‘Historic’ trials of vaccines begin
30,000 will take part in first large-scale US trial
The first large-scale American trial to test a potential COVID-19 vaccine began about 6:45 EDT Monday morning in Savannah, Georgia, when the first participant received a shot in the arm.
To test for safety and effectiveness, 15,000 people will get two shots of the candidate vaccine a month apart. Another 15,000 will receive a placebo on the same schedule.
The first trial is a collaboration between the National Institutes of Health and a biotechnology company called Moderna, based in Cambridge, Massachusetts. Four more equally sized trials of different candidate vaccines are expected to begin in the next two to three months, with all but one supported by billions in federal funding.
The $6 billion of public spending is intended to speed vaccine development by manufacturing hundreds of million of doses before clinical trials determine whether each candidate is safe and effective. The at-risk manufacturing approach has never been tried before. If a candidate vaccine fails this so-called Phase 3 testing, the doses will be thrown out, federal officials have said.
In a telephone briefing Monday to herald the start of the first Phase 3 trial, several people leading the effort described it as a milestone in the development of a vaccine against SARSCoV-2, the virus that causes COVID-19.
“This is a truly historic event in the history of vaccinology,” said Dr. Anthony Fauci, who is leading the government’s vaccine development as the head of the National Institute of Allergy and Infectious Diseases.
Fauci and NIH Director Dr. Francis Collins emphasized that although vaccine development is moving at unprecedented speed, these large Phase 3 trials will ensure that a vaccine is safe and effective.
“There is no compromise at all with regard to safety nor scientific integrity,” Fauci said.
Officials will use each trial to see if a candidate vaccine is at least 60% effective against SARS-CoV-2. About 150 to 160 people must become infected in each trial to prove a candidate vaccine is effective.
Fauci said results from the trials aren’t likely before November or December, but he did leave open the possibility of stopping a trial early if results quickly show a vaccine is effective.
One concern – that there would not be enough infections ito prove effectiveness – is unfortunately not likely to be a problem, Fauci said.
“We do believe we have enough activity in our own country to be able to get the answer from the sites in our own country,” he said. Sites in other nations, including Brazil and South Africa, could be used if the infection rate is too low here.
The U.S. government is pushing to get a diverse group of trial volunteers, Collins said, particularly from groups that have been hit hard by the virus: African Americans, Latinos, Native Americans, older adults and people with chronic illnesses.
More than 150,000 people have expressed willingness to volunteer for the clinical trials, but not all of them will qualify or will be part of target groups. To volunteer, people can visit coronaviruspreventionnetwork.org. Only people who are not currently infected will be eligible for the trials.
The speed of the trials will be determined by how quickly people sign up, Fauci said, though he hopes they will all be fully enrolled by the end of the summer. “The sites are open and they’re ready to go,” Fauci said.
All of the coronavirus vaccines in development use new technologies that have never been approved for a vaccine. None is grown in eggs, as many current vaccines are, so egg allergies won’t be a problem. None contains the whole, live virus – many vaccines use a weakened form of a virus – so they cannot transmit SARS-CoV-2.
The other three companies set to soon enter Phase 3 trials with federal funding are: Novavax of Maryland, Johnson & Johnson of New Jersey, and AstraZeneca, whose American headquarters is in New Jersey. AstraZeneca is working with a vaccine developed at Oxford University in the United Kingdom.
Pfizer is developing a vaccine using technology similar to Moderna’s, but it will accept $2 billion in federal funding only if its vaccine is approved and it delivers 100 million doses.
Early trial results of the Moderna and AstraZeneca vaccines were published in recent weeks. Pfizer has also released early results. All three were shown to be safe and triggered an immune response that could mean they would be effective, although that can only be shown with a Phase 3 trial.
Moderna CEO Stéphane Bancel promised that his company would be able to produce 500 million doses of its candidate vaccine in this fiscal year, and possibly another 1 billion doses next year.
All the vaccine candidates in or close to Phase 3 trials will likely require two doses a month apart, although the trials should be able to confirm that, Fauci said.
Scientists have estimated that at least 60%-70% of the roughly 328 million people in the U.S. would need to be protected to stop the widespread transmission of the virus.
Because not everyone will be able to get a vaccine the day a candidate is approved, the government, with help from the independent National Academies, will decide who will get priority, Collins said.
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