Is a vaccine coming? Large-scale tests, starting now, will tell.
The world鈥檚 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 鈥� one of several candidates in the final stretch of the global vaccine race.
There鈥檚 still no guarantee that the聽experimental vaccine, developed by the National Institutes of Health and Moderna Inc., will offer protection.
Volunteers won鈥檛 know if they鈥檙e getting the real shot or a dummy version - a placebo. 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.
鈥淯nfortunately for the United States of America, we have plenty of infections right now鈥� to get that answer, NIH鈥檚 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.
Several other vaccines made by China and by Britain鈥檚 Oxford University earlier this month began smaller final-stage tests in Brazil and other hard-hit countries.
But the United States 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 鈥� each one with 30,000 newly recruited volunteers.
The massive studies aren鈥檛 just to test if the shots work 鈥� they鈥檙e needed to check each potential vaccine鈥檚 safety. And following the same study rules will let scientists eventually compare all the shots.
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 鈥� if all goes according to schedule. Pfizer Inc. plans its own 30,000-person study this summer.
That鈥檚 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聽registry聽signaling interest, said Dr. Larry Corey, a virologist with the Fred Hutchinson Cancer Research Institute in Seattle, who helps oversee the study sites.
鈥淭hese trials need to be multigenerational, they need to be multiethnic, they need to reflect the diversity of the United States population,鈥� Dr. Corey told a vaccine meeting last week. He stressed that it鈥檚 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. The coronavirus wasn鈥檛 even known to exist before late December, and vaccine makers sprang into action Jan. 10 when China shared the virus鈥� genetic sequence.
Just 65 days later in March, the NIH-made vaccine was聽tested in people. The first recipient is encouraging others to volunteer now.
鈥淲e all feel so helpless right now. There鈥檚 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鈥檓 doing something,鈥� Jennifer Haller of Seattle told the AP. 鈥淏e prepared for a lot of questions from your friends and family about how it鈥檚 going, and a lot of thank-you鈥檚.鈥�
That first-stage study that included Ms. Haller and 44 others showed the shots revved up volunteers鈥� 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.
鈥淲e鈥檙e optimistic, cautiously optimistic鈥� that the vaccine will work and that 鈥渢oward the end of the year鈥� there will be data to prove it, Dr. Stephen Hoge, president of Massachusetts-based Moderna, told a House subcommittee last week.
Until then, Ms. Haller, the volunteer vaccinated back in March, wears a mask in public and takes the same distancing precautions advised for everyone.
鈥淚 don鈥檛 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,鈥� she said.
This story was reported by The Associated Press.聽AP photographer Ted Warren in Seattle contributed to this report.
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