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BioCommunique Article

Executives from AstraZeneca, Johnson & Johnson, Merck, Moderna, and Pfizer testified on the research, development, and manufacturing of their potential COVID-19

House Energy & Commerce Holds Hearing with COVID-19 Vaccine Candidates

  • 2020-07-23T19:00:00.000+0000
  • Washington DC
  • Author: Brittany Blocker

This week, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled "Pathway to a Vaccine: Efforts to Develop a Safe, Effective and Accessible COVID-19 Vaccine." Executives from AstraZeneca, Johnson & Johnson, Merck, Moderna, and Pfizer testified on the research, development, and manufacturing of their potential COVID-19 vaccine candidates.

The worldwide effort to develop vaccines and treatments for COVID-19 is now at 660 unique compounds in various stages of development, including 173 vaccine candidates, 196 antivirals, and 292 treatments. The United States has already invested nearly $2.3 billion and launched several initiatives in the effort to find a vaccine. The National Institutes of Health (NIH) launched the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. Additionally, the Trump Administration announced the Operation Warp Speed (OWS) initiative, a national program aimed at accelerating the development, manufacturing, and distribution of COVID-19 countermeasures. The Food and Drug Administration (FDA) also issued guidance on the “Development and Licensure of Vaccines to Prevent COVID-19” which states that the agency may approve or authorize a vaccine only if it is demonstrated to be at least 50 percent more effective than a placebo in preventing the disease.

Current Progress of Vaccine Candidates

AstraZeneca is partnering with the University of Oxford for the global development and distribution of the University’s potential recombinant adenovirus vaccine for COVID-19. Through OWS, AstraZeneca will receive up to $1.2 billion from the Biomedical Advanced Research and Development Authority (BARDA) to support the development and production of this candidate and will produce at least 300 million doses in the United States beginning as early as October. A Phase 3 trial is expected to begin later this summer and will involve approximately 30,000 participants. Human trials could be completed by September and agreements have been lined up to produce 2 billion doses by 2021.

Johnson & Johnson was awarded $456 million by BARDA to support the development of their lead vaccine candidate and expects to initiate Phase 1/2a trials in the second half of July, with the first batches of the vaccine potentially available for emergency use in early 2021. The company plans to supply more than one billion doses of its vaccine globally through the course of 2021 and has committed to bringing a vaccine to the public on a not-for-profit basis for emergency pandemic use.

Merck announced it would develop a recombinant virus vaccine platform for COVID-19 in partnership with the International AIDS and Vaccine Initiative (IAVI), using the same approach the company used to develop its approved Ebola vaccine. Under OWS, Merck and IAVI received $38 million from BARDA. Merck plans to start clinical studies later this year and will make the vaccine accessible and affordable globally if approved.

BARDA awarded Moderna up to $483 million and another $53 million in May to accelerate the development of and increase manufacturing capacity for the company’s vaccine candidate, which received fast track designation by FDA. Moderna plans to begin a Phase 3 trial in collaboration with NIH in July. The trial will consist of approximately 30,000 participants. Moderna expects to supply between 500 million doses per year beginning in 2021.

Pfizer received fast track designation for two vaccine candidates and plans to test at least one in a Phase 2b/3 trial with up to 30,000 participants starting in late July. Pfizer expects to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.

Speed of Vaccine Development

Several committee members expressed concerns about the possible consequences of a shortened timeframe for developing vaccines. The witnesses assured the committee that standards are not being lowered. Dr. Mene Pangalos of AstraZeneca said, “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.”

Merck’s Executive VP, Dr. Julie Gerberding, said they do not expect to be able to accelerate the safety assessment and are relieved that the FDA insisted upon applying the same high standards of safety and efficacy under these emergency conditions.

Pfizer’s Chief Business Officer, Dr. John Young, shared because of Pfizer’s financial strength, they are able to put their capital at risk in order to accelerate vaccine development.

Vaccine Safety

Ranking Member Brett Guthrie asked witnesses to explain if the unprecedented speed to develop a COVID-19 vaccine was sacrificing the safety or efficacy of the vaccine.

Young said the public should take great confidence in the FDA’s guidance, which lays out guidance for effectiveness and, importantly, for safety. He explains the company’s speed is due to taking an uncommon financial risk, not cutting corners in the normal process of developing a vaccine.

Dr. Macaya Douoguih of Johnson & Johnson told members that a lot needs to be done in parallel, but it can be done safely without compromising any of the standards. She said they are working on a plan for post-marketing surveillance.

Building Public Confidence

Ranking member Guthrie shared that concerns have also been raised about vaccine confidence and whether there will be sufficient vaccination coverage to ensure herd immunity.

Dr. Stephen Hoge, President of Moderna, said they are following the FDA's guidance to conduct a full phase 3 program with 30,000 participants in the fall, which they hope will generate a robust body of data that demonstrates the safety of the vaccine and will give the FDA and Americans confidence in its profile. Moderna is working with NIH to conduct its vaccine study. NIH’s independent data safety monitoring board will adjudicate and review the safety and efficacy of Moderna’s study, which hopefully provides another level of confidence in the conclusions.

Gerberding stated the need to engage doctors at the local level to get information to patients and build the public’s confidence in the vaccines at a community level.