Reti ShaneDr SHANE RETI (National): Thank you Madam Speaker. This is a bill under urgency looking for unusual measures. In a bullet-pointed fashion initially here's what we understand with this bill and here is what we need to know.First of all there is some evidence from offshore that a fourth dose—a second booster—may be beneficial to those most vulnerable to COVID. This includes particularly the immunocompromised and older people. On 19 May—that's three weeks ago—the US Centers for Disease Control and Prevention (CDC) made a recommendation in their document titled CDC Strengthens Recommendations and Expands Eligibility for COVID-19 Booster Shots. In this CDC document they say: In addition today CDC is strengthening its recommendation that those 12 and older who are immunocompromised and those 50 and older should receive a second booster dose at least four months after their first." This is CDC three weeks ago.On 4 June in what's called an update the Singapore Ministry of Health—and a number of jurisdictions referred to Singapore; in fact initially Australia did—referred to the work; there's a working group out of Singapore that's exploring this. The Singapore Ministry of Health said this: "Local data to date shows protection against severe disease as sustained after the third mRNA booster. However there can be waning of protection particularly in the elderly and medically vulnerable. International studies show that vaccine efficiency against hospitalisation declines after the third dose mRNA booster. Persons aged 80 years and above residents of aged care facilities and medically vulnerable persons are at increased risk of severe disease and will be most affected by waning vaccine efficiency over time. These persons are therefore recommended to receive a second booster dose—that is a fourth dose of receiving an mRNA vaccine—from about five months after receiving their first booster dose for personal protection against severe disease."We tend to follow the Australians somewhat and on 25 May—so roughly two weeks ago—they put out a recommendation as well. This is what they said: "In this updated advice an additional winter booster is now also recommended for other people at increased risk to be given four months after the first booster dose. This applies to people aged 16 to 64 who have (a) a medical condition that increases the risk of severe COVID-19 illness and (b) people with disability with significant or complex health needs or multiple comorbidities which increase risk of poor outcome from COVID-19."So Singapore Australia CDC and we know Israel has for a while had the fourth dose or the second booster—all of them making this recommendation in the past two or three weeks. Now here's the process that every other COVID vaccine to date has gone through. The company the pharmaceutical company—Pfizer in this instance—does phase one phase two and phase three studies. When they reach a satisfactory phase three then they've met the threshold for a vaccine generally being acceptable for public distribution. What happens then is they pass the data to Medsafe. Medsafe analyses it and then the third step is Medsafe makes a recommendation.What is happening here is Pfizer has not sent any data and therefore made approval to Medsafe—that is there is no Medsafe recommendation. Pfizer tells us however that they'll have the data in a month or two; in fact in a meeting we had with the ministry on Friday they suggested maybe even by the end of the month.What we know is that immunocompromised people are already getting the fourth dose the booster through what's called a "section 25 off-label authorisation" whereby a GP can write a prescription for off-label—have that discussion with the patient they've got their medical records in front of them. It's a high-level consenting process and people are already getting the fourth booster here in New Zealand.Of course what the regulatory impact statement also tells us is that under an Immediate Modification Order we could also potentially distribute the fourth dose. The Government's technical advisory committee is recommending New Zealanders therefore follow Singapore the US and Australia—to name but a few—and have a fourth vaccine. So what they're doing here is they're balancing off the need to protect the vulnerable—on evidence provided not by Pfizer to Medsafe in a Pfizer recommendation at this point but on evidence from other organisations and other studies outside the Pfizer multi-cohort study they started in January—and the evidence there does seem to be suggesting that there's benefits to a fourth dose.We all need more information. We need to hear more from Medsafe. We need to hear from the technical advisory committee and any legal advice that's being provided to support this bill. That is the benefit of what will be a truncated select committee process that we can now go through that due diligence.There's a number of questions that we'll be wanting to ask. What reassurances can the Government give for the vaccine without the Pfizer data? So I've mentioned international studies offshore. What reassurances does the Government have that non-Pfizer data provides efficacy and/or the side effect profiles we might want to know about? How many people will be protected over the month or two before Pfizer does have that data? So let's say it's six weeks then. Are we sure that the benefits to the vulnerable outweigh waiting for that six weeks and having that data moving through Medsafe? I think it's a good question to ask how many people might be protected.Is the legislation that we're talking about here tonight confirming COVID vaccines in perpetuity without the normal checks and balances that we'd normally have through Medsafe with Medsafe data or is it just for this vaccine? So we need to know if it's a for ever—certainly in the immediate future—that we're signing off here.Is the fourth vaccine that we're talking about here going to be mandated? Are there any ACC implications when vaccines are not approved by Medsafe but are given out for general distribution in this fashion? What legal opinions have been received for example from Crown Law?I think these are all questions that we'd like to explore in the select committee and hopefully bring back to this House an informed view that we can all agree on. Thank you Madam Speaker."