The coronavirus pandemic took the world by storm, killing hundreds of thousands and sickening millions in the U.S. alone. As nations across the globe raced to find treatments and a vaccine, one person slashed regulatory barriers, jacked up funding — and could have possibly helped save the world.
President Donald Trump launched Operation Warp Speed (OWS) in May, a public-private partnership with the goal of producing and delivering 300 million doses of a safe and effective coronavirus vaccine by January 2021. OWS was simultaneously set on accelerating the development of therapeutics to treat the pandemic.
Operation Warp Speed has 100 million vaccine kits ready to go if and when distribution of a coronavirus vaccine starts, Gen. Gustave Perna, Warp Speed’s chief operating officer, said last month. They include a written vaccination card that looks like this. https://t.co/O5luzLcrPK pic.twitter.com/WKmh06lrYL
— CNN (@CNN) December 5, 2020
In order to get the job done, OWS allowed companies to manufacture at risk — meaning they could both manufacture their vaccine candidates at an industrial scale prior to testing the efficacy of the vaccine and receiving Food and Drug Administration (FDA) emergency use authorization (EUA). While this cut to regulatory barriers may have increased the financial risk for companies, it did not increase product risk, according to the Department of Health and Human Services (HHS).
Further, under OWS some vaccine companies received millions in funds to produce their candidates. HHS announced in March that Johnson & Johnson was to receive $456 million in funds for their vaccine. By July the company was conducting clinical Phase 1 trials and by September they were conducting Phase 3 clinical trials.
HHS made up to $483 million available to Moderna in April, which began Phase 1 trials in March and “received a fast-track designation from FDA,” according to HHS.
Pfizer announced in November that their vaccine candidate was more than 90% effective and received up to $1.95 billion in funds in exchange for the distribution of 100 million doses of their vaccine candidate. The company also benefited from accelerated regulatory protocols.
“I would say it’s a historical moment,” Kathrin Jansen, Pfizer’s head of vaccine and research development said, according to The Washington Post. “First of all, the world was faced with such a terrible situation, the pandemic, and being able in such a short time to go through what usually takes many years.”
However, just after announcing the success of their trials, Pfizer tried to distance themself from OWS. (RELATED: Trump Administration Strikes Deal With CVS, Walgreens For Free COVID Vaccines For Residents Of Long-Term Care Facilities)
“We were never part of the Warp Speed … We have never taken any money from the U.S. government, or from anyone.”Jansen said in an interview, according to The New York Times (NYT).
— Carl Quintanilla (@carlquintanilla) November 9, 2020
Despite Jansen’s insistence that Pfizer was not involved in OWS, Pfizer’s nearly $2 billion dollar check says otherwise. Pfizer also announced in May that they were “taking a number of steps to scale up manufacturing operations at risk to accelerate” their ability to supply the vaccine once it’s approved, something only possible thanks to OWS. While Pfizer did not take funds for research and development, they still capitalized on regulatory protocols being fast-tracked, along with a near multibillion-dollar deal.
Doses of Pfizer’s vaccine could be sent out by the end of 2020 after the company submitted an EUA toward the end of November. North Carolina is slated to receive approximately 85,000 doses of the vaccine as soon as mid-December.
Meanwhile, Moderna, which partnered with HHS, also applied for EUA from the FDA at the end of November, according to USA Today.
When it came to trust in Trump and the vaccine, some were leery of whether Trump could deliver on his promises. The Atlantic wrote a piece entitled “All the President’s Lies About the Coronavirus,” in which they claimed that Trump lied about producing a vaccine.
Trump said in March that vaccines would be available “relatively soon.” The Atlantic reported that despite Trump’s claims, experts said it would take at least a year to 18 months to develop the vaccines.
Both were wrong.
Trump claimed Aug. 6 that a coronavirus vaccine could be ready by Election Day, according to The Atlantic. They wrote that Trump’s timeline “contradicts health experts’ consensus that early in 2021 is likely the soonest a vaccine could be widely available.”
In September during the first presidential debate, Trump said the U.S. was “weeks away from a vaccine,” according to the report. The Atlantic reported that a vaccine wouldn’t likely be ready until summer 2021 and that vaccine companies only expected to have initial clinical-trial results by the end of 2020.
However, recent findings show that the vaccine has exceeded skeptics’ expectations and fallen in line with some of Trump’s earliest predictions.