Yesterday, several vaccine manufacturers (and BIO members) testified during a House hearing on the state of research, development, and manufacturing of potential COVID-19 vaccines. Here are the key takeaways.
The hearing: On July 21, House Energy and Commerce’s Subcommittee on Oversight and Investigations held a hearing, Pathway to a Vaccine: Efforts to Develop a Safe, Effective and Accessible COVID-19 Vaccine.
The witnesses:
The takeaways:
1. They will not compromise safety and efficacy.“Speed is important, but we will not compromise scientific efficacy, quality, and above all, safety, despite the sense of urgency we all feel,” said Merck.
“While these are trying times, we are dedicated to creating a safe, effective vaccine that can help bring an end to the global pandemic,” said Moderna.
“Our first priority is to demonstrate the safety and efficacy of the vaccine and monoclonal antibody candidates through sound science and clinical data derived from adequate and well-controlled studies,” said AstraZeneca.
2. They commit to diversity in clinical trials.
“We are still in the process of designing our COVID-19 Phase 3 trials. However, ensuring diversity and inclusion is a key consideration balanced with the need to conduct the trial in areas of highest disease incidence,” said Johnson & Johnson. As the testimony explained, J&J will implement community outreach plans as well as work with Johns Hopkins to better understand the data.
“Ensuring diversity in these trials, including in terms of race, ethnicity, gender, age, and other factors, is a priority in our efforts,” said AstraZeneca.
3. They’re already scaling up manufacturing.
Even before the vaccines are approved, they’re scaling up manufacturing so they can be ready to produce the doses the world needs.
“[W]e are making considerable investments in key elements such as manufacturing capacity before we typically would, before we know whether we even have a successful product—in many cases building a manufacturing facility before we have fully developed the process at a smaller scale. As a result, we must think carefully about how these decisions will impact other development programs and allocation of investments, including considering the inevitable opportunity costs,” said Merck.
“Pfizer is dedicating its best-in-class global resources to ensure we can respond rapidly to the COVID-19 pandemic, including rapid development of a supply chain for the new potential vaccine while ensuring the necessary standards of quality and safety are achieved,” said Pfizer.
Read the prepared testimony.
Watch the entire hearing on C-SPAN.
Want to know more about the vaccine development process?Here’s a helpful infographic from the Adult Vaccine Access Coalition.
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