Drugmakers to Congress: Trust an FDA-approved COVID-19 vaccine

Regulatory NewsRegulatory News | 21 July 2020 |  By 

Pfizer Chief Business Officer John Young

The public should have confidence in any COVID-19 vaccine approved by the US Food and Drug Administration (FDA), according to the testimony presented by five top pharmaceutical executives at a hearing of the House Energy & Commerce Subcommittee on Oversight and Investigations on 21 July.
The executives – representing AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer – also stressed that the agency does not appear to be lowering its standards to rush a vaccine to market, despite the accelerated pace of development. (RELATED: FDA issues COVID-19 vaccine guidance, setting 50% effectiveness threshold, Regulatory Focus 30 June 2020; Marks on COVID-19 vaccine efficacy, EUAs and challenge trials, Regulatory Focus 9 July 2020).
Combined, the five drugmakers have the capacity to produce hundreds of millions of COVID-19 vaccine doses globally this year, and billions of doses in 2021, with some set to produce vaccines “at risk” so that doses of a successful candidate will available more quickly than if they were to begin commercial manufacturing after receiving regulatory approval.
Asked whether the companies’ vaccines might be available by the end of the year, Mene Pangalos, executive vice president, biopharmaceuticals R&D at AstraZeneca, said his company, which has partnered with Oxford University to develop its candidate, could see its vaccine authorized for emergency use contingent upon positive Phase 3 data, “any time from September onwards.”
Moderna President Stephen Hoge told the committee he’s “cautiously optimistic” that the company’s mRNA-based vaccine will be successful and that if a Phase 3 trial is able to accrue cases quickly, it could submit data to FDA, “in the Fall, or towards the end of the year.”
John Young, chief business officer at Pfizer, also said Pfizer’s vaccine, being developed in partnership with BioNTech, could be ready for emergency use by the end of the year.
“If all goes well, we hope to be able to provide our dossier of clinical data from our large Phase 2b/3 study to the FDA in October. Obviously, the FDA will then review that data and they will determine whether our dataset meets the requirements that they have already laid out ahead of time for what would determine an emergency use authorization,” Young said.
Vaccine candidates from Merck and Johnson & Johnson have yet to begin clinical testing. “We expect to be in clinical trials imminently for both of our products, but we would not expect to have a licensed product till 2021 at the earliest,” Merck Executive Vice President and Chief Patient Officer Julie Gerberding told the committee. Macaya Douoguih, head of clinical development and medical affairs at Janssen Vaccines said that Johnson & Johnson is hoping to have results from its planned Phase 3 trial by early 2021.
Several of the witnesses praised FDA for offering detailed guidance on its expectations on safety and efficacy for COVID-19 vaccines.
“The American public should take great confidence in the FDA’s guidance, which I think clearly and very transparently lays out standards for both effectiveness, but importantly, for safety,” Young said.
Pangalos added that, “All of our interactions with the regulators have given us no evidence that they’re lowering the standards or thinking about lowering the standards,” noting that due to the global nature of the pandemic, regulators from many countries will be reviewing the safety and efficacy of any promising vaccine.
Douoguih countered the notion that the companies would try to get ineffective vaccines approved if standards were lowered. “We have a target product profile which outlines the minimum characteristics and desired characteristics for the development of our product, and that includes assumptions on minimum vaccine efficacy. If we saw 10% … the study would fail …. We would not feel comfortable bringing forward a product that was not found to be efficacious.”
Gerberding said that FDA’s guidance is a great help and “creates more regulatory certainty about what we need to come forward with for a portfolio. We know we need six months of safety data, for example.”
The executives also gave a mix of answers when asked by Rep. Jan Schakowsky (D-IL) whether they would commit to selling their vaccines in the US at cost. Pangalos noted that AstraZeneca has agreed to sell 300 million doses of its vaccines to the US government at no profit. Douoguih said that Johnson & Johnson will sell its vaccine “at a not-for-profit price during the emergency pandemic phase,” while Young only conceded that Pfizer would price its vaccine “consistent with the global health emergency.”
Hoge and Gerberding both said their companies would not sell their vaccines at cost.


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