As you may be aware that the COVID vaccinations are currently being rolled out in New Zealand.
We are getting several enquiries about this daily.
Frequently Asked Questions:
Who is currently eligible to have COVID-19 vaccines?
The Government has directed that anyone in New Zealand over the age of 12 years old, whether they are eligible to publicly funded health services or not, will be eligible to COVID-19 vaccination until 31 December 2021.
Which COVID-19 vaccines are likely to be available for New Zealanders?
Currently, one COVID-19 vaccine (Comirnaty™, an mRNA vaccine by Pfizer/BioNTech) is available in New Zealand. Work is ongoing to procure further safe and effective vaccines.
As of December 2020, the New Zealand Government has Advanced Purchasing Agreements (APA) with Pfizer/BioNTech, Janssen, AstraZeneca/Oxford and Novavax. This means there is an arrangement to buy a pre-planned number of doses of vaccines from these companies if their vaccines are proven to be safe and effective. Also, as part of a global collaboration called COVAX, New Zealand will have access to additional vaccines. For more information about COVAX, please click here.
Will we still need other COVID-19 prevention measures such as social distancing if a COVID-19 vaccine is available?
As not all New Zealanders will be vaccinated at once, the current public health measures, including social distancing, mask usage, rapid contact tracing and managing cluster outbreaks, will continue for some time. With an effective vaccine programme, it is anticipated that these control measures can be reduced, albeit slowly. This will rely on a high proportion of the population being immunised.
Who can administer COVID-19 vaccines in New Zealand, and how are they trained?
Staff administering COVID-19 vaccines must be authorised vaccinators or qualified medical staff. The criteria for nurses to become authorised vaccinators is set out in Appendix 4 of the Immunisation Handbook. Training for administering the COVID-19 vaccines is in addition to this criteria; therefore, all vaccinators are already qualified and experienced.
What is the process New Zealand vaccinators are following to administer COVID-19 vaccines?
Vaccinators are following normal best practices in drawing up and administering the Pfizer/BioNTech vaccine. This is consistent with standard immunisation guidelines. Some nurses find they can sometimes get up to six doses out of the vial, compatible with what Pfizer has indicated.
How mRNA vaccines, like Comirnaty, work?
After injection, the mRNA contained within its lipid bubble is taken up by specialist immune cells (dendritic cells) in the muscle near the injection site. Using our cells’ protein-making machinery, the mRNA provides the recipe to make a new protein known to trigger an excellent immune response. As usually occurs in our cells, after the protein has been made, the RNA is broken down, and its components are recycled – its job is done.
Next, the protein produced is carried by the cell to the local lymph node. The protein is shown to lymphocytes (T and B cells) in the lymph node to stimulate a targeted immune response. In this way, the body recognises this virus component to provide future protection against the wild-type virus.
In the case of the COVID-19 vaccine, the protein made is a duplicate of the spike protein found on the surface of the SARS-CoV-2 virus (the virus that causes COVID-19). On the virus, this protein enables the virus to infect the cells in our airways. The vaccine targets our immune response against this spike protein to block the virus from entering our cells and stop infection. As a second line of defence, this primed immune response can also quickly kill any cells infected with the virus if it cannot completely block the initial infection. Watch this video for more information.
Two doses of the vaccine provide highly effective and lasting immunity against the virus.
How protective is this vaccine?
Protection against COVID-19
Vaccine efficacy is the measure of how well a vaccine protects in a clinical trial setting with a controlled population and compared with control groups – either another vaccine or a saline placebo. Participants are recruited based on predefined criteria and monitored for specific outcomes known as ‘primary endpoints’.
The Comirnaty clinical trial primary efficacy endpoint was the occurrence of symptomatic COVID-19 at least seven days after the second dose. After a known surveillance time (2,200 person-years in each group), the study observed 162 cases of COVID-19 in the placebo group compared with 8 cases in the vaccinated group – this gave a vaccine efficacy of 95%. In other words, 95 out of 100 people vaccinated are protected against symptomatic COVID-19.
Vaccine effectiveness is measured in real-world situations with a broader population. One way to measure it is to compare vaccinated with unvaccinated people to see if they catch COVID-19. In Israel, they reviewed surveillance data from over 6 million fully vaccinated people and found the vaccine was as effective in real life as in clinical trials; 7 days following two doses of Comirnaty, vaccine effectiveness against SARS-COV-2 infection was found to be 95% against symptomatic COVID-19 and 97% each against hospitalisation and COVID-19-related death. Recent preprint data from the UK shows that after two doses, Comirnaty is highly effective against symptomatic COVID-19 (80-95%), over 90% against hospitalisation and death.
