Wednesday, October 20

The AEMPS launches a campaign on the guarantees of vaccines against COVID

The Secretary of State for Health, Silvia Calzón, together with the Director of the AEMPS, María Jesús Lamas.

The Secretary of State for Health, Silvia Calzón, together with the Director of the AEMPS, María Jesús Lamas.

The Spanish Agency for Medicines and Health Products (AEMPS) has launched this Monday an awareness campaign on the vaccine guarantees against COVID-19.

The initiative was presented this Monday at a press conference by the Secretary of State for Health, Silvia Calzón, and the general director of the Spanish Agency for Medicines and Health Products (AEMPS), Maria Jesus Lamas, in which they also valued the decision of the European Medicines Agency (EMA, for its acronym in English) to approve the Pfizer and BioNTech vaccine against the coronavirus.

Coinciding with the approval of the first vaccine to be marketed in Europe, the objective of this campaign is to explain to the public why the development, evaluation and acquisition of vaccines has been accelerated so much without reducing the guarantees of quality, safety and efficacy, which all medicines authorized in the EU must have.

‘Vaccines with guarantees’ is the motto with which the AEMPS will share an informative video with interviews with the agency technicians involved in the arrival of the vaccine against COVID-19, video-capsules containing some of the most important milestones in the history of vaccines a web section of vaccines against COVID-19 on the web which details step by step how the availability of vaccines has been accelerated, how a drug of these characteristics is developed, the evaluation and authorization that follows, and what has been the role of the AEMPS in this whole process, as well as infographics and interactive triptychs to bring these concepts closer to the population in an informative and rigorous way.

This campaign will also focus on the role of pharmacovigilance, which is key to identifying any signal, analyzing whether it is related to the use of the drug, and reacting immediately to ensure that the balance benefit-risk on which the authorization is based Of all drugs, it continues to remain favorable once it is marketed and in use.

In addition, the AEMPS will organize meetings with some of the technicians who have played a leading role in the evaluation of vaccines against COVID-19 in order to resolve some of the most frequent doubts about the arrival of vaccines.

Why has the vaccine been sped up so much?

The AEMPS explains that the development of vaccines is “extremely complex” and involves an average of between four and seven years. “With the vaccine against COVID-19, the arrival has accelerated in an extraordinary way. For this, it has been essential to sum of forces between the scientific community and States around the world, who have supported this research by mobilizing resources like never before, financing production in order to have millions of doses available in the shortest time possible “, they argue.

“Further, We do not start from scratch, but we already have extensive and proven experience on how to develop vaccines with guarantees of quality, safety and efficacy. Proof of this is that the Spanish vaccination schedule includes vaccines against 14 different pathogens. This experience accumulated over more than 50 years on how to manufacture and verify the efficacy and safety of these drugs has been of vital importance in the rapid development of vaccines against COVID-19, “they add.

Similarly, drug agencies such as the AEMPS, in charge of authorizing the vaccine, are conducting a “extraordinary effort” evaluation, evaluating the data as it is generated, and the regulatory deadlines have been adapted to this emergency situation.

Finally, the AEMPS recalls that pharmaceutical laboratories are producing vaccines at risk, that is, they are manufacturing their models before knowing the results of clinical trials and if their vaccine proposals are going to be authorized by regulatory agencies such as the EMA or the AEMPS. “This will allow the vaccine to be used massively immediately, once it is approved “, they conclude.

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