The biggest in the world COVID-19 Vaccine Study It is now up and running with the first of 30,000 planned volunteers helping to test vaccines created by the US government, one of several candidates in the final stretch of the global vaccine race.
There is still no guarantee that the experimental vaccine, developed by the National Institutes of Health and Modern Inc., will actually protect against infection.
Volunteers will not know if they are receiving the actual injection or a placebo. 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. Dr. Stephen Hahn, commissioner of the Food and Drug Administration, said Monday that tests are being conducted at 89 sites across the country. At an event with Vice President Pence in Miami, he said that more than 100 vaccines worldwide are in different stages, and he expects at least two more to be in phase 2 in the coming weeks.
Several other vaccines made by China and by Britain’s Oxford University started smaller tests in the final stage in Brazil and other affected countries earlier this month.
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 is not just to test whether the shots work. They are also necessary to verify the safety of each potential vaccine. Following the same study rules will allow scientists to eventually compare all vaccines.
Next, in August, the final United States study on the Oxford shooting 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 multi-generational, they must be multi-ethnic, 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.
A new CBS News poll suggests that if a vaccine were available this year, many Americans could approach it with caution, and 20% say they would “never” receive the vaccine. Only 30% say they would get one “ASAP”. Many more, half the country, say they would consider it, but first they would “wait to see” what happened to the others.
It usually takes years to create a new vaccine from scratch, but scientists are setting speed records this time. NIH Director Frances Collins He told “CBS Evening News” presenter Norah O’Donnell last week that in his 27 years at NIH, “I have never seen anything this way, as we have tried to do and are now doing, for vaccine development. ”
If all goes well with the final studies, it will still take months for the first data of the Modern test to arrive, and then the Oxford one.
Governments around the world are trying to stockpile millions of doses of top candidates so that when regulators approve one or more vaccines, immunizations 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 Massachusetts-based Moderna, told a House subcommittee. last week. . Trump administration objective Under his “Operation Warp Speed” plan, he is to provide 300 million doses of vaccine by January 2021.
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