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The president of the National Medicines Authority (Infarmed) said today that none of the vaccines for covid-19 can be available without having undergone a safety and efficacy evaluation.
Taking a look at the situation of the vaccines under study at the meeting on the evolution of covid-19 in Portugal, which today brought together experts, politicians and social partners in the auditorium of the Faculty of Medicine of the University of Porto, Rui Ivo stated that “a significant number of vaccines.”
At this moment there are 176, of which 33 are in the clinical evaluation phase, they are already being studied in people, and there are eight vaccines that are in the third phase of the trials, a phase prior to their presentation to the authorities for their use said the president of Infarmed.
“Given the uncertainty and the specific situation with which we are working, it is important to cover a wide range of vaccines,” he defended, adding that at this time six of the eight vaccines that are in phase 3 are being discussed and negotiated at the level. European. .
Rui Ivo stressed that although he is “facing an emergency situation, which requires a pandemic situation,” this is “a different decision from all the others.”
“The vaccine has to be licensed in terms of quality, safety and efficacy. Only after this route, which will be carried out through the European Medicines Agency, where Infarmed also participates, will the vaccine be authorized ”, she defended.
According to the official, these vaccines will be subject to a security control system after authorization.
“The preliminary data that has already been made available, and we will have the data from this phase 3 study soon, are positive, therefore, they are very promising in terms of vaccine development,” he emphasized.
Regarding the negotiation that is taking place at the European level, Rui Ivo said that there is already a contract signed with AstraZeneca, which provides quantities for all the countries of the European Union, with 300 million units under negotiation for the EU, for “a period that – if it becomes authorized and available – from the end of this year, the beginning of 2021, until the middle of 2021 ”.
There are five more vaccines that are in a very advanced stage at this time. “I think that in the coming weeks we will verify the conclusion of these contracts,” he stressed.
The president of Infarmed also said that the quantities are distributed by the different types of vaccines and that there is a rule that underlies these procurement processes, which is the allocation of quantities to the population, which indicates that Portugal will receive throughout the period. of the contract. with AstraZeneca 6.9 million vaccines.
He also said that it is foreseen in the contracts that additional doses can be produced if necessary.
“So far, the data we have regarding vaccines points to the need for two doses, but it is not ruled out that advancing in the development process there may be a vaccine that only needs one dose,” he emphasized.
According to Rui Ivo, if the different vaccines are subject to authorization, they will appear gradually and will have “a more significant volume, that is, from the beginning of the second quarter of 2021.”
“This is of utmost importance, especially because of the work that will be the responsibility of the Directorate General of Health in terms of outlining the vaccination strategy and how to introduce and define it in development terms,” he stressed.
The covid-19 pandemic has caused more than 889,000 deaths worldwide since December last year, including 1,843 in Portugal.
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