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The world’s largest COVID-19 vaccine study began Monday with the first of 30,000 planned volunteers who helped test vaccines created by the US government.
There is still no guarantee that the experimental vaccine, developed by the National Institutes of Health and Modern Inc., will actually protect.
The Proof Needed: Volunteers won’t know if they’re getting the real shot or a fictionalized version. After two doses, scientists will closely monitor which group experiences more infections as they go about their daily routines, especially in areas where the virus is still spreading uncontrollably.
“Unfortunately for the United States of America, we have a lot of infections right now” to get that answer, NIH Dr. Anthony Fauci recently told The Associated Press.
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Earlier this month, several other vaccines made by China and by Britain’s Oxford University began smaller tests at the final stage in Brazil and other affected countries.
But the US requires its own tests of any vaccine that can be used domestically and has set a high standard: Every month through the fall, the government-funded COVID-19 Prevention Network will launch a new study of a lead candidate, each with 30,000 newly recruited volunteers.
Mass studies are not only to assess whether vaccines work, but are necessary to verify the safety of each potential vaccine. And following the same study rules will allow scientists to eventually compare all vaccines.
Next, in August, the final study of the Oxford shot begins, followed by plans to evaluate a candidate from Johnson & Johnson in September and Novavax in October, if all goes as planned. Pfizer Inc. plans its own study of 30,000 people this summer.
That’s an amazing number of people who needed to roll up their sleeves for science. But in the past few weeks, more than 150,000 Americans have completed an online registry indicating interest, said Dr. Larry Corey, a virologist at the Fred Hutchinson Cancer Research Institute in Seattle, which helps oversee study sites.
“These trials must be multigenerational, they must be multiethnic, they must reflect the diversity of the United States population,” Corey said at a meeting on vaccines last week. He emphasized that it is especially important to ensure that there are enough black and Hispanic participants, as those populations are greatly affected by COVID-19.
It usually takes years to create a new vaccine from scratch, but scientists are setting speed records this time, spurred by the knowledge that vaccination is the world’s best hope against the pandemic. The coronavirus was not even known to exist before the end of December, and vaccine makers took action on January 10 when China shared the virus’ genetic sequence.
Just 65 days later, in March, the NIH vaccine was tested on people. The first recipient is encouraging others to volunteer now.
“We all feel so helpless right now. There is very little we can do to combat this virus. And being able to participate in this test has given me the feeling that I’m doing something, ”Jennifer Haller of Seattle told the AP. “Be prepared for many questions from your friends and family about how it is going, and thank you very much.”
That first-stage study that included Haller and 44 others showed that the injections boosted the volunteers’ immune system in the way that scientists hope it will be protective, with some minor side effects, such as a short fever, chills, and pain in place. injection. The first tests of other main candidates have had equally encouraging results.
If all goes well with the final studies, it will still take months for the first data of the Modern test to arrive, followed by the Oxford test.
Governments around the world are trying to store millions of doses of top candidates so that when regulators approve one or more vaccines, the vaccines can start immediately. But the first available doses will be rationed, presumably reserved for people at increased risk of contracting the virus.
“We are optimistic, cautiously optimistic” that the vaccine will work and that “towards the end of the year” there will be data to prove it, Dr. Stephen Hoge, president of Moderna, based in Massachusetts, told a House subcommittee the last week. .
Until then, Haller, the volunteer vaccinated in March, wears a mask in public and takes the same recommended distance precautions for everyone, while waiting for one of the pipeline shots to develop.
“I don’t know what the chances are that this is the exact right vaccine. But thank God there are so many others fighting this right now, “she said.
(AP)
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