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Formelle Bekanntgabe der Operation Warp Speed durch President Donald Trump am 15 Mai 2020 im White House Rose Garden.

Operation Warp Speed ist eine von der Bundesregierung der Vereinigten Staaten von Amerika initierte Öffentlich-private Partnerschaft um die Entwicklung, Fertigung und Verteilung von COVID-19 Impfstoffen, Medikamenten und Diagnostika zu ermöglichen und zu beschleunigen.

Es ist ein ressortübergreifendes Förderprogramm zwischen dem Ministerium für Gesundheitspflege und Soziale Dienste der Vereinigten Staaten, einschließlich der Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), National Institutes of Health und der Biomedical Advanced Research and Development Authority (BARDA); dem Verteidigungsministerium der Vereinigten Staaten; privaten Unternehmen und anderen Bundesbehörden der Vereinigten Staaten.

Background

The idea for Operation Warp Speed was introduced in early April 2020. Operation Warp Speed will promote mass production of multiple vaccines based on preliminary evidence allowing for faster distribution if clinical trials confirm one of the vaccines is safe and effective. The plan anticipates that some of these vaccines will not prove safe or effective, making the program more costly than typical vaccine development, but potentially leading to the availability of a viable vaccine several months earlier than typical timelines.

The public-private partnership was unveiled 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.

Leadership and budget

In May 2020, Moncef Slaoui was named 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.

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 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, possibility wasting vaccine doses and their costs.

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 Vorlage:USD 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 (WHO), 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 international Solidarity 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.