Politico

Vaccine makers shrug off concerns about Trump admin cutting corners


Companies behind leading coronavirus vaccine candidates told lawmakers Tuesday they’re not worried that political pressure will lower standards for approval of any eventual shot — but they need the government to decide who gets it first.

President Donald Trump has repeatedly promised a vaccine by the end of the year, raising concerns that his administration will rush to approve one without adequate proof that it works.

Vaccine manufacturers say that the global nature of the vaccine race should keep U.S. regulators honest.

“Remember this is going to be a vaccine that is going to be used globally, so every regulatory authority is going to have a view on the safety and efficacy of our vaccine,” AstraZeneca’s Mene Pangalos told Energy and Commerce’s Oversight and Investigations Subcommittee amid questions about whether Trump could pressure the Food and Drug Administration to make a hasty decision.

Former CDC chief Julie Gerberding, now Merck’s chief patient officer, said she was “relieved” by the rigor of FDA guidelines for coronavirus vaccine development.

Democrats grilled the two witnesses — along with executives from Johnson & Johnson’s Janssen, Moderna and Pfizer — on how their vaccines would be distributed if they prove effective. The lawmakers argued that there is urgent need among communities disproportionately affected by the coronavirus, including Black and Latino populations.

Several of the companies, including AstraZeneca, Moderna and Pfizer, have published promising results from early human trials of their vaccine candidates. Of the five firms represented at the hearing, all but Pfizer have received anywhere from hundreds of millions to more than a billion in U.S. government funding for their experimental coronavirus shots.

All of the pharma company executives said they would depend on the U.S. government to allocate and distribute the vaccines, though Janssen’s Macaya Douoguih said the company also has a framework for high-priority individuals based on risk. The responses did not seem to satisfy several Democrats.

“Out of the five companies that are investing the most resources … one of you has a plan, all of you are relying on a government that couldn’t procure proper PPE for wide swathes of this population,” said Rep. Joe Kennedy (D-Mass.). “You’re saying you are relying on the federal government — clearly the federal government has failed on here multiple times over.”

But Gerberding said that the agency has a “very special responsibility” to allocate vaccines nationwide.

She also endorsed the idea of asking the independent, nonpartisan National Academy of Medicine to develop a framework for ethical distribution — something that Trump administration officials suggested at a Senate HELP hearing earlier this month.

The combination of CDC and academy know-how could “really help adjudicate those decisions independent of the administration,” Gerberding said.

Pfizer’s chief business officer, John Young, also cited an existing CDC framework to distribute vaccines to at-risk populations such as the elderly and ill. “We believe the CDC has laid out very clear criteria,” he said.

CDC Director Robert Redfield told Senate lawmakers this month that his agency would take the lead on distribution, but Army officials have also said on press calls that they would play a role. The Pentagon is co-leading Operation Warp Speed, the project to accelerate vaccine development, with the Health and Human Services Department.

While all five witnesses expressed optimism about the timeline for their shots to move into final stages of trials, none committed to having an approved vaccine readily available to all Americans this year.

Gerberding said there are still many unknowns about the coronavirus, which is a “much more formidable foe” than the SARS virus she dealt with as CDC director in 2003. Merck is aiming to have a vaccine ready for review in early 2021.

Rep. Jan Schakowsky (D-Ill.) asked each company to pledge to price their vaccines affordably and transparently. Gerberding and Moderna president Stephen Hoge said they would not sell their products at cost. AstraZeneca’s Pangalos said that under the terms of their agreement with the U.S. government, they are selling their shots at no profit; Janssen’s Douoguih repeated the company’s earlier promise that it would provide the vaccine at a “not-for-profit” basis during the pandemic.

Pfizer, the only company at the hearing that has not received any government funding for its vaccine, made a similar pledge to price responsibly during the pandemic.

“A vaccine is meaningless” if people cannot afford it, said Young, the company’s chief business officer.

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