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Coronavirus Vaccine Candidate Eyed for Human Trials by April (1)

Jan. 22, 2020, 7:28 PMUpdated: Jan. 22, 2020, 8:16 PM

A potential vaccine to prevent the spreading coronavirus could move into early-stage human testing in the next three months, the NIH’s infectious disease chief said.

Researchers may have a leg up on a new vaccine because the virus is part of a family that also includes Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). That experience is speeding up the response, but getting a vaccine across the finish line to U.S. Food and Drug Administration approval will still take time.

“The bad news is that it happened. The good news is that we have considerable experience with coronaviruses,” Anthony S. Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, said in an interview. “Everything we’ve learned with working with coronaviruses, with SARS and MERS, are helping us very rapidly get a jump on things with regard to this new virus.”

The World Health Organization began deliberating Wednesday whether to declare a public health emergency for the novel coronavirus, which would mark the sixth such declaration since 2009. Discussions will continue Thursday as WHO’s emergency committee gathers more evidence before making a final decision. The new respiratory virus has killed at least 17 and infected nearly 300 people since it emerged out of China last month. The Centers for Disease Control and Prevention confirmed Tuesday the coronavirus, which has already spread to Japan, Thailand, and South Korea and made its way to the U.S. The U.S. patient, who has been isolated about 30 miles north of Seattle, had traveled to Wuhan, China, where the virus originated.

U.S. health agencies are actively discussing vaccines as well as therapeutics, Nancy Messonnier, director of CDC’s National Center for Immunization and Respiratory Disease, said during a Tuesday press briefing.

“NIH has always been very active in this area and there is early work and early conversations,” she said.

Developing a Vaccine

Fauci said the vaccine work is the most concrete effort to date among the several countermeasures the agency is pursuing. The NIAID is collaborating with Moderna Inc., a Cambridge, Mass. biotechnology company, to use its RNA-based vaccine technology to develop a new vaccine.

“We’re already working on it. And hopefully in a period of about three months, we’ll be able to start a phase I trial in humans,” Fauci said.

The first step toward developing a vaccine is conducting small studies that introduce the experimental vaccine into the human body for the first time, known as phase I trials. If promising, the NIH would likely move onto larger phase II or phase III trials that are necessary to test whether it’s safe and effective enough for FDA approval.

Researchers needed about 20 months between sequencing the SARS virus in 2003 to move to a phase I study. The messenger RNA platform for developing vaccines sped up that process.

A Zika vaccine candidate went to a phase I trial in about four months,

The NIAID has enough funding to initiate a phase I trial, but a much bigger vaccine trial would require more money, Fauci said.

Other Treatments

In addition to pursuing a vaccine, the NIAID also is working on developing antivirals as well as monoclonal antibodies—proteins made in the laboratories that can be used to neutralize pathogens—to help patients who are infected. One such antiviral is remdesivir, which is an investigational agent Gilead Sciences Inc., has been studying to treat the Ebola virus.

Mark R. Denison, who’s been working on antivirals for SARS and MERS and animal coronaviruses, said in an email that remdesivir stops the virus by blocking an enzyme it needs to replicate. Viruses have trouble developing resistance to remdesivir, resulting in a weaker virus, he said.

The replication protein in the latest coronavirus outbreak “is highly similar to that of SARS-[coronavirus] so we predict it would be inhibited by [remdesivir],” Denison, director of infectious disease at Vanderbilt University medical school, said in an email.

Since the new virus is similar to SARS, Fauci said the NIAID is trying to determine if the monoclonal antibodies that it’s already made would have be effective. Then the NIH will begin developing point-of-care diagnostics to help physicians properly identify infected patients, he said.

“Obviously as is always the case when we have these outbreaks, it’s a lot of collaboration and synergy between the CDC and the WHO and the NIH. Our job ultimately is to develop countermeasures,” he said.

(Updated the fourth paragraph with WHO's decision to continue deliberations over whether the virus is a public health crisis into Jan. 23.)

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com

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