The first large-scale US trial to test a possible COVID-19 vaccine began around 6:45 a.m. Monday in Savannah, Georgia, when the first participant received an injection in the arm.
To assess safety and effectiveness, 15,000 people will receive two vaccines of the candidate vaccine one month apart. Another 15,000 will receive a placebo at the same time.
The first trial is a collaboration between the National Institutes of Health and a biotechnology company called Moderna, based in Cambridge, Massachusetts.
Pharmaceutical giant Pfizer, in association with German vaccine developer BioNTech, announced Monday night that it had also launched an equal-size late-stage trial of its candidate vaccine, which is based on similar technology. Several other trials of different candidate vaccines are expected to begin in the next two to three months.
The trials are backed by more than $ 6 billion in public spending to accelerate vaccine development by manufacturing hundreds of millions 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 the so-called Phase 3 trial, the doses will be discarded, federal officials said.
In a conference call Monday to announce 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 SARS-CoV-2, the virus that causes COVID-19.
“This is a truly historic event in the history of vaccination,” said Dr. Anthony Fauci, who leads the development of government vaccines as head of the National Institute of Allergy and Infectious Diseases.
‘No compromise’ on vaccine safety
Fauci and NIH Director Dr. Francis Collins emphasized that although vaccine development is moving at an unprecedented rate, these large Phase 3 trials will ensure that a vaccine is safe and effective.
“There is no compromise regarding safety or scientific integrity,” said Fauci.
Officials will use each test to see if a candidate vaccine is at least 60% effective against SARS-CoV-2. Approximately 150 to 160 people must be infected in each trial to demonstrate that a candidate vaccine is effective.
Fauci said trial results are not likely before November or December, but he left open the possibility of suspending a trial sooner if the results quickly show that a vaccine is effective.
A concern, that there would not be enough infections in the United States to demonstrate its effectiveness, unfortunately is not likely to be a problem, Fauci said.
“We believe that we have enough activity in our own country to be able to get the response 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 United States government is lobbying for a diverse group of test volunteers, Collins said, particularly from groups that have been affected by the virus: African Americans, Latinos, Native Americans, older adults and people with chronic illnesses.
More than 150,000 people have expressed their willingness to volunteer for clinical trials, but not all qualify or will be part of the target groups. To volunteer, go to coronaviruspreventionnetwork.org.
Only people who are not currently infected will be eligible for the trials. Viral testing will be part of the registration protocol, Fauci said.
The speed of the trials will be determined by how quickly people register, Fauci said, although he expects everyone to be fully registered by the end of the summer. “The sites are open and ready to go,” Fauci said, specifically citing those in Florida and other COVID-19 hotspots.
“Hopefully, there will be many people who will be vaccinated today and in the coming months.”
All coronavirus vaccines in development use new technologies that have never been approved for a vaccine. Neither is grown in eggs, like many current vaccines, so egg allergies won’t be a problem. Neither contains the complete live virus, many vaccines use a weakened form of the virus, so they cannot transmit SARS-CoV-2.
Three other possible vaccines that will soon be tested on a large scale
The other three companies slated to enter federally funded Phase 3 trials soon are: Novavax of Maryland, Johnson & Johnson of New Jersey, and AstraZeneca, whose US headquarters are in New Jersey. AstraZeneca is working with a vaccine developed at the University of Oxford in the United Kingdom.
Pfizer has said it will accept $ 2 billion in federal funds only if its vaccine is approved and it delivers 100 million doses. The federal government could buy an additional 500 million.
In a press release issued Monday afternoon, Pfizer and BioNTech said they had launched a Phase 2/3 study, which would include 30,000 participants from 120 locations, including 39 states, Argentina, Brazil and Germany.
If the trial is successful, the companies said they will seek a regulatory review as soon as October. According to the companies, up to 100 million doses will be available by the end of the year, and approximately 1.3 billion doses by the end of 2021.
The results of the first trials of the Moderna and AstraZeneca vaccines were published in the last few weeks. Pfizer has also released preliminary 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 test.
Moderna CEO Stéphane Bancel promised during Monday’s conference call that his company could produce 500 million doses of its candidate vaccine in this fiscal year, and potentially another 1 billion doses next year.
Federal funds guarantee that most of these doses will go to Americans first, although some vaccine developers are also making doses for others around the world.
All vaccine candidates in or near the Phase 3 trials will likely require two separate doses per month, although the trials should be able to confirm that, Fauci said.
Scientists have estimated that at least 60-70% of the approximately 328 million people in the US would have to protect themselves through natural infections or vaccines to stop widespread transmission of the coronavirus.
Since not everyone can be vaccinated the day a candidate is approved, the government, with the help of independent National Academies, will decide who will have priority, Collins said.
Trial participants will be monitored for one year to verify vaccine safety
Bancel de Moderna said he expects his company’s vaccine to be safe during the Phase 3 trial. In a previous trial, most people who received the same dose had typical vaccine side effects, such as fever and pain in the vaccine. arms.
The vaccine Bancel said that it does not enter the nucleus of a cell, so the chance of it integrating with human DNA is very low. It has a half-life of just six to 10 hours, so it doesn’t stay in the body long.
“We think there is very little chance of long-term safety concerns,” he said, although all trial participants will be followed for a year to make sure they don’t have reactions later. The FDA may add longer-term safety requirements as part of the approval process.
Vaccine trial participants are generally followed for two years, Fauci said, to determine if their protection continues for that long. Since SARS-CoV-2 is a newly discovered virus, no one knows how long people are protected after being vaccinated or infected.
Overall, Collins said, the trials are “a great American opportunity for people to come together as our partners, to try to participate in what has been a historic effort to end the worst pandemic our world has seen in more 100 years old. “
Contact Karen Weintraub at [email protected]
Patient health and safety coverage in USA TODAY is made possible in part by a grant from the Masimo Foundation for Healthcare Ethics, Innovation and Competition. The Masimo Foundation does not provide editorial contributions.
