President Trump held a press briefing in the White House Rose Garden last month to formally launch Operation Warp Speed, a public-private program intended to foster the development of pharmaceuticals to combat the novel coronavirus. During the event, Trump reiterated his pledge that a vaccine that prevents COVID-19 will be available to Americans by the end of the year.
The president’s assertion was met with skepticism on the part of many infectious disease experts, who point out that the process of developing, testing and manufacturing a vaccine normally requires a minimum of four years. Their doubts are all the more understandable since the source touting the unprecedented time line is an administration that has fallen short in delivering on promises about the availability of coronavirus testing and personal protective equipment.
Anyone seeking reassurance about the biopharmaceutical industry’s ability to counter COVID-19 would have been better served watching “Healthy Returns,” a virtual summit sponsored by CNBC, during which leaders of some of the nation’s leading drug companies and other experts, including former FDA commissioner Scott Gottlieb and Julie Gerberding, onetime head of the CDC and now chief patient officer at Merck, spoke about tackling the challenges at hand. Although the road ahead will be difficult and could be much longer than the president expects, the consensus view was that science will ultimately prevail in the war against coronavirus.
Preliminary evidence to support the optimists’ perspective emerged last month, when Moderna reported positive results from a small-scale test of the COVID-19 vaccine it has under development. Conducted in conjunction with the National Institute of Allergy and Infectious Diseases, the eight-person study found the vaccine produced an immune response and was safe to use. Further trials involving larger groups of patients are needed, but early signs are encouraging.
Speaking at the CNBC event prior to release of the study, Stéphane Bancel, Moderna’s chief executive officer, said the promise shown by the vaccine, which is based on messenger RNA (mRNA) technology, stems from nine years of work and an investment of between $600 million and $700 million in what he characterized as pure science. “This is the tenth vaccine we are putting into clinical studies, so there is a lot of learning there,” he said, adding that the company is working closely with the FDA, often on a daily basis, “to figure out how do we move fast but safely.”
Giovanni Caforio, chairman and CEO of Bristol Myers Squibb and current PhRMA chairman, also cited the high level of cooperation between pharmaceutical makers and government agencies, and between the companies themselves. Bristol Myers Squibb, which does not focus on vaccines but has a number of other therapies that could prove useful in the fight against the disease, exemplifies the trend. It is making thousands of compounds in its library available to outside researchers who are working to address the pandemic.
“This is a time for our industry and companies like Bristol Myers Squibb to step up to the challenge, work together and demonstrate what we are capable of when we work together,” Caforio said. That’s our industry, that’s what we stand for, that’s what we are, and this is a time in which the value of science and innovation is becoming clear. It is a difficult time, and we should not underestimate the challenges of the current situation, but ultimately it will be science that helps us solve the issues we’re facing today.”
Pfizer chairman and CEO Albert Bourla is another executive whose company is fully committed to the effort. As the coronavirus crisis accelerated in the U.S. and Europe, Pfizer expanded its partnership with BioNTech to develop an mRNA-based vaccine for COVID-19, as well as looking at existing products in its portfolio for their potential usefulness against the disease.
In parallel with the R&D program, Pfizer is preparing to begin manufacturing whatever turns out to be the most promising of its vaccine candidates (four are now undergoing clinical trials), even before it receives final regulatory approval. Bourla explained that that’s the only way millions of doses could be available this year.
After noting that Pfizer medications helped 500 million people last year, Bourla said, “How many fathers or mothers with cancer, for example, will live long enough to see the graduation of the daughter or the wedding of the son because of us? There is no other industry that can claim that it’s bringing humanity so much good. …
“I don’t want to declare any victory, but I think people right now across the globe — billions of people, millions of businesses and hundreds of governments — are investing their hope for a solution in the pharma industry. That should mean something.”
It does indeed.