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進入《TAIPEI TIMES》Moderna, Pfizer start crucial COVID-19 vaccine trials
Nurse Kathe Olmstead, right, gives volunteer Melissa Harting an injection as the world’s biggest study of a possible COVID-19 vaccine, developed by the US National Institutes of Health and Moderna, gets under way on Monday in Binghamton, New York. Photo: AP
/ Reuters
Moderna and Pfizer have launched two 30,000-subject trials of COVID-19 vaccines that could clear the way for regulatory approval and widespread use by the end of this year, the companies said on Monday.
The trials are the first late-stage studies supported by US President Donald Trump’s administration’s effort to speed development of measures against SARS-CoV-2, adding to hope that an effective vaccine will help end the pandemic.
Both vaccine candidates rely on a new technology that allows for faster development and manufacturing than traditional vaccine production methods, but does not have an extensive track record.
So-called mRNA, or synthetic messenger RNA （mRNA）, teaches the immune system to recognize and neutralize SARS-CoV-2 by mimicking its surface.
Moderna, which has never brought a vaccine to market, has received nearly US$1 billion from the US government, which is helping bankroll several vaccine candidates under its Operation Warp Speed program.
Pfizer has an agreement to sell vaccines for 50 million people to the US government for about US$2 billion, if the vaccine is effective.
More than 150 coronavirus vaccine candidates are in various stages of development, with about two dozen prospects already conducting human testing.
Johnson and Johnson is launching clinical trials in the US this week and could start a larger, late-stage trial as early as September.
British drugmaker AstraZeneca said it would begin large-scale US trials this summer of its vaccine under development with Oxford University researchers.
“Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people,” US National Institutes of Health （NIH） Director Francis Collins said in a release announcing the start of Moderna’s large phase III trial.
Moderna could have tens of millions of doses ready when and if the vaccine is deemed safe and effective, Collins told reporters on a call.
Pfizer said that if the trial was successful, it could seek regulatory approval as soon as October and supply vaccines for 50 million patients, at two doses each, by the end of the year.
Pfizer aims for about 1.3 billion doses by the end of next year, and Moderna aims for 500 million to 1 billion doses a year, beginning next year, Moderna chief executive Stephane Bancel said on the call.
The late-stage trials are designed to evaluate the safety of vaccines and determine if they can prevent symptomatic COVID-19.
US National Institute of Allergy and Infectious Diseases Director Anthony Fauci said a readout from the Moderna trial could come by November or even earlier.
Fauci said he was “not particularly concerned” about the vaccine’s safety after seeing data from earlier, smaller trials, adding that he had briefed Trump about the trial at the Oval Office on Monday.
新聞來源：TAIPEI TIMES
