COVID vaccines have been developed in record time. But how will we know they are safe?

With the rollout of COVID-19 vaccines about to begin in Australia, people may wonder if they are safe (and effective) in the long term. What could be the health consequences one year after vaccination or in the future?

While it’s true that COVID-19 vaccines have been developed in record time, the importance of vaccine safety monitoring is not new. We regularly monitor the safety of all vaccinations, years after they have been used in millions of people.

And in advice from the Therapeutic Goods Administration (TGA) this week, we have a clearer idea of ​​how we’ll know any unexpected, rare, or long-term side effects from COVID-19 vaccines. In fact, we are going to use and build on a lot of existing systems to research them.

Read more: Less than a year to develop a COVID vaccine – here’s why you shouldn’t be worried

Vaccine trials tell us a lot

Late-stage vaccine trials on tens of thousands of people only last for a defined period of time, usually 12 months. Vaccine manufacturers submit vaccine safety (and effectiveness) data for this period to regulatory authorities. Safety data is rigorously evaluated before a vaccine is approved for use.

But when approved vaccines are then given to the general public, we can watch for any new events that might unexpectedly arise both in the short and long term. Tracking potential side effects in the real world in everyone who has a vaccine, and outside of the tightly controlled conditions of a trial, means we can make sure the vaccine is safe when given to millions. – or billions – of people.

Learn more: How will COVID-19 vaccines be approved for use in Australia?

So how could this work for COVID-19 vaccines? The Pfizer / BioNTech Phase 3 vaccine trial reported safety data up to approximately 14 weeks after the second dose. The Oxford / AstraZeneca trial reported safety data approximately three months after the first dose and two months after the second dose.

However, participants in these two large trials will continue to be followed for both efficacy and safety until the end of the study, approximately 12 months after the first dose of vaccine.

The safety of COVID vaccines is monitored in several other ways as well, by individual countries, including Australia. Countries also share their vaccine safety surveillance data through a global database.

Read more: People with severe allergies have warned about the Pfizer COVID vaccine at this time. But that may change as more details emerge

Here’s how we will monitor COVID vaccine safety in Australia

The TGA has overall responsibility for overseeing drug and vaccine safety in Australia. Just this week, the TGA released its plans to monitor the safety of COVID-19 vaccines.

This includes the timely collection and management of reports of adverse events related to the COVID-19 vaccine, the ability to urgently detect any safety concerns, and to communicate safety concerns to the public.

“ Passive ” surveillance

“Passive” surveillance is the cornerstone of the system Australia has put in place for decades to capture possible vaccine reactions. In practice, this means that anyone can report a reaction to the TGA, including the public.

If your GP or nurse thinks you may have had a reaction, they should notify their state or territory’s health department, which then informs the TGA. This is mandatory in some jurisdictions but not in others.

The TGA encourages healthcare professionals and consumers to report suspected side effects of COVID-19 vaccines and there is a guide on their website on how to do this.

The TGA has a database which records all possible reported reactions. If there are any suspected security issues, these are immediately investigated and the necessary action taken. For example, if necessary, a vaccination program can be stopped or special precautions implemented. TGA can also issue security alerts.

‘Active’ monitoring

Since 2014, Australia has also actively researched any security concerns through the AusVaxSafety surveillance system, led by the National Center for Immunization Research and Surveillance, of which we are affiliated.

We send SMS or emails to people asking them to complete a survey about their health after being vaccinated. This system allows us to detect any suspected security problem in near real time. Last year, AusVaxSafety surveyed nearly 290,000 people after receiving the 2020 flu shot and found that over 94% felt perfectly fine. Others had mild and expected short-term side effects.

This system will be used to detect any safety concerns during the deployment of COVID-19 vaccines in the coming weeks. If you are vaccinated at selected sites, including GP surgeries and COVID-19 vaccination centers, you will be notified of this automated system. You are not required to register or register, but you will receive an SMS on days 3 and 8 after each dose of vaccine (you can decide whether or not to complete the survey). Your anonymized results will be shared with your state or territory’s health department and the TGA.

This system will likely be in place to monitor the safety of COVID-19 vaccines for a few years. And as new vaccine brands arrive on board, we’ll continue to monitor them as well.

Read more: What will Australia’s COVID vaccination program look like? 4 key questions answered

We can also learn from other countries

The United States recently developed an equivalent system, V-safe. Safety data for this system from about two million people who have received a COVID-19 vaccine indicates that the vaccines are safe. Short-term side effects are very similar to those reported in vaccine trials. The most common reactions include pain at the injection site, headache, fatigue, and muscle pain, usually within the first two days and then resolving within a week of vaccination.

And worldwide, more than 150 million doses of the COVID-19 vaccine have already been administered, with no unexpected safety concerns.

Learn more: Who pays compensation if a COVID-19 vaccine has rare side effects? Here’s how little we know about Australia’s new deal

In a word

The potential benefits for all of us from a mass COVID-19 vaccination program far outweigh the potential side effects, based on data from millions of people who have already been vaccinated around the world. Yet we know that all drugs, including vaccines, can have side effects.

However, by using and building on our already established safety monitoring system, we will be “on top” in promptly identifying any potential safety issues. It is immediately after vaccination and for a longer term.