Pfizer and BioNTech said they expected shortly to get regulatory approval to also start clinical trials in the U.S. Pfizer shares rose as much as 10% in early morning trading and were priced at $36.38 around midday. BioNtech stock surged 14% to $48.35.
The Phase 1/2 trial comprises 4 vaccine candidates. The trial will include about 200 healthy individuals between the ages of 18 to 55 and aims to test the safety and immunogenicity of the vaccine. The study will also evaluate the effects of repeated immunization for three of the four vaccine candidates which utilize uRNA or modRNA. Individuals with a higher risk for a severe COVID-19 infection will be included in the second part of the study.
“We are pleased to have completed pre-clinical studies in Germany and will soon initiate this first-in-human trial ahead of our expectations,” said BioNtech CEO and Co-founder Ugur Sahin. “The speed with which we were able to move from the start of the program to trial initiation speaks to the high level of engagement from everyone involved.”
Wall Street analysts have a Moderate Buy consensus rating for both Pfizer and BioNtech. For Pfizer ratings are evenly divided between 4 Buys and 4 Holds and for BioNtech they are divided between 2 Buys and 2 Holds.
“Now that the work in Germany can commence, we are looking forward to and actively preparing for the potential start of this unique and robust clinical study program in the United States in the near future,” said Pfizer Chairman and CEO Albert Bourla.
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