A sense of urgency, powerful science, relentless ingenuity, hope and trust drove the development of Pfizer and BioNTech’s mRNA vaccine during the height of the COVID-19 pandemic. As the crisis appears to lessen, Pfizer is preparing for the next pandemic.
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A sense of urgency, powerful science, relentless ingenuity, hope and trust drove the development of Pfizer and BioNTech’s mRNA vaccine during the height of the COVID-19 pandemic. As the crisis appears to lessen, Pfizer is preparing for the next pandemic.
“The scenario that a viral variant will evade the vaccine, one day, is real,” Pfizer CEO and Chairman Albert Bourla, DVM, Ph.D., said while speaking Monday at BIO Digital 2021. “We have tested our vaccine against almost all of the SARS-CoV-2 variants, including the latest one (from India and dubbed Delta), and no variant escapes our vaccine.”
A paper published June 14, 2021 in the Lancet confirms the Pfizer BioNTech vaccine is 92% effective against this variant. In comparison, the Oxford-AstraZeneca vaccine conferred 73% protection against the Delta variant.
The emergence of viral variants “tells us to be prepared,” Bourla said. That means checking all the variants constantly. Currently, data seems to suggest that a third vaccination administered 8-to-12 months after the initial vaccination may be needed. “We’re finalizing the study. Once the FDA approves, the Center for Disease Control & Development (CDC) will need a strategy to administer boosters.”
The company also is preparing for variants that may evade immune protection. The goal is to build a vaccine in less than 100 days.
“We’re doing that with the South Africa variant (Beta), as a rehearsal,” he said.
Bourla, whose parents survived the Holocaust, said having enough vaccination for everyone, at a price that governments can afford, is a moral imperative.
“I am only as protected as my neighbor, so we must do the right thing,” he said.
That means making vaccine affordable throughout the world, which means tiered pricing. In the U.S. and Europe, the cost per dose is “about that of a meal.” For middle income countries, the cost is halved, and for low- income countries, the vaccine is provided at cost. “This year we will produce 3 billion doses, and in 2022, 4 billion doses,” for a total of 7 billion doses in two years.
“The bottleneck is the raw materials, not the infrastructure,” he said, citing lipids. “This is the first time lipids have been manufactured at this scale, and its very challenging. We’re helping the suppliers financially and technologically and are doing more in-house to reach the 3-and 4-billion dose goals.”
When Pfizer and BioNTech joined forces to develop a vaccine, the agreement was oral, and sealed with the COVID-19 era equivalent of a handshake, long before contracts were signed and even before a letter of understanding.
“We agreed to build a partnership for the vaccine, and that it had to happen quickly. ‘Time is life,’ we said. We knew that waiting for contracts to be done would take months. So, we nodded our heads in a Zoom call and started work. Three weeks later, we signed a letter of intent,” Bourla recalled.
“The final contract agreement that regulates the allocation of expenses and revenues was signed January 2021,” after the first vaccines had been shipped and administered. “Developing a vaccine wasn’t about getting the credit, or even about the partners. It was about the outcome,” Bourla emphasized.
“We had a monumental obligation to meet the hopes and needs of billions of people,” Bourla said. The best outcomes come when each partner focuses on what it has to do and what it knows how to do best…but quickly.”
Consequently, regulators and pharmaceutical developers have learned more efficient ways to bring safe, efficacious products to patients faster. Digital technology, for instance, accelerated numerous aspects of development including structuring clinical research centers to be faster, organizing sample logistics for near-real-time results, and conducting many research steps in parallel rather than sequentially, while minimizing waste. “We learned a lot about the processes that will change the way we do things forever,” Bourla said.
The world also learned a lot about the power of mRNA technology.
“With mRNA vaccines, we’ve only scratched the surface of what we can demonstrate.” Many researchers now are exploring additional applications. “We will see great things from this technology,” he predicted.
One of the remaining challenges, regarding COVID-19, is overcoming vaccine hesitancy. “That was a consideration from day one,” Bourla recalled.
To do this, Pfizer included a diverse population in the clinical trials and, because the stakes were so high, engaged in unprecedented transparency.
“Before the pandemic, we never made public the detailed trial protocol,” Bourla continued. “We gave it to the regulators. For the pandemic, though, we did. We wanted everybody to be able to see how we did things. We continued being transparent about everything we faced. We published the preliminary results on a server rather than waiting until we had conclusive results. We considered it a ‘must.’ We put all the information in front of the people as soon as possible.
“At the end of the day,” he said, “it’s not Pfizer that makes the difference (regarding vaccine acceptance), but everyone – politicians, journalists, friends, mothers, community leaders…. The vast majority of people are afraid, and fear isn’t rational…so, this isn’t a data issue.”
Instead, Bourla said, “You need to speak to people’s instincts. They are very good people. Explain that vaccines are taken not only to protect yourself but to protect society. If you succumb to COVID-19, the ones who will be more vulnerable are the ones you love the most, those you hug and kiss in the coming months.
“The last thing we should do is be critical, or challenging or disparaging of these people. They have a real fear.”
In the end, “Science will win,” he said, echoing the theme of the PR campaign Pfizer began during the height of the pandemic. Now, as that is being proven with treatments, vaccines, and diagnostics,
“There is a renewed hope and trust in science – and biological sciences in particular. I see this with leaders and with everyday people,” he said. “There’s a huge trend in terms of young people wanting to work in biotech, because that is what really saved the world. The win of science over the virus will have a lasting impact on people.”
