How long will it take to develop a coronavirus vaccine? 31/03/20

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Source: https://www.politico.eu/article/coronavirus-vaccine-how-long-will-it-take-to-develop/

 

How long will it take to develop a coronavirus vaccine?

Researchers are racing against time, but there’s only so much they can do to speed things up.

By

3/31/20, 11:25 AM CET

Updated 4/4/20, 1:49 AM CET

Some are suggesting skipping one of the trial phases to get a vaccine out faster

The clock is ticking to find a vaccine for the coronavirus that's ravaging the world.

The development of a successful vaccine is one of the surest ways of stopping the pandemic in its tracks and enabling millions of people to safely come out of lockdown. The trouble is that it's not clear how long that will take — or even if a vaccine can be produced quickly enough to prevent the worst effects of the epidemic.

Researchers and regulators are working to compress the typical six-to-10-year time frame it usually takes for vaccines to get developed, approved and marketed to the public.

U.S. President Donald Trump has proclaimed developing one would take a few months. European Commission President Ursula von der Leyen said it could be on the market before the fall.

Experts' estimates are less exaggerated. The European Medicines Agency (EMA) says a vaccineis at least one year away, but even this is optimistic.

“There’s no question about it. Time is not on our side" — Lincoln Tsang, expert in vaccine approval

The truth, according to many public health experts, is that it’s impossible to predict with much certainty how long it will take before a vaccine is widely available. What’s undeniable is that no matter how much money and expertise are thrown at the effort, or how much regulatory red tape is cut, there are steps of the process that simply cannot be sped up.

“It could be [that] the first vaccine works perfectly ... and we'll get there faster than even I expect," said Seth Berkley, CEO of Gavi, the Vaccine Alliance. "But I wouldn't want to get people's hopes up."

The hope is that lockdowns will slow the spread of the disease, and in the meantime, a vaccine will be deployed that will safely build herd immunity in the population. But in the time it takes to develop, approve and produce a vaccine, the virus might have already spread its way around the globe. Even by the most optimistic estimates, 12 months might be too late.

“There’s no question about it," said Lincoln Tsang, a partner at the law firm Arnold & Porter and an expert in vaccine approval. “Time is not on our side."

State of the science

Coronaviruses, a family of viruses responsible for COVID-19, SARS, MERS and several strains of the common cold, are notoriously difficult to counter. No effort to create a vaccine against a coronavirus in humans has ever succeeded.

One reason is that after outbreaks like SARS and MERS passed, the funding dried up, leaving several promising approaches unfinished.

As soon as the so-called novel coronavirus hit, researchers went back into the labs and dusted off years-old research on coronaviruses that cause SARS and MERS. There are more than 30 vaccines currently in the works.

"You want the proverbial 1,000 flowers bloom moment here," said Berkley. "You want every potential idea and technology to get started."

Researchers also are trying out different kinds of vaccine technologies, from proven methods like a measles-style vaccine that the Pasteur Institute is developing to mRNA and DNA vaccines that German regulators say are promising.

“We are using all the knowledge already available from previous coronavirus outbreaks,” said Jerome Custers, senior scientific director of vaccine research at the Johnson & Johnson-owned Belgian pharmaceutical company Janssen.

First steps

Vaccines typically undergo a pre-clinical research phase, in which a potential jab is first tested on animals to ensure it’s safe and elicits an immune response.

Existing research — combined with the political urgency — have helped some vaccine developers cut the time dedicated to this phase from two years to two months.

One American company, Moderna, has already begun phase 1 clinical trials, in which a potential vaccine is injected into a small group of people — this time to check its safety on humans and determine dosing. Others are also gearing up to test on humans without waiting for the completion of pre-clinical animal trials.

Researchers work on a vaccine against COVID-19 at the Copenhagen's University | Thibault Savary/AFP via Getty Images

Both European and American regulators gave this shortcut a thumbs-up, even though some experts have warned against proceeding to a clinical trial before knowing whether a vaccine triggers an immune response in animals.

There are also some tests that can be done only on animals. For example, after the injection, a dissection can show where the vaccine went and whether there’s any damage.

Read further here: https://www.politico.eu/article/coronavirus-vaccine-how-long-will-it-take-to-develop/

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