Biden raises hopes for new course to jump-start rapid COVID-19 tests

President Biden is raising hopes that he will sharply scale up rapid at-home COVID-19 tests to help control the pandemic, but advocates say far more needs to be done beyond the administration’s early moves.

A vocal group of health experts has been pushing for months to ramp up production of cheap and simple tests that people can use multiple times a week and get results in a matter of minutes, helping the country safely return to work and school until vaccines are widely available.

While Biden has earned praise for taking some initial steps on production, some experts warn that much more is needed if the goal is to have households across the U.S. taking quick tests multiple times a week, especially for regular social events like meeting up with friends.

“The country is well behind where we need to be on testing, particularly the rapid at-home tests that will allow us all to get back to normal activities like work and school,” Tim Manning, the Biden team’s COVID-19 supply coordinator, said at a briefing last week when announcing that the administration will use the Defense Production Act to accelerate manufacturing of the kits.

The administration said the move will allow 61 million at-home or point-of-care tests to be available by the end of the summer. In addition, the White House awarded a $230 million contract to boost the number of rapid tests in circulation, though many of them won’t be available until the second half of the year.

Michael Mina, a professor at the Harvard T.H. Chan School of Public Health, who has been leading the push for rapid tests, said simpler, cheaper tests are needed to scale up faster and in much higher numbers, to as many as 20 million per day.

He praised the administration for last week’s announcements, while adding: “Both fall quite short of anything that I’ve been discussing. But I believe it means that they are willing to try.”

Mina has spoken to Carole Johnson, the Biden team’s testing coordinator, though he said the conversations so far have been “primarily one way,” and the administration officials have not fully shown their cards on testing plans.

Mina also wrote to the House Energy and Commerce Committee earlier this month requesting $20 billion for rapid tests in the next relief package. The bill released by committee Democrats on Tuesday includes $46 billion for testing, but no funds are specifically set aside for rapid tests.

Many of the cheaper, simpler and more plentiful rapid tests that advocates like Mina are pushing for are not yet authorized by the Food and Drug Administration (FDA). That has led to an intense debate over whether the FDA is a roadblock to more widespread at-home testing, or if it is simply doing its job by waiting to make sure there is adequate data supporting the tests and that any accuracy concerns are addressed.

After former President Trump drew widespread condemnation from scientists for publicly attacking the FDA over its vaccine reviews, Biden has stressed that he will not put inappropriate pressure on the agency.

Some experts say that while presidents shouldn’t be influencing what goes on at the FDA, scientists can still make their concerns known.

“I don’t want politicians putting pressure on FDA,” said Ashish Jha, dean of the Brown University School of Public Health.

But when it comes to authorizing more rapid tests, he said, “the scientific community needs to put pressure on FDA.”

The debate centers on the accuracy of the rapid tests. Some experts have raised concerns that they could miss people who are infected and who register positive on non-rapid tests, known as PCR tests.

Georges Benjamin, executive director of the American Public Health Association, warned that false negatives could give people a misplaced sense of security.

“I would prefer the FDA took its time, did it right, think about all the contingencies, and then when they roll it out have a well thought through roll-out plan,” he said.

Mina and other proponents of rapid tests say concerns about accuracy are a misunderstanding, and that the rapid tests are actually highly accurate during the period that matters: when someone is infectious and at risk of spreading the virus to others.

A PCR test, Mina said, will keep showing up as positive for weeks after someone is no longer infectious, but it doesn’t matter from a public health perspective if a rapid test does not show up as positive in that period because the person is no longer a risk to others.

Jeffrey Shuren, a top FDA official overseeing testing, said in an interview that “the doors are open” and that ramping up at-home testing is a priority. But he said companies seeking authorization need to have data to show their tests are effective.

He agreed that a standard PCR test will sometimes test positive on someone who is no longer infectious, but he added the problem is figuring out when that is the case if they are asymptomatic and it is unclear how far along in the course of the illness they are.

“The question is, can you tell when they are no longer infectious?” he said.

Those who want the FDA to rethink its stance found an ally in one of Biden’s advisers last month. Vivek Murthy, the president’s surgeon general nominee, shared in some of the criticism of the FDA during an interview with Ezra Klein of The New York Times.

“I do think we’ve been too conservative,” Murthy said.

“The fact that companies that potentially make public health diagnostic tests did not feel that there was, for example, a pathway to get those approved at the FDA, the fact that many of those companies then figured maybe it wasn’t worth investing in those tests because there wasn’t a pathway at the FDA, that, to me, speaks to our failure to think broadly enough about the kind of testing that we needed,” he added.

On Friday, though, asked about the FDA potentially being a bottleneck for rapid tests, Andy Slavitt, White House senior adviser for the coronavirus response, came more to the agency’s defense.

“We understand that everybody who has something submitted to the FDA wants their product approved, and I would only observe having been around the FDA for quite some time, that when they go fast people criticize them, when they go slow people criticize them,” he said at a press briefing.

Slavitt said he was “very excited” about having 61 million rapid tests by the end of the summer. The White House is signaling it is not going to pressure the FDA to change course, but instead wants to be a “resource and partner.”

“We are excited by the potential for at-home tests as a part of our COVID response national strategy and we all want to see them as quickly as possible,” Slavitt added in a statement to The Hill on Wednesday. “The best way for us to do that is to get out of the FDA’s way and let them do their jobs.”

One company working on rapid tests, Innova Medical Group, says it could be making millions of its tests available to the United States right now if the FDA would grant authorization. Instead, the company is making tests in a California plant and shipping them overseas.

“So California, actually, in an interesting way, is a net exporter of tests that the United States isn’t using, because of the challenges with the FDA,” Daniel Elliott, the company’s CEO, said in an interview.

The California facilities will be able to make 5 million tests per day by the end of February, the company says.

“If the U.S. government today said, ‘OK, go,’ I could deliver 60 million tests before the end of February,” Elliott said.

The company first applied to the FDA in August, Elliott said, and has been facing a series of questions from the agency for months.

Asked about the Innova application, Shuren, the FDA official, responded broadly, emphasizing the need for solid data. “We consider tests for at-home use to be a top priority,” he said. “And if they’ve got their data and the data looks good, we authorize.”