Vaccine manufacturers commit to safety, diversity in trials

July 22, 2020
Did you miss yesterday’s vaccine hearing? We have the takeaways. We also have news from Bayer on a new program to incentivize climate-smart ag practices. Here are around 880 words, 4 minutes.

Did you miss yesterday’s vaccine hearing? We have the takeaways. We also have news from Bayer on a new program to incentivize climate-smart ag practices. Here are around 880 words, 4 minutes.

Vaccine manufacturers commit to safety, diversity in trials

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.


More Health Care News:

POLITICO: White House weighs resurrecting key drug price initiatives
“The executive orders, which could be issued as soon as this week, will call for a series of actions aimed at lowering pharmaceutical costs and speeding the return of domestic drug manufacturing.”


How Bayer’s championing climate-smart agriculture

BIO member Bayer announced a new incentive program to get farmers to adopt more climate-smart practices and reduce the environmental impact of agriculture. Let’s dig into the details. 

Bayer will provide assistance and financial incentives to farmers in the United States and Brazil who adopt climate-smart farming practices, such as using cover crops and no-till agriculture—contributing to Bayer’s goal of reducing field greenhouse gas (GHG) emissions 30% by 2030, says the company.  

These practices lock carbon into the soil, research shows—helping reduce greenhouse gas in the atmosphere.

Why it matters: “Soil is one of the most effective ways of sequestering carbon. Incentivizing farmers to embrace no-till, precision nitrogen use or cover crops helps further sequester carbon into the soil, reduce fossil fuel usage, and reduce greenhouse gases. While today farmers get rewarded solely for their food, feed and fiber production, those participating in the Bayer Carbon Initiative will have the opportunity to be rewarded for their best farm management practices and other sustainability efforts as well,” explains the press release.

What they’re saying: “Farmers are passionate environmentalists and stewards of the lands they farm,” said Brett Begemann, Chief Operating Officer of Bayer’s Crop Science division. “Their lives and livelihoods depend on the weather, and they are some of the first to be affected by drought, flooding, and extreme conditions. If anyone has a vested interest in battling climate change, it’s farmers and we are committed to developing new business models like this unique Carbon Initiative to help them in that fight.”

Read more in Reuters.

BIO Beltway Report

President Trump’s Wednesday: Swearing in Office of Management and Budget (OMB) Director Russell Vought, then lunch with the veep. He’s scheduled to deliver remarks on crime at 3:15 PM ET, then join the coronavirus briefing at 5:00 PM ET. Meanwhile, Environmental Protection Agency (EPA) Administrator Andrew Wheeler is expected to make an announcement about air this morning.

What’s Happening on Capitol Hill: Still struggling over the next coronavirus aid package, per POLITICO, as well as funding bills.

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