It’s said that success has many authors, and the encouraging data from Pfizer Inc.’s experimental COVID-19 vaccine had plenty of people in Washington lining up to take credit.
Vice President Mike Pence was among Trump administration officials saying support from the government’s Operation Warp Speed program helped accelerate the development of the vaccine, which was found to be more than 90% effective in preventing symptomatic COVID-19 infections in an interim analysis.
The truth is that Pfizer didn’t receive any funding from Operation Warp Speed for the development, clinical trial and manufacturing of the vaccine. Rather, its partner, BioNTech SE, has received money — from the German government.
BioNTech is credited for contributing the messenger RNA technology, which prompts the body to make a key protein from the virus, creating an immune response. The biotechnology company already had a history of working with Pfizer on influenza vaccines, and in March they clinched a deal to co-develop a shot to prevent against COVID-19 at research sites both in the U.S. and Germany. The two companies began human testing of the vaccine in April, before the existence of Operation Warp Speed was revealed publicly.
Berlin gave the German company $445 million in an agreement in September to help accelerate the vaccine by building out manufacturing and development capacity in its home market.
Subscribe to The Capsule, a weekly brief monitoring advances in health care and biopharma, delivered free to your inbox.What the U.S. did, meanwhile, was commit to buying hundreds of millions of vaccines in advance to ensure Americans were among the first in line if it clinches an emergency-use authorization or approval from the FDA. The Trump administration agreed in July to pay almost $2 billion for 100 million doses, with an option to acquire as many as 500 million more, once that clearance comes.
As part of that agreement, the U.S. gets to decide who gets the vaccine first, and will work with the company on logistical support. While most vaccine front-runners that have been tapped by Warp Speed will distribute their doses through a government partnership with McKesson Corp., Pfizer is handling its own delivery of its products. The company has designed reusable containers that can keep the doses at ultracold temperatures, and is organizing trucks and flights to move them.
Operation Warp Speed is credited with speeding along several other vaccine programs, including one from Moderna Inc.that uses similar technology to Pfizer’s and could produce trial data later this month. The Trump administration’s rapid-vaccine operation, led by the Health and Human Services Department, the Defense Department, and other agencies, could well prove to be the reason many Americans get a vaccine in 2021, even if it’s not made by Pfizer.
Some Republicans, including Donald Trump Jr. and Texas Senator Ted Cruz, questioned the timing of Pfizer’s release of its positive data on Monday, almost a week after the presidential election — with the implication that the information could’ve changed the outcome and tipped the scales toward President Donald Trump, who lost to former Vice President Joe Biden.
Pfizer said on Oct. 27, a week before Election Day, that it hadn’t met the threshold for positive cases that would’ve allowed it to report the data. After that, it revised its trial protocols to raise that threshold higher, after consulting with the U.S. Food and Drug Administration on what would be acceptable to gain approval. The FDA has been under pressure from scientists to set tough standards for a vaccine so that Americans will feel it has been rigorously vetted and is safe to use.
If Pfizer hadn’t raised its threshold in response to the FDA’s recommendations, it’s possible it could’ve hit the lower bar of 32 positive cases before the Nov. 3 election. But it’s unclear when the trial hit that number. The company didn’t find out it had surpassed the new, revised threshold of 62 positive cases until Sunday.
All along, Pfizer’s top executives have attempted to quell notions that it has been influenced by political players.
Chief Executive Officer Albert Bourla has repeatedly said that the drug giant has avoided taking taxpayer dollars for research and development purposes.
“I wanted to liberate our scientists from any bureaucracy,” Bourla said in an interview on CBS’s “Face the Nation” on Sept. 16. “When you get money from someone, that always comes with strings. They want to see how we are growing to progress, what types of moves you are going to do. They want reports. I didn’t want to have any of that.”
“Basically I gave them an open checkbook so that they can worry only about scientific challenges, not anything else. And also, I wanted to keep Pfizer out of politics, by the way,” Bourla added.
