BNT162b2

Pfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19

Shots: The P-III study evaluating BNT162b2 (COVID-19 Vaccine) vs PBO in >44,000 participants age ≥16 yrs with 927 confirmed symptomatic cases of COVID-19 The results demonstrated that BNT162b2 is 91.3% effective against COVID-19, follow-up time of at least 6 mos after the 2nd dose, 100% effective in preventing severe disease by CDC, 95.3% effective against …

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Pfizer and BioNTech’s Comirnaty (BNT162b2) Receives EC’s Conditional Marketing Authorization for COVID-19

Shots: The approval is based on P-ll/lll study involve the assessment of Comirnaty (BNT162b2) vs PBO in 44,000 patients aged ≥16 yrs. in the ratio of (1:1) for COVID-19. The approval follows CHMP’s positive opinion to authorize the vaccine The P-III demonstrated 95% ER in participants without prior SARS-CoV-2 infection (first primary objective) and in …

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Pfizer and BioNTech’s BNT162b2 Receives the US FDA’s EUA to Prevent COVID-19

Shots: Pfizer & BioNTech received the US FDA’s EUA for BNT162b2 for patients aged ≥16yrs with COVID-19. The companies are gathering additional data & prepared to file a planned BLA with the US FDA anticipating full approval in 2021 The EUA is based on P-III pivotal study demonstrating 95% efficacy in participants without prior SARS-CoV-2 …

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Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19

Shots: Health Canada has granted authorization under interim order for the emergency use of BNT162b2. The distribution of the vaccine in Canada will be prioritized according to the populations identified in guidance from the NACI BioNTech will hold the regulatory approval in Canada while Pfizer will have the commercialization rights. The approval is based on …

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Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Shots: Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution of vaccine will be prioritized according to the populations identified in guidance from the JCVI The MHRA’s decision is based on a rolling submission, including data from the P-III study, …

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BioNTech and Fosun Pharma Initiate P-ll Study of BNT162b2 Against COVID-19 in China

Shots: The companies initiated the P-II study of their COVID-19 vaccine in China. The trial will generate data to support the BLA filing for approval of the vaccine in China The study will be conducted by Jiangsu Provincial Center for Disease Control and Prevention. The study will commence with the recruitment of 960 patients aged …

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Pfizer and BioNTech’s BNT162b2 Demonstrates 95% Efficacy in Preventing COVID-19

Shots: The primary efficacy analysis demonstrated that BNT162b2 is 95% effective against COVID-19 beginning 28 days after the first dose. The study evaluated 170 confirmed cases of COVID-19 with 162 in PBO group vs 8 in the vaccine group The observed efficacy in adults over 65yrs. of age was ~94% and was well tolerated across …

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Pfizer and BioNTech to Supply EU with up to 200M Doses of BNT162B2 Against COVID-19

Shots: The companies sign an agreement with the EC to supply 200M doses of BNT162b2 mRNA-based vaccine candidate against SARS-CoV-2 to EU member states, with an option to request an additional 100M doses Deliveries are anticipated to start by the end of 2020, following clinical success and regulatory authorization. The companies expect to produce ~1.3B …

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BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2

Shots: The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work with the EMA’s CHMP to complete the rolling review process …

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