Operation Warp Speed: implications for global vaccine security
Sustainable Development Goals: 3
- SDG 3 - Good Health and Well-Being
Several global efforts are underway to develop COVID-19 vaccines, and interim analyses from phase 3 clinical testing have been announced by nine organisations: Pfizer, the Gamaleya Research Institute of Epidemiology and Microbiology, Moderna, AstraZeneca, Sinopharm Group, Sinovac Biotech, Johnson & Johnson, Novavax, and CanSino Biologics. The US programme known as Operation Warp Speed provided US$18 billion in funding for development of vaccines that were intended for US populations. Depending on safety and efficacy, vaccines can become available through mechanisms for emergency use, expanded access with informed consent, or full licensure. An important question is: how will these Operation Warp Speed vaccines be used for COVID-19 prevention in global health settings? We address some key questions that arise in the transition from US to global vaccine prevention efforts and from ethical and logistical issues to those that are relevant to global vaccine security, justice, equity, and diplomacy.
At the end of January, 2021, 16 SARS-CoV-2 vaccine candidates around the world were in phase 3 clinical trials, with five of these vaccines funded by a US programme called Operation Warp Speed (OWS).1
Nine announcements of safety and efficacy have been made, ranging from 50% to 95% efficacy,2 several vaccines have been granted emergency approval, and vaccines from Pfizer, AstraZeneca, and Moderna have received recommendations from the Strategic Advisory Group of Experts in Immunization. OWS has invested an estimated US$18 billion mostly in the late-stage clinical development and early manufacturing of COVID-19 vaccines and has agreements in place to buy 455 million doses.3, 4
OWS is the largest of the global efforts for development of COVID-19 vaccines; by comparison, the Coalition for Epidemic Preparedness Innovations (CEPI) invested $1·4 billion in support of the development of COVID-19 vaccines. CEPI funding carries commitments to ensure global access and affordable cost. Recipients of OWS funding also have clear commitments: to the USA. Companies that are supported by OWS, and manufacturers in Russia and China, have approached countries and organisations independently, creating a complicated ecosystem for COVID-19 vaccines that is comprised of a patchwork of countries that have and do not have vaccines.
There were eight vaccines in the original OWS programme (but not all have entered phase 3 trials). The OWS vaccines that reached phase 3 testing included two non-replicating adenovirus-vectored vaccines (the AstraZeneca–Oxford chimpanzee adenovirus and the Johnson & Johnson adenovirus type 26 vaccine); one vesicular stomatitis virus-based vector (Merck–International AIDS Vaccine Initiative); two mRNA vaccines from Pfizer–BioNTech and Moderna; and two protein vaccines from Novavax and Sanofi–GlaxoSmithKline.1
The vaccine from Merck–International AIDS Vaccine Initiative has since been withdrawn. Vaccines from Pfizer, Moderna, and Johnson & Johnson have received US Food and Drug Administration approval for emergency use. The European Medicines Agency has approved vaccines from Pfizer–BioNTech, Moderna, and AstraZeneca. WHO has given emergency use listing to Pfizer–BioNTech, AstraZeneca, and Johnson & Johnson. Additionally, the adenovirus type 5 (Ad5) vaccine from the Gamaleya Research Institute of Epidemiology and Microbiology has been approved by the ministry of health in Russia, the whole inactivated vaccines from Sinopharm Group and Sinovac Biotech and the CanSino Ad5 vaccine have received approval in China, and the whole inactivated vaccine from Bharat Biotech has received approval in India. Other countries, for example the United Arab Emirates, Indonesia, Turkey, Brazil, and India (among others), have also granted approvals.
The USA should accelerate the rejoining of WHO, expand its role in COVID-19 Vaccines Global Access, and contribute funding and vaccines to this global effort.
Countries with excess vaccines (which were developed through funding from Operation Warp Speed or the Coalition for Epidemic Preparedness Innovations) through preorders should consider assignment of excess vaccines to COVID-19 Vaccines Global Access and support the mechanisms for logistics, implementation, and follow-up of vaccinated populations.
As a continuation of the work of Operation Warp Speed, research into efficacy against COVID-19 variants; optimisation of schedule, dose, and boosters; correlates of protection; effectiveness and herd immunity; long-term safety and adverse events after immunisation; and global surveillance for mutations should also be used as an opportunity to strengthen health systems and research capabilities in low-income and middle-income countries as a part of pandemic preparedness and global health security.
Operation Warp Speed funding should be followed by support for optimising vaccination practice and vaccine acceptance worldwide, to counter misinformation and vaccine hesitancy.