“Human Challenge Studies” Accelerate COVID-19 Drug Development

Researchers around the world are racing against time and each other to understand the virus and develop an effective and affordable vaccine. Already, Pfizer, Moderna, Johnson & Johnson, AstraZeneca, and Novavax have vaccines in late-stage human testing. To that end, Imperial College London will conduct over two dozen “human challenge studies” using volunteer participants who are administered an investigational vaccine (shown to be safe in early trials) before being exposed to the virus. The human challenge group is then monitored around the clock to identify any symptoms or COVID side effects.

Fully approved and meticulously controlled human challenge models for COVID-19 must be conducted by experienced experts. In order to run safe trials, research teams initially discover the smallest amount of SARS-CoV-2 virus it takes to cause COVID-19. The studies mainly tap small groups of healthy people, between 18 and 30 years old, who are at the lowest risk of harm.

Pfizer Success

Among the ever-growing collection of biopharma companies developing COVID-19 vaccines, Pfizer is emerging as a frontrunner after analyzing immunology and epidemiological trends. A Pfizer analyst said, “Our current assumption is that people [who get the vaccine] will need to be revaccinated every two years to maintain protective immunity.” The company estimates the price of the vaccine would be $30 per dose in the U.S. and $23 overseas with gradual price drops over time.

AstraZeneca

The vaccine being developed by Oxford University UK is considered a frontrunner in the race for an inoculation, in part because it produces a similar immune response among older and younger adults, according to UK drugmaker AstraZeneca. “It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher,” a company spokesman said in a statement. The results further build the body of evidence for the safety and immunogenicity of AZD1222, the scientific name of their vaccine.

Moderna’s Vaccine

Moderna was the first company to enter clinical trials and has maintained a record pace during Phase 3 human studies, which began in July. Results have shown that Moderna’s vaccine spurs immune responses in both young and elderly adults that are similar or higher to what’s been observed in recovered patients, making it a potential preventative vaccine which can also be used as a treatment for people who have already been infected.

Remdesivir Approved

The FDA approved Gilead’s antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 88 pounds for the treatment of COVID-19 requiring hospitalization. Previously authorized by the FDA for emergency use, Veklury is now the first and currently only approved COVID-19 treatment in the U.S. However, the approval comes following the World Health Organization’s (WHO) announcement that their own sponsored global study found that remdesivir did not help patients survive or recover faster. But, FDA Commissioner Stephen M. Hahn, MD, said in a statement, “[The] approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will  continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”

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