The data were posted on a preprint server and are currently undergoing peer review for potential publication. The companies anticipate starting a Phase IIb/III study for the vaccine, BNT162b1, this month, pending regulatory approval.
Drugmaker Pfizer and its German partner, BioNTech, have become the latest to release clinical data on a potential vaccine against Covid-19.
New York-based Pfizer and Mainz, Germany-based BioNTech announced Wednesday preliminary data from 24 subjects in the clinical trial of BNT162b1, their messenger RNA-based Covid-19 vaccine. The data were posted on a preprint server, meaning they have not been peer-reviewed. Moreover, while the data show that participants who received the vaccine developed neutralizing antibodies against SARS-CoV-2, the virus that causes Covid-19, they do not indicate whether the vaccine will actually be effective, or for how long. The companies said, however, that the data are currently undergoing peer review for potential publication.
Shares of Pfizer were up 3.6% on the New York Stock Exchange after markets opened. Shares of BioNTech were up 3.1% on the Nasdaq.
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BNT162b1 is one of four vaccine candidates that the companies are testing. The data showed that at day 28, or seven days after receiving the second dose, all 24 participants who received 10 micrograms or 30 micrograms showed concentrations of antibodies of 168 and 267, which were respectively 1.8 times and 2.8 times the levels seen in the convalescent serum of patients with Covid-19 who had recovered from the disease. SARS-CoV-2 receptor binding domain-binding immunoglobulin antibodies showed mean concentrations of 4,813 units and 27,872 units per milliliter, which are respectively eight and 46.3 times those of the levels seen in convalescent patients.
The companies said that the data would enable them to select a lead candidate for the Phase IIb/III study, which they anticipate starting this month.
“These preliminary data are encouraging, showing that BNT162b1 – which exploits RBD SARS-CoV-2 as a target antigen – is able to produce neutralizing antibody responses in humans at or above the levels observed in convalescent sera, and that it does so at relatively low dose levels,” BioNTech CEO Ugur Sahin said in a statement. “We look forward to providing further data updates on BNT162b1.”
The companies’ time frame for entering their vaccine candidate into late-stage development, which depends on getting the green light from regulators, is about the same as that of Moderna, which is also developing an mRNA-based vaccine candidate and plans to start a Phase III study this month. Moderna announced preliminary data for its vaccine, mRNA-1273, in May, while CanSino Biologics and Inovio have also released early data on their candidates.
Source: Medcity News