Monday, August 24, 2020

Pfizer enters phase three Covid-19 vaccine trial

Pfizer and BioNTech Provide Encouraging Data:
On 20 August 2020,New York-based Pfizer and its Mainz, Germany partner BioNTech released additional Phase-1 trial safety and immunogenicity data for their COVID-19 vaccine candidate.The early trial showed that,at 30 micrograms,7 days after the second dose of BNT162b2, the dose elicited SARS-CoV2 antibodies that in younger patients (18-55 years) were 3.8 times more than COVID-19 convalescent patient antibodies; and in older patients (65-85 years) elicited 1.6 times more antibodies than in convalescent patients.
What is more, across all populations,BNT162b2 was well- tolerated with mild to moderate fever in less than 20% of the participants.The companies continue to analyse the Phase 1 data in the US and Germany, they said, while they have progressed into the advanced Phase 2/3 trials, with more than 11,000 participants having already been dosed.Assuming clinical success of the advanced trials,they intend to apply for regulatory review as early as October 2020 and,if obtained, to supply up to 100 million doses worldwide by the end of 2020,and about 1.3 billion doses worldwide by the end of 2021.
As reported earlier, the Phase 1 trials indicated production of both antibodies and disease-fighting T-cells in the participants.Two doses of this vaccine candidate are administered to each participant three weeks apart.
Pfizer Inc (PFE), BioNTech SE (BNTX)


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