05 Jun 2020
Posted in Pharma
Operation Warp Speed’s finalists for COVID-19 vaccine are announced, but vaccines need to be accessible globally to control the pandemic
Following the news that the US Government’s ‘Operation Warp Speed’ picked AstraZeneca, Johnson & Johnson, Merck, Moderna, and Pfizer as finalists for COVID-19 vaccine funding;
Philipp Rosenbaum, PhD, Infectious Diseases Analyst at GlobalData, a leading data and analytics company, offers his view:
“Operation Warp Speed’s goal to support the production of 300 million vaccine doses for the US by early 2021 is very optimistic, but by picking big pharma companies that are seasoned vaccine developers and manufacturers, the initiative is taking a logical approach. However, a surprising choice was to leave out the COVID-19 vaccine candidate developed by Sanofi and GSK, since both Sanofi’s recombinant insect cell technology and GSK’s adjuvant are utilized in marketed products. Sanofi has not yet started clinical trials, but nor have vaccine candidates developed by J&J and Merck.
“mRNA vaccines developed by Moderna/NIH and BioNTech/Pfizer are in Phase I and Phase I/II, respectively, and Moderna is planning to start a Phase III trial with 30,000 participants in July. Considering that no mRNA vaccine has been approved to date, the speed of the development is astounding. However, given the urgent need to stop the COVID-19 pandemic, providing sufficient funds to run clinical trials and increase manufacturing capacities, as well as accelerating regulatory procedures like clinical trial approvals and adaptive trial designs, are paramount.
“AstraZeneca’s adenovirus vector-based vaccine candidate AZD1222, developed by Oxford University, is set to start Phase II/III trials in the summer as well. An additional trial with 30,000 participants is planned in the US and funded by BARDA. AstraZeneca furthermore announced to provide up to 300 million vaccines doses to CEPI and the Vaccine Alliance Gavi, as well as to license its vaccine to the Serum Institute of India for the production of up to one billion doses for low-and middle-income countries.
“Government funding is an important cornerstone of drug development during the ongoing global public health emergency, however the concern that primarily wealthy countries will benefit from successful vaccines is real. Without global access to a COVID-19 vaccine, it will be impossible to get the pandemic under control in the long-term.”