The first participants have been dosed in the US for a new phase 1/2 clinical trial assessing investigative mRNA coronavirus 2019 (COVID-19)
vaccine candidates from Pzifer and BioNTech SE.
The possible vaccines, which were first dosed in German participants as part of the BNT-162 global clinical development program last week, are 4 mRNA candidates with differing combinations of format and target antigen. The collaborating companies are assessing each against one another for the prevention of SARS-CoV-19 in healthy adults aged 18-85 years old.
The current phase 1/2 study will determine each candidate’s safety, immunogenicity, and optimal dose levels in a single, continuous trial featuring 360 health adults in the US broken up by 2 age cohorts—18-55; and 65-85 years old.
The first immunized participants in stage 1 will be the younger adult population, while older adults will only be immunized with a given dose vaccine candidate level set by evidenced safety and immunogenicity by the first round of assessment.
The novel trial design would allow investigators at the multiple US sites currently enrolling patients to simultaneously evaluate the 4 different mRNA candidates while sharing data with regulatory authorities in real-time—streamlining the process from identifying a safe and viable vaccine, and it reaching the public market.
BioNTech intends to provide clinical supply of the vaccine from its mRNA manufacturing facilities in Europe, while both companies are planning global supply scale-up production in anticipation of clinical success. Their collaborative program would mean millions of vaccine doses being made available in 2020—and hundreds of millions in 2021.
Pfizer chairman and chief executive officer Albert Bourla called the sub-four month timeframe in which the companies moved from pre-clinical assessment to current human trials an “extraordinary” feat.
“With our unique and robust clinical study program underway, starting in Europe and now the US, we look forward to advancing quickly and collaboratively with our partners at BioNTech and regulatory authorities to bring a safe and efficacious vaccine to the patients who need it most,” he said in a statement.
BioNTech chief executive officer and co-founder Ugur Sahin expressed optimism in their strategy to assess and advance multiple vaccine candidates at once.
“It is encouraging that we have been able to leverage more than a decade of experience in developing our mRNA platforms to initiate a global clinical trial in multiple regions for our vaccine program in such a short period,” Sahin said.
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