No medicine is 100% safe for everyone, but vaccines are the safest. This is not a pointless statement: it is a response to solid scientific and technical reasons.
All vaccines are included in Lifetime vaccination schedule The recommendations of the National Health System Regional Council and the development of autonomous community activities in each region, They are safe.
The safety of vaccines is neither an advertising slogan nor an unprovoked claim, but a response to solid scientific and technical reasons.
Before the vaccine reaches the vaccination schedule, it has conducted a long period of research and quality control. One of the phases of this process is clinical research, which is divided into three phases to be carried out in volunteers, the main goal of which is safety.
The research phase of the vaccine
In the first stage, there were only a few dozen people, and the purpose was to find out the dosage and the best method of administration, and to determine its safety and possible efficacy. In the second stage, there are a large number of volunteers (usually no more than 100), the purpose is to perfect the specific aspects of the product’s ability to enhance the immune response while keeping the participants safe.
In Phase 3 (which may involve hundreds or thousands of people), possible final formulations will be tested. Participants were divided into two groups, some received the study vaccine, others received only a placebo-a known product that was not active against the disease under study. Usually, participants are randomly assigned to one of two groups. Neither the volunteers nor the researchers knew which group each participant was assigned to in order to avoid any bias that might interfere with the interpretation of the results.
Only products that exhibit a high level of safety and effectiveness can pass Phase 3 and be eligible for authorization.
The Department of Public Health determines whether an approved vaccine is included in the vaccine plan/©Adobe Stock.
Now it is the turn of the public agency that controls drug use to conduct an assessment.In our case, they are European Medicines Agency (The abbreviation of EMA, located in Amsterdam) and Spanish Agency for Medicines and Health Products (AEMPS), depends on the Ministry of Health. Authorization can only be granted after confirming that the vaccine promoter has been proposed and meets all the strict requirements for product quality, safety and efficacy.
Public health authorities must now determine whether the approved vaccine is included in the vaccination plan, for whom, at what age and How will they be vaccinated. In Spain, including the vaccine in the official vaccination schedule means that it is free for the people it targets. The autonomous region is responsible for implementing the vaccination plan.
But the quality control here is not over. Indeed, the assessment of vaccine safety is endless, because during the course of use, the monitoring of its safety is always in an open state, the so-called stage 4.
New Drug Monitoring System
After the vaccine is approved, a new regulated procedure involving manufacturers will be opened-all new relevant information about their products must be notified-to health professionals; and citizens will be notified of the possible adverse effects of the vaccine through a voluntary notification system.
Can be used by health professionals and citizens themselves Adverse Drug Reaction Notification System. Through this system, it is possible to record events after vaccination that professionals or citizens think are related to immunization. Although it is recommended to provide all possible information, it is not necessary to provide evidence about the relationship, doubt is sufficient.
Only products that exhibit a high level of safety and effectiveness can pass Phase 3 and be eligible for authorization/©Adobe Stock.
All reported suspicions are reviewed and included in the European database. Therefore, when a problem is repeatedly reported, it can be studied in detail to clarify its relationship with the vaccine. Reactions after vaccination are relatively frequent, but also mild and short-lived: pain, redness and swelling at the injection site, general malaise and fever.
So far, it has been explained how to ensure a high level of vaccine safety. Although no medicine is 100% safe for everyone, vaccines are the safest.
However, in rare cases, when thousands of people use the vaccine, Negative impact More serious, it usually depends on some people’s genetics or other characteristics.
Until each vaccine is approved, these cases cannot be found in the study because if they occur, they will only show up with very low frequency after millions of doses have been administered.
For example, in the case of a severe allergic reaction (allergic reaction), it is estimated that one in every million doses occurs. Therefore, it is recommended to observe for a period of time after vaccination to properly detect and treat them.
Other adverse events are more rare, so it is necessary to monitor the use of all vaccines to ensure that they remain active during use and there is no time limit.
Therefore, it can be said that when the vaccine is approved for use, it is very safe and can prevent infectious diseases without any associated known risks or with a very low level of risk (favorable benefit/risk balance).
For the approved covid-19 vaccine, all these steps have been implemented and no steps have been skipped. They have carried out an important preclinical study for more than ten years. Thanks to the investment of many scientists, manufacturers and teams, it is possible to conduct large-scale clinical studies on 10,000 to 40,000 people within a few months. . Financial institutions in many countries. Mankind has made unprecedented achievements and has culminated in a new effective and safe covid-19 vaccine, which will help the pandemic to subside.
Therefore, don’t hesitate to get vaccinated if the public health service agency in your community and your primary care refer to the health staff to recommend vaccination.
Angel Hernandez, Nuria Garcia, Angel Carrasco with Pedro Gorrotxategi Is the Spanish Association of Primary Care Pediatrics (Epa)