Covid-19 vaccine still has big hurdles to cross

A recent article in the New Zealand Herald suggests that we may get a vaccine for Covid19 in the not too distant future. It is important to recognize that there are still plenty of challenges left.

Yes, a number of vaccines are at Phase 3, but even among drugs that reach Phase 3, 42 percent fail. Even when a drug does get through Phase 3, there is still a time lag before final approval (and about 15% 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 BMJ article 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 Covid19 among a small number of participants (as few as 150-160 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 organized by Gavi, the Vaccine Alliance, a philanthropic enterprise through its COVAX facility.  According 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 WHO, led by the consulting firm McKinsey & Company. This may be fine but it is not entirely clear who Gavi or the COVAX facility is ultimately accountable to and what its 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.”

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% 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% quota.

New Zealand has contributed $27million to the COVAX facility as essentially a pre-purchase of vaccines if and when produced.

But questions remain: USA, 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 that the companies like AstraZeneca do agree to provide vaccines to Gavi, there is currently no plan for generic production. This means that companies will be allowed to maintain patent protection of their vaccines.

Again, according to Doctors Without Borders, till recently the only two producers of the pneumonia vaccine have been Pfizer and GlaxoSmithKline, who were selling it to Gavi for US $9 per child in the poorest countries and for US $80 in middle and higher income countries. The Serum Institute of India has offered to sell the vaccine at US $6 per child in the poorest countries and for no more than about US $11 per child in middle-income countries.

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 that in the near future we will 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.