Today, the Ministry of Health offers an extremely important answer to a question that has been the subject of a lot of fake news online, and this is somewhat to be expected, considering that there are so many people who want to harm others.
The Ministry of Health says that the vaccines against COVID-19 are not experimental, as they say on social networks, they receive conditional approval for use around the world after being tested on tens of thousands of people each.
"Are anti-Covid-19 vaccines experimental?
Not. Before being licensed, vaccines went through phase 1, 2 and 3 clinical trials, proving their effectiveness and safety. The fact that they continue to be closely monitored does NOT mean that they are in the experimental phase.
Although vaccines go through a series of rigorous tests before being licensed, it is important that their safety is constantly monitored. Moreover, all authorized medicines, even those that have been on the market for many years, are subject to this continuous monitoring process, called pharmacovigilance.
In a clinical trial, which may include only a few tens of thousands of volunteers (for logistical and economic reasons), it is not possible to analyze the effects of a drug for all categories of people, and certain side effects are so rare that they do not appear in during the study.
That is why on the leaflet of certain medicines (vaccines, biological medicines or new substances appearing after 2011) a black triangle appears accompanied by the statement: This medicine is subject to additional monitoring, which tells us that for a period of several years, based on the information gained from widespread use, the benefit-risk balance is frequently reassessed. Even though clinical studies indicate a very high probability that this balance will tip in favor of benefit, it is good to remain vigilant and aware of possible unwanted effects.
The reason why phase 3 trials are still ongoing for EMA-approved vaccines (Pfizer BioNTech, Moderna, AstraZeneca and Johnson&Johnson) has to do with several unanswered questions, such as: Is there long-term protection? Will a new booster dose be needed and if so, when? How do blood antibody levels change over time? Important questions, but not so urgent that we have postponed vaccination of the population, risking a large number of deaths and the impossibility of controlling the pandemic for several years."
