The Trump administration’s Operation Warp Speed has now helped achieve the remarkable success of two vaccines shown to be very effective in preventing COVID-19. But pressure is mounting for a similar push from the administration in a different area key to tackling the pandemic: rapid testing.
Despite the success of the vaccines, they will not be widely available to the general public for several months, although hospitalizations and deaths continue to increase in severe winters.
A vocal group of experts says widespread rapid testing could help drastically slow the spread of the virus until the vaccine becomes widely available, and help open businesses and schools.
But such tests have not begun, despite existing technology. Proponents point to regulatory barriers to the Food and Drug Administration (FDA) and the lack of government investment to increase test production to the millions a day that would be needed.
The newly elected president Joe Biden calls for stronger government action. In a speech in October, he called for a “faster and cheaper screening test you can do at home or at school,” and the coronavirus team’s plan for his transition includes a call for “investing in next-generation testing, including home tests and immediate tests so we can increase our testing capacity by orders of magnitude. “
President TrumpDonald John Trump Ben Carson says he is “out of the woods” after being “extremely ill” from COVID-19 Biden will receive a @POTUS Twitter account on January 20, even if Trump does not admit, the company says Trump will participate in virtual G-20 summit against the background of a surge of coronavirus MOREin contrast, it often downplays the need for more tests.
“We have leadership in the country, [and] they don’t realize they’re leaders, “said Michael Mina, a professor at the Har Chan School of Public Health at Har Chan, who has been advocating for quick tests for months. “The number of people I’ve talked to who say, ‘Well, why isn’t that happening?’ And my only answer is, “Because you don’t.” ”
The tests insisted by Mina et al. Are simple paper strips that can be mass-produced so that every household in the United States can have supplies and use them several times a week. One can tell if they are positive for coronavirus by whether a line appears on the paper strip or not, within minutes.
That way, before going to work or school or making friends, people would know if they are positive and if they are, they could stay home.
“The government should send those with surgical masks to every household in the United States,” said Eric Topol, a professor of molecular medicine at Scripps Research.
Anthony FauciAnthony Fauci Fauci says Santa will not spread the coronavirus because of “innate immunity” Bill Gates: “I feel very confident” The COVID-19 vaccine is safe., the government ‘s top infectious disease expert, signaled such rapid tests at home as he spoke at the New York Times summit on Tuesday.
“What we really need now and hope to get it, but we don’t have it yet, is a care test that people can essentially do at home, like a pregnancy test, because the spread is a community spread from people without symptoms, ”Fautsi said.
Not everyone is fully on board, including, crucially, the FDA.
Some experts fear that rapid tests are not as accurate as the standard tests they currently rely on, and that people may get a false-negative result from a rapid test and then go out and infect others. Another concern is that if people do tests at home, they will not report their results to public health authorities and the country will lose data on the spread of the virus.
“There was a discussion about lowering standards to bring something to market, and I don’t agree with that,” said Peter Lurie, president of the Center for Public Interest Science and a former FDA associate commissioner.
An FDA spokesman cited a publication in The Hill that the agency’s top two officials wrote in September that included a warning of the dangers of lower accuracy tests giving false negatives.
“You may be falsely convinced that your symptoms are just summer cold,” wrote FDA officials Jeffrey Schuren and Timothy Stenzel. “You go around your normal day and then you put everyone you meet at risk.”
Still, they added that they are ready to listen to new ideas. “The FDA is always open to alternative proposals from developers and will continue to consider them,” they wrote.
Proponents of rapid testing say the FDA takes a too narrow view and that when rapid testing is often used on a large scale, it will help capture many more cases than a smaller number of slightly more accurate tests. Supporters also say that rapid tests are accurate in capturing positive cases when it is most important, when people are most contagious and at risk of spreading the virus to others.
Topol said he thought the FDA was “absurd, inappropriately too 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 startup called Lucira is more complicated than plain paper tape, which means it will cost about $ 50 and won’t be widely available until spring.
Mina said the government should take a much more active role in securing funding to speed up the production of rapid tests, rather than relying on small start-ups to do the work themselves. He estimates that the cost of a national rapid testing program will be about $ 30 billion, a small fraction of the many trillions Congress has spent on economic relief from the coronavirus crisis.
“This is stopping our society, and yet we are sitting here, actually having a discussion and clapping for a very small start-up that is offering a new product on the market that will be available in April,” Mina said.
“These tests could have allowed Thanksgiving to happen normally if we had started this in August,” he added.
Rahul Danda, CEO of Sherlock Biosciences, another rapid test company, said his company could grow faster with government funding.
“We could have made it much more risky sooner if there was government support for the work we and others are doing,” he said.