The European Medicines Agency (EMA) explained: “The regulatory agency must strike a balance between providing patients with new medicines as soon as possible and collecting sufficient information about their quality, safety and efficacy.” A well-designed system will detect the failure of clinical trials as quickly as possible Unexpected event detected.
With the vaccination of covid-19, Pharmacovigilance Its testing has never been like this. “We are in a special special situation, we are watching closely, almost in real time“An expert said Spanish Agency for Pharmaceuticals and Healthcare Products (AEMPS), responsible for Pharmacovigilance in Spain. At the European level, the responsible agency is EMA.
The goal they added to AEMPS is to “detect effects that will not occur in the early stages of the trial, and they can only be discovered after using drugs on many people. Without pharmacovigilance, we will have a false sense of security.”
The previous test did not fail
Unexpected effects in approved drugs do not mean failure in previous clinical trials. Even in the best designed experiment, there are variables that cannot be considered.
only at Long exposure Or through Interactions with other drugs. As experts from the Spanish Association of Primary Care Pediatrics explained on the forum, the incidence may be very low.
Such as EMA, “The patient may be taking other medications, [o el efecto puede emerger] Only when the drug has been used by a large number of people or has been used for a long time”.
Rare effect on pharmacovigilance
The existing COVID-19 vaccine in Europe has been tested by thousands of volunteers. He said these trials answered “questions about efficacy and the incidence of fairly common adverse events,” such as pain or headaches at the needle site. natural Hilda Bastian, The collaborator Cochran, This is a global network of researchers and doctors that can generate health information without commercial interest.
The rare effect only affects pharmacovigilance. This rare effect affects hundreds of thousands of cases and only begins to show one’s face after receiving millions of doses.
Time coincidence or causality?
The great challenge of pharmacovigilance is to determine that the actual time that coincides with the time of drug administration (days or weeks) is caused by the drug.
Pharmacovigilance begins after the drug is placed on the market and continues until use.In 2007 European network of pharmacoepidemiology and pharmacovigilance centers, EMA.But this process is open to the general public: except for health professionals, all citizens Can notify Any incident that you think is suspicious.
The notification arrives at a large database called AEMPS Federal Express, Connected to another country in Europe, EudraVigilance. Spanish and European experts-experts from the European Pharmacovigilance Risk Assessment Committee, wash-Analyze information.
AEMPS explained: “The assessment takes into account all data available globally” and its recommendations “have been applied in all countries of the European Union”.
They stated in AEMPS: “All notifications have been thoroughly analyzed.” Is there a detailed review? other factors This may be the cause of the incident, and if the number of cases is greater than expected under normal circumstances, then: “It must be considered that other diseases will not disappear during the administration of drugs or vaccines.”
In the two months of 2018, 205 people per million inhabitants were admitted to hospital for acute myocardial infarction; 357 cases of acute cerebrovascular disease were admitted to hospital; 77 cases of asthma were admitted to hospital; 123 new cases of epilepsy or epilepsy; 580 new cases of diabetes .
If the frequency of reported adverse events is higher than usual, an alarm may sound.
Adverse events are not adverse reactions
Expert analysis to decide when Adverse events (Notice that matches the time) becomes Adverse reactions -It has been confirmed that the drug is its origin.
Information about confirmed adverse reactions should be included in Flyer medicine.
In addition, experts will try to discover Biological mechanism Causes adverse reactions, which may take some time.