New study to monitor safety and effectiveness of COVID-19 vaccines
The University of Dundee is seeking thousands of volunteers for a new study assessing the effectiveness and safety of COVID-19 vaccines as they are rolled out to the public.
Vaccines are crucial for reducing COVID-19 and the harm it causes to health. By taking part in the VAC4COVID study, people can help scientists and doctors understand people’s health experiences after vaccination and support public confidence in COVID-19 vaccines.
VAC4COVID has been launched by the University’s Medicines Monitoring Unit (MEMO Research) to help ensure vaccines work as they should.
All vaccines must meet rigorous quality, safety, and efficacy standards before being approved but, as with any new medicines or treatments, ongoing research is needed to fill any gaps in the knowledge obtained from clinical trials. It is important that these studies report any safety or lack of effectiveness signals in real-time, so that action can be taken promptly. MEMO Research will work closely with vaccine regulators to inform them of any findings.
Many thousands of people are needed to take part in VAC4COVID to detect if there are any unexpected, rare conditions linked to vaccination. Participants will provide information about their health before and after vaccination. Members of the public are invited to sign up on the VAC4COVID study website, which provides a user-friendly way to report diagnoses and symptoms. Those who sign-up will be contacted at regular intervals before and after vaccination to check on their health.
“New medical conditions, like heart problems, and neurological diagnoses, occur all the time, whether people are vaccinated or not,” said project leader Professor Tom MacDonald. “The difficulty for medicines regulators is to know how many new conditions are related to vaccination and how many would have happened anyway. For this reason, we want to be able to track medical events both before and after vaccination, as well as in unvaccinated people.
“Another challenge is determining exactly what medical condition a person is reporting. People may describe the same symptoms in different ways. Many of the most feared possible side-effects are related to the neurological or immune systems, but the symptoms reported by patients may not be easily linked to a diagnosis.
“We will contact participants’ doctors and review their medical notes if they report concerning symptoms or diagnoses. This will allow us to confirm possible side-effects and maintain the quality of the study.”
Even people who do not plan to get vaccinated are encouraged take part to enable researchers to gauge whether medical conditions are coincidental or a result of the vaccination.
The MEMO Research team has many years’ experience of post-marketing surveillance of vaccines, including monitoring the safety of the new vaccines for swine flu during the 2009 pandemic.
Professor Isla Mackenzie, deputy director of MEMO Research, added, “Asking people to report their own medical events in our previous study of swine flu-vaccination worked very well and most participants reported no problems with their health. This information, provided by both vaccinated and unvaccinated people, helped immensely with the assessment of swine flu vaccine safety.
“Studies like VAC4COVID are crucial to understanding how to maximise safety and effectiveness of COVID-19 vaccination programmes. Better understanding of these vaccines will support greater public confidence in vaccination.”
Anyone interested in taking part in the study can sign up at http://www.vac4covid.com/.