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The Trump administration’s Operation Warp Speed has now contributed to the remarkable success of two vaccines that have been shown to be highly effective in preventing COVID-19. But pressure is mounting for a similar push from the administration in another key area in the fight against the pandemic: rapid testing.
Despite the success of the vaccines, they will not be widely available to the general public for several months, even as hospitalizations and deaths continue to rise as a severe winter approaches.
A group of experts said rapid large-scale testing could help slow the spread of the virus dramatically until a vaccine is widely available, and help open businesses and schools.
But such tests have not started, despite the existing technology. Supporters point to regulatory hurdles at the Food and Drug Administration (FDA) and the government’s lack of investment in speeding up the manufacture of tests to the millions a day that would be needed.
President elect Joe biden
Joe Biden Outside groups flood Georgia with ad buys before runoff Biden will receive @POTUS Twitter account on Jan. 20, even if Trump doesn’t concede, company says Trump will attend virtual G-20 summit amid outbreak of coronaviruses PLUS calls for stronger government action. In a speech in October, he called for a “faster, cheaper drug test, which you can do at home or at school,” and his coronavirus transition team’s plan includes a call for “Invest in next-generation testing, including at home. instant testing and testing, so that we can increase our testing capacity by orders of magnitude. “
President Trump
Donald John Trump Ben Carson says he’s ‘out of the woods’ after being ‘extremely ill’ with COVID-19 Biden will receive @POTUS Twitter account on January 20 even if Trump doesn’t concede, company says Trump will participate in the virtual G-. 20 summit amid coronavirus outbreak MORE, by contrast, often minimized the need for additional testing.
“We have leadership in the country, [and] they don’t realize they’re leaders, ”said Michael Mina, a professor at Harvard TH Chan School of Public Health, who has been advocating rapid testing for months. “The number of people I’ve spoken to that say, ‘Well, why isn’t that happening?’ and my only answer is, “Because you don’t.” “
The tests Mina and others are calling for are simple strips of paper that could be mass-produced so that every household in the United States can have a supply and use them several times a week. Someone could find out if they are positive for the coronavirus by indicating whether a line appears on the strip of paper or not, within minutes.
That way, before going to work, school, or a gathering of friends, people would know if they are positive and if they are, they could stay home.
“The government should send those who wear surgical masks to every home in the United States,” said Eric Topol, professor of molecular medicine at Scripps Research.
Anthony Fauci
Anthony FauciFauci Says Santa Claus Won’t Spread Coronavirus Due To “ Innate Immunity ” Bill Gates: “ I’m Very Confident ” COVID-19 Vaccine Sure Fauci Is Frustrated: “ Get Rid Of It of those ridiculous conspiracy theories ” MORE, the government’s leading infectious disease specialist, winked at such rapid home tests during a New York Times summit speech on Tuesday.
“What we really need now and hope to get, but we don’t have it yet are point-of-care tests that people can basically do at home, like a pregnancy test, because the spread is community-based from people without symptoms, ”Fauci said.
However, not everyone is fully on board, including, most importantly, the FDA.
Some experts are concerned that rapid tests are not as accurate as the standard tests that are currently relied on, and that people could get a false negative from a rapid test and then go out and infect them. other. Another concern is that if people take tests at home, they will not report their results to public health authorities, and the country will lose data on where the virus is spreading.
“There has been a discussion about lowering standards to bring something to market, and I don’t agree with it,” said Peter Lurie, president of the Center for Science in the Public Interest and former associate commissioner from the FDA.
An FDA spokesperson pointed to an editorial in The Hill that two senior agency officials wrote in September, which included a warning about the danger of lower precision tests giving false negatives.
“You could be falsely assured that your symptoms are just a summer cold,” wrote FDA officials Jeffrey Shuren and Timothy Stenzel. “You go about your normal day and then you put everyone you meet at risk of infection.”
Still, they added that they were ready to listen to new ideas. “The FDA is still open to alternative proposals from developers and will continue to consider them,” they wrote.
Advocates of rapid tests say the FDA takes too narrow a view and that when rapid tests are used frequently on a large scale, they will help detect many more cases than a smaller number of somewhat more precise tests. Advocates also say rapid tests are accurate at detecting positive cases when it matters most, when people are most contagious and at risk of spreading the virus to others.
Topol said he thinks the FDA is “absurdly, overly cautious” in approving rapid tests.
The FDA took a step forward on Tuesday when it authorized the first home test. But the test, from a start-up called Lucira, is more complicated than just a strip of paper, meaning it will cost around $ 50 and won’t be widely available until spring.
Mina said the government needs to take a much more active role in providing funds to accelerate the manufacture of rapid tests, rather than relying on small start-ups to do the work themselves. He estimates the cost of a national rapid testing program would be around $ 30 billion, a small fraction of the multibillions of dollars Congress has spent on economic relief from the coronavirus crisis.
“It puts our company on hiatus, and yet we are sitting here chatting, applauding about a very small start-up that is getting a new product to market that will be available in April,” Mina said.
“These tests could have allowed Thanksgiving to go smoothly if we had started this in August,” he added.
Rahul Dhanda, CEO of Sherlock Biosciences, another company working on a rapid test, said his business could grow faster with government funding.
“We could do a lot more at risk sooner, if the government supported the work that we and others are doing,” he said.
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