The approval procedure has begun for the COVID-19 vaccine from The German pharmaceutical company BioNTech SE and the US company Pfizer Inc. , the two corporations announced Tuesday.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) showed in a press that an “ongoing review” of knowledge on the COVID-19 vaccine called BNT162b2 had been launched.
BioNTech is the corporate time in Europe to launch the approval procedure for a COVID-19 vaccine. Last week, the EMA announced the first ongoing review of a candidate vaccine being developed through AstraZeneca with oxford University.
According to the EMA, an ongoing review was one of the teams to speed up the evaluation of a drug or vaccine as a public fitness emergency. In general circumstances, all knowledge and documentation on the “efficacy, protection and quality” of a medicinal product should be submitted at the beginning of the evaluation.
During an ongoing review, knowledge of existing studies would be reviewed before filing a formal application. “The ongoing review will continue until sufficient evidence is available for an official marketing authorisation application,” ema said.
“We will continue to have a normal and open discussion with the EMA about the ongoing review process,” said Ugur Sahin, CEO and co-founder of BioNTech.
The BioNTech and Pfizer candidate vaccine is recently being tested in a 2/3 phase global study. According to the companies, the study was conducted at more than 120 sites worldwide, including the United States, Brazil, South Africa and Argentina.
To date, the candidate vaccine has concerned some 37,000 participants, of whom more than 28,000 have already won their COVID-19 vaccination time, according to companies.
Preliminary knowledge of the Phase 1/2 exam showed that BNT162b2 was “well tolerated” and had mild to moderate side effects in all age groups, according to BioNTech and Pfizer.
“We are working to expand an effective vaccine following the recommendations of regulatory agencies,” said Peter Honig, Pfizer’s senior vice president and director of global safety and regulation.
As the global fight against the pandemic, countries around the world, including Germany, China, Russia, the United Kingdom and the United States, rush to locate a vaccine.
According to the World Health Organization’s website, as of October 2, 193 COVID-19 candidate vaccines were in international progression and 42 of them were in clinical trials.