People, events, technology—all can be disruptors. Certainly the novel coronavirus and the disease it causes, COVID-19, have upended the way we live and conduct business.

Our changed world is about to transition again. Innovation in the form of a safe and effective preventative—a vaccine—is nearing regulatory approval.

No fewer than 13 major COVID-19 vaccine programs are in the final stages of development.

Pfizer and its German partner, BioNTech, announced this week that Phase 3 clinical data for their vaccine indicate it is more than 90% effective in preventing COVID-19 (with no serious safety concerns reported).

Moderna, AstraZeneca, Johnson & Johnson, Sanofi, GlaxoSmithKline, and Merck are not far behind. 

A World Without Covid

Suddenly a world without COVID, free to operate at 100% capacity, free of masks, quarantines, travel restrictions, and school closures, is well within reach.

This is a spectacular outcome in many ways, especially the speed and efficiency of the research that led to an effective vaccine. 

The COVID vaccines in late-stage development, like Pfizer’s, were all created in less than 10 months. Typically,  it takes 10-13 years to bring a new vaccine from concept to FDA approval.

To understand the significance of what Pfizer—which has a major presence in Connecticut—achieved, bear in mind that the Federal Drug Administration had indicated that it was unlikely to approve a vaccine unless it was at least 50% effective.

Scientists were hoping for efficacy in the 60-70% range. Seasonal flu vaccines typically reduce the risk of influenza by between 40% and 60%, and some years their effectiveness is as low as 10% (2004-2005).  

What drove this impressive outcome? Three things—focus, expertise, and innovation.

Focus

The biopharma industry brought unprecedented focus to combating COVID-19.

It marshaled the intellectual power of its scientists to—in many cases—drop what they were doing, putting other research projects on hold, to concentrate on COVID.

This meant that schedules, research labs, R&D budgets, and manufacturing facilities were freed up to zero in on Covid. 

The COVID-19 offensive benefited from biopharma company expertise on several fronts.

The industry has much experience researching and developing an array of vaccines over a long period, including those for polio, ebola, rabies, mumps, measles, pneumonia, tetanus, typhoid and shingles (to name only a few). 

COVID-19 research has benefited as well from biopharma scientists' experience with other coronaviruses, which include the virus that causes the common cold, SARS, and MERS.  

Manufacturing Challenges

Almost as difficult as creating a vaccine is manufacturing one, in quantity and distributing it to a vast number of people across the globe.

Ridding the world of COVID-19 will require billions of vaccine doses. And vaccines often require very specialized handling—Pfizer’s vaccine, for example, must be stored at -90 degrees Fahrenheit. 

Fortunately, the biopharma industry has a deep well of experience over many decades with vaccine production and distribution.

These biopharmas' willingness to bet on their R&D is evidence of their confidence, financial resources, and track record.  

Indeed, Pfizer and Moderna (which also has a COVID vaccine in phase 3 clinical trials) began production of their vaccines during clinical trials so that the vaccines would be ready for distribution upon FDA approval. 

Pfizer will have 50 million doses available for the U.S. in December and 100 million by March 2021. The company intends to produce 1.3 billion doses globally for all of 2021. 

Moderna plans to have 20 million doses of its vaccine available by the end of this year and between 500 million and one billion in 2021.

These biopharmas’ willingness to bet on their R&D—that their experimental vaccines would work—is evidence of their confidence, financial resources, and track record.  

Innovation

Perhaps most critical to the speed and success of COVID R&D is biopharma’s embrace of innovation and calculated risk taking.

The two vaccines closest to seeking FDA approval, Pfizer’s and Moderna’s, are a new type that use messenger RNA (mRNA) technology.  mRNA vaccines uniquely enlist the body’s own cells to produce antigens to stimulate production of disease-fighting antibodies.

By taking a risk on innovation, it looks as if we will soon have a safe and effective vaccine created, manufactured, and distributed in record time.

This characteristic simplifies and speeds manufacturing, and potentially results in a more robust immune response.

The biopharmas which pursued mRNA technology—developed, refined, and tweaked it—were taking a risk on cutting edge science that might have produced only more science, not necessarily a workable vaccine.

Overall, 66% of vaccine candidates are unsuccessful. But by taking a risk on groundbreaking innovation, it looks as if we will soon have a safe and effective COVID vaccine created, manufactured, and distributed in record time.


For more information, contact the Connecticut Bioscience Growth Council's Paul Pescatello (860.244.1938) | @CTBio