According to the results of a Nature poll, experts generally agree that the COVID-19 strain of SARS-CoV-2 is either likely or very likely to become an endemic virus. While this may seem like a daunting reality, it’s not all bad news. The continued circulation of COVID-19 doesn’t necessarily mean that months-long lockdowns, travel restrictions, and social distancing are here long-term. The creation of successful vaccines represents only the beginning of investigative efforts into COVID-19.
COVID-19 has sped up the process in terms of generating new kinds of vaccines and developing ways to gather real-world data. Read more about how this data and research continue to make moves in healthcare.
This pandemic has greatly increased research initiatives. A desire to “drastically accelerate” research into treatments and vaccines has rendered the healthcare community receptive to real-world data, according to an article published by the Boston Consulting Group.
These research initiatives have led to the emergency use authorization approval of three COVID-19 vaccines in the U.S.: mRNA vaccines from Pfizer-BioNTech and Moderna, and an adenovirus-based vaccine from Johnson & Johnson. Next on the docket are studies evaluating how long, exactly, these vaccines last and studies into variant-proof vaccines.
Vaccines and the Viral Variants
“Variant-proof” vaccines would represent the second generation of COVID immunizations. Current vaccines create immunity to the SARS-CoV-2 virus and effectively prevent both mild and severe symptoms of COVID-19, hospitalization, and death. Still, questions remain about the vaccine’s efficacy in preventing viral transmission. Because a transmission-blocking vaccine is, according to one expert, the only way to gain herd immunity on the population level, researchers will be looking to transmission prevention as a new research target.
There’s also concerns around the current well-known variants from South Africa and Brazil. These “variants of concern” appear to be both more transmissible and deadlier and may ultimately require a new type of vaccination to prevent illness and death. Clinical studies, then, must move quickly to understand how these variants work and how, ultimately, we might combat them.
In addition to targeting the spike protein—the route of the currently available COVID vaccines—scientists have been looking for other ways to neutralize the threat of SARS-CoV-2. A team of scientists at the University of Minnesota has been studying and mapping ACE-2 receptors to identify treatments that might neutralize the virus before infection can take hold. Understanding the receptor recognition mechanism, they said, is “key to tackling this pandemic.”
Scientists at Bristol University in the United Kingdom (UK) are also developing a vaccine that would induce antibodies in the upper airway mucosal linings, ultimately preventing infection and transmission.
Gathering Real-World Data
Real-world evidence in healthcare has become increasingly valuable in informing decision-making across stakeholder groups. These data are gathered from routine use or practice and often allow researchers to conclude things like long-term safety and efficacy. For disease epidemiology, real-world evidence lets researchers understand unmet needs and evaluate interventions in population subsets.
The world has already benefitted from real-world COVID-19 research following Israel’s successful vaccine rollout program. Beginning in December 2020, Israel was able to vaccinate 50% of the population ages 16 and older within nine weeks. To test the effects of this widespread vaccination, researchers analyzed vaccination rates in communities across the country to determine the relationship between vaccinations in adults and the rates of positive COVID-19 tests in children over 35 days.
Results of this real-world study were positive, showing a “strong negative association” between vaccination rate and infection risk for unvaccinated community members. More specifically, in the weeks following the administration of the Pfizer-BioNTech vaccine, infection risk in children too young to be vaccinated dropped proportionally based on the percentage of adults who had received the shot.
In the United States, real-world data has come from those living in long-term care facilities and healthcare workers, two populations who were eligible for the vaccine immediately after approval. Data from two long-term care facilities in Connecticut that experienced outbreaks of COVID-19 showed that even partial vaccination—defined as more than 14 days after dose one through seven days after dose two—was 63% effective against COVID-19 infection.Learn more about PRA’s Real World Solutions
PRA has also been helping to conduct COVID-19 studies. As of September 2020, PRA is supporting three national and global COVID-19 trials funded by the Therapeutics Accelerator. One study, led by researchers at the University of Washington in Seattle, investigated hydroxychloroquine as a post-exposure prophylaxis (PEP) for patients who had close contact with someone who had a confirmed COVID-19 diagnosis, such as household contacts, medical staff, and first responders. The results, which were presented at IDWeek 2020, determined that those taking the drug were just as likely to test positive as were those taking the placebo. The findings will be published in Open Forum Infectious Diseases.
Caring for COVID Long Haulers
A less commonly known and unfortunate aspect of the coronavirus pandemic is post-acute COVID-19, more colloquially known as “long-haul” COVID-19. For roughly one in 10 people who contract COVID—regardless of severity—the initial illness marks only the beginning of a slate of lingering side effects and complications.
Because COVID-19 is so new, though, not much is known about post-acute COVID-19. Researchers are only just beginning to understand the implications of long-term disease, including chest pain, brain fog, arrhythmias, gastrointestinal distress, depression, anxiety, and insomnia.
To gain a deeper understanding of post-acute COVID, the University of Birmingham in the UK has launched a two-year project to fund “Long COVID” research. Researchers hope to recruit upwards of thousands of non-hospitalized post-acute COVID patients who have experienced symptoms for more than 12 weeks to participate in a digital clinical study. Investigators will use the Atom5™ digital platform, powered by Aparito Limited, to allow patients to self-report symptoms, quality of life, and the ability to work. In addition to laboratory testing for a subset of participants, these data will be used to develop targeted Long COVID interventions customized to individual patient needs.
“It’s clear now more than ever that we must learn to live with COVID-19,” says PRA’s Jay Lieberman, Medical Director-Medical Affairs. “The virus is likely here to stay, and research needs and priorities must shift. The research focused on vaccine variants and post-acute COVID-19 is only the beginning of the long-term work that we must do to help the healthcare system adapt to this ‘new normal.’”
PRA offers full post-marketing services for authorized COVID-19 vaccines and therapeutics, including post-authorization safety studies (PASS) delivered by Real World Solutions.
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