COVID-19 Vaccine: American National Institute Of Health Lays Down Prerequisites On Human Infection Models To Support SARS-CoV-2 Vaccine Development
Members of the National Institutes of Health's Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Vaccines Working Group assess practical considerations and prerequisites for using controlled human infection models (CHIMs), which can be used for human challenge studies, to support SARS-CoV-2 vaccine development.
In a new report published in the New England Journal For Medicine, ACTIV Team determine the timeline for developing robust CHIMs that meet the essential criteria for limiting risk for study volunteers could take one to two years.https://www.nejm.org/doi/10.1056/NEJMp2020076
The researchers conclude that large, randomized, controlled trials of SARS-CoV-2 are the fastest and most effective path forward for establishing vaccine safety and efficacy.
While parallel development of CHIMs may provide complementary tools to address additional questions such as the duration of immunity and correlates of protection, such studies have to be conducted ethically.
Typically in a CHIM study, participants are intentionally exposed to an infectious agent to help scientists understand the virus or test interventions to prevent or treat infection.
It should be noted that CHIMs use well-characterized microorganisms that either do not cause serious disease, are easily treated, or both.
Furthermore, CHIM studies must take place in laboratories with rigorous isolation to ensure that the infection does not spread into the community.
The team notes that ethical evaluation of the risk to participants and the potential value to society are essential to future considerations of whether to conduct CHIM studies for COVID-19; currently there is no highly efficacious treatment for moderate or severe illness.
The researchesr propose that development of a SARS-CoV-2 GMP stock, preferably with attenuating mutations, should proceed along with preparation of facilities and procedures and engagement of a broad set of stakeholders.
Also, the researchers recommend developing CHIMs for seasonal coronaviruses, which cause about 30% of cases of the common cold and can provide insights into more deadly coronaviruses such as SARS-CoV, MERS-CoV, and SARS-CoV-2.
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