(RTTNews) - Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced early positive update from German phase 1/2 covid-19 vaccine study, including first T cell response data.
The preliminary clinical results are for the most advanced investigational vaccine candidate in Pfizer's and BioNTech's BNT162 mRNA-based vaccine program against SARS-CoV-2, BNT162b1. Overall, the new preliminary data from this German study support and expand upon the recently disclosed early results from the corresponding U.S. trial with BNT162b1.
Pfizer noted that the data further demonstrated the ability of BNT162b1 to elicit high SARS-CoV-2 neutralizing titers BNT162b1 elicited strong CD4+ and CD8+ T cell responses against SARS-CoV-2- receptor binding domain (RBD), compared to baseline.
The strength of T cell responses varied between subjects. There was no clear dose level dependency of the T cell response between 1 µg to 50 µg, indicating that stimulation and robust expansion of T cells might be accomplished at low mRNA dose levels.
Overall, the data suggested that BNT162b1 could potentially be administered safely, with a manageable tolerability profile. Local reactions and systemic events after injection with BNT162b1 at all dose levels were transient, generally mild to moderate, with occasional severe events of flu-like symptoms and injection site reactions, the company said.
Pfizer noted that all adverse events resolved spontaneously and were managed with simple measures. No serious adverse events were reported, and there were no withdrawals due to adverse events related to the vaccine.
Pfizer stated that preliminary data from both the German and U.S. Phase 1/2 studies, together with additional preclinical and clinical data being generated, will be used by the two companies to determine a dose level and select among multiple vaccine candidates to seek to progress to an anticipated large, global Phase 2b/3 safety and efficacy trial. The trial may involve up to 30,000 healthy participants and is anticipated to begin in late July 2020, if regulatory approval is received.
The BNT162b1 candidate remains under clinical study and is not currently approved for distribution anywhere in the world. If the ongoing studies are successful and the vaccine candidate receives regulatory approval, the companies expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021.
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