Covid 19 coronavirus: Ananish Chaudhuri: Vaccine has a few hurdles yet to clear

Opinion

OPINION

A recent article suggested we may get a vaccine for Covid-19 in the not-too-distant future. It is important to recognise there are still plenty of challenges left.

Yes, several vaccines are at phase 3, but even among drugs that reach phase 3, 42 per cent fail. Even when a drug does get through phase 3, there is still a time lag before final approval (and about 15 per cent fail to make the cut) before proceeding to production.

What is less widely known is that a vaccine, if and when it comes, will have only limited efficacy. According to a recent article in British medical journal BMJ none of the current vaccine candidates may be successful in reducing severe Covid-19 (hospital admission, ICU, or death) or interrupting transmission (person-to-person spread).

At least, the trials are not designed to test for these. The trials will be considered a success if they can prevent symptomatic Covid-19 among a small number of participants (as few as 150 to 160 overall cases). This is mostly due to the compressed time-frame. Testing for wider efficacy will take much longer.

But the challenges do not end at this point. We will still need to produce and distribute seven billion vaccines around the world. Other than the one being developed by Johnson and Johnson, every vaccine needs to be frozen, a serious challenge in less developed tropical countries with high temperatures and often unreliable power supplies.

Then there is the issue of cost and availability.

The distribution of this vaccine is being organised by Gavi, the Vaccine Alliance, a philanthropic enterprise through its Covax facility. According to Doctors Without Borders (MSF), the facility was designed by an invited group of organisations and individuals.

The core group of decision-making partners are Gavi's Secretariat, the World Bank, the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation, Unicef, and the World Health Organisation (WHO), led by the consulting firm McKinsey & Company.

This may be fine but it is not entirely clear who Gavi or the Covax facility are ultimately accountable to and what their mandates are.

According to the same press release from Doctors Without Borders, "Gavi also does not have experience negotiating with pharmaceutical companies on behalf of these countries.

"Meanwhile, the WHO Pandemic Influenza Preparedness (PIP) Framework is an example of WHO's global normative and operational role to develop public health instruments that help to prepare for and respond to global pandemics. The PIP Framework includes requirements from manufacturers that they set aside specific quantities of medicines or vaccines in the case of a global influenza pandemic, with WHO determining the equitable allocation of those medical tools."

Clinical research co-ordinator Tammy Lewis-McCauley injects Katelyn Evans during a Pfizer Covid-19 vaccine trial. Photo / AP / Cincinnati Children's Hospital Medical Centre

Gavi envisages a two-tiered system for vaccine distribution; self-financing countries (richer countries that can afford to pay) and funded countries (poorer countries that need help).

Once a vaccine is available, the self-financing countries will be entitled to receive enough vaccines for at least 20 per cent of their population. Countries will then decide who gets those vaccines.

The funded countries that need help will only get the vaccine if and when all the self-financing countries have received their 20 per cent quota.

New Zealand has contributed $27 million to the Covax facility as essentially a prepurchase of vaccines if and when produced.

But questions remain: the United States, China and Russia are not signatories to Covax. If and when a vaccine is produced and demand far outstrips supply, it is not clear why and whether pharmaceutical companies will sell to Gavi at a cost-plus pricing model rather than to others. The relationship with Gavi does not rule out other bilateral relationships.

Even assuming companies such as AstraZeneca agree to provide vaccines to Gavi, there is currently no plan for generic production. This means companies will be allowed to maintain patent protection of their vaccines.

Again, according to Doctors Without Borders, the only two producers of the pneumonia vaccine unitl recently have been Pfizer and GlaxoSmithKline, who were selling it to Gavi for $13.50 per child in the poorest countries and for $120 in middle and higher income countries. The Serum Institute of India has offered to sell the vaccine at $9 per child in the poorest countries and for no more than about US $16.50 per child in middle-income countries.

Ananish Chaudhuri. Photo / Supplied

But providing the vaccine cheaply is crucially dependent on the ability to produce generic substitutes without running into charges of violating patent protection.

It seems likely we will soon be in a world of vaccine-haves and vaccine-have-nots. Citizens of countries in the former group will be able to travel freely among each other but travel and trade relations with vaccine-have-not countries will be severely curtailed.
This, in turn, will have serious adverse impact on the lives and livelihoods of those countries' citizens.

• Ananish Chaudhuri is professor of experimental economics at the University of Auckland. Views expressed are his own.