Warp Speed

Donald Trump’s Operation Warp Speed (OWS) was launched on May 15th under the leadership of Moncef Slaoui, a notable former vaccine scientist developer turned venture capitalist, and General Gustave Perna, the head of logistics of the US army.

In fact, Slaoui was just the scientific adviser of the project which would be run by the Health and Human Services department headed by Secretary Alex Azar and the DoD logistics department headed by General Perna, thus combining the resources of government with the expertise of private enterprise.

Therefore, the development, regulatory approval and manufacturing and distribution of COVID-19 vaccines could be compressed in a shorter timeline and the distribution brought forward. Warp Speed’s goal was to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by the end of 2020. In Trump’s mind this meant that he might be able by election time to trumpet that he had saved the nation. Thus, he would secure his re-election and retain his White House dwelling for another 4 years.

Trump must have fumed when, a mere 6 days after the election, Pfizer announced better than expected trial results for its Covid-19 vaccine. On Monday November 16th, just a week later, Moderna provided an “encore” that must have been another blow to this paranoiac individual so fearful of losing.  Probably the only thing he could think of was: “why did this not all happen three weeks ago? I would have won. Another trick of these Democrats”. 

Meanwhile the infections were multiplying at a rate of 1 Million cases a week and the death tolls were rising over a thousand fatality a day, particularly in the Mid-West and the Southern states which represented the core of his voters. Having minimised the dangers of the virus, he had bet the farm on the vaccine to save his credibility, but he had narrowly lost.

Although Operation Warp Speed was hyped as an American technological prowess, ever since, as of  January10th 2020, when the first genome sequence of this novel coronavirus had been made publicly available, in every corner of the world, the race to develop the vaccine had been on.

In view of the pandemic, in an effort to accelerate the development process most industrial countries decided without fanfare to short cut traditional regulatory and commercial practices by financing industry to bring forward the date of vaccine conclusion wrap-up and its certification.

Human trials are normally conducted in three distinct phases financed by the developer, each one is more expensive than the previous one. Therefore, a great deal of time is dedicated to assessing the results after each phase and the financial risks in investing in the next phase which increases dramatically as the number of subjects tested increases.

Whereas phase1 involving safety may be as small as 50 participants, phase 3 which involves testing the safety and efficacy may involve 30,000 people. At the end of trials, a long regulatory approval process further defers the approval of the drug or vaccine.  Only at this point of time can investments in production facilities be made and only then can production and distribution start. At every stage, funds must be raised which creates further delays.

The new approach was to support financially the development and accelerate the regulatory phases. After each firm has established and verified at the cellular level their initial technological approach, they can elicit the potential financial support of governments. If approved they can then proceed to the trials and development of their product in a compressed time sequence. During the trials, the vaccine is produced in large quantities at the expense of the government so as to be available for distribution to the public immediately after regulatory approval. In the intermediate period the vaccine may be approved for emergency use.

The support for vaccine candidates had started before the initiation of Operation Warp Speed (OWS) when HHS had allocated almost 1 Billion USD between Johnson & Johnson’s (Jansen unit) and Moderna. Interestingly, in addition to being on the board of Moderna, M. Slaoui was a partner in a biotech venture capital firm, Medicxi, which had on its scientific board a director from Jansen.

This may explain his selection as OWS scientific leader. Subsequently, after OWS was created, HHS was highly active in supporting new candidates: AstraZeneca, Novavax, Pfizer, Sanofi, and GlaxoSmithKline’s (GSK), and providing additional funding to Johnson & Johnson and Moderna. In all 10 additional billions were disbursed to help the various candidates to finish their trials and produce 100’s of million of doses.

This accelerated approach has proved beneficial and resulted in a record time, in not only the emergence of 2 successful candidates using the mRNA technology, but also of Astra Zeneca using the more classical of a modified adenovirus to produce the spike S protein of Covid-19. Although less efficacious (about 70%) than its competitors (about 95 %), its result outshine those of conventional flu vaccines (40-60%). Other vaccines are expected to be approved within the next 6 months. The availability of many different vaccines is a good thing considering the magnitude of people to be vaccinated and the problems in production and distribution across the globe.

