Vaccine development for COVID-19 vaccines is being fast-tracked globally.
Approval of vaccines in the European Union: European Vaccination Information Portalįast-track vaccine development in a public health emergency.
The reduction in number of people with symptoms, severe disease or diagnosed with the infection can help to measure the efficacy of the vaccine.įor information on ongoing COVID-19 clinical trials in the European Economic Area (EEA), see COVID-19 vaccines: research and development. This phase shows how efficacious the vaccine is at protecting against the infection compared with placebo (dummy) or alternative treatment and what are the less common side effects in those receiving the investigational vaccine. In certain cases, it could also provide some preliminary indications of how well the vaccine will work ( efficacy).Ĭlinical efficacy and safety studies (phase III trials) include thousands of volunteers. These studies also check that the vaccine triggers a good immune response in a broader population. The purpose of this phase is to study the best doses to use, the most common side effects and how many doses are needed. Therapeutic exploratory studies (phase II trials) involve several hundred volunteers.
if the vaccine is safe to move into larger studies.
if the vaccine triggers the expected immune response.
Human pharmacology studies (phase I trials) generally involve between 20 and 100 healthy volunteers to confirm if the medicine behaves as expected based on laboratory tests. National competent authorities and ethics committees ensure that studies are scientifically sound and conducted in an ethical manner. Ĭlinical trials in human medicines, including those for COVID-19 vaccines, are authorised and managed at national level in the EU. Scaling up production and adaptations to commercial manufacturing ca n continue in the post-authorisation phase. The vaccine developer conducts more studies in laboratory models, using in vitro studies or animal models ( in vivo studies), to show how the vaccine triggers an immune response and works to prevent infection.įinally, the vaccine developer studies the vaccine in three phases of clinical trials, with larger numbers of volunteers in each phase.įor approval, companies must also show that large scale commercial manufacturing produces vaccines of the required quality. Studies on pharmaceutical quality look at the individual vaccine components, the final formulation to be used and at the whole manufacturing process in detail. To assure that the vaccine meets its intended quality profile and complies with regulatory standards, the company develops a suitable and effective quality control strategy. Then the company decides whether to continue development and scale up production. They perform studies to determinate a suitable formulation that can keep vaccine components stable to the end of its shelf life. Standard vaccine development is a long process and studies are done in sequential steps.Ĭompanies first make small batches and do small scale studies to characterise and optimise the production process. These tests help confirm how the vaccines work and, importantly, to evaluate their safety and protective efficacy. Then vaccines are tested in human volunteers in studies called clinical trials. studies on their pharmaceutical quality and studies to check first the effects in laboratory tests and animals). Like all medicines, COVID-19 vaccines are first tested in the laboratory (e.g.