Every year, respiratory syncytial virus, RSV, sends over a thousand infants to hospital.

Six years ago, Kiwis volunteered to be part of a large international study testing whether vaccinating pregnant women for RSV would protect their newborns.

The trial was successful. America’s FDA and Europe’s EMA approved Abrysvo in August 2023. It is now available in about forty countries.

Abrysvo has been funded for pregnant women in Australia since 2025.

Earlier this week, a large British trial showed the vaccine’s effectiveness. Pregnant women in England have been offered the vaccine since 2024. The study followed almost three hundred thousand infants. Those born to vaccinated mothers were far less likely to wind up hospitalised.

Unfortunately, Medsafe’s processes do not protect Kiwis from the virus, only from the vaccine. It has not yet been approved by Medsafe, so it is not available. At least hundreds of infants will wind up in hospital annually as a consequence.

The coalition agreements that formed the government promised that drugs approved by at least two trusted overseas regulators would automatically be approved – the ‘Rule of Two’.

The legislation passed last year instead proposed a ‘fast-track’ approval process for medicines fully approved overseas.

That process, currently being developed, still requires someone to put a new medicine up for a tiny, remote country’s approval.

My select committee submission noted Abrysvo. Despite the vaccine’s approval in dozens of countries, Medsafe’s database showed no application in progress then, and still doesn’t now.

If New Zealand automatically approved medicines that had been approved by at least two trusted regulators, Abrysvo would have been NZ-approved in 2023. Whether it should be funded would be a separate decision.

It may be tempting to blame Pfizer, the vaccine’s manufacturer, for not having put through application paperwork. But that would be both lazy and wrong.

New Zealand’s market is not that large. About 58,000 babies are born here per year. Prior to its being funded, Abrysvo cost $300 in Australia. Uptake here could be low. And whether funding here would be warranted would be a separate decision.

Hopefully, Pfizer is just waiting for the new ‘fast-track’ approvals process to be available mid-year. But it could be that our market is just not worth the hassle.

Making it hard for international companies to roll out their latest and greatest innovations in small remote countries only hurts those countries’ residents.

Parliament should reconsider its approach.