Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 17 May 2022)
Joint Statement from the International Coalition of Medicines Regulatory Authorities and World Health Organization
Healthcare professionals and public health authorities have a central role in discussing vaccination against COVID-19 with their patients. Vaccines play a critical role in preventing deaths, and hospitalisation caused by infectious diseases, and are contributing to controlling the spread of the disease, thus their impact on infection and serious illness is significant. Both vaccinated and unvaccinated people also 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. Reports of adverse events (side effects) have led some people to express concerns about getting vaccinated, delay getting vaccinated or 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 in many, but not all, children and young adults are less clinically affected by COVID-19 infection and therefore some may see limited value in vaccinating this population. Clear and consistent communication of evidence and uncertainties is therefore essential to support people in making the critical choice to be vaccinated.
We appreciate that you, your colleagues and your patients may have a number of questions around the development, regulatory review and ongoing safety monitoring of COVID-19 vaccines.
This joint International Coalition of Medicines Regulatory Authorities (ICMRA)* and World Health Organization (WHO) 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.
Vaccination has been shown to contribute to reducing deaths and severe illness from COVID-19, and to reduce the transmission of COVID-19. Vaccinating as many people as possible and reducing the spread of disease is important. Vaccination of a significant proportion of the population also protects vulnerable people, including those who cannot receive vaccines, or the small proportion of people who might remain at risk of infection after vaccination. Failure to vaccinate widely also enables continued circulation of the virus and the generation of variants, including some that may pose a greater risk. Widespread vaccination has contributed to fewer people getting sick and being hospitalised, ultimately alleviating the burden of COVID-19 on healthcare systems. It has also helped allow the move back to normal societal functioning and the re-opening of economies…
Full text of statement available here