The administration of President Joseph Biden announced March 17 a $10 billion allocation of funds for testing to reopen schools in the final months of the current school year, a source of revenues that was provided by the recently passed $1.9 trillion American Rescue Plan. The news follows by one day a new FDA policy on screening tests that allows test developers to distribute tests designed to screen those who are asymptomatic without first validating the test for this use, although there are still questions as to whether this new push will yet again crimp vital testing supplies.
The Biden administration held a March 17 press detailing the effort the CDC will undertake in distributing the testing funds to assist the resumption of schooling for K-8 schools. CDC director Rochelle Walensky said the monies will be distributed to states, counties, cities and rural locations to foster more widespread screening testing, adding that some public health departments will receive as much as $20 million. Walensky said the testing funds and the guidances are designed to “turn the corner in this pandemic.”
Also on the White House briefing was Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who said real-world data on the use of the currently authorized vaccines suggest those vaccines are exerting the intended effect.
An example is a study conducted in the U.K., which indicated that vaccines distributed there were highly effective against the B.1.1.7 variant of the SARS-CoV-2 virus. “Bottom line: The vaccines work in the real world,” Fauci said, adding that there is no biological reason to believe the vaccines would function in a fundamentally different manner in pediatric patients.
Carole Johnson, who serves as the director of the testing program for the Department of Health and Human Services, said, “we hope that the President’s commitment to testing … is a strong signal to all about our commitment to testing.” Johnson said this applies to those who manufacture the equipment and supplies needed for testing, although she declined to offer details regarding the prospect that the emphasis on expanded testing would create a new series of shortages.
Advamed’s Whitaker says companies ‘are working 24/7’
Scott Whitaker, president and CEO of the Advanced Medical Technology Association (Advamed), said in a March 17 statement that the announcement by the Biden administration “is a big step forward for our country.” Whitaker said Advamed member companies “are working 24/7 to manufacture the tests needed to prevail over this pandemic, and I know our diagnostics companies will continue their hard work to ensure that we have the tests we need to get back to normal in our society more broadly.”
Susan Van Meter, executive director of Advamed Dx, said the FDA screening policy and the Biden administration’s announcement will combine with “the substantial supply of quality COVID-19 tests and augmented manufacturing capacity” to “improve our collective efforts to recover and rebound from the pandemic.” Van Meter said the diagnostics industry is “grateful to assist schools by providing millions of quality COVID-19 molecular and antigen, lab-based and point-of-care tests to support the widespread screening that is so critical to safe, in-person gatherings.”
Mina references ‘massive’ study prior to FDA announcement
A number of voices have made themselves heard regarding the use of rapid antigen tests to reopen the economy, including COVID testing gadfly Michael Mina of Harvard University. Mina announced March 10 via Twitter the enrollment of a “new massive public health research study” for the frequent use of at-home tests for screening purposes. The FDA’s Tim Stenzel did not directly reference this study on the March 17 COVID testing town hall, but Stenzel said the agency’s March 16 policy on serial testing for screening purposes was prompted by a review of a “a very well-designed, well-executed study” that allowed the agency to “usher in this new policy.”
The FDA posted notice of the new policy, which allows developers to seek an emergency use authorization prior to conducting “certain performance evaluations with asymptomatic individuals.” The policy calls for the test to be authorized for screening those who are asymptomatic, assuming the test has demonstrated “strong performance in symptomatic individuals,” and assuming the test will be used in serial testing scenarios rather than as a one-off test for diagnostics purposes.
The template for serial screening testing states that a study protocol for the post-authorization study should generally include at least 20 positive asymptomatic individuals, and that the sponsor and the FDA will have to come to terms on the study design prior to study initiation. These studies will have to be completed within an agreed-upon period of time, and will have to demonstrate adequate performance in asymptomatic individuals, the template says. A failure to meet either of these requirements may prompt the FDA to “consider taking additional actions as appropriate,” which includes “revoking or revising the authorization to remove any intended use(s) that is not adequately supported.”
This development was followed by a March 17 announcement regarding serology tests for detection or correlation with neutralizing antibodies, as well as an updated serology testing template. Toby Lowe, associate director of the FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said the updated template for serology test developers offers some clarification about viral mutations and variants, while the EUA template for neutralizing antibodies is the subject of some anticipation by developers.
Tim Stenzel, director of the FDA’s OIR, said antigen testing was significantly less sensitive than molecular testing, but noted that the study regarding serial testing for screening purposes that was presented to the agency demonstrated that serial testing with the antigen test significantly mitigated the risk of false negatives. He said this data “was the first firm evidence that we had” that confirmed the utility of these tests for screening purposes, thus allowing the agency to confidently broach the subject with a policy change.