US pharmaceutical giant Pfizer has withdrawn its application for emergency use authorization of its BNT162b2 COVID-19 vaccine in India. This decision comes after a series of interactions with the Indian drug regulator, which had requested additional information regarding the vaccine. Regulatory Hurdles and Safety Concerns Initially submitted for approval in December 2020, the application faced […]
Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the use of the BNT162b2 Covid-19 vaccine from US pharma giant Pfizer and German biotech company BioNTech. The Swiss pharma regulator said that as per the data it has assessed, the level of protection afforded seven days following the second dose of the mRNA vaccine is […]
BNT162b2 FDA EUA : Pfizer and BioNTech have been granted emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for BNT162b2, their Covid-19 mRNA vaccine. BNT162b2 has been authorized by the FDA for its use in the prevention of Covid-19 in individuals aged 16 years or more. Pfizer and BioNTech will look […]
US pharma giant Pfizer and German biotech company BioNTech have bagged Health Canada approval for their BNT162b2 Covid-19 vaccine. The BNT162b2 vaccine has been authorized to be used in Canada under the regulator’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to Covid-19. Canada has now joined the UK […]
The UK has given a temporary authorization for emergency use for the BNT162b2 Covid-19 vaccine candidate developed by Pfizer and BioNTech. The emergency use authorization (EUA) from the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for the mRNA vaccine candidate follows the release of positive results of a global phase 3 trial. Pfizer and […]
Pfizer and BioNTech announced that the BNT162b2 mRNA-based vaccine candidate has been shown to be more than 90% effective in the prevention of Covid-19 in participants of a phase 3 trial who were not previously exposed to the SARS-CoV-2 infection. The data is based on the first interim efficacy analysis from the phase 3 clinical […]
Biopharmaceutical New Technologies (BioNTech) has agreed to acquire a GMP certified manufacturing facility in Marburg, Germany from Novartis to expand the production capacity of its BNT162 COVID-19 vaccine candidates. The financial terms of the deal were not revealed by the parties. BioNTech said that the production capacity of its five mRNA COVID-19 vaccine candidates under […]