Are COVID-19 vaccines are manufacturable at scale?

We’re bombarded every day with news about the latest miracle vaccine candidate: when it will be available, which vaccines have reached clinical trials, the stock market performance of the manufacturers, and so on.

1. Can any of these vaccines be manufactured at scale?

2. How often do people need to be vaccinated… annually? Every 6 months?

3. Who gets the first 100 million doses? The first billion?

4. How do we reliably distribute these doses? Can we?

Manufacturing and distributing billions of doses of a COVID-19 vaccine will be one of the biggest logistical challenges in history. It’s an understatement to say that there are a lot of challenges ahead.

In this blog, I want to address the four challenges listed above. Ultimately, I’m hoping that many will succeed. We need them all.

Here are four of the roadblocks to manufacturing and distributing a safe and effective COVID-19 vaccine.

1. Having an ability to scale -- fast!

We need 4.4 billion annual doses to vaccinate adults worldwide. That number will increase if we also have to vaccinate children. And it will increase further if more than one dose per adult is required. (Note: Most scientists believe that two doses per adult will be needed, a primary and a booster shot some weeks later.)

Meeting this challenge will likely require the combined output of several vaccine manufactures over the next 12-18 months.

Several of the top vaccine candidates, including the AstraZeneca / Oxford partnership, Moderna, and Pfizer, have committed to producing at least 100 million doses in 2020. Additionally, each company has pledged to produce at least 1 billion doses in 2021. COVAXX committed to producing 100 million COVID-19 vaccine doses by early Q1 2021, and 1 billion doses by the end of next year. But plans are not enough. execution of these goals is essential for our collective success.

2. Using a commercially proven manufacturing platform

For example, Moderna’s and Pfizer’s mRNA-based vaccine is based on a technology platform that has never been approved for human use. We don’t know if the tech can reliably be scaled to handle hundreds of millions and eventually billions of doses in the timeframe we need.

One major advantage that COVAXX is offering the world is proven manufacturing. The same technology platform being used to manufacture the COVID-19 vaccine already produces >500 million animal vaccines per year, and has produced over 5 billion doses in total to date.

3. Ensuring that distribution is reliable

Even the safest and most effective vaccine won’t work if it can’t reach patients. One major concern is that some of today’s top vaccine candidates (specifically the mRNA vaccines) require storage in freezers at -112 degrees Fahrenheit (-80 degrees Celsius) for the vaccine to be effective and not degrade. That means using liquid nitrogen. That may work in a factory or a warehouse. But most clinics, doctor’s offices, and pharmacies don’t have such sophisticated storage technology.

So how do we get these vaccines to an individual patient?

Now consider the billions of people we need to reach in remote regions and emerging economies where normal refrigeration is a problem, let alone keeping vaccines at -112 degrees Fahrenheit (-80 degrees Celsius). In our interconnected world, an outbreak anywhere is an outbreak everywhere.

In other way COVAXX platform uses a “synthetic peptide technology” that only requires normal (widely available) refrigeration.

4. Distributing the vaccines in an ethical way

The truth is, this will not be a winner-takes-all model. We’ll likely need multiple vaccines from different manufacturers to meet the high demand. And for this reason, I wish all of the vaccine teams great success.

But even then, there are critical questions that we’re not sufficiently discussing in the media.

Who should get the vaccine first? Healthcare workers? The elderly? What about waiters? Are corporate executives more essential than grocery store clerks?

These are some of the questions we’ll have to answer as the first vaccines become available.

Here is a sample of several companies’ planned production of COVID-19 vaccines.