How will we know if COVID-19 vaccines are safe?

There are many strict protections in place to help ensure that COVID-19 vaccines will be safe. Like all vaccines, COVID-19 vaccines should go through a rigorous, multi-stage testing process, including large (phase III) trials that involve tens of thousands of people. These trials, which include people at high risk for COVID-19, are specifically designed to identify any common side effects or other safety concerns.

If a clinical trial shows that a COVID-19 vaccine is safe and effective, a series of independent reviews of the efficacy and safety evidence is required, including regulatory review and approval in the country where the vaccine is manufactured, before WHO considers a vaccine product for prequalification. Part of this process also involves a review of all the safety evidence by the Global Advisory Committee on Vaccine Safety.

An external panel of experts convened by WHO will analyze the results from clinical trials and along with evidence on the disease, age groups affected, risk factors for disease, and other information, will recommend whether and how the vaccines should be used. Officials in individual countries will decide whether to approve the vaccines for national use and develop policies for how to use the vaccines in their country based on the WHO recommendations.

After a COVID-19 vaccine is introduced, WHO will support work with vaccine manufacturers, health officials in each country, and other partners to monitor for any safety concerns on an ongoing basis.

healthysoch