Widescale testing began Monday in the United States on two potential COVID-19 vaccines to determine their safety and effectiveness.
A volunteer in Savannah, Georgia early Monday morning received the first dose of an experimental vaccine manufactured by U.S.-based biotech firm Moderna and developed by researchers at the National Institute of Allergy and Infectious Diseases. The volunteer is the first of 30,000 healthy people around the country who will receive two doses of the vaccine over the next several weeks in a late-stage phase of the study to see whether people get infected or sick from COVID-19.
An earlier phase of the study discovered that while none of the volunteers experienced a serious side effect from the new vaccine, more than half reported mild or moderate reactions such as fatigue, headaches, chills, muscle aches and pain at the injection site.
Dr. Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, told reporters Monday that the first results of the late-stage trial of the vaccine may be known by as early as November. If the trial is successful, Moderna will produce 500 million doses a year, with the hopes of making 1 billion doses annually beginning in 2021.
Development of the Moderna/NIAI vaccine is part of President Donald Trump’s Operation Warp Speed initiative, which is aimed at delivering 300 million doses of an approved vaccine by January. Moderna has received nearly $1 billion in funding from the program, including $472 million committed just on Sunday to support the late-stage testing phase.
The second experimental vaccine, made by U.S.-based Pfizer in collaboration with Germany-based BioNTech SE, will also be given to 30,000 people across the United States, Brazil, Argentina and Germany. Pfizer, which is conducting its research independent of Operation Warp Speed, has received a $1.95 billion commitment to produce 100 million doses of a COVID-19 vaccine if it proves to be safe and effective.
Researchers on both projects are relying on a new process called messenger RNA to improve the efficacy of their respective vaccines. Messenger RNA, or mRNA for short, tricks the body into producing a similar protein found in COVID-19, which the immune system sees as foreign and learns to recognize. The immune system would then be prepared to protect the body if the person is exposed to the real virus.
Utilizing Messenger RNA has yet to result in the production of any new vaccines, but it has the potential, more than current methods, to quicken the process.
“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,” Dr. Francis Collins, the director of the National Institutes of Health, told reporters Monday. Dr. Collins said the government is seeking volunteers from groups who have been the most affected by COVID-19, including African Americans, Hispanics, Native Americans and the elderly.
He also insisted that safety is not being compromised despite the fast pace of development.
The two potential COVID-19 vaccines are among the nearly 150 being developed around the world that are in various stages of testing. Three more new vaccines developed, respectively, by U.S.-based biotech firm Novavax, pharmaceutical giant Johnson and Johnson, and a joint collaboration between Britain’s University of Oxford and U.S.-based AstraZeneca will soon enter late-stage testing also involving 30,000 participants. All three companies are taking part in the Trump Administration’s Operation Warp Speed.
More than 16.4 million infections have been reported around the world, including over 654,000 deaths, according to Johns Hopkins University statistics.
The United States leads the world in the number of confirmed cases with more than 4.2 million, including 148,011 deaths.