Pharmaceuticals, Biotechnology and Life Sciences
European Commission’s decision on conditional marketing authorization is expected imminently, after the positive CHMP opinion, which will make BNT162b2 if authorized, the first COVID-19 vaccine available in the European Union.
Pfizer and BioNTech said that the FDA is expected to make a decision on Emergency Use Authorization in the coming days after giving a positive vote based on totality of scientific evidence presented by the companies, including Phase 3 efficacy and safety data, which would make BNT162b2 the first COVID-19 vaccine available in the U.S.
The UK has approved Pfizer’s COVID-19 vaccine on Wednesday, becoming the first country in the world to do so, going ahead of the United States and the EU countries, who expect to bring the decisions on authorization in December.
Pfizer’s and Biontech’s vaccine candidate for COVID-19 has met all the study’s primary efficacy endpoints.
Pfizer says its vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
First participants have been dosed at NYU Grossman School of Medicine and University of Maryland School of Medicine.
BioNTech SE said Monday its development a potential vaccine to induce immunity and prevent COVID-19 infection in response to the growing global health threat posed by the disease has seen rapid progress. BioNTech’s product candidate, BNT162, is a potential first-in-class mRNA vaccine in the worldwide effort against COVID-19.
BioNTech pulled one of the largest private EU biotech funding events expands global shareholder base with $325 from investors
Sanofi and BioNTech A.G. have entered into a multiyear exclusive collaboration and license agreement.