The Pfizer/BioNTech vaccine (Comirnaty) has been provisionally approved for use by New Zealand’s medicines regulator. Medsafe has placed 58 conditions on the approval, most of which relate to seeing more data as the company scales up its manufacturing.
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It should be immensely reassuring to health professionals and the broader public in New Zealand that the first COVID-19 vaccine to be approved for use has received close scrutiny. This scrutiny has clearly been at the same level of all newly introduced medicines and vaccines, but at “warp speed”, like the whole process of development and trials for vaccines against COVID-19. While regulators are doing their job at a gallop rather than a canter or a trot, they are still jumping all the hurdles.
This has been a tremendous effort on the part of the NZ regulatory agency MedSafe, assisted by close collaboration with comparable agencies overseas such as Australia’s Therapeutic Goods Administration and European and US agencies, for which they should be congratulated. It is important to note the Pfizer vaccine (Trade name Comirnaty) while the result of a technology new to vaccines for general use (using messenger RNA, the code which allows cells to produce proteins – in this case the spike protein of the SARS-CoV-2 virus) is a technology which has been long-studied in multiple small previous clinical trials for other vaccines and is well understood.
New Zealand has the important advantage over the US and Europe of being able to take advantage of their experience with many millions of doses. At the January meeting of the US Advisory Committee for Immunisation Practice, the peak advisory body, it was reported that about 12 million doses of the Pfizer vaccine had been given in the US as of January 24th with 7,330 reports of an adverse event, only 590 serious. In a detailed study at 9 large health care centres giving 12 million vaccine doses each year – to date 87,000 doses of the Pfizer vaccine – there was no difference in the rates of any of a series of 21 health events ranging from appendicitis to stroke in people who had received the Comirnaty vaccine compared with those who had not, with a total of 14 events in vaccinated versus more than 1,600 in unvaccinated.
This is a key step in NZ COVID-19 vaccine strategy and is important for several reasons. The Pfizer vaccine was shown to be 95% effective, on par or better than vaccines we already use for other diseases. It prevented symptomatic COVID-19 disease as well as severe disease and hospitalization, and is planned to be the first vaccine made available in New Zealand – to border, MIQ workers and possibly healthcare workers. We really want a highly effective vaccine in these groups to ideally prevent illness for them as well as onward spread into the community.
We can’t be certain that current COVID-19 vaccines, like the Pfizer vaccine, prevent all transmission of the virus, but it’s likely that they will reduce it. Regarding the new variants, there is lab data suggesting that the Pfizer vaccine is likely to also be highly protective against the UK and South Africa viral variants. We need to wait for additional real-world data to confirm this.
The provisional approval from Medsafe is also important, since it assures New Zealanders that regulators will be frequently reviewing new safety data as it becomes available. They need to make sure there is additional long-term safety and vaccine stability data in order to provide full authorisation. It’s important to remember that this vaccine has not been fully tested in some populations such as children under age 16, pregnant women or some immunocompromised groups, so more clinical trial data is needed for these groups. Finally this vaccine has been used in millions of people over the past few months in other countries, which adds to the safety information that NZ was able to review for approval. This should reassure people that NZ is moving forward safely. I look forward to learning more details about this provisional approval.
Today’s announcement by the Director-General of Health, Dr Ashley Bloomfield, and Medsafe’s Group Manager, Chris James, regarding the provisional approval of the vaccines is to be welcomed. They have given a concise explanation of the measures taken to ensure that the vaccines are safe for New Zealanders. It should provide many New Zealanders with some strong reassurance ahead of plans to roll out the vaccines.
However, a lot of New Zealanders will still have concerns about the safety of the vaccines. It is a common fear that the development of the vaccines was rushed and/or used new technologies. Reports of severe side effects need to be responded to immediately and transparently. What the Government needs to do now is to avoid confirming any reasons people might have for not trusting a vaccine. This aspect is especially important for members of vulnerable and diverse communities.
Today’s announcement signals a new chapter in the country’s COVID response. A key feature of this next phase in the pandemic has to be clear, calm, and compassionate efforts to address the concerns of vaccine hesitant New Zealanders.
Medsafe’s provisional approval includes several conditions, relating to requirements for additional manufacturing data as the company scales up production and further updates from clinical trials from around the world. Requirements of this type are not unusual for evaluations of new therapeutics products, and were anticipated.
Unlike other countries, there will be no emergency authorisation process in New Zealand for COVID-19 vaccines. Indeed, Medsafe does not have the ability to grant emergency use authorisation. However, Medsafe has stated that it has streamlined its processes in order to prioritise the evaluation of COVID-19 vaccines, without compromising the integrity of the process or the safety of the vaccines.
The other three vaccines in the New Zealand portfolio of negotiated purchase agreements, from AstraZeneca, Janssen and Novavax, have yet to complete the Medsafe evaluation process.
Medsafe has conducted a thorough assessment of the Pfizer vaccine and it is great news for New Zealand that it has been approved for use.
The Pfizer vaccine is highly effective at preventing symptomatic SARS-CoV-2 infection (COVID-19). Along with other vaccines that have been shown to be effective in clinical trials, it will be an important tool for the control of SARS-CoV-2, both in New Zealand and around the world. It is an outstanding effort to have a licensed and highly efficacious vaccine within 13 months of the emergence of a new pathogen. It highlights the power of the RNA vaccine platform.