Amidst impatience and populism, there seems to be more and more voices seeking to use vaccines that are not authorized by the European Medicines Agency on European people. It would be a huge stupidity to give up all our guarantees, and it is actually unthinkable.
see European Medicines Agency (EMA) on TV.but Pandemic With these things, EMA became popular, initially about Marketing authorization In the European Union (EU) covid-19 vaccine Pfizer, Modern, AztraZeneca ÿ Jensen.
In recent weeks, this European institution has once again made headlines about the announcement of the confusion about the purchase of vaccines. Sputnik 5 Some EU countries (Currently under continuous review, But has not been authorized by EMA), the most important thing is to doubt Adverse reactions of AstraZeneca and Janssen vaccines It has not been found in clinical trials before, but it is still very rare and may be serious.
What is EMA
EMA is a decentralized EU agency responsible for scientific assessment, supervision and monitoring of the safety of EU medicines.
It is configured as a network organization whose activities, in addition to the drug administrations of member states, also attract thousands of experts from all over Europe through the work of the scientific committees of its two main departments. Human drugs And Veterinary drugs.
EMA and European Medicines Authorization
Without rigorous scientific and technical evaluation, new drugs or vaccines and other medicines cannot be sold in the EU. Efficacy, safety and quality, Including good manufacturing practices. Except for certain special circumstances that allow the import of unapproved drugs, it is impossible to prescribe or use drugs without prior evaluation. This is one of the main tasks performed by EMA since 1995.
These assessments have historically been based on Clinical Trials, Allowing the balance between the risks and benefits of each drug to be characterized in each possible indication. Those with positive risk-return characteristics will obtain marketing licenses that are valid in all countries in the Common European Region (those countries in the European Union and Norway, Iceland and Liechtenstein).
The authorization of EMA and its risk-benefit analysis does not mean that the public insurance system (in the case of Spain, the national health system) is obliged to include drugs in its benefit package.
The authorization of EMA and its risk-benefit analysis does not mean that the public insurance system (in the case of Spain, the national health system) is obliged to include drugs in its benefit package.The decision is the jurisdiction of the member states, and may require evaluation of the role of drugs with the same indications in the entire treatment arsenal (comparative effect analysis, evaluation Therapeutic positioning) And economic evaluation (cost-benefit analysis, budget impact analysis).
EMA and pharmacovigilance
Pre-market authorization assessment is Security Mechanism basic. This is not the only pre-commercialization. EMA has been reviewing its vaccine development process at different stages in an ongoing dialogue and has coordinated Good manufacturing practices, Including inspection of manufacturing facilities.
New adverse reactions are not uncommon: the drug must be monitored throughout its use and in the real world
But this is not enough. The trial evaluated the safety of a relatively small number of patients (mostly young adults with no comorbidities or concomitant treatments). However, after authorization, these drugs will be used by more people and for longer periods of time. It is not uncommon for new adverse reactions to appear: the drug needs to be monitored throughout the course of use and in the real world.
Pharmacovigilance is a discipline and activity specifically used for detection, evaluation, causal analysis, and prevention of adverse drug reactions or other problems. ÿ EMA harmonizes the EU’s pharmacovigilance systemIn addition to supporting various pharmacovigilance activities, it is mainly developed by Member States.
This Pharmacovigilance Risk Assessment Committee (PRAC)There has been a lot of discussion these days. It is responsible for the safety assessment of EMA. In addition to representatives of national institutions, it also includes representatives of experts and professionals, and patient.
If countries can veto drugs from other countries or approve their own drugs on selfish grounds, then there can be no single market.The objective and unified scientific evaluation of drugs is of vital importance to the European Union
Pharmacovigilance is a planned activity in which all agents involved should collaborate.For example, in covid-19 vaccine, pharmacovigilance program Include a plan Risk Management There are specific requirements, regular (monthly) safety reports, Traceability All batches and Exhibition record For vaccines, with research centers (e.g. projects Admission Ø proficient), spontaneously announce suspicious adverse reactions, methods of detecting risk signals, and exchange of information with other institutions.
It is these mechanisms that make it possible to detect and initiate safety signal assessments associated with rare cases of patients with thrombosis and thrombosis reduction. AstraZeneca and Janssen vaccines. There are clear signs that the EU’s security surveillance is effective.
EMA and Europe
EMA is an indispensable part of the European architecture. If countries can use more or less interesting efficacy and safety arguments to veto drugs from other countries or support drugs from other countries, then there can be no single market. The objective and unified scientific evaluation of drugs is of vital importance to the European Union.
But this is encouraging and promoting Innovation In a vital industry in Europe, it is very urgent for many patients.It is necessary for each country/region to adopt heterogeneous standards to approve a drug, which is important for Pharmaceutical Industry And it is wasteful for processes with huge economies of scale.
Managing vaccines not approved by EMA is tantamount to abandoning all our guarantees: a huge stupidity
Timely delivery of effective drugs to patients is as important as avoiding the risks and benefits of other drugs entering the market. EMA’s strategy to encourage people to get medicines Rare diseaseThis is also an important part of the services provided by EMA to the EU to help small and medium-sized enterprises realize commercialization or take their own actions in emergency situations such as pandemics. And, don’t forget, it is also a reference for countries that cannot have drug agencies with similar powers and prestige.
In short, EMA is the main guarantee for the efficacy, safety and quality of the medicines and vaccines we consume in Europe. In the midst of impatience and populism, the voice of trying to administer a population vaccine that is not authorized by the EMA seems to be increasing. Giving up all our guarantees would be a huge stupidity, which is actually unthinkable.
Salvador Peiro He is a researcher in the field of health services and drug epidemiology. The Valencia Community of Valencia (FISABIO) Foundation for the promotion of health and biomedical research.