9 biopharma CEOs sign historic pledge on vaccines

Nine biopharma companies (including several BIO members) pledged to uphold the integrity of science in their search for a COVID-19 vaccine. We dig into what this is, and why it matters.

Nine biopharmaceutical companies pledge “to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines,” according to a joint statement.

The signatories are the CEOs of companies (including BIO members) working on COVID-19 vaccines: AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi.

Collectively, these companies have developed more than 70 novel vaccines—“underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.”

Specifically, they agree to:

• Always make the safety and well-being of vaccinated individuals our top priority.
• Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
• Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as the U.S. Food and Drug Administration (FDA).
• Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access. 

This follows the example set by BIO leadership last week, when we released an open letter to the biopharmaceutical industry, articulating principles to ensure the “integrity, transparency, and objective assessment” of COVID-19 clinical data and secure public trust in new medical products developed in response to the pandemic.  

And this is in line with the FDA’s guidance—which “requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations."

We applaud our members for taking a stand for science—and we know science, and the biotech industry's innovation and willingness to collaborate, is what will bring us out of this pandemic.

Read more from the AP.

Some researchers think so, according to a new report from the Financial Times. So, how do we take advantage of that knowledge? 

By now, you know that animals are responsible for a lot of human diseases—including SARS, MERS, Ebola, HIV, and avian flu, to name a few—and 3 in 4 emerging diseases are thought to be zoonotic in origin.

COVID-19 is a zoonotic disease, too—with researchers in agreement “that it originated in bats and jumped to humans either directly or, more likely, via an intermediate host,” as Science Mag put it.  

Now, researchers think studying bats can help us understand how to treat the virus—because bats carry SARS-Cov-2, and likely a lot of other diseases, but they don’t seem to get sick like humans do, as the Financial Times reports.

They want to study bats’ immune systems, because “bats produce larger amounts of interferons, molecules that play a key role in activating the wider immune response and in preventing the virus from replicating.”

And the role of fever: “‘The incredible exertion of flying causes bats’ body temperature to rise to a high fever twice a day, something that pathogens that have co-evolved with bats for millennia have grown accustomed to,’ says Professor Andrew Cunningham of London’s Institute of Zoology.” 

This could tell us about how to get “adaptive immunity” in humans, which is the ability “to search out and destroy specific antigens—protein molecules on invading pathogens—and remember these in case of future infection,” continues FT.

How do we do this? Through One Health policies, which explore the links between human, animal, and environmental health, and could help us solve this pandemic and, equally important, prepare for the next one. 

Learn more about why we need to promote One Health collaboration.