NEW YORK • 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 trials, announced on Monday, are the first late-stage studies supported by the Trump administration’s effort to speed development of measures against the coronavirus, adding to hope that an effective vaccine will help end the spreading pandemic.
Moderna stock rose 9 per cent on the news. Pfizer shares rose 1.6 per cent in after-hours trade and its partner BioNTech, which developed the vaccine, was up 4.2 per cent.
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 recognise and neutralise the coronavirus by mimicking its surface.
Moderna, which has never brought a vaccine to market, has received nearly US$1 billion (S$1.4 billion) from the US government, which is helping to bankroll several vaccine candidates under its Operation Warp Speed programme.
Pfizer has an agreement to sell vaccines for 50 million people to the US government for around US$2 billion, if the vaccine is effective. More than 150 coronavirus vaccine candidates are in various stages of development, with some two dozen prospects already conducting human testing.
Johnson and Johnson is launching clinical trials in the United States this week and could start a larger, late-stage trial as early as September.
British drugmaker AstraZeneca has said it will 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,” 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 under way in order to respond as soon as possible to the virus, which is still spreading rapidly. 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, Mr Collins told reporters.
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 is aiming for about 1.3 billion doses by the end of next year, and Moderna is targeting for 500 million to 1 billion doses a year, beginning next year, said its chief executive Stephane Bancel.
The late-stage trials are designed to evaluate the safety of vaccines and determine if they can prevent symptomatic Covid-19.
Dr Anthony Fauci, the top US infectious disease official, has said a read-out from the Moderna trial could come by November or even earlier. Dr Fauci said he was “not particularly concerned” about the vaccine’s safety after seeing data from earlier, smaller trials.
He also said he had briefed President Donald Trump about the trial on Monday.
Meanwhile, the Covid-19 Prevention Network, a US government-funded programme formed by the NIH, said it plans to roll out a large-scale clinical trial of a coronavirus vaccine candidate with at least 30,000 participants each month through autumn.