Pfizer, Germany’s BioNTech release new data on Covid-19 vaccine

August 24, 2020 5:02 pm Published by Leave your thoughts

The companies also said their Phase II/III study, slated to enroll about 30,000 participants, had already dosed more than 11,000.

Early clinical trial data from a Covid-19 vaccine that is among those currently in late-stage testing have shown favorable responses among participants in terms of antibody and immune cell responses.

Mainz, Germany-based BioNTech and New York-based Pfizer said late Thursday afternoon that among U.S. Phase I study participants receiving the vaccine BNT162b2 at 30 micrograms, participants aged 18-55 showed mean concentrations of antibodies against SARS-CoV-2 at 3.8 times those of convalescent patients seven days after the second dose, while those aged 65-85 showed levels 1.6 times higher.

Adverse events among those receiving BNT162b2 included fever, fatigue and chills, but no serious effects, and the vaccine was described as having a favorable tolerability profile compared with a similar vaccine candidate, BNT162b1.

BNT162b2 was chosen at the end of last month from among multiple messenger RNA vaccines against SARS-CoV-2 and is currently being developed in Phase II/III study that will enroll about 30,000 participants. The companies said that as of Thursday, more than 11,000 participants had already been dosed in the trial, which includes 113 sites in the U.S., Argentina, and Brazil.

“The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decisionto select BNT162b2 as the lead candidate to advance into pivotal trials,” Pfizer head of vaccine research and development Kathrin Jansen said in a statement. “We are especially pleased to offer these early data showing our vaccine candidate’s promising safety and immunogenicity profile from the U.S. trial, and we look forward to sharing T-cell immune response data from the German trial in the near future.”

However, it remains yet to be seen whether any Covid-19 vaccine candidate provides long-term protection, such that annual vaccinations would be enough to guard against infection. Other vaccines in late-stage development include Moderna’s mRNA-1273, also a messenger RNA vaccine, and AZD1222, which AstraZeneca licensed from the University of Oxford in the U.K.

An example of a vaccine being rushed to market early occurred earlier this month, when authorities in Russia claimed a vaccine they had developed was ready for the market despite there not even being Phase III data, let alone data on long-term efficacy.

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