The pharmaceutical industry does not want you to worry about the safety or efficacy of a future Covid-19 vaccine.
Officials from five major vaccine makers — AstraZeneca, Johnson & Johnson, Merck, Moderna, and Pfizer — all used their testimony before a House investigative subcommittee on Tuesday to push back on concerns that the Food and Drug Administration might prematurely approve a vaccine for the novel coronavirus and thereby put Americans at risk.
“The American public should take great confidence in the FDA’s guidance, which clearly lays out guidance for effectiveness and, importantly, for safety,” said John Young, Pfizer’s chief business officer. The company’s speed is due to taking an uncommon financial risk, not cutting corners in the normal process of developing a vaccine, Young said, a statement echoed by the other four executives.
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The hearing of the House Energy and Commerce Oversight and Investigations Subcommittee comes as drug manufacturers race through the normally sluggish process of testing vaccines. AstraZeneca has already started a trial that will enroll more than 30,000 volunteers, while Moderna and Pfizer plan to do the same later this month.
Committee members from both parties repeatedly asked the executives whether they were prioritizing safety, whether such rapid development was possible, and whether the FDA was up to the challenge of responsibly vetting vaccine candidates. Their assurances were of little comfort to some Democrats on the committee, who voiced concerns that President Trump, in search of a pre-election polling boost, might overrule the agency and demand an approved vaccine.
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“Historically I’ve been very confident in the FDA,” said Rep. Frank Pallone, a New Jersey Democrat. “But now that Trump is president, I still think there’s a real possibility that he will pressure the FDA to lower its standards.”
Four of the companies endorsed the White House’s ambitious goal of having at least one widely available vaccine by the winter, with only Merck, represented by Chief Patient Officer Julie Gerberding, cautioning that the process could take longer.
“Merck has a long experience, and science is a stern taskmaster in this regard,” Gerberding said. “There is a lot we don’t know about this virus.”
Only two companies, AstraZeneca and J&J, committed to selling their vaccines on a not-for-profit basis, at least as long as the coronavirus pandemic remains a national emergency. Gerberding promised Merck’s eventual pricing would be transparent but said it was too soon to make a specific commitment. Young said Pfizer recognizes that “these are extraordinary times, and our pricing will reflect that.”
The hearing took a few off-topic turns, such as when Rep. David McKinley (R-W.Va.) accused the panel of “waffling” on whether they’d send their children to school this fall and asked the executives whether they were “insulted” by the question of whether they’d sell a vaccine that had not been thoroughly tested.
It also underlined the reputational issues at stake for the drug makers involved.
Each company committed to ensuring that its clinical trials would prioritize the enrollment of Black, Hispanic, and Native American people, a population that has been disproportionately affected by Covid-19. But when asked how they would make sure those groups had access to vaccines once they’re approved, the executives deferred to the federal government, which would handle distribution.
That spurred rebukes from Democratic Reps. Joe Kennedy of Massachusetts and Raul Ruiz of California, who urged the companies to develop their own distribution plans and warned that relying on an administration that has struggled to provide testing and protective equipment could backfire.
“If you don’t think there’s going to be a problem for your companies when communities of color and lower-income communities don’t have access to this, you’re going to come back here and have another hearing where we’re grilling you on this stuff,” Kennedy said. “Buyer beware on this.”
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July 22, 2020 at 01:24AM
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Pharma promises, again and again, not to cut corners on Covid-19 vaccine - STAT
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