Access and R&D, World Health Organization, New England Journal of Medicine, University of Oxford, Lancet, Harvard Business Review, Pan American Health Organization, Global

Organisations. World Health Organization WHO, New England Journal of Medicine NEMJ, University of Oxford, Lancet, Harvard Business Review, Pan American Health Organization PAHO
Period. 14 – 21 July 2020
  • Over 150 efforts are currently underway around the world to develop COVID-19 vaccines and therapeutics, according to the WHO, with 23 vaccine candidates currently in human trials. Most of these studies are in Phase 1 trials that typically include a small number of healthy people where the goal is to determine safety and whether an immune response is observed. A small number of Phase 2 trials are also underway that include a larger and more diverse population, while none of the vaccine candidates have entered Phase 3 trials that focus on balancing efficacy (i.e. vaccine dosage to elicit immune response against SARS-Cov-2) and safety (i.e. minimizing adverse side effects). A number of papers over the past week reported on promising developments in three leading vaccine trials currently underway in the U.S., the U.K. and China.
  • A paper in the New England Journal of Medicine last week shows encouraging interim results for Moderna’s mRNA-1273 that targets the “spike” protein used by SARS-Cov-2 to enter cells. The Phase 1 clinical trials conducted by the U.S. National Institutes of Health confirmed that 45 health adults who received two doses of the vaccine 28 days apart had higher levels of antibodies than those who had recovered from being infected by COVID-19 (with the peak in antibody production coming only after the second dose). Moderna will begin Phase 2 trials on July 27, while mRNA-1273 is also expected to be the first vaccine candidate to enter Phase 3 efficacy trials later this year, with efforts underway to recruit over 30,000 people.
  • The Lancet this week also published encouraging results for another leading vaccine candidate from the U.K., AZD1222, developed by Oxford University and AstraZeneca. The interim findings show the vaccine continues to induce antibody and T-Cell immune responses up to day 56 of the ongoing Phase 1/2 trials that involve 1,077 health adults. A sub-group study of 10 patients receiving a second dose showed an even greater immune response to SARS-Cov-2. While no major adverse events were observed, 60% of patients did report mild side effects (fever, headaches, muscle aches, and injection site reactions) compared to the control group, a meningitis vaccine. AZD1222 is expected to advance to Phase 2 trials this month of a diverse patient population.
  • A research team from China also published results in the Lancet this week on Phase 2 trials for a vaccine candidate developed by CanSino. The latest findings validate previous Phase 1 data that show the vaccine induces an immune response to SARS-Cov-2, but that the neutralizing antibody response is not as strong in some key demographics, including people over the age of 55.
  • While these early results are promising, Merck’s CEO in the Harvard Business Review claimed it would be a “great disservice” to raise hopes that a vaccine would be available to the public by the end of the year. Novel vaccines often take years or decades to develop, due to established research protocols to ensure safety and efficacy. Vaccines also present unique manufacturing and distribution challenges that often limit production capacity while requiring complex logistical efforts. This is further strained by the global demand for a COVID-19 vaccine, as civil society groups have urged the international community to establish vaccine distribution agreements to prevent hoarding by wealthier countries.
  • The WHOhas confirmed that 165 countries representing 60% of the world’s population have engaged in COVAX, the COVID-19 vaccine global access facility that is designed to promote rapid, fair and equitable access. As part of the mechanism, 75 countries would finance the vaccines using domestic budgets, while partnering with up to 90 lower income countries that would be supported through voluntary donations to the COVAX Advance Market Commitment coordinated by GAVI. Other regions like PAHO announced parallel pooled procurement plans to ensure countries receive vaccines at subsidized, affordable prices.

This development is part of the digest;