying for Medsafe authorisation. 

And I worried that the fast-track would not solve the problem if the underlying problem is pharma companies not seeing NZ approval as being worth the time. We're an afterthought. 

The FDA and EMA authorised Abrysvo in pregnancy, to protect infants against RSV, in 2023. 

When I made my submission on the bill last year, a search of the Medsafe database showed no evidence that application for NZ approval had been made. 

As of this afternoon, the same search yields the same result. 

If you're pregnant or are thinking of becoming pregnant, talk to your GP about s29 access to Abrysvo. It might be tough. There might not be anyone importing it. And a lot of doctors don't like using s29. 

It is approved in Australia. I don't know whether Australian doctors are willing to dispense for Kiwis willing to pay. 

This is so stupid. 

Medsafe authorisation stands between pregnant women and this vaccine, approved in dozens of countries, and well-proven in the UK. 

Fingers crossed that Pfizer is just holding off until the 'fast-track' verification process is live, and that it goes live fairly soon. 

A closing snippet from the BBC piece. Delays can be costly. 

The vaccine didn't come in time for Laine Lewis's son Malachi, now 12 years old. He developed a cold as a baby which deteriorated so much that he was taken to hospital, diagnosed with RSV and put on oxygen. Malachi later stopped breathing and a scan soon after revealed brain damage.

His mum has said it's important his story "doesn't scare people" because what happened to Malachi was very rare.

But she added: "I'd encourage people to take the vaccine for RSV because it will help their child."

Dr Watson said the vaccine could "make a big difference to keeping babies safe" through the winter.

"I would strongly encourage any pregnant woman to discuss it with their midwife, other health professionals, and be ready to have the vaccine at their week 28 appointment, or another vaccine appointment arranged soon after that."

Latest figures show around 64% of pregnant women in England are getting the RSV vaccine, but that falls to 53% in London.

No comments:

Post a Comment