How Covid-19 Vaccines Are Regulated for Safety and Effectiveness

This joint statement aims to help healthcare professionals answer questions about the role of regulators in the oversight of Covid-19 vaccines. 

The International Coalition of Medicines Regulatory Authorities (ICMRA) and World Health Organization (WHO) released today (June 11) a joint statement about the safety and effectiveness of Covid-19 vaccines.

According to the statement, healthcare professionals and public health authorities have a central role in discussing vaccination against Covid-19 with their patients. The statement adds that the vaccines play a critical role in preventing deaths, hospitalisation caused by infectious diseases. Emerging data on effectiveness indicates that licenced Covid-19 vaccines are contributing to controlling the spread of the disease. 

Until widespread vaccination has been achieved, both vaccinated and unvaccinated people need to be aware of the additional protective behaviours required to control the pandemic locally.

The global impact of the Covid-19 pandemic has resulted in an unprecedented level of public interest in vaccines. This includes a focus on the development of vaccines and their regulatory review and safety monitoring. Much of this coverage has taken place through mass and social media.  

According to WHO, reports of adverse events (side effects) have led some people to express concerns about getting vaccinated, delay getting vaccinated or even be strongly opposed to vaccination. There are also differences in individual confidence in national safety monitoring systems. 

Another challenge in communicating the importance of Covid-19 vaccination is that younger adults are typically less clinically affected by Covid-19 infection and so may see limited value in getting vaccinated, including until further data confirms that vaccines prevent transmission and that vaccines are effective against variants. Clear and consistent communication is therefore essential to support people in making the choice to be vaccinated.

This joint statement aims to help healthcare professionals answer questions about the role of regulators in the oversight of Covid-19 vaccines. It explains how vaccines undergo robust scientific evaluation to determine their safety, efficacy and quality and how safety is closely and continually monitored after approval.

The statement asserts that widespread vaccination will help prevent people from having to go to hospital and contribute to fewer people getting sick, ultimately alleviating the burden of Covid-19 on healthcare systems. It will also help allow a return to normal societal functioning and the re-opening of economies, the statement added.