How are vaccines developed, tested and authorised?
Vaccines are first studied in the laboratory. Developers determine their quality, safety and efficacy. Then, clinical trials are undertaken with human volunteers. These help confirm how vaccines work and how many doses are needed. Next, the vaccine developer submits the testing results to the medicines regulatory authorities. The vaccine is approved after it is verified that its benefits outweigh any side effect or potential risks. Due to the public health emergency, COVID-19 vaccines are being developed and approved much faster, while following the same standards as all other medicines in the EU. This is possible because of early scientific advice, pooling of experts, massive investments and using existing facilities and methods as for other vaccines.