Protection against spreading the virus
Protection after vaccination can last longer by slowing the spread of the virus. This will work in two ways – to reduce the amount of virus in the community to lower your chance of being exposed to an infected person and to lower the risk of more infectious and virulent strains emerging that may bypass any immunity generated by the vaccine.
An ideal vaccine stops everyone from carrying and passing on the infection and protects them from becoming seriously ill. Initially, data from Israel showed that its mass COVID-19 vaccination campaign (using the Comirnaty vaccine) was working well with two doses cutting documented infection by 92% across all vaccine-eligible age groups. Data reported by the CDC in the US has also shown that mRNA COVID-19 vaccines were 90% effective in health care workers against SARS-CoV-2 infection (with and without symptoms). These data showed that Comirnaty could prevent infection as well as symptomatic disease. However, its ability to do this has been reduced with the more infectious variants, such as the Delta variant. Still, data from the UK shows that Comirnaty remains around 80% effective against infection.
When the vaccine can only stop the symptoms of the disease but cannot stop the virus from infecting us and reproducing, then the virus may still be able to be spread to those who are not immunised or have a suboptimal response. Even in this case, if infected, the time you are infectious and producing the virus is much shorter, which helps to slow the spread. Reducing the number of people with symptoms will help control the spread of the virus because fewer people will be producing large quantities of the virus and spreading it by coughing. See this Conversation article for further information on infection in vaccinated individuals.
However, particularly with the emergence of more transmissible virus variants, this potential limitation highlights the importance of continuing to follow public health advice such as mask-wearing, contact tracing, hand washing and isolating when unwell, even post-vaccination. Find more information here.
How long does protection last?
It remains uncertain how long Comirnaty will protect against COVID-19. As part of the conditional approval of the COVID-19 vaccine, further data will be provided on the durability of the immune response post-vaccination in the coming months. The original clinical trial data confirmed protection for at least two months, and more recent data released by Pfizer in April 2021 showed protection for at least six months. This is similar to those who have had COVID-19; in New Zealand, antibodies have been shown to last for at least eight months without any further boosting.
After vaccination, immune memory of the spike protein in the lymph nodes that can produce high quality and durable antibody responses against SARS-CoV-2 spike protein has been reported.
The duration of protection against COVID-19, both after vaccination and after the SARS-CoV-2 infection, is dependent on a combination of the following factors and will vary between individuals, countries and changes in the virus.
If you had the virus and recovered, will you still be able to or need to get the vaccine?
Vaccination is being offered to people who have and have not had SARS-CoV-2 infection previously. Data from clinical trials and from countries with a lot of COVID-19 cases have shown the vaccines to be safe and effective in this group of people. It is expected that the vaccine will boost the immune response and provide good protection for those who have previously had SARS-CoV-2 infection. For more information, please click here.
Will the vaccine make a person test positive on COVID-19 tests?
No. The nasal swab detects the virus genetic material not proteins, such as antibodies or spike protein. You must be infected by the virus for the genetic material to be detectable in your nose.
Also, the spike protein that is made in using the vaccine’s instructions does not travel far and will not reach your nose because your immune system sees it as foreign and quickly removes it. Likewise, the RNA in the vaccine is also destroyed very quickly if it gets outside of your arm muscle and will not be detectable in your nose.
Can I have other vaccines if I have had a COVID-19 vaccine?
Currently Medsafe advice is only available for the mRNA vaccine from Pfizer/BioNTech (Comirnaty™) vaccine. A two-week gap is recommended between any influenza vaccine and the Pfizer COVID-19 vaccine, and a four-week gap is recommended following MMR or any other vaccine. Please note that two doses of the mRNA vaccine are required, given at least 21-days apart. These recommendations are likely to be reviewed.
I am due an MMR vaccine, but I am also due a COVID-19 vaccine. Which is the priority?
COVID-19 vaccine should be given priority over the MMR vaccine. It is recommended to complete the COVID-19 vaccine course (i.e. two doses, at least 21 days apart) before having the MMR vaccine. Please book to have your MMR four weeks after completion of your second COVID-19 vaccination so that the opportunity to be protected against measles is not lost.
The COVID-19 mRNA vaccine two-dose schedule should take priority over the influenza (flu) vaccine. Patients are recommended to receive two doses of the COVID-19 vaccine given 21 days apart and then wait two weeks before receiving a flu vaccine. Please book to have your influenza vaccine two weeks after completion of your second COVID-19 vaccine so that the opportunity to be protected against influenza is not lost.
Will COVID-19 vaccines be safe?
