By Manojna Maddipatla and Carl O'Donnell
(Reuters) - Moderna Inc's (O:MRNA) vaccine against COVID-19 could be ready for widespread use by the end of this year, U.S. and company officials said on Monday, after the drugmaker announced the start of a 30,000-subject trial to demonstrate it is safe and effective, the final hurdle prior to regulatory approval.
The trial is the first such late-stage study under the Trump administration's program to speed development of measures against the novel coronavirus, adding to hope that an effective vaccine will help end the pandemic. Moderna shares were up 7.5%.
Moderna, which has never brought a vaccine to market, has received nearly $1 billion from the U.S. government, which is helping bankroll several vaccine candidates under its Operation Warp Speed program.
More than 150 coronavirus vaccine candidates are in various stages of development, with some two dozen prospects already conducting human testing.
Pfizer Inc (N:PFE) and Johnson & Johnson (N:JNJ) are launching advanced stage clinical trials this month for their COVID-19 vaccine candidates. British drugmaker AstraZeneca Plc (L:AZN) said it will begin large-scale U.S. 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," National Institutes of Health (NIH) Director Francis Collins said in a release announcing the start of Moderna's large Phase III trial.
Manufacturers are ramping up production while testing is underway in order to respond as soon as possible to virus, which is still spreading rapidly around the world. COVID-19 has killed nearly 650,000 people worldwide and battered economies.
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.
The company remains on track to deliver about 500 million doses a year, and possibly up to 1 billion doses a year, beginning 2021, Moderna Chief Executive Stephane Bancel said on the call.
The large late-stage trial is designed to evaluate the safety of Moderna's mRNA-1273 vaccine and determine if it can prevent symptomatic COVID-19 after two doses.
Anthony Fauci, the top U.S. infectious disease official, said a readout from the 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.
Trial volunteers will receive two injections about 28 days apart of either 100 micrograms of mRNA-1273 or a placebo.
Results of a small early-stage study published earlier this month showed volunteers who got two doses of Moderna's vaccine had levels of virus-killing antibodies that exceeded the average seen in people who had recovered from COVID-19.
Moderna's vaccine candidate uses synthetic messenger RNA (mRNA) to mimic the surface of the coronavirus and teach the immune system to recognize and neutralize it. The technology allows for quicker development and manufacturing than traditional vaccines.
The COVID-19 Prevention Network, a U.S. government-funded program formed by the NIH, said it plans to roll out a large-scale clinical trial of a COVID-19 vaccine candidate with at least 30,000 participants each month through fall.