When a coronavirus vaccine will finally be developed?

Optimists claim it will be ready by June, realists answer it won’t be earlier than next year

When will we have a Covid-19 vaccine? Some like the UK’s chief scientific adviser, Sir Patrick Vallance, and his US counterpart, Anthony Fauci, keep repeating that it won’t be before 12 to 18 months from now. Other voices, including some of those in the race to create a vaccine, have suggested that it could be as early as June. Who is right?

It is rather complicated because this pandemic is forcing change at almost every step in the process by which a new vaccine arrives. Currently at least 70 coronavirus vaccines are in development, with three already in clinical trials, according to the World Health Organisation. China has approved early-stage human tests for two experimental being developed by a Beijing-based unit of Nasdaq-listed Sinovac Biotech, and by the Wuhan Institute of Biological Products, an affiliate of state-owned China National Pharmaceutical Group. The US-based biotech startups Inovio Pharmaceuticals and Moderna have also begun human testing

Developing a new vaccine is typically an expensive, complicated, and lengthy process, requiring hundreds of millions of cash and years of testing to determine whether it is safe and effective. While this pandemic is the third coronavirus outbreak of the 21st century, the first two being SARS and MERS, there still aren't any approved vaccines for coronaviruses.

New vaccines are generally required to be tested first in a lab, then in animals, and then among a small group of people for safety before they're finally tested in larger groups to see whether they can prevent a disease. But experts are concerned that bypassing any of those steps to get a vaccine approved risks leading to "immune enhancement," in which a vaccine actually weakens a person's response to the virus.

“It really depends on what you mean by ‘having a vaccine’,” says Marian Wentworth, president and CEO of Management Sciences for Health, a Massachusetts-based global not-for-profit organisation that seeks to build resilient health systems, and a long-time observer of vaccine development. “If you mean one that can be used in a mass vaccination campaign, allowing us all to get on with our lives, then 12 to 18 months is probably right.”

But in terms of an experimental vaccine that is deemed safe and effective enough to be rolled out in a more limited way – to high-risk groups such as health workers, say – that could be ready within weeks or months, under emergency rules developed by drug regulatory agencies and the WHO in the context of the recent Ebola epidemics in Africa.

Dr. Anthony Fauci, the director of the US National Institute of Allergy and Infectious Diseases, has said the US is still at least 12 to 18 months from seeing a coronavirus vaccine, and some experts have warned that even trying to hit that deadline is a risky plan that could backfire. "When Dr. Fauci said 12 to 18 months, I thought that was ridiculously optimistic," Paul Offit, the co-inventor of the rotavirus vaccine in the late 1990s, told CNN. "And I'm sure he did, too."

"The way you reduce that risk is first you show it does not occur in laboratory animals," Dr. Peter Hotez, the dean of the National School of Tropical Medicine at Baylor College of Medicine, told Reuters. But in the rush to find a vaccine for the novel coronavirus, some drugmakers are skipping animal trials, Stat News reported. "I understand the importance of accelerating timelines for vaccines in general, but from everything I know, this is not the vaccine to be doing it with," Hotez said.

In an article published in The New England Journal of Medicine on 30 March, representatives of the Oslo-based not-for-profit Coalition for Epidemic Preparedness Innovations (Cepi), which is helping to finance and coordinate Covid-19 vaccine development, laid out an accelerated version of this process that they believe is more suited to a pandemic.

This “pandemic paradigm” implements certain steps in parallel, such as animal and phase-1 clinical testing. It also involves scaling up production capacity before sufficient safety and efficacy data are available – a financially risky step, given that that may never materialise, and one that requires governments and not-for-profit organisations such as Cepi to share that extra financial risk with pharmaceutical companies if they want them to engage. The accelerated paradigm is being implemented now.

At the Pasteur Institute in Paris, on the other hand, a Covid-19 vaccine candidate is still in pre-clinical development, but because it piggybacks on established technology – a licensed measles vaccine – the testing and licensing processes will go faster. And this kind of vaccine can already be produced in large quantities.

There are still many unknowns with respect to Covid-19, including for how long any vaccine will provide protection. A strong indication of this will be whether people who have recovered from the disease can catch it again. There have been anecdotal reports of re-infection, but the phenomenon is not well understood. “If our own body can’t prevent us from getting it again, that would be one pretty damning signal,” Wentworth said.

Once a vaccine is licensed, there will still be political obstacles to getting it to where it’s needed, because each country or public health jurisdiction has to make its own decision to roll it out. There will also be issues of prioritisation – who should get it first, if supplies are limited – which authorities are discussing now.

A vaccine that is approved a year from now may arrive after the end of the current pandemic, but if so it won’t be wasted – first because Covid-19 may recur seasonally, and second because the vaccine could itself be repurposed in the event of an outbreak of a different coronavirus. That will be no consolation to victims of this pandemic, or their relatives, but it does mean that humanity will be better protected in future.

More on this subject: Coronavirus

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