Who decides whether a vaccine can be marketed and how it should be administered?
Text updated on 2021-02-17
To be placed on the market, a vaccine must obtain a marketing authorisation (MA) from the regulatory authorities responsible for the safety of pharmaceutical products. The manufacturer must submit a complete dossier to the regulatory authorities: the EMA (European Medicines Agency) in Europe, the FDA in the USA, Swissmedic in Switzerland, and the WHO for the whole world. The manufacturer must also show that it is able to produce the vaccine safely and on a large scale.
For a vaccine to be mass-produced, laboratories developing vaccines often have to partner with one or more large, specialized pharmaceutical companies that have the necessary technical resources.
Before a batch of the vaccine is placed on the market, the manufacturer must submit it for approval to the regulatory authority that controls its quality, safety, and action on the immune system. In this way, regulatory authorities are not only responsible for analyzing the safety of vaccines, but also for authorizing their placement on the market. In Europe, the EMA (European Medicines Agency) gives its opinion and it is the European Commission that grants marketing authorization.
Vaccine recommendations (in which cases the vaccine is recommended, to which persons, in which packaging, how many doses and how often) are the responsibility of the health authorities responsible for vaccine recommendations (in France: ANSM, HAS and HCSP, in the United Kingdom: Medicines and Healthcare products Regulatory Agency (MHRA) and Joint Committee on Vaccination and Immunisation (JCVI), in Switzerland: the Federal Commission for Vaccinations and the FOPH - Federal Office of Public Health). In the United States, the federal government has recommended that the states allow people aged 65 and over to be vaccinated, but each state chooses its own vaccination recommendations.
Vaccination against a disease is recommended only if the benefit far outweighs the risk of adverse effects. Several approved vaccines can be used against the same disease. The health authority may then recommend the use of one vaccine rather than another, depending on the characteristics of the population. It is the health authority that determines to whom (age, risk factors) the vaccine is recommended, in how many doses and how often it should be given, when a booster is needed based on the risk of disease in the country, etc. The health authority may also recommend that the vaccine be given to people who are at higher risk of developing the disease.
Health authorities are also responsible for negotiating vaccine costs with producers.
In the particular context of Covid-19 and the European Union, orders were placed directly by the European Commission, well in advance of the AMM. No EU Member State can order vaccines in its own name, as pharmaceutical companies have agreed to refuse all national orders.
The European regulatory system for medicinal products, European Medicines Agency.https://www.ema.europa.eu/en/documents/leaflet/european-regulatory-system-medicines-european-medicines-agency-consistent-approach-medicines_fr.pdf
The WMA and the drug pathway, ANSM.https://vaccination-info-service.fr/Generalites-sur-les-vaccinations/Qualite-securite-et-efficacite-des-vaccins/Securite-et-qualite-des-vaccins/Procedure-de-mise-sur-le-marche-des-vaccins
In France, the recommendations of the vaccination strategy against COVID-19 have been developed by the High Authority for Health.https://www.has-sante.fr/jcms/p_3221338/fr/strategie-de-vaccination-contre-le-sars-cov-2-preliminary recommendations-on-population-priorization-strategy-to-vaccinate
On December 21, 2020, the European Medicines Agency and then the European Commission gave the green light to Pfizer and BioNTech's vaccine against the COVID-19 disease.https://www.ema.europa.eu/en/news/ema-recommends-first-covid-19-vaccine-authorization-eu
Regularly updated description of the immunization situation in the different states of the United States.The New York Times. See How the Vaccine Rollout Is Going in Your State. Last accessed February 2, 2021.