President Trump officially announced the public-private partnership in mid-May 2020. Operation Warp Speed will coordinate existing Health and Human Services-wide efforts, including the NIH ACTIV partnership for vaccine and therapeutic development, the NIH RADx initiative for diagnostic development, and work by BARDA. The Food and Drug Administration announced on June 30, 2020 that the vaccine will need to be at least 50% effective to gain approval, in at least diminishing the severity of COVID-19 symptoms.
Leadership and budget
In May 2020, Moncef Slaoui was named by the Trump administration as Operation Warp Speed chief adviser. Slaoui is a vaccine researcher and, formerly, Chairman of Global Research and Development and Chairman of Global Vaccines at GlaxoSmithKline, where he led the development of five major novel vaccines. General Gustave F. Perna, Commanding General, Army Materiel Command, was named Operation Warp Speed chief operating officer. The project has other scientists, physicians, and military officers involved in management of the key focus areas of development, manufacturing, and distribution. The project has a budget of $10 billion, with additional funds allocated through BARDA.
Funded companies
As of July, eight companies had been chosen for funding to expedite development and preparation for manufacturing their respective vaccine candidates: Johnson & Johnson, AstraZeneca-University of Oxford, Pfizer-BioNTech, Moderna, Merck, Vaxart, Inovio, and Novavax. In June agreements of $1.2 billion for successful vaccine were signed with AstraZeneca and $483 million with Moderna. In July, Operation Warp Speed agreed to pay $1.6 billion to Novavax if clinical trials are successful to produce 100 million doses of its candidate vaccine. Novavax is a company with no history of marketed products. Also in July, Pfizer and BioNTech received an order of $2 billion to manufacture 100 million doses of a COVID-19 vaccine when it is shown to be safe and effective, and is licensed. On July 31st, Sanofi and GSK were funded for $2.1 billion.
Criticism
Timeline
The goals of the project to develop, manufacture, and distribute hundreds of millions of COVID-19 vaccine doses by the end of 2020 have been criticized as being unrealistic, based on decades of experience in developing viral infection vaccines which normally require years or decades for assuring the chosen vaccine will not be toxic and has adequate efficacy. Most viral infections do not have vaccines because the vaccine technology has failed in early-stage clinical trials. Because many vaccines cause side effects, such as pain at the injection site, headaches, and influenza symptoms, safety testing requires years of observation in thousands of clinical trial participants. Similarly, sufficient time - a year or usually many years - is needed to be certain a vaccine has durable efficacy while the virus remains pandemic. For these reasons, despite extensive previous research attempts to produce safe, effective vaccines against coronaviruses, such as SARS and MERS, all vaccine candidates for coronavirus infections have failed during clinical research, and no vaccine exists to prevent any coronavirus infection. To prepare for manufacturing and distribution, Operation Warp Speed will expend resources and financing before the safety and efficacy results of vaccine candidates are known, possibly wasting vaccine doses and their costs. The government is intentionally accepting likely losses that a private company normally would not, because doing so means any successful vaccine would become available much sooner, limiting the massive health and economic impacts of the COVID-19 pandemic.
Competition
There is potential that the Warp Speed project will expend effort and funding in direct competition with publicly-traded American vaccine companies already fully engaged and financed for development. There is also the possibility that a billion dollars or more of US taxpayer money will be expended on only American efforts or a narrow alternate choice, such as investing in one other vaccine platform - the University of Oxford-AstraZeneca candidate for which the US already paid billion in May 2020 to receive 300 million doses for American use, if the AstraZeneca vaccine is successful in advancing to proof of safety and efficacy beyond its status as an early-stage Phase I-II trial in May. Warp Speed will not partner with Chinese vaccine development organizations - which have more vaccines in clinical development, as of May 2020 - or with the World Health Organization, the Coalition for Epidemic Preparedness Innovations, or the European Commission, which are coordinating and financing international programs for multiple vaccine development, having raised $8 billion together from international partners on 4 May for a Coronavirus Global Response. The US government chose not to include Operation Warp Speed as part of the internationalSolidarity trial on vaccine development, organized by the WHO.
Vaccine hesitancy
The proposed haste of Operation Warp Speed to have one or more vaccines sufficiently studied for safety and efficacy, approved internationally, and manufactured in hundreds of millions of doses by the end of 2020 is a potential barrier to public acceptance about safety and need to vaccinate against COVID-19, possibly harming vaccine acceptance. Failure of the public to have confidence in a new vaccine and refuse vaccination is a global health threat called "vaccine hesitancy", which increases the risk of further viral spreading that could lead to ongoing COVID-19 outbreaks during 2020-21.
Leader neutrality
The leader of the Operation Warp Speed project, Moncef Slaoui, had been a board member of the US vaccine developer, Moderna, and divested his shares in Moderna stock, at a potential personal gain of $10 million, raising questions of his neutrality in judging vaccine candidates. Although Slaoui resigned from the Moderna board when named to head Warp Speed, his share value in Moderna stock increased by $3 million in one day when Moderna announced an advance in vaccine clinical research.
