Operation Warp Speed: U.S’ Strategy To Finding A Covid-19 Vaccine

What is this programme all about and what has been done so far?

A couple of weeks ago, we wrote about COVAX, a Covid-19 vaccine initiative by WHO. Today, we will be talking about Operation Warp Speed.

What Is It?

Operation Warp Speed (OWS) is a public-private partnership, initiated by the Trump administration. It is a partnership of the Department of Health and Human Services (HHS), the Department of Defense (DOD) and the private sector. The initiative’s aim is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021.

OWS is offering support to promising candidates and enabling the swift, parallel execution of the necessary steps toward approval or authorisation of safe products by the Food and Drug Administration (FDA). The firms will take care of the clinical or process development and manufacturing plans. Meanwhile, OWS will take advantage of the full capacity of the U.S government to make sure that no technical, logistic or financial obstacles impede either the vaccine’s development or its deployment.

The Key People: The initiative is co-chaired by Defense Secretary Dr Mark T. Esper and Health and Human Services Alex Azar, with Dr Moncef Slaoui designated as chief advisor and Gen. Gustave F. Perna confirmed to serve as Chief Operating Officer.

The Funding: Almost $10 billion has been directed to this effort by Congress via supplemental funding, which includes the CARES Act. Other flexible funding has also been appropriated by Congress. The almost $10 billion specifically directed includes over $6.5 billion designated for countermeasure development via Biomedical Advanced Research and Development Authority (BARDA) and $3 billion for National Institutes of Health (NIH) research.

The Strategy of OWS

The program’s strategy depends on a few major principles. Firstly, OWS seeks to build a diverse project portfolio that includes two vaccine candidates based on each of *the four platform technologies.

*The four platform technologies are the mRNA platform, the replication-defective live-vector platform, the recombinant-subunit-adjuvanted protein platform, and the attenuated replicating live-vector platform. These vaccine-platforms are believed to be the most likely to yield a safe and effective vaccine against Covid-19.

Secondly, the vaccine program development should be expedited without compromising on the safety, efficacy or product quality. Lastly, the initiative is supporting the firms financially and technically to begin process development and increase manufacturing while their vaccines are in preclinical or very early clinical stages.

The Vaccines & Their Progress

There are eight vaccines in OWS’s portfolio. Of the eight, six have been announced and partnerships executed with the following companies — Moderna and Pfizer/BioNTech (both mRNA), AstraZeneca and Janssen (both replication-defective live-vector), and Novavax and Sanofi/GSK (both recombinant-subunit-adjuvanted protein). These candidates cover three of the four platform technologies and are currently in clinical trials. The rest of the two candidates will enter trials soon.

Earlier this month, in a telephone briefing with reporters, HHS policy deputy chief of staff Paul Mango said, that four of the six vaccine candidates are in phase III clinical trials. He was quoted saying, as mentioned in the website of U.S Department of Defense, “For all of these vaccines — all six vaccine candidates — we are already manufacturing at industrial scale”.

In conclusion, OWS sounds like a great initiative for America and its people. However, President Donald Trump’s top medical advisers, led by Anthony Fauci have repeatedly said that a coronavirus vaccine won’t be ready for 12 to 18 months at best. On top of that, Democrats have accused the Trump administration of politicising the vaccine development process. Kamala Harris, the candidate for Vice President, accused Trump of trying to rush the process to boost his electoral hopes.

So, will this program develop a safe and effective vaccine before the COVAX initiative or the other countries’ efforts to build a vaccine? Only time can answer that question. Even though we would love to have a vaccine as early as we possibly can, wouldn’t we all prefer a safe vaccine over a quick one? And that’s the question we would want to leave you here with…

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