OPINION

Hoping for a vaccine this year, or even next? Don't count on it

There's no indication even an approved vaccine is likely to work beyond three months. Picture: Shutterstock
There's no indication even an approved vaccine is likely to work beyond three months. Picture: Shutterstock

Politicians and a lot of Australians think it's only a matter of time before we have an effective vaccine for SARS-CoV-2 (the strain of coronavirus that causes COVID-19) and then life will return to "normal". That seems very unlikely to be the case.

While I don't profess to be a medical expert, I have in the past worked on biological warfare, intelligence estimates, fake news, risk management, and business continuity - all of which are relevant to the current pandemic situation.

At the moment there is an information tug-of-war going on between politicians who want to get economies up and running, and scientists who are trained to be cautious and methodical.

Australian politicians are listening to scientists for a change, but an extreme example of disconnect is that between waspish US President Donald Trump and respected US National Institute of Allergy and Infectious Diseases director Dr Anthony Fauci.

The pandemic's economic consequences and increasing death rate have generated an unprecedented international race to produce an effective vaccine. As of last month, 218 vaccine candidates were in development, of which 24 were undergoing clinical trials.

There are six stages of vaccine development and marketing: exploratory, pre-clinical, clinical development, regulatory review/approval, manufacturing, and quality control.

The clinical development stage involves three phases of human testing for a candidate vaccine:

  • Phase I: administration to a small group (less than 100 people) with the aim of determining whether it's safe and to learn more about any side-effects.
  • Phase II: administration to hundreds of human test subjects. The aim is to deliver more information about safety, immunogenicity, immunisation schedules and dose sizes.
  • Phase III: administration to thousands of test subjects. This phase continues to measure the safety aspect (rare side-effects may not appear in smaller groups) and effectiveness of the vaccine, preferably in a high-threat environment.

Four vaccine candidates are in Phase III testing: Oxford University/AstraZeneca in Brazil, Moderna in the US, Sinovac in Brazil, and Sinopharm in the UAE.

If a candidate vaccine successfully passes all three phases of clinical development, the vaccine developer will seek regulatory review/approval and approval to manufacture. Quality control continues throughout the life of a vaccine.

The safety bar is set high because of past instances where rushing vaccines into use resulted in adverse consequences. One example was a seasonal flu vaccine intended to help Gerald Ford's presidential election prospects in 1976. The flu turned out to be reasonably benign, but the vaccine caused paralysing Guillain-Barré syndrome in several hundred people.

Established drug manufacturers will create the hundreds of millions of vaccines needed and reap the profits. They will of course prioritise signed-up customers (like the US and UK) and focus on the most profitable markets. There is little incentive for them to magnanimously share manufacturing information for global use in poor countries.

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While several COVID-19 trials look promising, a researched vaccine is far from guaranteed to work effectively. Only 6 percent of research projects successfully get through the three clinical development phases. Even then, an approved vaccine may provide immunity for as little as three months. Studies so far indicate the human body does not produce long-term antibodies against SARS-CoV-2.

Another potential complication is the mutation factor - a vaccine might not work against a mutated coronavirus and might need to be continually updated. Furthermore, a vaccine is unlikely to prevent person-to-person transmission.

The respected British medical journal The Lancet noted in June: "Vaccine development is typically a long game. The US Food and Drug Administration only approved a first vaccine against Ebola virus last year, 43 years after the deadly virus was discovered. Vaccinologists have made little headway with HIV or respiratory syncytial virus, despite huge investments. On average, it takes 10 years to develop a vaccine."

In the most optimistic case, a COVID-19 vaccine could be available to Australians in 2021, however today's precautions of face-masking, hand-hygiene and social-distancing will probably need to be carried through into future years. This has implications for the hospitality industry, airline travel, tourism, and any business that makes money out of social interaction.

Businesses that prosper in the year ahead will be those that are agile and insightful enough to take advantage of COVID-19 opportunities and use them to gain market share. Businesses that plan to wait out COVID-19 and expect to return to pre-2020 conditions in 2021 are setting themselves up for failure.

  • Clive Williams is a visiting professor at the ANU's Centre for Military and Security Law.
This story Hoping for a vaccine this year, or even next? Don't count on it first appeared on The Canberra Times.

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