By Adekunle Yusuf
Hope of victory over coronavirus (COVID-19) pandemic rises as Pfizer and BioNTech said they have begun delivering doses of their experimental coronavirus vaccines for initial human testing in the United States.
What this means is that if the vaccine proves to be safe and effective in trials, it could be ready for wide distribution in the US by the end of the year, the US drug maker and German partner said.
Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq: BNTX) announced on Wednesday that the first participants have been dosed in the US in the Phase 1/2 clinical trial for the BNT162 vaccine programme to prevent COVID-19.
The trial is part of a global development programme, and the dosing of the first cohort in Germany was completed last week. The phase 1/2 study is designed to determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates evaluated in a single, continuous study.
The vaccine, which uses messenger RNA (mRNA) technology, has the potential to be among the first vaccines against the virus that has infected more than one million people in the US and killed some 68,000.
The dose level escalation portion (stage 1) of the phase 1/2 trial in the US will enrol up to 360 healthy subjects into two age cohorts (18-55 and 65-85).
The first subjects immunised in stage one of the study will be healthy adults between 18 and 55. Older adults will only be immunised with a given dose level of a vaccine candidate once testing of that candidate and dose level in younger adults has provided initial evidence of safety and immunogenicity.
Sites dosing participants include NYU Grossman School of Medicine and the University of Maryland School Of Medicine, with the University of Rochester Medical Centre/Rochester Regional Health and Cincinnati Children’s Hospital Medical Centre to begin enrolment shortly.
“With our unique and robust clinical study programme underway, starting in Europe and now the US, we look forward to advancing quickly and collaboratively with our partners at BioNTech and regulatory authorities to bring a safe and efficacious vaccine to the patients who need it most.
‘’The short, less than four-month timeframe in which we’ve been able to move from pre-clinical studies to human testing is extraordinary and further demonstrates our commitment to dedicating our best-in-class resources, from the lab to manufacturing and beyond, in the battle against COVID-19,” said Albert Bourla, Chairman and CEO, Pfizer.
There are no approved treatments or vaccines for the new coronavirus, though some drugs are being used on patients under an emergency use authorisation. Pfizer and BioNTech’s development programme includes four vaccine candidates, each representing a different combination of mRNA format and target antigen.
The novel design of the trial allows for the evaluation of the various mRNA candidates simultaneously in order to identify the safest and potentially most efficacious candidate in a greater number of volunteers, in a manner that will facilitate the sharing of data with regulatory authorities in real time.
“It is encouraging that we have been able to leverage more than a decade of experience in developing our mRNA platforms to initiate a global clinical trial in multiple regions for our vaccine program in such a short period.
We are optimistic that advancing multiple vaccine candidates into human trials will allow us to identify the safest, most effective vaccination options against COVID-19,” said CEO and Co-founder of BioNTech, Ugur Sahin.
During the clinical development stage, BioNTech will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. In anticipation of a successful clinical development programme, Pfizer and BioNTech are working to scale up production for global supply.
Pfizer plans to activate its extensive manufacturing network and invest at risk in an effort to produce an approved COVID-19 vaccine as quickly as possible for those most in need around the world. The breadth of this programme should allow production of millions of vaccine doses in the year, increasing to hundreds of millions next year.
Pfizer-owned sites in three US states (Massachusetts, Michigan and Missouri) and Puurs, Belgium have been identified as manufacturing centers for COVID-19 vaccine production, with more sites to be selected.
Through its mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech plans to ramp up its production to provide further capacities for a global supply of the potential vaccine.
BioNTech and Pfizer will commercialise the vaccine worldwide upon regulatory approval (excluding China, where BioNTech has a collaboration with Fosun Pharma for BNT162 for clinical development and commercialisation).
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