Coronavirus vaccine update: Moderna, Pfizer begin late-stage trials, aim for year-end launches
The studies aim to enroll 30,000 people each and determine whether the potential COVID-19 vaccines are safe and effective. Both candidates rely on a new technology that allows for faster development and manufacturing than traditional vaccine production methods.
Moderna Inc and Pfizer Inc have launched two 30,000-subject trials of potential COVID-19 vaccines -- the first late-stage studies supported by the Trump administration's effort to speed development of measures against the novel coronavirus. 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. The companies say the trials launched on Monday could clear the way for regulatory approval and widespread use by the end of this year.
The late-stage trials are designed to evaluate the safety of vaccines and determine if they can prevent symptomatic COVID-19.
MODERNA VACCINE CANDIDATE'S TRIAL
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.
"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.
A volunteer in Savannah, Georgia, received the first shot at 6.45 am, Dr Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said at a news briefing.
The study, a Phase 3 clinical trial, will enroll 30,000 healthy people at about 89 sites around the country this summer. Half will receive two shots of the vaccine, 28 days apart, and half will receive two shots of a saltwater placebo. Neither the volunteers nor the medical staff giving the injections will know who will get the real vaccine.
Following this, experts will monitor the subjects, looking for side effects. And their main goal will be to see if significantly fewer vaccinated people contract COVID-19, to determine whether the vaccine can prevent the illness.
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.
Fauci said a readout from the Moderna trial could come by November or even earlier. He said he was "not particularly concerned" about the vaccine's safety after seeing data from earlier, smaller trials. He also said he had briefed Trump about the trial the Oval Office on Monday.
PFIZER-BIONTECH VACCINE CANDIDATE TRIAL
Pfizer Inc announced that it has also begun a late-stage study of a coronavirus vaccine. It has been working with a German company, BioNTech. Their study will also include 30,000 people, from 39 states in the United States, and from Brazil, Argentina and Germany, according to the New York Times.
The first subjects received injections at the University of Rochester on Monday, US media reported. If the 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. The 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 2/3 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. 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. It is in talks with other governments, including the European Union, about similar deals.
Over 150 vaccines are being developed against COVID-19, which has claimed nearly 650,000 lives globally and crippled economies.
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 Plc said it will begin large-scale US trials this summer of its vaccine under development with Oxford University researchers.