COVID-19 pandemic: Statement of international medicinal product regulatory authorities about vaccines

Vaccines undergo rigorous scientific evaluation


The members of the International Coalition of Medicines Regulatory Authorities (ICMRA) signed a joint statement about confidence in vaccine safety and effectiveness.

Vaccination is one of the most effective health measures. Vaccines are rigorously reviewed and tested to make sure there is evidence that they are safe, effective and high quality before they are approved for use and administered to the public. Regulators and health authorities continue to rigorously monitor the vaccines after they are approved and released for use.

Vaccines and the regulatory process

Vaccines undergo a rigorous scientific evaluation by regulatory authorities.

Each vaccine is rigorously assessed for safety, quality and effectiveness to determine whether it can be authorised, using all available scientific evidence from animal data, human clinical trials, and manufacturing information to assess its benefits and risks.

Regulators assess vaccines and their ingredients before they can be placed on the market.

Vaccines contain antigens, active ingredients from the virus or bacterium that cause the disease that is being protected against by the vaccine. In some cases, vaccines contain other ingredients such as adjuvants to stimulate the body’s immune response to make the vaccine more effective, or stabilisers that keep the vaccine active during storage. When evaluating a vaccine for safety and quality, regulators take all of the ingredients of a vaccine into account, including the active ingredients as well as other substances.

The decision to approve new vaccines, as well as for medicines for human use, is often informed by independent advice.

Regulators may seek independent expert advice from scientific expert committees to inform their decision whether to approve a vaccine. These committees are made up of experts in science, medicine and public health.

Vaccines are of proven pharmaceutical quality.

Vaccines are manufactured according to stringent regulatory standards. Vaccines are required to meet manufacturing high quality standards, and batches may undergo laboratory testing by individual national regulatory authorities before they can be supplied.

Vaccines are among the most successful interventions to prevent and control infectious diseases and ensuring their safety is vital.

Vaccines are usually given to large numbers of healthy people, mostly children, to prevent disease. Rigorous safety standards are essential to ensure that vaccines bring about their protective effects while minimising the potential risk of harm. Regulators will only approve a vaccine if its benefits outweigh potential risks for the whole lifecycle of the vaccine.

Regulators, often in collaboration with public health authorities, rigorously monitor safety, quality and effectiveness of vaccines after they are approved for use.

Safety monitoring includes passive surveillance (receiving and assessing any adverse event reported by consumers, parents or health professionals) as well as active surveillance systems used to investigate potential associations between vaccines and adverse events. Regulatory authorities receive adverse event reports from consumers, health professionals and vaccine manufacturers, and information is shared between regulators internationally such as through discussions with WHO’s Global Advisory Committee on Vaccine Safety.

Regulators, in collaboration with public health authorities, are able to take decisive action if a safety issue is identified.

These actions might include issuing safety communications for patients, healthcare professionals and the community; updating the product information or consumer information for the vaccine; preventing the release of a particular batch of vaccine; and, taking other regulatory actions as necessary.

Many vaccines have been used safely to protect millions of people for many years.

High quality studies over many years have compared the health of large numbers of vaccinated and unvaccinated children, and an increasing number of vaccines have been assessed for safety in pregnant women and elders. Some vaccines have contraindications or precautions for their use to ensure that they are not given to people who have a higher risk of serious adverse events.

Globally, the public can have confidence in the rigour of the process used to scientifically evaluate the safety and effectiveness of vaccines to make a determination whether to approve them for use in the wider population.