On July 27, it was announced by the researchers that they had decided to advance BNT162b2 to phase 2/3 of the human trials.
Pfizer coronavirus vaccine: Pfizer, a US-based pharma giant, and BioNTech, a German biotechnology company, have together been working on the testing of four vaccine candidates for coronavirus under Project Lightspeed. The two companies on Thursday released the data for the first phase of one of the vaccine candidates, the tests of which are being conducted in the US, according to a report in The Indian Express. The report quoted the study as saying that the candidate was being well-tolerated among all members of the population and a strong immune response was being demonstrated. The study added that the giants were looking to seek regulatory review in October this year.
Pfizer vaccine candidate: Project Lightspeed
The project contains the development of four coronavirus vaccine candidates and it is based on BioNTech’s proprietary platforms based on mRNA technology. The project, according to the report, had commenced in the middle of January, after the genetic sequence of the novel coronavirus SARS-CoV-2 was made publicly available. The report added that of the four candidates, two — BNT162b1 or BNT162b2 — have reached the stage of human clinical trials till now. They are being tested in the US and Germany right now and are in phase 1/2 of the trials.
Progression of trials
The two vaccines went into human trials in Germany on April 23, where 12 participants were administered a dose of either one of the vaccines. In the US, these trials began on May 5. The two vaccine candidates then received a fast-track designation from the Food and Drug Administration (FDA) of the US on July 13.
On July 27, it was announced by the researchers that they had decided to advance BNT162b2 to phase 2/3 of the human trials. The decision was based on the review of preclinical as well as clinical data and in consultation with the Center for Biologics Evaluation and Research of the FDA. Around 30,000 participants were projected to be a part of the phase 2/3 of the study.
Pfizer’s vaccine candidate: About BNT162b2
According to the report, the BNT162b2 is a single nucleoside-modified messenger RNA vaccine, and the messenger RNA instructs the human cell to harmlessly replicate the target protein, which would be the spike proteins of SARS-CoV-2 in this case. This is supposed to trigger the immune response against the protein. The vaccine is tested for three things during a clinical trial — its ability to produce common, adverse reactions or its reactogenicity, its ability to trigger an immune response, or its immunogenicity and its safety.
The report stated that as per the data released on Thursday, during the phase 1 trials in the US, a week after the second dose of 30 micrograms was administered, it was found to have demonstrated a strong immunogenicity in adult as well as young participants, when compared to the levels that were found in a convalescent serum panel, or the serum that is obtained from someone who has recovered.
Advancement to phase 2/3 trials
On Thursday, the data that was released indicated that in both young and adult participants, both the candidates elicited similar immune responses. But BNT162b2 vaccine candidate was found to be associated with less systemic reactogenicity in adults especially, which means that it generates a lower adverse reaction among the vulnerable population as compared to the other vaccine. This makes it safer out of the two candidates.
Significance of these findings
The findings of this study are quite significant since Pfizer is planning to activate the extensive manufacturing network to produce this vaccine. It said that by the end of the year, it would manufacture up to 100 million or 10 crore doses, and by the end of 2021, this figure is projected to be over 1.2 billion or 120 crore doses. Till now, Pfizer has decided that it would produce the vaccine in its own facilities in Massachusetts, Missouri and Michigan in the US and in Puurs, Belgium.
At the same time, BioNTech is planning to increase the production capacity using its existing mRNA production sites in Idar-Oberstein and Mainz in Germany.