Pfizer withdraws emergency use application for COVID-19 vaccine in India

Pfizer withdraws emergency use application for COVID-19 vaccine in India

US pharmaceutical giant Pfizer has withdrawn its application for emergency use authorization of its BNT162b2 COVID-19 vaccine in India.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 […]

UK authorizes Pfizer and BioNTech’s BNT162b2 Covid-19 vaccine

UK authorizes Pfizer and BioNTech’s BNT162b2 Covid-19 vaccine

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 […]

BNT162b2 Covid-19 vaccine candidate more than 90% effective in phase 3 trial, say Pfizer and BioNTech

BNT162b2 Covid-19 vaccine candidate more than 90% effective in phase 3 trial, say Pfizer and BioNTech

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 […]

BioNTech to acquire Novartis’ Marburg manufacturing plant to expand production of COVID-19 vaccine candidates

BioNTech to acquire Novartis’ Marburg manufacturing plant to expand production of COVID-19 vaccine candidates

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 […]