COVID and VACCINES IN GENERAL

Medsafe is New Zealand’s medicines safety authority. It evaluates applications for all new medicines, including vaccines, to make sure they meet international standards and local requirements.

COVID-19 vaccines are being held to the same standards and requirements as all vaccines before they get full approval. This is the same process used to assess other medicines, like the flu vaccine.

There have been no shortcuts taken in granting approval. Medsafe will only recommend a medicine is approved to use in New Zealand if it meets these standards.

Three vaccines are approved in Aotearoa. Medsafe has granted provisional approval of the Janssen (Johnson & Johnson) and the AstraZeneca COVID-19 vaccine. This does not mean we will use these vaccines in Aotearoa, that will need a decision by Cabinet on any future use. However, Aotearoa has purchased enough Pfizer vaccines for the entire country to be vaccinated.

There is a focus on providing vaccinations to everybody in Aotearoa but Māori currently have lower rates of vaccination and are likely more susceptible to the symptoms of COVID-19.

The vaccine is safe for children as young as 12.

Medsafe only grants consent for using a vaccine in Aotearoa once they’re satisfied it has met strict standards including for safety, efficacy and quality.

The Pfizer vaccine has been approved for 12-15year olds in Canada, USA, Europe and Japan.

No. The Pfizer vaccine will not affect your genes or fertility. The mRNA from the vaccine does not enter the nucleus of any cells, which is where your DNA is.

Above 95% protection. Pfizer’s study in 12 to 15years looked for signs of a strong immune response to the vaccine. Pfizer reported 100% efficacy in this age group (a higher antibody response than those studied in the 16 to 25 age group)

Our iwi health providers, Ngati Porou Hauora & Turanga Health and our District Health Board are holding clinics across the rohe. You can find a vaccination clinic near you by clicking this link.

The vaccine does not stop you from getting COVID-19 although rates of infection for those fully vaccinated are far lower compared to those unvaccinated.

The vaccine helps prevent your from getting infected and having COVID-19 symptoms, or severe illness. This means you could have no COVID-19 symptoms or will have much fewer, milder symptoms and recover faster.

No, once you are fully vaccinated then you’re far less likely to get infected, have COVID-19 symptoms, or severe illness.

Getting a COVID-19 vaccine is an important step you can take to protect yourself, your kaumātua and whānau from the effects of the COVID-19 virus. It’s one way we can protect the welfare and wellbeing of our communities from COVID-19.

Like all medicines, you might experience some mild side effects 1—2 days after getting your vaccination. This is common, and a sign that your body is learning to fight the virus.

Most side effects do not last long and will not stop you from having a second dose or going about your daily life. Some side effects may temporarily affect your ability to drive or use machinery.

The most common reported reactions are:

  • pain or swelling at the injection site
  • feeling tired or fatigued
  • headache
  • muscle aches
  • chills
  • joint pain
  • fever
  • redness at the injection site
  • nausea.

The fact a vaccine is safe does not rule out some side effects. All medicines and vaccines carry the risk of some reaction.

Severe side effects are very unlikely, but include anaphylaxis – a severe, life-threatening allergic reaction – occurring most often in those with a history of allergy. Medsafe have concluded that myocarditiis – inflamation of the heart muscle after vaccination is also a rare side effect of the Pfizer vaccine. If you have any questions about your current health conditions and what effect the vaccine may have, contact your local healthcare professional.

The Pfizer vaccine (Comirnaty) is an mRNA vaccine that contains the genetic code for an important part of the SARS-CoV-2 (COVID-19) virus called the ‘spike protein’. Spike proteins are the little projections on the surface of the virus.

  • Once you’ve had the vaccine, your body reads the genetic code and makes copies of the spike protein.
  • Your immune system detects these spike proteins and learns how to recognise and fight against COVID-19. It knows it needs to attack the virus to protect it from spreading in your body.
  • The genetic code then gets broken down and removed very quickly and easily by our body.

mRNA vaccines have been developed through major international collaboration.

Researchers have studied and worked with mRNA vaccines for decades. This includes studies for vaccines against flu, Zika, rabies and cytomegalovirus (CMV). Scientists have also researched past coronavirus infections (SARS and MERS). Once scientists identified the coronavirus that causes COVID-19, they could quickly adapt the technology for COVID-19.

Although it’s relatively new technology, this vaccine has gone through all the usual safety checks and regulations. This includes international clinical trials to help demonstrate the efficacy and safety of the vaccine. The Pfizer vaccine is being used worldwide and continually and closely monitored for effectiveness and safety.

There’s never been this level of global collaboration amongst scientists and governments in vaccine development. This has improved the speed of its development and the launch of clinical trials around the world.

Researchers were able to use their knowledge of other coronaviruses and vaccine development to give them a head start.

Clinical trials were also able to recruit large numbers of volunteers faster than usual because of the worldwide interest and concern about COVID-19. Some clinical trials could be done at the same time instead of one after the other. This meant they could quickly determine whether the vaccine was effective in a short amount of time – under normal circumstance this could take many months or even years.

Large manufacturing plants have been developed, so vaccines can be produced faster and on a larger scale than was previously possible.

The vaccines have been developed very quickly but without taking any shortcuts in the necessary processes or compromising safety.

2 doses. It’s very important you get your second dose; you’ll have your best protection once you’ve had both. Both doses of the Pfizer vaccine are the same. The second dose increases your protection – giving you better and likely longer-lasting immunity than the first dose alone.

