Pfizer-BioNTech COVID-19 vaccine shows positive results, on track for regulatory review in October
US pharmaceutical company Pfizer and German biotech firm BioNTech released the safety and immunogenicity data from the phase 1 trial of their second and lead mRNA-based vaccine candidate against coronavirus.Pfizer and BioNTech said the Covid-19 vaccine they are jointly developing is on track to be submitted for regulatory review as early as October.
The companies said the vaccine was well tolerated with mild to moderate fever in fewer than 20% of the participants. The companies are continuing to analyze data from the Phase 1 trials in the U.S. and Germany, they were quoted as saying in a statement by Bloomberg.
The BNT162b2 vaccine seemed to generate a similar immune response, but fewer side effects than the other vaccine BNT162b1. Systemic events after administration of BNT162b2 were milder than those with BNT162b1, they said in the release.
“The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials. We are proud to share our findings with the scientific community as we continue our work to deliver a safe and effective vaccine to combat this devastating virus,” said Kathrin U Jansen, Ph.D, Senior Vice President and Head of Vaccine Research & Development, Pfizer.
“We are especially pleased to offer these early data showing our vaccine candidate’s promising safety and immunogenicity profile from the US trial and we look forward to sharing T cell immune response data from the German trial in the near future.”
The confirmation of their October goal, first announced last month, would make the vaccine one of the fastest-moving in the world. Some analysts expect a vaccine to be approved for use by November in the U.S., a move which may give President Donald Trump a new foothold in the election.
If trials succeed and regulatory authorization or approval is obtained, the companies plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.
Pfizer and BioNTech last month clinched a $2 billion deal to supply an initial 100 million doses of the vaccine to the U.S. Governments around the world are looking to lock up supplies of still-experimental candidates in hope of stabilizing local economies and stopping spread of the virus that’s taken almost 800,000 lives globally.
