Brown on Business
November 16-22, 2020
Pfizer’s COVID-19 vaccine offers new hope for return to normalcy
By Wesley Brown
wesley@dailydata.com
Although COVID-19 cases are spiking in Arkansas and across the U.S., there seems to be some sense of normalcy in the middle of the “most un-normal” time of our lives.
In fact, I traded smiles with a stranger this week after we both got “the look” in the parking lot of the local grocery store from people wearing mask because our faces were uncovered. Of course, we both had to turn around and go back to your car after forgetting that being “maskless” is sort of a modern-day scarlet letter.
Then there was the incident a few months back when U.S. Center for Disease and Control Director Robert Redfield had to walk back comments before the Senate Subcommittee on Labor, Health and Human Services that wearing a mask could become a way of life if current vaccines prove ineffective.
In the now infamous video, a maskless Redfield held up his N95 face covering during the Senate hearing and uttered this cringeworthy words: “I can go far as to say that this face mask is more guaranteed to protect me against COVID than when I take a COVID vaccine because the immunogenicity maybe 70%. And if I don’t get an immune response, then the vaccine is not going to protect (but) this face mask will.”
Although I am not an epidemiologist and did not understand half of what Redfield said, I do know there is a growing number of people tied to vaccine research who believe that the so-called efficacy of the current crop of COVID-19 drugs in Phase 3 is very ineffective, as noted by the CDC chief.
But alas, there was good news on Nov. 9 when Pfizer’s Inc. and BioNTech SE announced their mRNA-based vaccine candidate, called BNT162b2, demonstrated evidence of efficacy against COVID-19 in participants without prior evidence the SARS-CoV-2 coronavirus. In Pfizer’s first interim efficacy analysis conducted on Nov. 8 by the independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer’s Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”
After discussion with the federal Food & Drug Administration (FDA), the companies then decided to drop the interim analysis study of 32 cases and conduct a new trial with a minimum of 62 cases. Upon further talks, the case count reached 94 and the DMC performed its first analysis on all cases. The final verdict was split between vaccinated individuals and those who received the placebo, indicating a vaccine efficacy rate above 90% seven days after the second dose.
This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary, Pfizer’s officials said. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.
“I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavor,” added Bourla. “We could not have come this far without the tremendous commitment of everyone involved.”
“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” said Prof. Ugur Sahin, BioNTech co-founder and CEO. “When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.”
Pfizer’s and BioNTech said they are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization – will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Along with the efficacy data generated from the clinical trial, Pfizer’s and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced. Based on current projections, Pfizer’s hopes to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
Despite a potentially effective COVID-19 vaccine in the pipeline, Pfizer’s has said it is involved in the Trump administration’s Operation Warp Speed program to accelerate efforts to find a cure – but only as a supplier. On the other hand, the New York pharmaceutical giant with headquarters in Mainz, Germany announced Wednesday (Nov. 11) that it had already reached an agreement to produce its vaccine overseas.
Under one agreement with the European Commission, Pfizer’s and BioNTech will supply 200 million doses of their investigational BNT162b2 mRNA-based vaccine candidate to European Union (EU) members states, with an option for the EU to request an additional 100 million doses. Deliveries are anticipated to start by the end of 2020, subject to clinical success and regulatory authorization.
In the U.S., the Trump administration has yet to announce how it plans to roll-out a COVID-19 vaccine. President-elect Joe Biden has pledged to invest $25 billion in manufacturing and distributing COVID-19 vaccines, but House and Senate leaders have failed to reach an agreement on a second stimulus deal that could coverage some of the costs.
Based on the estimated range of $10 to $50 per shot for all the COVID-19 vaccine in Phase 3 trials, the final price tag to inoculate more than 330 people in the U.S. by most recent Census Bureau data would easily exceed trillions of dollars once manufacturing, distribution and other health care expenses are figure in the total costs.
No matter how the Pfizer’s vaccine or another potential COVID-19 cure is rolled in the coming weeks, the events of the past week provide hope that some sense of normalcy could arrive in time for Christmas.
