COVID-19 vaccine trial now underway with 30,000 volunteers


World’s largest COVID-19 Vaccine Study It is now running with the first of 30,000 employed volunteers helping to test shots made 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 Moderna Inc. will actually protect against infection.

Volunteers will not know if they are getting a real shot or 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 is still spreading uncontrollably. Food and Drug Administration Commissioner Drs. Stephen Hahn said on Monday that testing is being done at 89 sites across the country. In an event with Vice President Pence in Miami, he said that more than 100 vaccines worldwide are in various stages, and he expects to have at least two more in Phase 2 in the coming weeks.

Several other vaccines, made by Oxford University in China and Britain, began small final-stage trials in Brazil and other hard-hit countries earlier this month.

But the US needs its own trials of any vaccine used in the country and has set a high bar: every month through the fall, the government-funded COVID-19 prevention network rolls out a new study of a key candidate Will – each with 30,000 newly recruited volunteers.


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Large-scale studies are not meant to test only if shots work. They are also required to check the safety of each potential vaccine. Adhering to the same study rules will ultimately help scientists compare all shots.

Next August, Oxford Shot’s final US study begins, followed by a plan to test a candidate from Johnson & Johnson in September and Novaxax in October if all goes according to schedule. Pfizer Inc. plans to study its 30,000 people this summer.

This is a surprising number of people needed to roll up their sleeves for science. But in recent weeks, more than 150,000 Americans filled an online registry signaling interest, Dr. a virologist with the Fred Hutchinson Cancer Research Institute in Seattle. Said Larry Corey, who helps oversee the study sites.

“These tests need to be multi-dimensional, they need to be multi-lingual, they need to reflect the diversity of the United States population,” Corey said at a vaccine meeting last week. He stressed that it is important to ensure adequate Black and Hispanic participants in particular because those populations are hard hit by COVID-19.

A new survey by CBS News suggests that if a vaccine became available this year, many Americans might look at it carefully, and 20% say they would not take the vaccine. Only 30% say they will get it “as soon as possible”. More than half of the nation says they would consider it, but first “wait to see what happened to others”.

It usually takes years to create a new vaccine from scratch, but scientists are setting speed records at this time. NIH Director Frances Collins Nora O’Donnell, anchor of “CBS Evening News”, said last week that in her 27 years at NIH, “I have never seen anything together like this, as we’ve tried to do and are doing now.” For the development of vaccines. ”

If everything goes right with the final study, it will still take months before the Modern Test for the first data, and then Oxford.

Governments around the world are trying to stock millions of doses of those leading candidates, if and when regulators approve one or more vaccines, vaccination can begin immediately. But the first available dose will be rationed, possibly reserved for those at highest risk from the virus.

“We are optimistic, cautiously optimistic” there will be data to prove that the vaccine will work and “towards the end of the year”, Massachusetts-based Modern President Dr. Stephen Hoge said in a House subcommittee last week. Of the Trump administration aim As part of its “Operation Warp Speed” plan to provide 300 million doses of the vaccine by January 2021.

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