What side-effects are known from COVID-19 vaccines and should we be concerned?

Covid-19 Vaccine Side Effects

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Health authorities are reacting to the suspension and review of the AstraZeneca COVID-19 vaccine in several European countries, following reports of severe side-effects. But what side-effects could occur after receiving a COVID-19 vaccine, and are they cause for concern?


Highlights
  • Symptoms can include a sore arm, mild fever or elevated temperature, headache, muscle aches or skin rash.
  • Professor Peter Collignon from the Australian National University says side-effects are common even with non-COVID vaccines, such as those that protect you from the flu.
  • Women may experience stronger side-effects of COVID-19 vaccines than men, because of hormones.
"Some people get no side-effect at all. Nothing. While others sometimes get a little headache. This isn't unusual. Your body is working hard to develop really important antibodies to COVID. Don't be surprised if you just don't feel normal. That is not dangerous."

 Professor Marylouise McLaws is an epidemiologist and an advisor to the World Health Organisation.

 She is a leading voice on the coronavirus pandemic in Australia. She says the banning of some vaccines in Europe because of side-effects is an over-reaction. Denmark, Norway, Italy and Iceland have temporarily suspended their administration of the AstraZeneca COVID-19 vaccine, following reports of severe blood clots. The European Medicines Agency has launched an investigation into these reports, which include an Austrian woman who died from multiple thromboses just over a week after inoculation.

 Professor Julie Leask  is a an infectious disease and immunisation expert from the University of Sydney. She says government leaders will respond differently but public confidence and protection from COVID-19 remains a priority.

 "They need to keep investigating that. Some countries, while they are investigating that, will pause the vaccine program, investigate it, make sure they are on balance, make sure it is not the vaccine and then resume the vaccination program. Other countries will say no, we are going to keep the vaccination program going, because we still want to get that COVID-19 protection into people and we are willing to tolerate this little risk, this little bit of uncertainty temporarily."

Professor McLaws says severe side-effects are not expected in Australia.

"This particular woman, who has died of a clot, there are many things the reviewers have to look at: what side of the body it was on, was it related to the side that she had the injection, were her lymph glands in her groin large, did she have a history of clots in varicose veins? Australia is not expecting this at all. The UK have had over 24 million people injected and not one adverse event."


 

 

A spokesperson from AstraZeneca issued this statement on the issue:

"Patient safety is the highest priority for AstraZeneca. Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine. The safety of the vaccine has been extensively studied in Phase Three clinical trials and Peer-reviewed data confirms the vaccine is generally well-tolerated."

So, what side-effects can we expect from COVID-19 vaccines?

Some recipients overseas have reported symptoms of fever and fatigue. Medical experts say this is common with all kinds of vaccinations, and tend to fade away after 24 to 48 hours. Symptoms can include a sore arm, mild fever or elevated temperature, headache, muscle aches or skin rash.

 Professor Leask says there are also some rare but serious side-effects. 

"Like for example severe allergic reaction, or anaphylaxis. That is known to occur with the COVID-19 vaccine at a rate of about 5 in every million people vaccinated. Then there are times when you might wonder whether there is a rare serious side-effect occurring, because you get reports of people getting, things like in this case, clotting problems after they have received the vaccine."

 Are side-effects something to worry about?

 Research shows about 200 people for every 100,000 have blood clots form in their lungs or in their legs each year. Reactions may be generally unpleasant but they are usually short-lived and not serious. Vaccines are extensively tested for safety before they are approved. Once they are in large-scale production, they are monitored in a process called 'post-marketing' surveillance, which looks for unexpected or rare reactions that were not recorded in trials.

 Ms Mclaws says vaccines would not be aproved for use in Australia if they were likely to cause severe or long-lasting side-effects.

"Emergency authorities have approved these vaccines because they have very low serious side-effects. They have sore arms, muscle pain, a bit of fever. We have heard of at least three (cases) around the world that have had a couple of deaths and now this 60 year old woman with a clot. These are very, very, very rare and none of them yet have been linked to the vaccine itself."

 Professor Peter Collignon  from the Australian National University says side-effects are common even with non-COVID vaccines, such as those that protect you from the flu.

"You have to remember, if you are in a country like England or the US you have a high chance of getting COVID, unlike Australia. If you get it and you are over the age of 80 you probably have a 1 in 5 chance of dying. So even if you do see a side-effect that is 1 in 100,000 or 1 in 500,000, if your chance of dying is 100 times higher than that or more you are silly not to take the vaccine. Every vaccine will have side-effects, some will even have serious side-effects. So far this appears to be no worse than the influenza vaccine for side-effects but much more effective against a disease that is probably 10 times more lethal."

 Why might women have stronger side-effects than men?

Vaccines are designed to mimic natural infection without contracting the actual disease, thus generating immunity.

 Professor McLaws says women can experience stronger side-effects from the Moderna vaccine. This is because the estrogen in women's bodies forces a stronger immune response, whereas testosterone in men is a hormone that slows down the response.

 So how might this affect Australia's vaccine rollout?

 Of the almost 90,000 ((86,369)) Australians vaccinated so far, the Therapeutic Goods Administration ((TGA)) says its monitoring services have not detected any new safety concerns in relation to COVID-19 vaccines. The Administration warns older age and underlying illnesses make it more likely that coincidental adverse events, including deaths, will occur.

Prime Minister Scott Morrison says the TGA will continue to review data.

 "All the data from all of the places that we have relationships (with), which obviously includes Europe, is being fed into the TGA. That data is examined and that what informs the decisions that we take here in Australia. Remember, the batches that we distribute across Australia are tested here in Australia. So we have a robust process for examining that. I trust our Therapeutic Goods Administration."

 Labor Deputy leader Richard Marles told the Nine Network he too trusts the judgement and testing processes of the TGA.

 "It really is important that we do have cool heads in this space. The TGA have gone through this very carefully. We need to be rolling out the vaccine and there does need to be a sense of confidence about this and people can rightly feel confident about the safety of the vaccines."

And finally, how should you report issues regarding side-effects?

Firstly, if it is an emergency call 000. 

If you're concerned about something you feel after getting your vaccine, you should seek advice from a health professional like your GP. Or you can call the Medicinewise Adverse Medicine Events line on 1300 134 237.

Or report online by filling out a form at

 


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