CAMBRIDGE (CBS/AP) – The world’s biggest COVID-19 vaccine study got underway Monday with the first of 30,000 planned volunteers helping to test shots created by the U.S. government — one of several candidates in the final stretch of the global vaccine race.
There’s still no guarantee that the experimental vaccine, developed by the National Institutes of Health and Moderna Inc. of Cambridge, Massachusetts, will really protect.
The needed proof: Volunteers won’t know if they’re getting the real shot or a dummy version. After two doses, scientists will closely track which group experiences more infections as they go about their daily routines, especially in areas where the virus still is spreading unchecked.
“Unfortunately for the United States of America, we have plenty of infections right now” to get that answer, NIH’s Dr. Anthony Fauci recently told The Associated Press.
Moderna said the vaccination was done in Savannah, Georgia, the first site to get underway among more than seven dozen trial sites scattered around the country. Brigham and Women’s Hospital in Boston is one of those sites. The estimated time commitment is seven visits in two years.
Co-investigator of the study at the Brigham Dr. Lindsey Baden said, “the speed in which we will get an answer is hard to predict but will be related to how much COVID transmission there is in the community.”
The trial will be a blind study. Half of the volunteers will receive two shots of the vaccine, 28 days apart. The other half will get shots of a saltwater placebo. The Brigham plans to give its first patient dose later this week.
“The people doing the delivery of the dose won’t know and the patients won’t know. That’s part of the way that we find out for sure whether something works,” said NIH Director Dr. Francis Collins, during a Monday webcast hosted by the agency.
Read: How To Volunteer
During the live stream, Robyn, a current trial volunteer, shared her testimony. “I have to say that when I told my friends and relatives that I was going to participate, they were absolutely adamant that it was a bad idea,” Robyn said.
She pointed out the infamous Tuskegee Trials of the 1930s and the suspicions African Americans have about the public health community. “I just did not want to be one of those people who was too afraid years later to participate in something that could benefit us.”
Dr. Collins said a transparent process is important in building back trust. “If this a trial that enrolls mostly people in their 20s, who are entirely healthy, and most of whom are white, we would have failed to really understand what the vaccine’s benefit might be,” he said.
Dr. Fauci called the collaboration between Moderna and the NIH historic, and said the development of the vaccine was the fastest in the country’s history of vaccinology.
“We want to make sure people understand that safety has not been compromised, scientific integrity has not been compromised. This is just something where all hands have been on deck to make this happen,” Dr. Fauci said.
Moderna’s President Dr. Stephen Hoge said they’ve been working on the science for years. “For Moderna’s side, that has been working on a new technology for making vaccines called messenger RNA, we’ve been working on diligently for almost 10 years now.”
The World Health Organization said Moderna’s candidate vaccine is one of 25 under clinical evaluation around the world.
Several other vaccines made by China and by Britain’s Oxford University earlier this month began smaller final-stage tests in Brazil and other hard-hit countries.
But the U.S. requires its own tests of any vaccine that might be used in the country and has set a high bar: Every month through fall, the government-funded COVID-19 Prevention Network will roll out a new study of a leading candidate — each one with 30,000 newly recruited volunteers.
The massive studies aren’t just to test if the shots work — they’re needed to check each potential vaccine’s safety.
And following the same study rules will let scientists eventually compare all the shots.
We just announced that the Phase 3 study of mRNA-1273, our vaccine candidate against COVID-19 has begun. The Phase 3 study being conducted in collaboration with @NIH and @BARDA. Read more here: https://t.co/Xi9SV6fk4z pic.twitter.com/oESeuKjF08
— Moderna (@moderna_tx) July 27, 2020
Next up in August, the final study of the Oxford shot begins, followed by plans to test a candidate from Johnson & Johnson in September and Novavax in October — if all goes according to schedule. Pfizer Inc. plans its own 30,000-person study this summer.
That’s a stunning number of people needed to roll up their sleeves for science. But in recent weeks, more than 150,000 Americans filled out an online registry signaling interest, said Dr. Larry Corey, a virologist with the Fred Hutchinson Cancer Research Institute in Seattle, who helps oversee the study sites.
“These trials need to be multigenerational, they need to be multiethnic, they need to reflect the diversity of the United States population,” Corey told a vaccine meeting last week. He stressed that it’s especially important to ensure enough Black and Hispanic participants as those populations are hard-hit by COVID-19.
It normally takes years to create a new vaccine from scratch, but scientists are setting speed records this time around, spurred by knowledge that vaccination is the world’s best hope against the pandemic. The coronavirus wasn’t even known to exist before late December, and vaccine makers sprang into action Jan. 10 when China shared the virus’ genetic sequence.
Just 65 days later in March, the NIH-made vaccine was tested in people. The first recipient is encouraging others to volunteer now.
“We all feel so helpless right now. There’s very little that we can do to combat this virus. And being able to participate in this trial has given me a sense of, that I’m doing something,” Jennifer Haller of Seattle told the AP. “Be prepared for a lot of questions from your friends and family about how it’s going, and a lot of thank-you’s.”
That first-stage study that included Haller and 44 others showed the shots revved up volunteers’ immune systems in ways scientists expect will be protective, with some minor side effects such as a brief fever, chills and pain at the injection site. Early testing of other leading candidates have had similarly encouraging results.
If everything goes right with the final studies, it still will take months for the first data to trickle in from the Moderna test, followed by the Oxford one.
Governments around the world are trying to stockpile millions of doses of those leading candidates so if and when regulators approve one or more vaccines, immunizations can begin immediately. But the first available doses will be rationed, presumably reserved for people at highest risk from the virus.
“We’re optimistic, cautiously optimistic” that the vaccine will work and that “toward the end of the year” there will be data to prove it, Hoge told a House subcommittee last week.
Until then, Haller, the volunteer vaccinated back in March, wears a mask in public and takes the same distancing precautions advised for everyone — while hoping that one of the shots in the pipeline pans out.
“I don’t know what the chances are that this is the exact right vaccine. But thank goodness that there are so many others out there battling this right now,” she said.
(© Copyright 2020 CBS Broadcasting Inc. All Rights Reserved. Associated Press Medical Writer Lauran Neergaard contributed to this report.)