Washington, D.C. – This week, members of the Energy and Commerce Committee heard directly from representatives of five companies developing a COVID-19 vaccine at an Oversight and Investigations Subcommittee hearing. The drug manufacturers represented were AstraZeneca, Johnson & Johnson, Merck, Moderna, and Pfizer.
These were the witnesses:
- Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca
- Macaya Douoguih, Head of Clinical Development and Medical Affairs, Janssen Vaccines, Johnson & Johnson
- Julie Gerberding, Executive Vice President and Chief Patient Officer, Merck
- Stephen Hoge, President, Moderna
- John Young, Chief Business Officer, Pfizer
Here are some highlights:
Representatives from the companies provided a promising update on when a vaccine may be available to Oversight and Investigations Subcommittee Chairwoman Diana DeGette (D-CO).
At the hearing, DeGette directly asked Pangalos if AstraZeneca expects to have a vaccine available on an emergency basis by the end of the year in the United States.
“Yes, we do,” he replied.
In his written testimony, Stephen Hoge, MD, president of Moderna, said his firm is set to begin a phase 3 trial this month of its COVID-19 vaccine candidate. About 30,000 participants are expected to enroll in a randomized and placebo-controlled study, conducted in collaboration with the National Institute of Allergy and Infectious Diseases.
In his exchange with DeGette, Hoge said Moderna might by the end of the year have data that they can submit to the FDA for them to make a determination about its distribution. Moderna also hopes at that time to “have millions of doses of vaccine available.”
In his written testimony, John Young, Pfizer’s chief business officer, said his firm is scaling up manufacturing capacity “at risk to be able to quickly supply a vaccine at scale if we are successful,” with about $1 billion to be invested toward this goal this year. Pfizer to date has not accepted any federal government funding for this vaccine development program.
“If our clinical trials progress well, and we receive regulatory approval, we hope to be able to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses in 2021 globally, subject to final dose selection from our clinical trial,” Young said
In her written testimony, Douoguih said Johnson & Johnson will continue to work with the FDA, BARDA, and other global authorities to complete a phase 3 trial and “have results in-hand in early 2021.”
Gerberding said at the hearing that Merck does not expect to have a licensed COVID-19 vaccine “until 2021 at the earliest.”
E&C Republican Leader Greg Walden (R-OR) asked if the companies are comfortable with the guidance released by the Food and Drug Administration (FDA) to ensure safety and efficacy in a vaccine.
On efficacy, the FDA guidance “…conveys that the FDA would expect that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50% of people who are vaccinated.”
“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.
Oversight and Investigations Subcommittee Republican Leader Brett Guthrie (R-KY) asked to explain if the unprecedented speed to develop a COVID-19 vaccine was sacrificing safety or efficacy of the vaccine. Guthrie went on to ask how the drug manufacturing companies could develop a vaccine in 12-18 months, when the fastest vaccine developed, which was for Mumps, took four years.
The federal government has sought to help pharmaceutical companies bring COVID-19 vaccines to market. The FDA last month, for example, issued a guidance document for development of COVID-19 vaccines. The FDA has said that companies need to run clinical trials large enough to demonstrate to the agency the safety and effectiveness of a vaccine. The FDA also said it expects that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50% of people who are vaccinated. The agency may also require postmarketing studies to further assess known or potential serious risks.
AstraZeneca’s Pangalos cited the extraordinary cooperation of regulators around the world, as well as long hours put in by AstraZeneca staff. “I don’t think any of the regulatory bodies we’ve interacted with are lowering their standards,” Pangalos said. “By the end of our pivotal studies, we’ll have dosed nearly 50,000 people,” which he says compares favorably with patient testing pools for already approved vaccines.
Douoguih said that the experience with the fairly rapid recent development of Ebola vaccines can serve as a model in this work. Johnson & Johnson won approval of its Ebola vaccine earlier this month by the European Commission.
“A lot needs to be done in parallel, but it can be done safely without compromising any of the standards that we usually undertake for any clinical trial,” she said. “There may be a need to perform post-marketing surveillance and we’re working on a plan there.”
“First of all, all of our interactions with the regulators have given us no evidence that they’re lowering the standards or thinking about lowering their standards,” Pangalos. “Secondly, as a company, we will always think about safety and efficacy first and foremost and making sure that we have an effective medicine.”
Pangalos added that all of the company’s studies regarding the vaccine’s effectiveness and any changes in FDA requirements would be made public.
E&C Republican Leader Greg Walden (R-OR) said in opening remarks that he is interested in learning how the companies are working to boost public trust in the vaccine once it has been approved.
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The companies also flagged vaccine hesitancy concerns. “We recognize the public distrust, and the speed may be perceived as a problem,” AstraZeneca Executive Vice President Mene Pangalos said. Janssen’s Macaya Douoguih, meanwhile, called for an educational campaign aimed at boosting trust and access to an eventual vaccine, with the executives focusing on outreach to minorities and the underserved.