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The doctor Alexis Kalergis, director of the Millennium Institute of Immunology and Immunotherapy (IMII), called for caution after the announcement made by the US pharmaceutical Pfizer and the German biotechnology company BioNTech that the efficacy in the tests of its vaccine against Covid-19 reaches 90 percent, above that required by the United States regulators.
“I am on the path of optimism, but with caution. The communication of the safety and efficacy of a vaccine requires the publication of the results and the development of the study in its entirety, “the researcher told What Remains of the Day, from Cooperative, pointing out that the news anyway “is still positive. “
Kalergis also referred to the words of the Minister of Health, Enrique Paris, who this morning, once the Pfizer-BioNTech statement was known, assured that the vaccine would not need tests in our country if it is approved by the US Food and Drug Administration (FDA), given that that North American regulatory entity, like the Institute of Public Health of Chile (ISP), It is category 4.
“It’s a positive sign that a Type 4 agency like the FDA could approve the emergency use or emergency approval of the vaccine. It would obviously be considered as a precedent by another regulatory agency, but it is not a guarantee that the latter regulatory agency will make the same approval or allow its use. There is a possibility, but it is not automatic “, clarified the immunologist.
“The ISP is quite rigorous in terms of the review it does of clinical trials and drugs. … You have all the authority to do an independent and absolutely unbiased review“, he stressed.
