COVID-19 is both highly contagious and lethal. There is no vaccine.

• R0 is the measure of how many people a single infected person will infect over the period they are contagious.
  
  COVID-19’s R0 has been estimated between 2 and 3.3. Compare this to the R0 of seasonal influenza which is about 1.3. The R0 of Spanish flu was also 2-3.

• The death rate (case fatality rate) of COVID-19 has been estimated between 2.3% and  4%. Seasonal influenza is 0.1% and Spanish flu was estimated at 2-3%, killing an estimated 40-50 million people. In reality, it is difficult to calculate at such an early stage and is highly skewed by misreporting of data. It appears that older people (60+) are more affected.

Prevention & lockdown

At this stage, there is no vaccine for COVID-19. Thus the only effective method of stopping the spread is to prevent person-to-person contact. China has locked-down infected areas and in the rest of the world it has been reported that people are self-isolating.

Vaccine development

Many companies are developing a vaccine for COVID-19. Several have announced that they have formulated the DNA and are ready to go into animals for testing as soon as next week. With a following wind, this could still take 18 months to 2 years to get a vaccine approved by the regulatory agencies, especially in the USA and Europe. China may well be considerably faster as they already have the animal models for testing available.

When we do have a vaccine, with an R0 of 3.3, 70% of the population would have to be vaccinated to stop the spread. In the USA that would be 229 million doses, in Europe over 500 million doses, the rest of the world even more… 

Pandemic vaccine logistics

In a pandemic, speed is of the essence. The numbers to be vaccinated on a global scale are staggering, potentially in the billions of doses. This will be a challenge even in a developed country. The key issues:

• speed of development, testing and authorisation by the regulatory agencies – under normal conditions, this can take over 2 years.
• can a vaccine be manufactured in sufficient volume?
• most vaccines have to be shipped between 2℃ and 8℃, this is called the “cold chain”. Is there a cold chain large enough to ship millions of doses in weeks?
• many of the latest generation vaccines have to be shipped at -80℃, this is a “cryo-chain”. The cryo-chain does not exist to enable shipping of millions of doses in a short timeframe.
• traditional vaccines are injected and require a healthcare professional, another bottleneck.
• to be vaccinated, people will have to attend a clinic (schools/halls/hospitals etc). Simply standing in line may expose healthy individuals to others who are already infected. Healthcare professionals will be most at risk.

A radically superior approach – Stabilitech’s COVID-19 capsules

Stabilitech’s vaccine is dramatically different and superior to other approaches. (Full disclosure, I chair Stabilitech). We are producing a COVID-19 Vaccine Capsule that can be self-administered.

Why is Stabilitech’s COVID-19 capsule approach better?

Stabilitech’s COVID-19 capsules:

• give two levels of immunity – mucosal and systemic
• are self-administered – just swallow the capsule
• can be sent by mail – they are thermally stable
• do not require a healthcare professional for administration – removing a bottleneck and saving the largest cost element
• are thermally stable which means shipping them anywhere in the world is possible
• are quick to develop and cheap to manufacture.

What’s the alternative?

The alternative is the traditional vaccine which is taken from a fridge and administered by a healthcare professional using a needle:

• normally vaccines either give mucosal or system immunity, not both.
• needing a healthcare professional means you have to attend a clinic and stand in line to be vaccinated. This is slow and as mentioned, the real cause for concern is the other people who may be infected standing next to you.
• shipping worldwide requires a cold chain – 50% of all vaccines go out of temperature range which renders them ineffective.

Regulatory approval

A vaccine could take 2 years or more to get regulatory approval. Every vaccine has to have extensive testing in animals and in humans before it will gain regulatory approval. The good news is that if a vaccine passes phase 2 trial (which tests for safety and some efficacy) then they have a good chance of going all the way to marketing approval. This is not the case for pharmaceuticals which have a significantly higher failure rate.

Again, Stabilitech’s oral approach has a distinct advantage in timescales and safety. The viral vector we use has been administered to the gastrointestinal tract many millions of times without serious adverse events. In the case of a pandemic, it may be that the regulators will look at this and decide that with such a low risk that small trials will be sufficient to allow mass vaccination – this could cut many months or even a year off the development timescale.

What if you have already caught it? Chloroquine – anti-viral therapy for COVID-19

According to a paper in Nature (Cell Research (2020) 0:1–3) the antivirals (chloroquine and remdesivir) may be effective therapies for people suffering from COVID-19, although this has only been tried in vitro, ie not in man yet. It isn’t a vaccine so no point in taking it before contracting COVID-19, it is for use when you have the virus.

Bayer said it has expedited supply and transportation of 300,000 tablets of Resochin (its version of chloroquine phosphate)  after receiving a request from the Guangdong provincial government.

Chloroquine phosphate is an anti-malaria drug which has been going for over 70 years. It’s a generic so it’s cheap and available online. I bought some earlier this week, just to make sure that if there is a run on the drug, I have some available. Today, every online site I tried had sold out.

Implications for global economy and pharma share prices

Manufacturers will ramp up supply but once the chloroquine therapy is known, stocks will go fast leading to a possible global shortage. Small manufacturers such as such as Alliance Pharma plc (market capitalisation: £452 million) may see a material short term boost to their share price. Big pharma manufacturers such as Bayer and Sanofi will have some benefit but chloroquine is very cheap and unlikely to make a significant increase in revenues.

Medium term effect of China being in lockdown may push the global economy into recession. Interest rates are already low so central-banks have limited ability to provide monetary stimulus. Any short-term benefit is likely to disappear in the melee of all shares suffering. 

What happens next?

Both the UK government and CEPI (the Coalition for Epidemic Preparedness Innovations) are proactive and have announced £20m each to fund a COVID-19 vaccine development. Each innovative approach will cost a minimum of £3m to develop, test in animals and produce a pharma grade vaccine for use in humans. In this context, £20m isn’t a lot of money, but it is enough to get the ball rolling.  

We are in an age where vaccine development can be quicker than ever but clinical trials are becoming ever slower and more demanding. It may be that the COVID-19 enables us to streamline our approvals process for the greater good.