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Politics, Policy & Law

McMurry-Heath calls for increased transparency on vaccine evaluations

Plus: Bourla denounces politicization of vaccine timeline, commits to ‘moving at the speed of science’

Oct 3, 2020 | 3:26 AM GMT

Amid questions of whether FDA has been compromised by political pressure to approve a COVID-19 vaccine ahead of the U.S. presidential election, industry leaders are calling for increased transparency regarding FDA’s vaccine guidelines and pushing back against the politicization of vaccine timelines. 

BIO President and CEO Michelle McMurry-Heath on Friday urged HHS Secretary Alex Azar to publicly release FDA guidance regarding emergency use authorization (EUA) of COVID-19 vaccines to “provide scientists and researchers greater regulatory clarity and strengthen public confidence in any future vaccine that may be authorized or approved.”

While vaccine developers are already working closely with FDA and have designed trials to reflect the standards the agency has said it would apply to the vaccines, release of the guidance would provide the public with clear reference points to assess EUA decisions (see “FDA Will Require Data Similar to BLA Standard”). 

“All new FDA guidance should be finalized and communicated with those on the frontlines developing potential vaccines. Just as importantly, it must also be shared more broadly with the American public,” McMurry-Heath said. “The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic.”

McMurry-Heath’s comments come amid a backdrop of controversial EUAs for hydroxychloroquine and convalescent plasma and inconsistent claims from government officials on when a vaccine will become available, ranging from this month from President Donald Trump to late 2Q21 or 3Q21 from CDC Director Robert Redfield (see “The Missing Dimension in COVID-19 Vaccine Development”).

Trump, who has since been hospitalized with COVID-19, added fuel to the fire last week, repeatedly stating at a press conference that the White House will make the final decision about criteria for approving vaccines and accusing FDA of attempting to delay approvals for political reasons (see “Trump Contradicts Hahn”; “Trump Receives Regeneron COVID-19 mAb”).

During a House Committee on Energy and Commerce hearing on Wednesday, Paul Offit and Mark McClellan both offered testimony highlighting the safeguards in place — including advisory committee meetings and independent data safety monitoring boards — to protect the vaccine authorization and approval process from political pressure.

Offit is a member of FDA’s Vaccines and Related Biological Products Advisory Committee and director of the vaccine education center at the Children’s Hospital of Philadelphia; McClellan is a former FDA commissioner who now directs the Duke-Margolis Center for Health Policy  (see “Testimonies Aim to Bolster Trust”). 

Company commitments

Companies are also taking new measures to increase transparency.

On Thursday, Albert Bourla published an open letter highlighting the pharma’s commitment to “moving at the speed of science,” stating it “would never succumb to political pressure.” 

“Our priority is the development of a safe and effective vaccine to end this pandemic,” wrote Bourla, who is chairman and CEO of Pfizer Inc. (NYSE:PFE). “The amplified political rhetoric around vaccine development, timing and political credit is undercutting public confidence. I can’t predict exactly when, or even if our vaccine will be approved by the FDA for distribution to the public. But I do know that the world will be safer if we stop talking about the vaccines’ delivery in political terms and focus instead on a rigorous independent scientific evaluation and a robust independent approval process.” 

He added: “Imagine the compounded tragedy if we have a safe and effective vaccine that many people didn’t trust. That is a risk none of us should accept.”

Moderna Inc. (NASDAQ:MRNA), Pfizer and partner BioNTech SE (NASDAQ:BNTX), AstraZeneca plc (LSE:AZN; NYSE:AZN) and Johnson & Johnson (NYSE:JNJ), all of which have financial support from the U.S.’s Operation Warp Speed, have taken the unprecedented step of publishing the complete protocols for their pivotal trials (see “Criteria for COVID-19 Vaccines”). 

Pfizer and BioNTech may offer the first look at late-stage COVID-19 vaccine data in October, when the partners are expected to announce the first interim analysis from the Phase II/III trial of mRNA vaccine BNT162b2.

Phase III data for mRNA-1273 from Moderna and JNJ-78436735 from J&J, and Phase II/III data for AZD1222 from AstraZeneca, could come later this year. 

Among the most advanced vaccine developers with Warp Speed funding, Pfizer, J&J and Moderna are BIO members; AstraZeneca and BioNTech are not. 

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