Widespread vaccination has contributed to fewer people getting sick and being hospitalised, ultimately alleviating the burden of COVID-19 on healthcare systems. Failure to vaccinate widely also enables continued circulation of the virus and the generation of variants, including some that may pose a greater risk. 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. Vaccinating as many people as possible and reducing the spread of disease is important. Vaccination has been shown to contribute to reducing deaths and severe illness from COVID-19, and to reduce the transmission of COVID-19. 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. 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. 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. Clear and consistent communication of evidence and uncertainties is therefore essential to support people in making the critical choice to be vaccinated. 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. There are also differences in individual confidence in national safety monitoring systems. 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. Much of this coverage has taken place through mass and social media.
This includes a focus on the development of vaccines and their regulatory review and safety monitoring. The global impact of the COVID-19 pandemic has resulted in an unprecedented level of public interest in vaccines.
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