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By Jacqueline Lisk
| July 3, 2020
It is easy to take scientific progress for granted when the world is held hostage by a virus. While no one can guarantee we will develop a successful COVID-19 vaccine, the pace at which clinical research teams are working — and collaborating — is unprecedented.
There are about 108 potential COVID-19 vaccine candidates — eight in clinical trials and more than 100 in the lab, says Dr. Daniel Fagbuyi, an ER Physician and Obama Administration Biodefense Appointee who played an instrumental role in disaster response, recovery, and public policies for H1N1 and Anthrax.
Of the eight vaccines in clinical trials, one has been approved for Phase 2 clinical trial: Cambridge biotech Moderna’s vaccine candidate, mRNA-1273. Moderna announced positive clinical data from its Phase 1 study on May 18. Fagbuyi says it is “a unique RNA type vaccine, novel in its own right; the FDA has never approved a vaccine like it.”
Moderna appears to be a frontrunner, but other candidates across varying stages of development could still prove promising. Mark Poznansky, MD, PhD, director of the Vaccine & Immunotherapy Center at Mass General Hospital says having so many “runners in the race is a really good thing because it means there is a significant chance of multiple ‘shots on goal,’ as they say in biotech.”
We need as many of these solid “shots on goal” as we can get: the scientific community is just beginning to learn about COVID-19’s immunology and what is needed to protect people from the virus. Poznansky says having vaccine candidates that use different approaches to take their shot increases the likelihood of success. He is working on a new COVID-19 vaccine co-invented with Dr. Jeff Gelfand along with Voltron Therapeutics that uses a heat shock protein to activate the immune system, rather than one of the other chemical adjuvants that are commonly employed by vaccine developers. The heat shock protein is engineered to simply snap together with peptides or small proteins that are derived from the virus itself and target the human immune response. The vaccine will enter animal testing in June.
Unlike anything the planet has ever seenDeveloping a vaccine from scratch usually takes 10-15 years. When Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said it is possible a vaccine for novel coronavirus could be available in the next 12-18 months, it was the quote heard round the world. How did we shave years off the process? Vaccine developers aren’t starting from scratch. They are exploring existing vaccine platforms so they can skip pre-clinical studies, which often take years. The pace of their progress is unprecedented: “I don’t think we have ever witnessed vaccine development at this speed before,” Poznansky says.
He notes that the degree of international collaboration is also extraordinary. Groups around the globe, his included, are sharing data and working together to better understand how the disease works. This collaboration contributes to Poznansky’s “baseline optimism that a goal can be achieved.” But his optimism is not unbounded. Viruses such as HIV have stumped us before, but it is also possible a vaccine could take longer than hoped to develop.
“It is not opinion and anecdote that will determine whether or not we can find a safe and effective vaccine, it is science and data,” Poznansky explains.
Like Poznansky and Fauci, Fagbuyi is cautiously optimistic. “In the corporate world, you under-promise and over-delivery. With a pandemic or public health emergency, you give the facts and communicate the truth, hoping and praying for the best.”
He adds that developing a safe and effective vaccine is not the only challenge. We need people to take it. Twenty-three percent of people say they would not get a COVID-19 vaccine, according to a study conducted in April. Some of those responders identify as anti-vaxxers, others are skeptical of this one for reasons including the accelerated approval process.
Accelerated timelines are a good thing when you are up against a pandemic, but they also beget concern. Developers will not have time to test the vaccine across all patient populations, explains Dr. Suzan Davis, CEO of Boston-based Global Regulatory Partners. Davis is helping a number of pharma companies that are developing coronavirus vaccines and treatment navigate the FDA approval process.
Scaling the vaccine is also a challenge. “No one has the capacity to make enough units for the whole world’s population,” notes Davis. Likely, the health care system would prioritize high-risk groups and front-line workers.
She adds that there is a lot of talk about vaccination, but treatment is just as important. There are more than 200 potential drugs in development, according to Biorender’s COVID-19 Vaccine Tracker. Much like vaccine candidates, the drugs in the pipeline are based on or leverage existing compounds, allowing researchers to accelerate timelines, says Davis.
Mass. companies step up
Whether or not we will develop a successful vaccine and treatment remains to be seen, but Massachusetts’s role in the effort is already clear. In addition to Moderna, Bambu Global, a Lowell-based technology company, is one of more than two dozen Mass. companies that has announced plans to create vaccines, treatments or devices for COVID-19.
We can’t safely reopen the country without an understanding of who has, and has had, the disease. Bambu Global has created NowAware, which offers both READ (Rapid Enzyme Activity Detection) and POND (a Point of Need Detection indicator) for coronavirus that people can administer at home. Bambu Global CTO Satish Agrawal, Ph.D. used to be the CTO for Polaroid. Bambu Global Chairman and CEO Robb Osinski explains NowAware leverages stimulus-triggered color change technology that dates back to Polaroid instant photography. The invention combines chemistry and biology and represents an emerging trend in science: the rise of multidisciplinary collaboration.
Osinski believes collaboration across the various science disciplines will unlock scientific breakthroughs in the fight against COVID-19, and beyond. Researchers will continue to learn to hybridize disciplines for a much greater impact and “to solve problems that may have been difficult to solve in the past with conventional thinking.”
Let’s hope that COVID-19 is one of those problems. Let’s put our hope in science.
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