The European Medicines Agency (EMA) assured this Friday that any authorization for vaccines against COVID-19 will have “all safeguards and controls” in place and that the assessment will continue after it is put into use.
In a public internet panel, several experts from the agency reinforced the idea that the speed with which the various vaccines under analysis were developed did not compromise neither the guarantees of efficacy or safety that would be possible in a normal vaccine development process.
According to Lusa, the director of the Vaccination Strategy and Biological Sanitary Threats department, Marco Cavaleri, said that the process of creating, clinical trials and approving the use of a vaccine takes an average of five to ten years, but that “unprecedented” novelty in relation to vaccines for COVID-19 was that the steps “were taken with the same rigor, with everything more compressed, in parallel and without intervals”.
That is what allowed “to see a vaccine developed in months instead of years, without cutting steps, with the same amount of information available and the same regulatory standards”.
The head of the Clinical Studies department, Fergus Sweeney, said that the evaluation process by the agency was done “in less time, but without generally reducing the size or rigor of the scientific evaluation and data” provided by the manufacturers to the EMA.
This also contributed to the unprecedented number of experts gathered in evaluation committees, which were divided to carry out, on the one hand, the medical evaluation of the candidate vaccines and, on the other, to assess their risks and safety.
Fergus Sweeney said the format of conditional marketing authorization that the European agency could grant guarantees that “all safeguards and controls are working” and that manufacturing companies are “legally obliged” to continue studies on the application of the vaccine .
This authorization is foreseen for emergency public health situations and can be withdrawn if manufacturers do not meet any of the requirements or if there are problems with the vaccine.
The control mechanisms that will continue to be applied even after the mass vaccination of the population begins include “a robust monitoring plan”, recurrent controls of several vaccine batches as they become available, specific vaccination plans for children, specific studies covering the most vulnerable populations such as pregnant women or heart patients.
The director of the data analysis department, Peter Arlett, indicated that even after vaccination begins, there will be “a strong pharmacological surveillance mechanism” in place and that “safety will not be compromised” in the event of adverse effects.
“Vaccines will only be approved if the benefits outweigh the risks”, he guaranteed, at the same time that at European level and national regulators “additional resources” are being added to closely monitor the application of the vaccines and evaluate any new data.
Under special attention will be the adverse effects of vaccines, the totality of which will only be known with time and application, and Arlett said that there is a network that includes doctors, regulators, manufacturers to share information, as well as the citizens themselves, which he encouraged to report. any adverse effects to health authorities.
He stressed that “since millions of people will be vaccinated in a short period of time, many will have symptoms of illness” close to the vaccine intake, so they may be reported as adverse effects, but they will only be a temporal coincidence.
Currently, the EMA has two mRNA vaccines (those from Pfizer / BioNtech and Moderna), which give the human body a genetic instruction to create an immune response to the new coronavirus and two viral vector (AstraZeneca). / University of Oxford and Jannsen), which use inert viruses to stimulate the body to develop immunity.