What seemed like an epic race for an effective COVID-19 vaccine has produced several options that have people rolling up their sleeves across Rhode Island and the world.
But a number of new vaccines remain in development, including two that have a research base in the Ocean State.
As people scramble for appointments to take vaccines that have been approved, more alternatives are likely on the way. Potentially, they could either serve as supplementary vaccines in the U.S. later this year or be deployed internationally.
Some vaccines are at predevelopment stages, such as one proposed by Providence-based immunology company EpiVax Inc., which did not receive federal funding through the massive Operation Warp Speed, the program that threw billions of dollars into the vaccine race last year. The company is continuing to raise funds for a clinical trial, according to Dr. Anne S. De Groot, EpiVax founder and CEO. She estimated a trial would cost $2.2 million.
She sees the EpiVax vaccine, which is aimed at enabling the body’s T-cells to mount an attack against the COVID-19 virus, as a potential booster to another vaccine, or potentially as a “prime” for one. The need for vaccine development won’t fade soon in the fight against COVID-19, she said.
“We have learned a lot about pathogens like coronavirus in recent years,” De Groot said, citing HIV and the influenza viruses. “They tend to mutate over time. And vaccines have been difficult to make effective. HIV, in fact, we still don’t have one. Flu, as everyone knows, we have to get a shot every year. It would not be surprising at all to see the same kind of evolution with coronavirus. We will have to make more vaccines as the virus mutates.”
‘We will have to make more vaccines as the virus mutates.’
DR. ANNE S. DE GROOT, EpiVax Inc. founder and CEO
As viruses naturally mutate, the variations can make them more difficult to contain. Dr. Alan Rothman, a viral immunologist at the University of Rhode Island, teaches courses on virology and has found students more interested in the subject as they live through a pandemic.
“Viruses are the perfect Darwinian things in the universe because they reproduce really quickly and they find a niche and they exploit it,” Rothman said. “They mutate in any way they can to take advantage of it.”
Trying to stay on top of those mutations is a task for developers of vaccines. One of the most promising ones on the horizon is made by Maryland-based Novavax Inc., which is in its third phase of clinical trials, a large-population trial to determine its effectiveness.
Rhode Island is one of 120 locations in which the trial is taking place in the U.S. and Mexico, and the vaccine’s effectiveness in fending off COVID-19 will be reported to the U.S. Food and Drug Administration.
Novavax has produced a vaccine that would require two injections. The Miriam Hospital is one of the local trial sites. Each day, about 130 participants – a mix of genders, ethnic backgrounds and ages – check in using smartphone apps to register symptoms or any health issues, according to Dr. Karen Tashima, an infectious-diseases specialist and director of clinical trials at the Immunology Center for Lifespan Corp.
A Warwick lab run by Velocity Clinical Research, of Durham, N.C., is also participating in the Novavax study.
About half of the local trial subjects were given the Novavax vaccine; half were given a placebo injection.
Phase-three trials in the United Kingdom and South Africa determined the Novavax COVID-19 vaccine was 96% effective, setting the stage for high expectations for the trial in North America. The trial results overseas showed the vaccine is 86% effective against the so-called U.K. variant of the infection, which is spreading rapidly in the U.S.
A more contagious version of the new coronavirus, the U.K. variant accounts for about 40% of the infections in Rhode Island and is expected to soon be responsible for the majority of infections, according to public health officials.
The phase-three trial is an exciting professional moment for many local researchers, Tashima said.
As soon as the FDA receives the completed trial data, the participants will be injected with the vaccine if they received the placebo, or a benign placebo if they received the vaccine. The study will continue for two years, with all health data on the vaccine being reported back to the FDA.
“We’re looking for any side effects, anything that is happening to any participant during the time they are in the study, whether it’s a stubbed toe or a sore arm,” Tashima said.
As the rollout of approved vaccines has accelerated in Rhode Island, Tashima said she has received requests from some trial participants to get vaccinated. They’ve asked her, essentially to “unblind” the process and let them know if they received the vaccine or the placebo. In some cases, she said, she did release subjects from the study so they could get a vaccination.
Nevertheless, the study has been exciting to Tashima. “It’s almost like real time that we’re getting to see the results of our efforts, so it’s pretty amazing,” she said.
Mary MacDonald is a PBN staff writer. Contact her at Macdonald@PBN.com.