Just a day after the Moderna biotech company started one of the largest trials to test the Covid-19 vaccine on Monday, the pharmaceutical company Pfizer has announced that it is joining the final phase, and that, together with BioNTech, they are also starting their human trial, after which, if successful, "they hope to get regulatory approval in October 2020."
"After an extensive review of preclinical and clinical data from phase 1/2 trials, and in consultation with the Center for Biological Research and Assessment (CBER) of the US Food and Drug Administration and others Global regulators, Pfizer and BioNTech have chosen to advance their BNT162b2 vaccine candidate to phase 2/3", the US pharmaceutical company said in a statement.
The candidate vaccine, the report, "encodes an optimized full-tip glycoprotein (S) from SARS-CoV-2, which is the target of virus-neutralizing antibodies."
The executive director and co-founder of BioNTech assured that "many steps have been taken towards this important milestone" and announced that the new test phase of the vaccine will include the participation of up to 30,000 people between 18 and 85 years old.
"Our selection of the BNT162b2 vaccine candidate and their advancement to a phase 2/3 study are the culmination of an extensive, collaborative and unprecedented R&D program involving Pfizer, BioNTech, clinical researchers and study participants with a unique focus on developing a safe and effective COVID-19 RNA vaccine", said Dr. Kathrin U. Jansen, Senior Vice President and Head of Vaccine Research and Development at Pfizer, adding that" the start of the phase 2 trial / 3 is a great step forward in our progress towards supplying a potential vaccine to help combat the ongoing COVID-19 pandemic, and we hope to generate additional data as the program progresses."
The decision to advance phase has been made after obtaining favorable results in the preclinical studies, with the candidates BNT162b1 and BNT162b2, which "induced favorable cellular responses specific to viral antigens, high levels of neutralizing antibodies in various animal species, and beneficial protective effects in a primate SARS-CoV-2 challenge model", explains the American pharmacist in the brief.
Thus, after having evidence of the effectiveness of the second candidate (BNT162b2), they have approved the phase pass, which represents a new stage of tests, which will be carried out in approximately 120 clinical research centers around the world, "including 39 states in the United States and countries like Argentina, Brazil, and Germany."
"Pfizer and BioNTech are committed to reducing health inequalities in underrepresented populations through the process of clinical trials," says the pharmacist, adding that if the phase 2/3 trial is successful, "Pfizer and BioNTech they hope to be ready to seek emergency use authorization or some form of regulatory approval as early as October 2020". And, in the case of obtaining this authorization, "the companies intend to supply, globally, up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021," they conclude.