It is distribution and inoculation that may be the most problematic area especially when dealing with vaccines that must be kept at ultra cold temperatures, which is the case for the US front runners Pfizer and Moderna.

Releases by the Administration in August and September reveal an insufficient attention to the distribution

On August 14, CDC and DoD announced its centralized distributor contract by executing an existing contract option with McKesson, which distributed the H1N1 vaccine during the H1N1 pandemic in 2009–2010. Detailed planning was underway to ensure rapid distribution as soon as the FDA would authorize one or more vaccines and CDC make recommendations for who should receive initial doses.

On September 16, HHS and DoD released two documents developed by HHS in coordination with DoD and the CDC,  that outlined the Administration’s detailed strategy to deliver safe and effective COVID-19 vaccine doses to the American people as quickly and reliably as possible. They were meant to provide a strategic distribution overview  along with an interim playbook for public health programs and their partners whether at the  state, the tribal, the territorial or local level on how to plan and operationalize a vaccination response to COVID-19.

Both documents, a summary of which is given in appendix to this article describe the intention of delivering the vaccine to distribution sites. However, there are no criteria or specifications as to what such a specialised site should adhere to.

On September 16, President Donald Trump predicted that a safe and effective vaccine against the coronavirus could be ready as early as next month (read shortly before the election) and in mass distribution soon after. What he did not say was that the likely vaccines to emerge first would require to be maintained at large sub-zero temperatures to maintain their efficacy.

At the September 16th press Conference, Dr Redfield said: “States are not ready to deal with the demand for such a distribution and some $6 billion in new funding would be needed to get the nation prepared. Adding to logistical complications, likely vaccines would have to be given in two doses spaced weeks apart and needed to be refrigerated at temperatures considerably below normal vaccines.

It may also reveal a lack of communication between the main actors of Operation Warpspeed namely HHS and DoD and the CDC but more than likely it was a resolve by the administration to skew reality with the sole purpose of enhancing the re-election prospects of the commander in chief.

When looking back at the disastrous Covid 19 testing campaign by the administration, the present succinct plans for a mass vaccination of the US population with vaccines that must be maintained at ultra cold temperatures do not look adequate to warrant the present optimism. It will take a gigantic logistic effort by the new Biden administration to achieve a rapid vaccination of the whole US population. The prompt emergence of traditional vaccines will probably facilitate the task, not only in the US but, also in the rest of the world. As Dr Redfield subsequently told the Senate:

“The worst thing that could happen is if we have a vaccine delivered and we’re still not ready to distribute it. There was absolutely no political thinking about it.”

Strategic Distribution Overview

To a non expert the “Strategic Distribution Overview” looks like a standard pamphlet that could be published for any type of intense vaccine distribution program. It must have been constructed on elements of experience and knowledge of the H1N1 epidemic and inter alia relied on the distribution through pharmacists. Although it must have been known that the main contenders for crossing first the FDA approval stage were based on a new technology mRNA which required the vaccines to be maintained at much lower temperature, there was very little reference to vaccine ultra-cold storage and their special distribution constraints

“If necessary, the McKesson contract can cover rapid distribution of doses of refrigerated (2–8º Celsius) and frozen (-20ºC) vaccines. Some vaccine with ultra-cold storage requirements may be shipped directly from the manufacturer to the administration sites, but all distribution will be managed by this centralized system.”

 A more detailed document, the Interim play book was prepared by CDC comprising 75 pages in an attempt to cover all factors pertinent to a successful vaccination project. However, as its title indicates, it is not the final document. Only pages 33 and 34 are devoted to distribution.  It reiterates that the program will make maximum use of all healthcare professionals licensed to administer vaccines, including allied health professionals such as pharmacists. It mentions that:

“Certain COVID-19 vaccine products, such as those with ultra-cold temperature requirements, will be shipped directly from the manufacturer to the vaccination provider site. If redistributing vaccine, jurisdictions must adhere to all cold chain requirements and should limit transport of frozen or ultra-cold vaccine products”.

By Digenis

16 December 2020

Read also: When Covid-19 hits the Fan

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