The new data showed that BNT162b2 administration was well tolerated across all populations, with mild to moderate fever in less than 20% of the participants
Pfizer, BioNTech releases positive data from Phase 1 study of Covid-19 vaccine. (Credit: Arek Socha from Pixabay.)
Pfizer and BioNTech unveiled additional safety and immunogenicity data from their ongoing Phase 1 clinical of the mRNA-based Covid-19 vaccine BNT162b2, in the US.
BNT162b1 is a modified messenger RNA (modRNA) designed to encode an optimised SARS-CoV-2 full-length spike glycoprotein (S), which is the target for body’s virus neutralising antibodies. The vaccine has entered into the late-stage clinical studies.
The new safety and immunogenicity data from the US Phase 1 trial, which evaluated the BNT162b2 vaccine candidate at 30μg dose, showed the SARS-CoV-2-neutralizing geometric mean titers (GMTs) after 7 days of the second dose, with superior immunogenicity in younger and older adults.
The data showed that the GMTs in younger adults, aged 18-55 years, were 3.8 times than that of a a panel of SARS-CoV2 convalescent patients, and the vaccine candidate elicited 1.6 times more neutralizing GMTs in older adults, aged 65-85 years, than that of the same panel.
The newly released data from the early-stage studies showed that BNT162b2 administration was well tolerated across all populations, with mild to moderate fever in less than 20% of the participants.
Pfizer senior vice president and vaccine research and development head Kathrin U Jansen said: “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. 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.”
Pfizer, BioNTech will continue a Phase 2/3 clinical study with 30µg dose level of BNT162b2
The companies have previously announced their plans to advance a 2-dose regimen of the 30µg dose level of BNT162b2, into a Phase 2/3 clinical study. The totality of data is said to have contributed for their decision to begin the global Phase 2/3 safety and efficacy clinical study.
Additional data from the US Phase 1 randomised, placebo-controlled, observer-blinded study, which is being analysed in the US and Germany, was used to evaluate the safety and immunogenicity of varying dose levels of BNT162b1 and BNT162b2.
The companies said that they will continue the clinical evaluation of the BNT162b2 and is not currently approved for distribution anywhere in the world.
Furthermore, the companies are on track to receive regulatory review for BNT162b2 by October 2020, and intend to supply up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021, if the vaccine is authorised or approved by the regulatory agencies.
BioNTech CEO and co-founder Ugur Sahin said: “It is important to us to continue sharing data and related information on our COVID-19 vaccine lead candidate.
“The favorable safety profile of BNT162b2 and the breadth of T cell responses we previously announced have supported our decision to select this candidate for the pivotal Phase 2/3 study. As of today, we have already dosed more than 11,000 participants with BNT162b2 in that study.”