German biotech BioNTech and US drugmaker Pfizer will begin a pivotal global study of 30,000 people to evaluate their lead Covid-19 vaccine candidate. The announcement came as US company Moderna also announced a 30,000-subject trial of its Covid-19 vaccine.
The move could clear the way for regulatory approval and widespread use by the end of this year, the companies said.
The trials are the first late-stage studies supported by the US administration’s effort to speed development of measures against the novel coronavirus, adding to hope that an effective vaccine will help end the pandemic. They are designed to evaluate the safety of vaccines and determine if they can prevent symptomatic Covid-19.
BioNTech and Pfizer said that, it their study is successful, the companies could submit the vaccine for regulatory approval as early as October, putting them on track to supply up to 100 million doses by the end of 2020 and 1.3 billion by the end of 2021.
Patients are each given two doses of the drugmakers’ vaccine to help boost immunity, so the first 100 million doses would vaccinate around 50 million people.
Moderna aims for 500 million-one billion doses a year, beginning in 2021, Moderna chief executive Stephane Bancel.
The Pfizer / BioNTech study is expected to include about 120 sites globally and could include up to 30,000 participants. It will include regions heavily impacted by Covid-19.
"The initiation of the Phase II/III trial is a major step forward in our progress toward providing a potential vaccine to help fight the ongoing Covid-19 pandemic," said Kathrin Jansen, head of vaccine research and development at Pfizer.
The trial hones in on Pfizer’s most promising vaccine candidate, which it calls BNT162b2. Earlier studies filtered out other potential vaccines.
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 the coronavirus by mimicking its surface.
Moderna, which has never brought a vaccine to market, has received nearly $1 billion from the US government, which is helping bankroll several vaccine candidates under its Operation Warp Speed program.
Pfizer has already has an agreement to sell 100 million doses of its vaccine to the US government and give it the option to buy 500 million more. A similar deal on a smaller scale had previosuly been signed in the UK. The companies is in talks with other governments, including the European Union, about similar deals.
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 US this week and could start a larger, late-stage trial as early as September. British drugmaker AstraZeneca 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.
Anthony Fauci, the top US infectious disease official, said a readout from the Moderna trial could come by November or even earlier. Mr Fauci said he was "not particularly concerned" about the vaccine's safety after seeing data from earlier, smaller trials.
Moderna stock rose 9 per cent. Pfizer shares rose 1.6 per cent in afterhours trade and its partner BioNTech, which developed the vaccine, rose 4.2 per cent.
