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%… Read More »Pfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19
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… Read More »Pfizer and BioNTech’s Comirnaty (BNT162b2) Receives EC’s Conditional Marketing Authorization for 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… Read More »Pfizer and BioNTech’s BNT162b2 Receives the US FDA’s EUA to Prevent 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… Read More »Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat 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… Read More »Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19
Shots: The companies have submitted CMA to the EMA for BNT162b2, against COVID-19. The submission completes the rolling review process initiated on Oct 6, 2020 The submitted data showed a 95% efficacy rate, efficacy was consistent across age, gender, race, and ethnicity demographics, with an… Read More »BioNTech and Pfizer Report CMA Submission of BNT162b2 to EMA for COVID-19
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… Read More »BioNTech and Fosun Pharma Initiate P-ll Study of BNT162b2 Against COVID-19 in China
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… Read More »Pfizer and BioNTech’s BNT162b2 Demonstrates 95% Efficacy in Preventing 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… Read More »Pfizer and BioNTech to Supply EU with up to 200M Doses of BNT162B2 Against COVID-19
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… Read More »BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2
The companies also said their Phase II/III study, slated to enroll about 30,000 participants, had already dosed more than 11,000.
The companies said they had started a Phase II/III trial BNT162b2. The news comes the day after Moderna announced the launch of its Phase III study and days after Pfizer and BioNTech signed a nearly $2 billion vaccine supply deal with the federal government.