Since COVID-19 first upended our lives in early 2020, a vaccine has been considered our ticket back to ‘normal life’.
This week, we got one step closer to that goal, with the national medicines regulator approving the first COVID-19 vaccine (from Pfizer) for use in Australia.
While most of us are eager to get immunised, many people still have questions about the safety of the incoming vaccines.
With the help of vaccine experts, we’ve answered five of the most common questions identified by the ABC and Google Trends.
Are COVID-19 vaccines safe?
In order for a vaccine to get approved for use in Australia, it needs to go through a series of rigorous safety checks.
The Therapeutic Goods Administration (TGA) — which is responsible for approving vaccines — carefully assesses the results of vaccine trials, makes sure manufacturing standards are up to scratch, and uses its own laboratories to “assess the quality of every batch of a vaccine before it can be supplied”.
Earlier this week, the TGA said following a thorough and independent review of Pfizer’s COVID-19 vaccine submission it decided the vaccine met the high safety, efficacy and quality standards required.
The approval is on a provisional basis, meaning it is valid for two years, and allows the vaccine to be supplied in Australia for people aged 16 and older.
The Therapeutic Goods Administration has given the Pfizer vaccine the green light.(ABC News)
All other COVID-19 vaccines undergoing evaluation by the TGA (including the Oxford-AstraZeneca vaccine) will also have to meet the same strict safety requirements.
Like any vaccine approved for use in the community, COVID-19 vaccines have been studied extensively across multiple pre-clinical and clinical trials.
The process begins with research on cells and animals in the lab (these are the pre-clinical studies), and then progresses to large-scale testing in humans (these are the clinical trials).
Over a period of several months, more than 43,000 people were involved in the clinical trials for the Pfizer vaccine, and another 23,000 were included in the Oxford-AstraZeneca trials.
Both vaccines were found to be effective at stopping people getting sick (to differing degrees), and both companies reported very few serious side effects (more on those below).
What are the ingredients in COVID-19 vaccines?
COVID-19 vaccine ingredients vary depending on the vaccine.
According to the Department of Health, vaccines may contain some of the following ingredients:
a protein component of a virusa piece of genetic code (DNA or mRNA)a very small dose of a weakened virusa substance to boost the immune response (an adjuvant)a small amount of preservativesterile salt water (saline) for injections
The newly-approved Pfizer vaccine contains mRNA (which encodes the SARS-CoV-2 spike protein), plus a handful of pharmaceutical ingredients that help to stabilise it. You can find a full list of the ingredients on the vaccine’s product information sheet on the Australian Register of Therapeutic Goods.
Once other COVID-19 vaccines are approved by the TGA, their specific ingredients will also be listed here.
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Read moreAre there any side effects?
People who get immunised may experience some mild side effects, and these have been reported in places where COVID-19 vaccines have been rolled out.
The US Centers for Disease Control describes these as ‘normal signs that your body is building protection’.
Common side effects include:
pain and swelling in your arm (where you get the jab)tirednessheadachefeverchills
Severe side effects from vaccination are rare, but sometimes can emerge after a vaccine or drug has been rolled out in the community and tested on millions of people.
To date, there have been very few serious side effects reported following COVID-19 vaccination, however there have been some instances of severe (though treatable) allergic reactions.
Health authorities estimate the rate of anaphylaxis (the most severe type of allergic reaction) is about 11 cases per 1 million doses of the vaccine — a rate they describe as “exceedingly rare”.
There have also been reports of several deaths in frail, elderly people in Norway who received the Pfizer COVID-19 vaccine.
Despite some initial concern, the Global Advisory Committee on Vaccine Safety has since found the vaccine was not the likely cause of the deaths and recommends older people still get vaccinated.
One person out of the 11,000 people included in the Oxford-AstraZeneca vaccine trial results experienced transverse myelitis, a very rare condition that involves the inflammation of the spinal cord, but it is unknown whether or not this is related to the vaccine (another person who received the placebo also experienced transverse myelitis, as did another person with a history of multiple sclerosis).
Space to play or pause, M to mute, left and right arrows to seek, up and down arrows for volume.WatchDuration: 2 minutes 59 seconds2m 59s Scott Morrison confirms the TGA has approved the Pfizer COVID-19 vaccine for Australians.Could there be some long-term side effects?
Rare but serious side effects are why health authorities continue to closely monitor vaccines once they’ve been approved for use.
So far, no long-term adverse effects have been reported in people who participated in clinical trials (who were immunised several months ago), but researchers will continue to keep a close eye on them.
Similarly, regulators like the TGA will oversee the safety of COVID-19 vaccines in the community for several years after they have been approved.
Because the approval of the Pfizer vaccine is on a provisional basis, the company is required to keep providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment.
It’s also worth noting that while serious side effects from vaccination are rare, people who get infected with COVID-19 can become seriously ill and/or suffer debilitating symptoms months after infection.
Read more about coronavirus:Who shouldn’t get the COVID-19 vaccine?
In general, it’s safe for most people in the community to be immunised, but there are some exceptions.
When it comes to the Pfizer vaccine, the TGA recommends anyone who is allergic to any ingredients in the vaccine does not get immunised. People with a history of allergies not related to vaccines are still recommended to get the COVID-19 jab.
The TGA, however, recommends you speak to your doctor first if you:
have had a severe allergic reaction or breathing problems after any other vaccine (or after being given the first dose of a COVID-19 vaccine)have fainted following any needle injectionhave a severe illness or infection with high feverhave a weakened immune system (such as due to HIV infection or are on a medicine that affects your immune system)have a bleeding disorder, bruise easily or are on a blood thinning medicine
If you are pregnant or breast-feeding, or are planning to have a baby, you should also talk to your GP first before getting a COVID-19 vaccine.
For expert input into this article, we thank: Dr Kylie Quinn, vaccine expert, RMIT University.
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