The phase 2/3 trial, which precedes the application for a marketing authorization, began in the United States, it said in a statement to Pfizer.
The clinical tests will involve about 30 thousand adults, between 18 and 85 years old, recruited by almost 120 centers, none of them in Portugal, the Portuguese subsidiary of the North American pharmaceutical multinational, who hopes to obtain efficacy and safety results, told Lusa solid in late August or early September.
If the candidate vaccine proves to be effective and safe to prevent covid-19, an infectious respiratory disease caused by the new coronavirus SARS-CoV-2, Pfizer and BioNTech “will submit the evaluation request to the regulatory authorities” of the drug in October .
If marketing is authorized, Pfizer and BioNTech expect to deliver up to 100 million doses of the vaccine by the end of 2020 and around 1,3 billion doses by the end of 2021.
The candidate vaccine aims to stimulate, with synthesized genetic material, the organism to produce a protein equal to that of SARS-CoV-2, the spike protein, so that later it knows how to recognize it when it is infected with the coronavirus and, thus, triggers the desired immune response, that is, the production of antibodies that neutralize the virus.
According to the World Health Organization, as of July 31, there were 26 vaccine candidates for covid-19 in clinical trials, including five in phase 3 (phase that precedes the application for authorization for the introduction of a new drug on the market. ).
The covid-19 pandemic has already claimed more than 701 deaths and infected more than 18,5 million people in 196 countries and territories, according to a report by the French news agency AFP.
In Portugal, 1.740 people of the 51.848 confirmed as infected died, according to the most recent bulletin from the Directorate-General for Health.
Covid-19 is transmitted by a new coronavirus (virus type) detected in late December in Wuhan, a city in central China.