Developing a coronavirus vaccine at warp speed sounds good for a presidential reelection campaign, but Trump may have ignored safety when he said hoped to have a vaccine in production “by the end of the year or shortly thereafter”.
The much-repeated 12-to-18-month time frame to develop an effective coronavirus vaccine is “very aggressive,” said Kenneth C. Frazier, CEO of drug manufacturer Merck & Co Inc., according to Financial Times.
A $190-billion pharmaceutical company, Merck announced in a Tuesday press release that it’s working on two coronavirus vaccines and an experimental antiviral pill. The two vaccines will begin human trials this year, Merck said, but the company did not release timelines or financial details.
“COVID-19 is a global challenge and requires global solutions,” Frazier said in a prepared statement. “Merck intends to make any vaccine or medicine we develop for this pandemic broadly accessible and affordable globally, and we are working now to accomplish this goal as quickly as possible. Though the challenge of this pandemic is immense, we know that science and collaboration will triumph, just as they have before. While we cannot predict when this battle will be won, we are confident that science is on our side, that collaboration is already well underway, and that together, we will prevail.”
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Vaccines should be tested in “very large” clinical trials that can take years to complete, Frazier told Financial Times. “You want to make sure that when you put a vaccine into millions if not billions of people, it is safe.”
A rushed timeline “is not something I would put out there that I would want to hold Merck to,” Frazier added.
“Speed is one factor, but in some ways we don’t really accept the concept of a race,” Frazier said. “We understand the urgency, but our goal isn’t to be the frontrunner in the early stages — it’s to develop a vaccine that is safe and effective.”
At least 23 biopharmaceutical companies are working on covid-19 vaccines. With more than 70,000 employees, Merck has one of the largest vaccine businesses in the world and stands apart as one of a few with the experience and resources to impact a pandemic, Business Insider reported.
One of Merck’s recent announcements includes acquiring Themis Bioscience, a privately owned biotech company in Vienna that has been developing a coronavirus vaccine.
Merck is also collaborating with the nonprofit IAVI to build off its successful Ebola vaccine. The vaccine was approved in December in the U.S. with funding from the U.S. Biomedical Advanced Research and Development Authority, an office of the U.S. Department of Health and Human Services.
“As we just demonstrated with our Ebola vaccine, when the world needs to come together to tackle new and daunting challenges, Merck can be counted on to do our part,” Frazier said.
Merck has decided to work on vaccines for which it already has experience of the underlying technology, FT reported. By comparison, some rival drugmakers are pursuing less-proven science that could yield quicker results but higher risks of failure.
For example, U.S. biotech company Moderna is a frontrunners in the race to develop a vaccine using a “messenger RNA” (mRNA) platform that has never yielded a product approved by regulators, David Crow reported for Financial Times.
“It helps to start with hardware you know,” Frazier said. “Some of the other approaches give the promise of faster progress, but we have to be clear none of those approaches have produced an approved vaccine, and no one has tried to scale them up.”
Merck also announced a licensing agreement with a small U.S. biotech company, Ridgeback Biotherapeutics, to develop an experimental drug to treat patients already infected with covid-19. If all goes according to plan, the oral antiviral drug, taken in the form of a pill, could be a more convenient rival than Gilead’s remdesivir, which has to be taken intravenously.
The Trump administration announced on May 15 the creation of Operation Warp Speed, a program to accelerate the development, manufacturing, and distribution of covid-19 vaccines, therapeutics, and diagnostics.
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“President Trump’s vision for a vaccine by January 2021 will be one of the greatest scientific and humanitarian accomplishments in history,” said Alex Azar, secretary of the Department of Health and Human Services, in a prepared statement.
The son of a janitor, Frazier joined Merck as general counsel of one of the drugmaker’s subsidiaries in 1992, working his way up to CEO of the company in 2011, according to Reuters.
Frazier resigned from Trump’s manufacturing advisory council shortly after Trump praised white supremacists at a 2017 rally in Charlottesville, Virginia. The rally turned violent and claimed the life of a counter-protester and injured 19 people. Trump said some of the people at the Unite the Right rally in Charlottesville, Virginia, in 2017, were “very fine people.”
One of just a handful of Black leaders of Fortune 500 companies, Frazier was the first to leave Trump’s American Manufacturing Council following the initial response by the commander-in-chief, BBC reported.