Made in the Capital Region: COVID treatments
Developments by biotech and medical research institutions for vaccine hope to go to market
A month or so from now, first responders across the country could be receiving the first batches of a promising COVID-19 vaccine made by drug giant Pfizer that was found to be 90 percent effective protecting against the coronavirus in a clinical trial.
A new COVID-19 antibody drug designed to help people recover from the virus — the same one President Donald Trump’s doctors gave him at Walter Reed Military Medical Center in October — could also soon receive emergency federal approval.
Both have connections to the Capital Region’s biotech and medical research institutions.
What makes the COVID-19 vaccine that Pfizer is developing with the German company BioNtech SE so unique is that it is the first vaccine to rely on technology based on RNA, or ribonucleic acid. RNA is responsible in the body for making sure that a person’s cells have the correct genetic instructions to create certain proteins. The molecules that carry these instructions are known as messenger RNA, or MRNA.
For decades, RNA researchers — many of them based in the Capital Region — have been working to customize MRNA in the lab to provide human cells with the instructions on how to fight specific diseases.
“It’s really cool science,” said Andrew
Berglund, director of the RNA Institute at the state University at Albany.
Berglund joined Ualbany from the University of Florida, which is wellknown for its work on infectious diseases, in the fall of 2019.
He said one of the reasons he decided to bring his research to Ualbany was the long-standing work on RNA done in the Capital Region over the decades.
Pfizer isn’t the only drug company making a COVID-19 vaccine using MRNA. The other is the Boston drug firm Moderna.
Until now, vaccines have mostly been made using live or dead versions of a virus, which can pose limited dangers to patients.
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But the vaccines using lab-designed MRNA, which carries special information for the body to produce antigens designed to kill the coronavirus, are expected to be safer and cheaper to produce than traditional vaccines, and could usher in a wave of advances against new viruses and pandemics.
“New may be better,” Berglund said. “This technology has been right on the cusp.”
Besides Ualbany, the state’s Albany-based public health lab, the state Department of Health’s Wadsworth Center in Albany, is well-known for its RNA research, along with SUNY Polytechnic Institute in Albany, Rensselaer Polytechnic Institute in Troy and Williams College in the Berkshires.
About two dozen scientists and labs at those various institutions participate in what is known as the Hudson Valley RNA Club, which meets once a month.
The biosciences group at GE Global Research in Niskayuna has also been involved in both RNA and DNA vaccine development and was awarded a $4.7 million grant from the Defense Department to study how to bring such vaccines to market faster so that one day they could even be used in the battlefield if an unknown virus is released by the enemy. Albany Medical Center partnered with GE on that study.
Atop the local RNA research field is Marlene Belfort, a Ualbany biology professor who once led the genetics division at Wadsworth.
And former Wadsworth and Ualbany scientist Joachim Frank won the 2007 Nobel Prize for chemistry for his work at Wadsworth developing imaging technology that has helped scientists better understand RNA, leading to a new wave of medical breakthroughs. Frank is now at Columbia University but keeps close ties with his former colleagues in Albany.
“The history of RNA research in the Capital Region has always been an interest to me,” Berglund said. “To be a part of that has been really exciting.”
Scott Tenenbaum, a professor of nanobio science at SUNY Poly who is involved in RNA research, said this is an amazing moment in history for the RNA field, including local researchers, even if they didn’t have direct involvement in the new COVID-19 vaccine.
What it points to is the emergence of potentially a whole new generation of medical treatments based on RNA technology, he said.
“It’s a strength of ours,” Tenenbaum said. “This is a fertile place for RNA research, and I expect that to continue.”
Pfizer’s claim that its vaccine candidate is 90 percent effective is based on a clinical study with 43,538 participants. About half were given a placebo, the other half the vaccine. Of those participants, 94 later developed COVID-19. The 90 percent number likely means that roughly 9 participants who received the vaccine still got sick. Participants are not intentionally exposed to the virus.
Tenenbaum said vaccines created with RNA can be made in larger batches than traditional vaccines. And RNA technology can be quickly repurposed for other viruses and diseases, Tenenbaum said, by inserting new instructions into the MRNA to make different proteins or antigens.
“It’s just so easily adaptable,” Tenenbaum said. “All we have to do is change the sequence.”
The one negative aspect of MRNA is that it easily breaks down in certain environments, which is why the Pfizer COVID-19 vaccine needs to be stored at minus 94 degrees Fahrenheit.
The federal government has a $1.95 million order with Pfizer for 100 million doses of its version, pending FDA approval.
The man in charge of making sure that the hundreds of millions of doses of COVID-19 vaccine are made available to the American public is U.S. Gen. Gus Perna, who was in charge of the Army’s Materiel Command until he was tapped by Trump earlier in the year to lead the race for a vaccine. As chief operating officer of Operation Warp Speed, Perna is in charge of making sure the vaccine gets safely into the hands of medical professionals as soon as possible.
Perna, who grew up in New Jersey, is acquainted with the Capital Region, having visited the Watervliet Arsenal, the Army’s main cannon-making factory, in 2017.
“Leveraging our military planning and logistics capability and combining that with proven methods will allow existing systems to scale quickly to get the vaccine to the American people,” Perna said in a Defense Department update on Operation Warp Speed published last month.
The Defense Department and the CDC will also work closely with individual states, including New York, which like all other states has submitted a detailed vaccine distribution plan to the CDC. Gov. Andrew Cuomo also created two task forces that will evaluate vaccine safety and plan distribution.
The state distribution task force includes several Capital Region leaders, including Alicia Ouellette, president of Albany Law School, and Micky Jimenez, executive director of Capital District Latinos.
The military won’t be distributing the vaccine or administering the shots. Instead, the CDC has
hired Mckesson Corp., a longtime flu vaccine distributor, to get the vaccine to medical offices and pharmacies where vaccines are given to the public. Pfizer has opted to handle its vaccine distribution itself. The state will help set up sites for vaccine storage, including one in the Capital Region, although no potential sites have been revealed yet. The state Department of Health’s Bureau of Immunization will also be involved in tracking all of the vaccine orders
Of course vaccines aren’t the only solution to combat COVID-19. One of the first antibody treatments being developed for the coronavirus is being made by Regeneron, a Westchester drug development firm that does all of its manufacturing in East Greenbush in Rensselaer County.
Trump took the socalled antibody “cocktail” developed by Regeneron when he was at Walter Reed, along with other treatments, including the steroid dexamethasone.
While the Regeneron treatment, called REGNCOV2, has been shown to be effective in reducing symptoms of high-risk COVID-19 patients with mild symptoms, it is not expected to replace the need for a vaccine, especially since the hope is to prevent people from becoming infected with the virus in the first place.
Regeneron has been testing REGN-COV2 in clinical trials taking place in New York state and across the world, company spokeswoman Alexandra Bowie said.
“We think both vaccines and antibody medicines are important and necessary to combat the COVID-19 pandemic,” Bowie said. “Prevention is always a critical strategy, so there’s an obvious longterm role for vaccination. Even once we have a wellproven and widely-available vaccine, there will remain a need to treat infected patients and others who may not have access to or do not respond well to vaccination.”
Robert Bednarczyk, a public health professor at Emory University who formerly taught at Ualbany’s School of Public Health, said it is encouraging that COVID-19 treatments are quickly coming to market, including Eli Lilly’s new antibody treatment that just received emergency FDA approval last week.
But he noted that while the antibody treatments are encouraging, he thinks that the public is still looking at vaccine development as the top priority.
“I have not seen any evidence that these (antibody) treatments are making people think less about a vaccine,” Bednarczyk said.