Trial of coronavirus vaccine begins in Seattle

The US National Institute of Allergy and Infectious Diseases announced the first testing in humans of an experimental vaccine for the new coronavirus began on Monday.

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The New York Times reports the main goal of this first set of tests is to find out if the vaccine is safe. If it is, later studies will determine how well it works.

Dr Anthony Fauci, the institute’s director, said the trial was “launched in record speed”.

Such rapid development of a potential vaccine is unprecedented, and it was possible because researchers were able to use what they already knew about related coronaviruses that had caused other diseases outbreaks, SARS and MERS.

Despite the rapid progress, even if the vaccine is proved safe and effective against the virus, it will not be available for at least a year.

The tests, which are being conducted at Kaiser Permanente Washington Health Research Institute in Seattle, use a vaccine made by Moderna Inc.

Washington State has been hard hit by coronavirus, with more than six hundred and seventy cases so far. However, Seattle was chosen as a test site before the US had any known coronavirus cases.

Moderna uses genetic material, messenger RNA, to make vaccines, and the company has nine other vaccines in various stages of development, including several for viruses that cause respiratory illnesses. But no vaccine made with this technology has yet reached the market.

Dr Barney Graham, the deputy director of the institute’s Vaccine Research Center, said the infectious disease institute has been working with Moderna because the RNA approach can produce vaccine very quickly.

He said the researchers at the vaccine centre were focused on pandemic preparedness.

He said “The goal here is to be ready for all the virus families that can infect humans.”

As bad as this epidemic is, Barney Graham said in one way it is lucky that a coronavirus caused it, because the researchers were at least partly ready for it. If another type of virus had caused the outbreak, it could have taken months longer to create a potential vaccine.

Other companies, using different approaches, are also trying to manufacture coronavirus vaccines. Moderna is the first to reach a clinical trial.

The trial will enrol forty five healthy adults aged between eighteen and fifty five. Each will receive two shots, twenty eight days apart. Moderna calls the vaccine mRNA-1273.

Three different doses will be tested, each in fifteen people, and the participants will be studied to determine whether the vaccine is safe and whether it stimulates the immune system to make antibodies that can stop the virus from replicating and prevent the illness it causes.

Four participants were vaccinated on Monday, and four more are to get shots on Tuesday. Barney Graham said there will then be a pause to monitor them, before more participants receive injections.

The participants will be followed for a year, but Stéphane Bancel, the chief executive of Moderna, said in an interview that safety data would be available a few weeks after the injections were given. He said if the vaccine then appears safe, Moderna will ask the FDA for permission to move ahead to the next phase of testing even before the first stage is finished.

The second round of testing, to measure efficacy as well as to verify safety, will include many more participants.

Moderna, with headquarters in Cambridge, Massachusetts, and a manufacturing plant in nearby Norwood, is already buying new equipment so that it will able to produce millions of doses. Stéphane Bancel acknowledged that the company was taking a risk, because neither safety nor efficacy has been proved yet.

He said “Humans are suffering and time is of the essence. Every day matters. We have taken these decisions to take the risk, because we believe it is the right thing to do.”

The company’s stock price jumped in February in response to news reports about the vaccine. And on Monday Moderna’s stock rose more than 24%, rising $5.19 to close at $26.49.

Work on the vaccine started in January, as soon as Chinese scientists posted the genetic sequence of the new coronavirus on the internet. Researchers at Moderna and the National Institute of Allergy and Infectious Diseases identified part of the sequence that codes for a spike-like protein on the surface of the virus that attaches to human cells, helping the virus to invade them.

A nonprofit group, the Coalition for Epidemic Preparedness Innovations, helped pay to manufacture the vaccine for the trial.

That spike sequence is the basis for the vaccine. Moderna does not need the virus itself to produce its vaccine. The company synthesises the stretch of RNA required for the vaccine and embeds it in a lipid nanoparticle.

By February 24th Moderna had a batch of vaccine ready to ship to the infectious diseases institute, for use in the trial. On March 4th the FDA gave permission for the trial to begin.

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