Moderna Inc and Pfizer Inc launched two trials of 30,000 subjects of COVID-19 vaccines that could open the way for regulatory approval and widespread use by the end of this year, the companies said Monday.
The trials, both announced Monday, are the first late-stage studies backed by efforts by the Trump administration to accelerate the development of measures against the new coronavirus, adding to hopes that an effective vaccine will help end to the pandemic.
Moderna’s shares rose 9%. Pfizer’s shares rose 1.6% in after-hours trading and its partner BioNTech, which developed the vaccine, rose 4.2%.
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Both vaccine candidates rely on new technology that enables faster development and manufacturing than traditional vaccine production methods, but which do not have a long history.
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 United States government, which is helping to fund several vaccine candidates under its Operation Warp Speed program.
Pfizer has an agreement to sell vaccines for 50 million people to the United States government for around $ 2 billion, if the vaccine is effective.
More than 150 candidates for the coronavirus vaccine are at various stages of development, with about two dozen prospects already conducting tests on humans.
Johnson and Johnson will launch clinical trials in the US this week and could start a larger trial at a later stage starting in September. British pharmacist AstraZeneca Plc said it will begin large-scale trials in the United States this summer of its developing vaccine with researchers from the University of Oxford.
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“Having a safe and effective vaccine distributed by the end of 2020 is a difficult goal, but it is the right goal for the American people,” said director of the National Institute of Health (NIH), Francis Collins, in a statement announcing the start. of the great phase of Moderna. III trial.
Manufacturers are increasing production while testing to respond as quickly as possible to the virus, which is still rapidly spreading worldwide. COVID-19 has killed nearly 650,000 people worldwide and has hit economies.
Moderna could have tens of millions of doses ready when and if the vaccine is deemed safe and effective, Collins told reporters in a call.
If the trial was successful, Pfizer said, it could seek regulatory approval as early as October and provide vaccines for 50 million patients, in two doses each, by the end of the year.
Pfizer is aiming for around 1.3 billion doses by the end of 2021, and Moderna aims for 500 million to 1 billion doses a year, starting in 2021, Moderna CEO Stephane Bancel said in the call.
Late-stage trials are designed to assess the safety of vaccines and determine if they can prevent symptomatic COVID-19.
Anthony Fauci, the top US infectious disease official, said a reading of Moderna’s trial could come in November or even earlier. Fauci said he was “not particularly concerned” about the safety of the vaccine after looking at data from earlier smaller trials. He also said he had informed President Donald Trump of the trial to the Oval Office on Monday.
While other companies prepare the vaccines, the COVID-19 Prevention Network, a US government-funded program formed by the NIH, said it plans to launch a large-scale clinical trial of a candidate for the COVID vaccine- 19 with at least 30,000 participants each month through fall
.