COVID-19 vaccines are being held to the same high safety standards as all vaccines. They will not be given approval for use in New Zealand until sufficient data on both safety and how well the vaccine works (efficacy) have been extensively reviewed. All clinical trials involve an independent safety monitoring committee that oversees safety and decides if it is safe to continue should adverse events arise, albeit coincidentally. Furthermore, tens of thousands of participants were enrolled in each Phase 3 trial, and mass vaccination campaigns involving millions of people are currently underway. Safety information on those who have been vaccinated is being carefully collected and closely monitored. We can be confident that no shortcuts with regards to safety have been taken even though these vaccines have seemingly been produced quickly (see more below).
Is it true that they are skipping steps to make a vaccine more quickly?
No. It is true that COVID-19 vaccines have been produced faster than previous vaccines, but this is not because steps are being skipped. Instead, a combination of increased funding, international collaboration and removing barriers that usually slow progress (i.e. by doing some of the processes at the same time rather than one after the other) has sped up progress. Further information on this topic is available here.
Can mRNA vaccines change the DNA of a person?
No. RNA vaccines do not interact with a person’s genome as our genetic material is contained within the nucleus of our cells, and mRNA cannot enter this area. Following injection with an mRNA vaccine, the mRNA is taken up locally by cells where the instructions to produce the immune system stimulant are followed. At this point, the RNA is broken down, ready to be recycled. For more information on RNA and DNA vaccines, please click here.
Can COVID-19 vaccines be safely given to frail and older adults?
Following reports of deaths of frail, elderly adults in residential care facilities after COVID-19 vaccination, independent reviews by both the CDC and the WHO concluded that the mortality rate in this population is high and a substantial number of deaths will occur coincidentally following vaccination. There are no safety concerns around giving the COVID-19 vaccine to older and frail adults.
Can mRNA COVID-19 vaccine affect fertility or affect future babies?
There is no biologically plausible reason why this vaccine could have any effect on our genes or fertility. Upon injection, the lipid nanoparticle containing the mRNA is taken up by specialised cells (dendritic cells) at the injection site in the arm. These cells use the instructions from the vaccine mRNA to make only the SARS-CoV-2 spike protein, and the mRNA degrades rapidly. The mRNA from the vaccine does not enter the nucleus of any cells. Furthermore, no components of the vaccine or the spike protein produced to reach the ovaries or the testes. More information about how this concern arose can be found here.
What are the ingredients of COVID-19 vaccine available in New Zealand?
Vaccine ingredients depend on the type of vaccine. As vaccines are approved for use, the contents and presentation of each vaccine is published by Medsafe as a data sheet and consumer medicine information. These form part of the information that companies submit during the approval process. See below vaccine ingredients from two vaccine candidates which are being used in COVID-19 vaccination programmes internationally.
Comirnaty ™, manufactured by Pfizer/BioNTech
The Pfizer/BioNTech mRNA vaccine (Comirnaty™; also known as BNT162b2) contains:
30µg of a nucleoside modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2
Fats (these ingredients make up the lipid nanoparticle which is the transport mechanism for the active ingredient to make it inside a cell without being broken down)
0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
0.09 mg 1,2-distearoyl-sn-glycero-3- phosphocholine
0.2 mg cholesterol
Salts (these ingredients help ensure the vaccine pH is close to that of human cells)
0.01 mg potassium chloride
0.01 mg monobasic potassium phosphate
0.36 mg sodium chloride
0.07 mg dibasic sodium phosphate dihydrate
Sugar (this ingredient protects the lipid nanoparticle at the very cold temperatures (-80 degrees C that the vaccine is stored at)
How are vaccines authorised in New Zealand?
All medicines approved for use in New Zealand, including vaccines, go through strict review by Medsafe to make sure they meet local and international safety and efficacy guidelines. Once Medsafe has reviewed all available data, it will make a recommendation to the NZ Government as to whether a medicine can be granted approval in NZ. More comprehensive information on this process is available on the Medsafe website. For further information on vaccine approvals in New Zealand, click this video link here.
What does provisional approval mean in New Zealand?
The mRNA COVID-19 vaccine by Pfizer/BioNTech was granted ‘provisional’ approval for use in New Zealand on 3 February 2021. This means that it has been approved for use in a defined group and on the condition that Medsafe continues to receive and review further data about this vaccine’s safety and effectiveness. Click here to find out more.
This approval differs from that granted in other countries, such as the US, UK and in Europe, in which these vaccines were granted ‘emergency-use approval’ based on early data and an urgent need to start vaccinating soon as safely possible. New Zealand has been fortunate to be able to wait, while receiving the most current clinical trial and post-licensure data, to make the decision to approve the use of this vaccine. Once sufficient data as been obtained, it is likely that Medsafe will convert the provisional consent to full consent in due course.
Updated 17 October 2021