A CEO Perspective: Seeing a Vaccine All the Way Through the Process

Many of us have seen the TV images this week of the recently approved Pfizer and BioNtech COVID-19 vaccines either being taken out of the delivery box and placed into cold storage or of health care workers being vaccinated. These images remind everyone that—from development all the way through the US Food and Drug Administration (FDA) approval and actual vaccinations—the whole process took less than a year.

This feat in that amount of time has never been accomplished.

While seeing a vaccine all the way through takes many people and numerous departments, the responsibility ultimately falls on the CEO of the pharmaceutical or biotech company. Funding, vaccine development, navigating the regulatory bodies, creating a supply chain, delivery, storage, and market share are all front-of-mind challenges CEOs must consider when looking at the development of a vaccine. This doesn’t even include other aspects like ethics.

For example, even with the approval of his company’s vaccine, Pfizer CEO Albert Boula had not yet been vaccinated as of this past Monday. And his company was still weighing the ethical aspects of who should be getting the vaccine with its limited supply.

Covaxx CEO Mei Mei Hu is certainly thinking of these aforementioned challenges as her company develops its COVID-19 vaccine. She previously worked on animal vaccines and oversaw the launch of one of the first endobody vaccines in the world.

“There’s a whole road map that gets [you] from the plant to the end user. It’s not often on the front pages [of the newspapers] but it is critical,” Hu said.

In thinking about logistics, for example, she is considering things like vaccine temperature stability and packaging size formats to ensure doses can be delivered safely and do not go unused.

“You have to think about how you are going to administer it. Is this going to be in a mass vaccination center or can it make it all the way to a doctor’s office or pharmacy?”

Since Contagion® last spoke with her a few months ago, Hu has gone from a Co-CEO to taking on the position solely. While she said not much has changed for her from a day-to-day perspective, Hu has overseen significant business deals to match the clinical development of the company's vaccine.

For example, Covaxx reached a partnership deal with Maersk in October. Drive on any major highway or any city port in the US, and it is likely you will see the name Maersk on cargo containers. They are one of the largest shipping and logistics providers in the world. This partnership sets the groundwork for delivery of Covaxx’s vaccine, once it is approved by various countries’ regulatory authorities.

In thinking about their prospective markets, Covaxx certainly has an eye on South America. The company announced a few weeks ago it had secured advanced purchase commitments of more than 140 million doses of its vaccine, totaling over $2.8 billion, to deliver vaccines to multiple countries, including Brazil, Ecuador, and Peru.

Hu believes there is plenty of room in the market for additional COVID-19 vaccines.

“There simply is not enough supply to meet the global demand,” Hu said. “And traditionally, the first in class is not the market leader.”

Hu says the Covaxx vaccine differentiates itself in a couple of different ways including its platform and storage needs.

The company’s COVID-19 vaccine, UB-612, has been developed on a platform using a multi-antigen peptide approach. It is the first multitope peptide-based vaccine activating both B and T cells.

She points out their vaccine can be stored at normal refrigeration temperatures, so they do not have the storage challenges associated with the Pfizer vaccine.

“It can be held in 2 to 8 degrees, which is normal refrigeration,” Hu explained. “And that’s a big deal, particularly in developing markets that don’t have the infrastructure.”

A phase 1 trial in Taiwan is wrapping up, and the vaccine is expected to begin trials in Brazil and the United States in 2021.

In our most recent discussion, Hu spoke to Contagion® about the challenges for vaccine makers, an update on their vaccine, and what they believe will be their place in the market.