From The Editor | April 27, 2020

A COVID-19 Vaccine, Outsourcing, And Made In The USA

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By Louis Garguilo, Chief Editor, Outsourced Pharma

Vaccine Medication

That’s an unwieldy title for an editorial. But we’ll bundle it up quickly.

Start here:

1. The Makers And Market

“The vaccine market has grown six-fold over the past two decades, worth more than $35 billion today, according to AB Bernstein,” and reported in a recent CNBC update. “The industry has consolidated to four big players that account for about 85% of the market — British drug-maker GlaxoSmithKline, French pharmaceutical company Sanofi, and U.S.-based Merck and Pfizer.”

2. Many Smaller Searches

However, as has been widely reported, there’s a substantial and growing contingent of smaller U.S.-based vaccine-development companies working on COVID-19.

If any of these companies eventually succeed, they’ll have decisions to make on with whom to manufacture – should they in fact retain control of their product.

3. CDMOs And China

While large quantities of flu and other vaccines are produced internally by the big four (mentioned above), there are CDMOs in the U.S. producing vaccines, although today those capable of vaccine work appear to be relatively limited (compared to providers of other biologics and small molecule services).

Knowledgeable sources say no (or practically no) vaccines provided to Americans are produced in China. There’s no need to “bring the supply chains back.” However, the question is then: Can a vaccine developer – large or small – build a large-scale COVID-19 vaccine supply chain in the U.S.?

A Vaccine Narrator

GeoVax Labs, Inc. (OTCQB: GOVX) CEO David Dodd is the quintessential professional to tie these three components together, and assist readers in assessing and contemplating current and future realities.

David DoddDodd has 40 years experience in pharmaceuticals, vaccines, and life sciences. Among other positions, he ran Wyeth’s U.S. pharmaceutical business before it became part of Pfizer, and was CEO at Solvay. He’s been Chairman of GeoVax since 2011, stepping into the CEO role in September 2018.

The Atlanta, GA-based company started in 2001 with “a single focus on preventive vaccine for HIV.” Although without a commercial product, Dodd says, “We have been very successful in advancing the science for this disease.”

Today the company is more widely focused, with a pipeline of human vaccines (e.g., Ebola, Marburg, Zika, Malaria) and immuno-oncology therapies.

GeoVax utilizes a novel Modified Vaccinia Ankara-Virus Like Particle vaccine platform (GV-MVA-VLP™). On this platform, MVA (Modified Vaccinia Ankara) – a large virus capable of carrying several vaccine antigens – expresses proteins that assemble into VLP immunogens in vivo (within those receiving the vaccine). Application of this platform has been validated across both infectious diseases and cancer immunotherapy applications.

GeoVax is now employing its internal expertise to develop vaccine candidates using genetic sequences from SARS-CoV-2, the virus responsible for the COVID-19 outbreak.

Three vaccines have been designed and developed, according to Dodd. GeoVax is now looking to advance the vaccines into animal testing to select one candidate based on safety, immunogenicity, and efficacy profiles.

A selected candidate will be targeted for manufacturing scale-up and initial human clinical trials to determine the appropriate dose and further confirm safety and efficacy in prevention.

Outsourcing In America

“Any successful vaccine from GeoVax will be manufactured in the U.S.,” Dodd says.

“We design, develop and construct our vaccines, then outsource the further activities to validated experts in various areas. We outsource everything within the development process through manufacturing.

“I wouldn’t call it ‘outsourced pharma,’ though, because we are talking about vaccines; you might call it ‘outsourced life sciences.’”

He continues: “For that outsourcing, we have a network – I think of it as a consortium. We work extensively with people we've had success with in the past, and that are approved and validated by government authorities for exactly what we are doing.

“In the case of COVID-19 – a point I think is lost on many – vaccines for the U.S. population are for the most part manufactured here.”

Good news to many of us.

But challenging on at least this front: Finding CDMOs.

“There’s a challenge in working with MVA. It’s not run-of-the-mill,” explains Dodd. “There aren’t many manufacturers – and certainly few contract manufacturing organizations – handling vaccines who have the particular experience in working successfully with this viral vector. We work with organizations who have previously supported us into the clinic related to our HIV vaccines or with CDMOs who we have validated as capable of manufacturing MVA-based vaccines.”

“Between our own requirements and those of the government in the form of regulatory and safety oversight, there is a handful of qualified contract manufacturers we are able to work with on process development. Internally, we have qualified people familiar with our platform, and we know very well our partners capabilities.”

He adds: “Yes, those partners are all U.S.-based, with one headquartered outside the U.S., but with a core here. Each are outstanding in their capabilities and experience.”

Still Connected To China

Even a GeoVax has at least some ties to China, which is, after all, forecast to become the biggest single drug market in history.

In January, GeoVax announced a Letter of Intent with Wuhan-based vaccine-developer BravoVax, to jointly develop a vaccine for COVID-19.

“Our agreement with BravoVax is one in which we remain fully responsible, and the vaccine is solely the property of GeoVax,” he tells me.

“BravoVax is a highly capable manufacturer, with experience in vaccines and working with viruses, but has not worked with our particular viral platform
(MVA).  We feel confident they will demonstrate their capability to either manufacture, or manage the manufacturing of a GV-MVA-VLP™ based COVID-19 vaccine, in order for us to transfer materials, technologies, etc. under a joint-development business agreement.

“We would potentially transfer our vaccine for them to initiate their animal testing and development in China,” Dodd continues. “We will maintain responsibility for all development activities through manufacturing and registration relative to the U.S. BravoVax will follow a parallel path for their assigned territory.

“Our intention is to manufacture our COVID-19 vaccine for the U.S. and related markets in the US. Similarly, we hope the BravoVax efforts result in success whereby they are manufacturing within China for Greater China and other related regions.”

In short, product for China produced in China. For the U.S., produced in the U.S. Sounds like a proper balance.

And it’s good to learn a smaller organization like GeoVax has U.S.-based vaccine manufacturers to make it work.