- Trump Administration secures 100 million doses of Pfizer and BioNTech’s vaccine for US$1.95 billion to meet the Operation Warp Speed (OWS) program’s goal of delivering 300 million doses of COVID-19 vaccine in 2021.
- In May 2020, Trump administration had introduced OWS aiming to provide safe and effective COVID-19 vaccine for Americans by January 2021.
- Pfizer and BioNTech remain on track to commence a projected Phase 2b/3 safety and efficacy clinical trial in this month. Two of the four candidates in the BNT162 received FDA’s Fast Track Designation earlier this month.
- The two partners intend to manufacture nearly 100 million doses by 2020 and possibly over 1.3 billion by the end of 2021.
The world continues to struggle with the devastating impact of the ongoing COVID-19 pandemic that has affected more than 14.76 million people worldwide and caused 612,054 deaths as of 6:18 PM CEST, 22 July 2020 (WHO statistics).
Scientists, research institutes, and healthcare organizations all over the world are working round the clock to find a safe and effective vaccine/treatment against SARS-CoV-2, the virus causing the COVID-19 pandemic. Due to this global health emergency, unprecedented public-private partnerships are developing to combat the COVID-19.
During mid-May 2020, the Trump administration announced Operation Warp Speed (OWS) for accelerating the timeframe for development, manufacturing, and distribution of COVID-19 medical countermeasures. The countermeasures include vaccines, therapeutics, as well as diagnostics to combat the COVID-19. Operation Warp Speed is a collaboration of several US federal government departments.
At present, the whole world is closely watching the development of COVID-19 vaccine with investigational vaccine candidates developed jointly by Pfizer and BioNTech gaining attention. On 22 July, the US government placed an initial order of 100 million vaccines.
Let us delve deep and discuss how both companies are advancing towards developing a vaccine against COVID-19:
Trump Administration Secures 100 million Doses for US$1.95 billion
On 22 July 2020, pharma giant Pfizer Inc (Nasdaq:PFE) and Germany-based biotech player BioNTech SE (Nasdaq:BNTX) revealed the execution of an agreement with the US Department of Health and Human Services and the Department of Defense to meet the OWS goal of the US government to commence delivering nearly 300 million doses of COVID-19 vaccine in 2021.
Under the agreement, the US government will get 100 million BNT162 doses of the investigational vaccine candidate against COVID-19 being developed by Pfizer and BioNTech once Pfizer successfully manufactures and obtains US FDA approval or emergency use authorization (EUA).
The US government will pay the companies nearly US$1.95 billion upon the receipt of the first 100 million doses, following FDA authorization. Moreover, the US government also can acquire an additional 500 million doses.
Moreover, Americans will get the vaccine for free, consistent with the commitment by the US government for free access for COVID-19 vaccines.
Dr Albert Bourla, Pfizer Chairman and CEO stated-
On this agreement, HHS Secretary Alex Azar said that broadening the already-diverse portfolio of Operation Warp Speed (OWS) by adding Pfizer’s and BioNTech’s vaccine enhances the probability of developing a safe and effective vaccine as quickly as the end of 2020. Depending on the success in clinical studies, this agreement will facilitate the delivery of nearly 100 million doses of this vaccine to the Americans.
It is noteworthy to mention that Pfizer and BioNTech remain on track to commence a projected Phase 2b/3 safety and efficacy trial this month and pursue regulatory review as soon as October 2020. Both the companies aim to manufacture ~100 million doses worldwide by the end of 2020 and possibly over 1.3 billion doses by 2021 end.
Earlier, on 13 July, the US FDA granted Fast Track Designation to two of the four candidates in the BNT162 program.
On 22 July 2020, PFE stock ended the day’s trading at US$38.56, up 5.1% from its previous close and BNTX (ADS) last quoted at US$104.17, an impressive 13.72% higher.
UK Agreement to supply 30 million doses of BNT162
On 20 July 2020, Pfizer and BioNTech disclosed an agreement with the UK to supply 30 million doses of their mRNA-based vaccine candidate BNT162, against SARS-CoV-2. BNT162 is currently under development, subject to clinical success and regulatory approval.
The financial details of the agreement were not revealed, but the terms were based on the timing of delivery and the volume of doses.
HAVE YOU READ: COVID-19 Vaccine Development: Where Do We Stand?
Early positive data from German Phase 1/2 clinical trial
On 20 July 2020, Pfizer and BioNTech disclosed preliminary data from an ongoing German Phase 1/2 clinical trial that is part of the global mRNA-based vaccine program against SARS-CoV-2.
The Phase 1/2 clinical trial is a non-randomized, open-label, non-placebo-controlled, dose-escalation trial.
The preliminary clinical findings are for the most advanced investigational vaccine candidate in BNT162 mRNA-based vaccine program against novel coronavirus, BNT162b1. The information further showed the ability of BNT162b1 to provoke high SARS-CoV-2 neutralizing titers. BNT162b1 stimulated strong CD4+ and CD8+ T-cell responses against SARS-CoV-2-RBD compared to baseline.
Overall, the findings suggested that BNT162b1 could be administered safely, with a controllable tolerability profile.
The local and systemic events after injecting all dose levels of BNT162b1 were short-lived, mostly mild to moderate, with infrequent severe events of flu-like symptoms as well as injection site reactions. Notably, all adverse events were resolved spontaneously and controlled with simple measures.
Moreover, no serious adverse events and study withdrawals were reported.
Pfizer and BioNTech are jointly evaluating at least four experimental vaccines, each representing a distinctive combination of mRNA (messenger RNA) format and target antigen.
The BNT162 program is based on the proprietary mRNA technology of BioNTech and backed by global vaccine development and manufacturing capabilities of Pfizer. BNT162 vaccine candidates are under clinical development and currently not approved for distribution.
Notably, BioNTech will hold all trademarks for the potential product. Both the companies are committed to developing these novel vaccines with pre-clinical and clinical data at the forefront of all their decision-making.