Drugmaker Moderna has shipped its first batch of a possible coronavirus vaccine for humans to government researchers for testing.
Shares of the biotech company soared yesterday, a day after the company said it sent vials to the National Institute of Allergy and Infectious Diseases (NIAID) for early-stage testing in the United States.
The institute expects by the end of April to start a clinical trial of about 20 to 25 healthy volunteers, testing whether two doses of the shot are safe and induce an immune response likely to protect against infection, NIAID Director Anthony Fauci said in an interview. Initial results could become available in July or August, The Wall Street Journal reported yesterday,
Modern’s turnaround time in producing the first batch of the vaccine—co-designed with NIAID, after learning the new virus’s genetic sequence in January—is a stunningly fast response to an emerging outbreak.
If a trial starts as planned in April, it would be about three months from vaccine design to human testing. In comparison, after an outbreak of an older coronavirus, severe acute respiratory syndrome, in China in 2002, it took about 20 months for NIAID to get a vaccine into the first stage of human testing, according to Dr Fauci, quoted by WSJ.
“Going into a Phase One trial within three months of getting the sequence is unquestionably the world indoor record. Nothing has ever gone that fast,” he said.
Public-health authorities say advances in vaccine technology, aided by government and private investments, are shortening development timelines when outbreaks occur. In the past, researchers scrambled to develop vaccines in response to outbreaks such as SARS, Ebola and Zika with mixed results. Older types of vaccines are developed from viral proteins that must be grown in eggs or cell cultures, and together with animal testing it can take years before a vaccine can be used in humans.
Newer approaches rely on what are known as platform technologies—building blocks that can be tweaked quickly with the genetic information from a newly emerged pathogen.
The fast production of a vaccine and plans to test it soon don’t guarantee its success. “You’re never sure until you’re at the end what you have,” said Bruce Gellin, president of global immunization at the Sabin Vaccine Institute.
Saying there are other coronavirus vaccines in the works, he added: “The sequence of testing is designed to sort out what works from what doesn’t. That’s why it’s important to try as many things as possible that seem feasible, because not all horses will finish the race.”
It is uncertain whether Moderna’s vaccine will work because its gene-based technology hasn’t yet yielded an approved human vaccine. And even if the first study is positive, the corona virus vaccine might not become widely available until next year because further studies and regulatory clearances will be needed, D. Fauci said.
More than 80,000 people have been infected globally from the viral outbreak that began late last year in China. A total of 35 cases have been reported in the United States.
More than 2,600 people have died from the virus in mainland China, including one U.S. citizen. MDT/Agencies
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