Pfizer vaccine announcement: fact check

by



[ad_1]

President Donald Trump’s administration was quick to applaud.

“HUGE NEWS: Thanks to the public-private partnership forged by President @realDonaldTrump, @pfizer has announced that its coronavirus vaccine trial is EFFECTIVE, preventing infection in 90% of its volunteers,” Vice President Mike Pence tweeted.
Others, however, pointed out that Pfizer’s senior vice president and head of vaccine research and development, Kathrin Jansen, had publicly left the company behind the Operation Warp Speed ​​vaccination initiative. the Trump administration. Jansen was quoted by The New York Times on Monday as saying, “We have never been in Warp Speed. We have never taken money from the US government, or anyone.”

The real story is more nuanced than Pence’s tweet and Jansen’s commentary made it sound.

Facts first: Pfizer’s vaccine advancements are certainly not attributable solely to the Trump administration’s Operation Warp Speed ​​public-private partnership program. But it was not correct for Pfizer to suggest that it operates entirely independently of Operation Warp Speed; the company has a major agreement to sell at least 100 million doses of its vaccine to the federal government, and Pfizer admitted in a statement Monday to CNN that it was in fact “participating” in Operation Warp Speed ​​through this agreement. Additionally, at least some independent experts say the Trump administration deserves partial credit for Pfizer’s progress.

It is true that Pfizer, unlike other pharmaceutical companies, has not accepted federal money for research into a coronavirus vaccine. Pfizer, unlike these competitors, does not obtain upfront payments even before proving that its efforts have been successful.

However, the Trump administration agreed in July to purchase at least $ 1.95 billion of a Pfizer vaccine, at least 100 million doses, if Pfizer obtains a vaccine approved by the Food and Drug Administration.

Three experts told CNN that the promise to purchase may have played a significant role in accelerating Pfizer’s vaccine development process. So, after Pfizer’s initial claim to the New York Times that it had never been a part of Operation Warp Speed, CNN asked the company if there was more nuance in the situation.

In response, Pfizer spokeswoman Sharon Castillo provided a statement that the company was indeed part of Operation Warp Speed.

“Pfizer is one of various vaccine manufacturers participating in Operation Warp Speed ​​as a supplier of a potential COVID-19 vaccine,” Castillo said in an email. “Although Pfizer has entered into an early purchase agreement with the US government, the company has not accepted funding (Biomedical Advanced Research and Development Authority) for the research and development process. All R&D investments were made by Pfizer at risk. Dr Jansen emphasized this last point. “

There is many us again do not know on the Pfizer vaccine. The company released the Monday news via a press release, and because this is provisional data and not a final analysis, no peer-reviewed studies are available yet. Final peer-reviewed data will not be provided until the company is ready to apply to the FDA for emergency use authorization.
We also don’t know exactly what went on behind the scenes at Pfizer, so we can’t determine for sure the extent of the U.S. government’s influence over its development timeline. Also, it should be noted in response to Pence’s tweet that Pfizer’s coronavirus vaccine partner, German company BioNTech, has received significant funding from the German government – and that Pfizer and BioNTech have purchase agreements. with other countries besides the United States.

Still, three experts contacted by CNN said the U.S. federal government likely played a significant role in the vaccine’s progress. (Another expert disagreed.)

Dr Robert Wachter, professor and president of medicine at the University of California at San Francisco, said advance guarantees from the federal government to purchase large quantities of the coronavirus vaccine from Pfizer and its competitors “reduced the risk of the company, for Pfizer et al. “Wachter said that the development of previous vaccines has been slowed by the fact that” the payoff in the end is uncertain and companies are very risk averse. “

“You could say that Pfizer, recognizing that it was working on the world’s biggest problem, would have been willing to go full steam ahead in any case, but I clearly think the federal dollars (with the promise more) tilts the playing field for fast-paced action, ”he said in an email.

Dr Paul Spearman, professor and director of infectious diseases at the Cincinnati Children’s Hospital Medical Center, said he, too, believed that “Operation Warp Speed ​​had an influence on the development program of Pfizer vaccines ”. He said the government’s advance purchase agreement had helped – as had the competitive “pressure” he said had been placed on Pfizer by the speed at which a vaccine candidate from rival company Moderna, which effectively took federal research funding, was “moved by Operation Warp. Speed.” And Spearman said Pfizer “definitely agrees with the same test designs and criteria as other manufacturers,” in consultation with the Food and Drug Administration.

Dr Peter Hotez, co-director of the Center for Vaccine Development at Texas Children’s Hospital and dean of the National School of Tropical Medicine at Baylor College of Medicine, said: “I think Operation Warp Speed ​​helped design the clinical trial and helped provide the financial incentive, knowing there would be an advance purchase commitment for the vaccine. I think those were critical items. ”

Not everyone agrees. Dr Michael Mina, assistant professor of epidemiology at Harvard TH Chan School of Public Health, said he would “put the role of the US government at the bottom of the list” of what helped Pfizer achieve this preliminary positive result .

“Pfizer is a company large enough that in this case it was not the promise to purchase that enabled this early result and the rapid acceleration of a vaccine.” Global demand is such that with or without a vaccine purchase agreement, Pfizer would most likely have had the same path, ”Mina said in an email.



[ad_2]

Source link