The vaccine helps prevent you from getting infected and having COVID-19 symptoms, or severe illness. This means you could have no COVID-19 symptoms or will have much fewer, milder symptoms and recover faster.

Tamariki who are 11 and under currently don’t have the opportunity to be vaccinated are more likely to contract COVID-19 from an unvaccinated person.

There are no safety concerns about getting the Pfizer vaccine if you’re breastfeeding (as with all vaccines on the New Zealand Immunisation Schedule). When you’re vaccinated, this can also provide some protection against COVID-19 for your baby through your breastmilk.

Summary of ingredients

The Pfizer vaccine contains

  • messenger RNA encoding SARS-CoV-2 spike protein
  • lipid nanoparticle – a stabilised fat-based bubble to protect and carry the mRNA into our cells
  • salt buffers – to maintain the pH of the vaccine
  • sucrose – to protect the vaccine while in storage.

Active ingredient

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 make sure 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 very cold temperatures (-80 degrees celsius that the vaccine is stored at).
  • 6 mg sucrose

The Pfizer vaccine does not contain

  • animal products
  • antibiotics
  • blood products
  • DNA
  • egg proteins
  • fetal material
  • gluten
  • microchips
  • pork products
  • preservatives
  • soy
  • latex (the vial stopper is made with synthetic rubber – bromobutyl).

Common side effects

In the clinical trials, common side effects were reported in every 1 in 10 to 1 in 100 people. These include:

  • pain or swelling at the injection site
  • feeling tired or fatigued
  • headache
  • muscle aches
  • chills
  • joint pain
  • fever
  • redness at the injection site
  • nausea

Uncommon side effects

In the clinical trials, uncommon side effects were reported in every 1 in 100 to 1 in 1,000 people. These include:

  • enlarged lymph nodes
  • feeling unwell
  • pain in limb
  • insomnia
  • itching at injection site

Rare side effects

Temporary one-sided facial drooping and temporary inflammation of the heart wall (myocarditis) have been reported as rare side effects, affecting every 1 in 1,000 to 1 in 10,000 people.

https://www.medsafe.govt.nz/safety/Alerts/comirnaty-myocarditis-alert.htm

Clinical trials for a COVID-19 vaccine are designed to assess the safety and efficacy of the vaccine. The Pfizer vaccine has been assessed in global studies across three phases.

  • Phase one and two assessed the safety and immunogenicity (the immune response after each dose) of different dose levels of the vaccine in a small population.
  • Phases two and three assessed the safety and efficacy of the vaccine against symptomatic COVID-19 after two doses of the chosen level, given 21 days apart, in a larger population.

In addition, early findings from a small number of well-designed studies, show that an extended gap of 6 weeks or more between doses of the Pfizer vaccine gives at least an equally robust immune response.

Ongoing clinical trials, safety monitoring, and real-world data from COVID-19 vaccination programmes worldwide provide us with useful information. This includes the long-term safety and benefits of the vaccine.

To understand the long-term efficacy and safety of the vaccine, participants in the clinical trials are tracked for at least two years from their second dose of the Pfizer vaccine.

Participants will:

  • have their health monitored
  • attend regular follow-up visits.

This is closely observed by Pfizer/BioNTech and an independent group of experts called the Independent Data Monitoring Committee. They decide if a clinical trial can continue.

Regulatory authorities, like Medsafe, have procedures to closely review all new data and will update their recommendations as this becomes available.

On June 30 2021, Medsafe published its provisional approval of the Pfizer/BioNTech vaccine for 12- to 15-year-olds in New Zealand.

Medsafe’s experts only grant consent for a vaccine to be used in New Zealand/Aotearoa once they are satisfied it has passed required levels of safety and effectiveness.

The Pfizer/BioNTech vaccine has already been approved for 12- to 15-year-olds in Canada, the USA, Europe and Japan.

Pfizer’s study in 12- to 15-year-olds looked for signs of a strong immune response to the vaccine. Pfizer reported 100 percent efficacy in this age group (a higher antibody response than those studied in the 16- to 25-year-old age group).

The process used to assess the safety of the vaccine is the same robust process used to assess other medicines, like the flu vaccine.

Medsafe publishes weekly reports summarising the number and type of adverse events following immunisation (AEFI) reported with COVID-19 vaccines. Please note there is a time lag between receipt of AEFI reports and publication of the weekly report.

https://www.medsafe.govt.nz/COVID-19/vaccine-report-overview.asp

All across the world. As at 16th September, 217.8million people have had the Pfizer vaccine. This is the largest amount of any available vaccines across the world.

The Pfizer vaccine has shown to be safe and effective overseas. Hospitalisations and severe symptoms are largely of those who are unvaccinated.

Medsafe continues to monitor vaccine efficacy against any new COVID strains but the Pfizer vaccine continues to be effective against COVID-19.

If you’re pregnant, you can get a COVID-19 vaccine at any stage of your pregnancy.

We encourage you to get the vaccine because while you’re pregnant you can become very sick if you get COVID-19.

Data from the large number of pregnant people already vaccinated globally shows that there are no additional safety concerns with giving COVID-19 vaccines.

Vaccinating during pregnancy may also help protect your baby as there’s evidence that infants can get antibodies to the virus through cord blood and breast milk.

If you have any questions or concerns, discuss them with your health care professional