Pfizer Coronavirus Vaccine’s Preliminary Data Shows ‘Positive, Preliminary, Topline Findings’

A Pfizer sign hangs on the outside of their headquarters.
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On Wednesday, Pfizer and its German partner BioNTech announced in a joint statement that the trials for the coronavirus vaccine they are working on have yielded positive preliminary results. According to the data released by the company, the potential vaccine — known in tests as BNT162b1 — was able to create an immune defense in participants stronger than what was found in the average recovered COVID-19 patient.

The trial, called the BNT162 mRNA-based vaccine program, consisted of giving injections of 10 micrograms and 30 micrograms of the prospective vaccine to 24 out of the 45 people participating, who range between the ages of 18 and 55. Nine of the other participants were given two injections of a placebo and 12 were given a single 100-microgram injection of the vaccine.

Four weeks after receiving their first injection, those that had received the two doses of the vaccine exhibited “significantly elevated” antibodies than found in a recovered patient. Those that had received the single higher injection of the vaccine also had elevated antibodies, though not as high as those that received two doses.

Kathrin U. Jansen, senior vice president and head of Vaccine Research & Development at Pfizer, had a positive outlook on the preliminary results.

“We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings. We are dedicated to develop potentially groundbreaking vaccines and medicines, and in the face of this global health crisis, we approach this goal with the utmost urgency.”

The headquarters of German immunotherapy company BioNTech stands on April 22, 2020 in Mainz, Germany.
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Ugur Sahin, CEO and co-founder of BioNTech, also voiced his pleasure at the preliminary results and looked forward to providing more updates on the BNT162b1 testing.

“These preliminary data are encouraging in that they provide an initial signal that BNT162b1 targeting the RBD SARS-CoV-2 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.”

This early data will be used by Pfizer and BioNTech to determine the strongest vaccine candidates and the most effective dosage levels before moving on to the next phase of testing. That phase would include 30,000 healthy participants and is expected to begin before the end of July, if they are given regulatory approval to proceed. If the vaccine studies prove to be successful and one of the candidates receives regulatory approval, the two companies plan to manufacture 100 million doses by the end of 2020 and 1.2 billion doses by the end of 2021.