Michael Mina, assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, again criticized the U.S. FDA for taking a conventional regulatory approach to rapid antigen tests for the pandemic. However, not everyone at the FDA’s parent department deserves brickbats. Mina said Assistant Secretary for Health Brett Giroir deserves a lot of credit for assisting in the effort to stand up pilot studies for rapid antigen tests that could be used to restore the U.S. economy even in the absence of a fully rolled-out vaccination campaign.

Mina, who was addressing the U.S. testing environment in response to the COVID-19 pandemic on a Dec. 11 Zoom meeting, said there are a lot of problems with any movement toward a vaccine mandate, a question prompted by the FDA advisory panel vote in support of the Pfizer Inc./Biontech SE vaccine. Mina also expressed frustration at the FDA’s persistent treatment of surveillance testing as diagnostic testing, stating that schools and restaurants could be reopened safely if an inexpensive strip test was available at the door.

“A lot of accolades to Brett Giroir, who is in a very difficult position,” Mina said, given the absence of cooperation from the FDA and the lack of an executive order to override the agency on surveillance and screening tests. Giroir “has been trying to work with us and others around the country to see how we can best utilize these tests,” an effort that deserves accolades despite the intransigence at the FDA.

CDC nominee may help drive non-Dx testing

President-elect Joseph Biden has indicated he will nominate Rochelle Walensky as the next director for the Centers for Disease Control and Prevention, a pick Mina said may boost the fortunes of nondiagnostic testing. Despite what might seem to be broadening support for a change in the FDA’s approach to surveillance and screening test standards, the agency may need a presidential order to release the tests not as medical devices, but as instruments of public health. “The FDA is not in a great position to evaluate public health tools,” Mina said, adding that it might be optimistic to believe that such tests will be available in homes in the near term.

With the proper social distancing and quick tests available at the door, the risk of indoor dining at restaurants would be largely alleviated, Mina said, adding that one of the inexpensive lateral flow assays offers a sensitivity of 99% for the SARS-CoV-2 virus. Manufacturers in the U.S. are cranking out roughly 8 million units per day, but the bulk of the production is set for export because the FDA adamantly refuses to recognize them as public health tools rather than as diagnostics.

The FDA advisory panel’s 17-4 vote to grant an emergency use authorization for the Pfizer/Biontech vaccine was widely and immediately heralded as a turnabout from a bleak outlook for the first part of 2021. However, Mina said he was worried that the availability of the vaccine would lead to more ignorance about the other tools available to public health officials. The pandemic will be at peak form for another few months, and “it’s going to be a very small fraction of our population” that gets vaccinated in the near term, he said. The vaccine will provide hope to the public at large that the pandemic can be controlled, but the data do little to disclose how much the vaccine will block transmission, and there is still little certainty as to the durability of effect.

Mina said policymakers may be taking too much for granted because of the vaccine, particularly given that daily mortality numbers are hovering at 3,000. The pandemic is costing the economy $16 billion a day, he said, adding, “now is not the time to say, ‘the vaccine is here, let’s not worry anymore’.”

Despite reports that some enrollees in the clinical trial for the Pfizer/Biontech vaccine with severe allergies have experienced problems, there are few major concerns about the safety of the vaccine at the moment. However, Mina noted that there is a small but non-zero chance someone will die from the vaccine, although the numbers at present suggest the risk is small when compared to not vaccinating. He was not supportive of any move to shift the emphasis on testing away from areas where a vaccine might be intensely administered in part because some will refuse vaccination. Another issue with any such shifting of resources is that public health surveillance is not up to the task of determining when the residents of a particular population center has achieved herd immunity.

More data needed from placebo arm

Politically and socially, the pressure will be on to unblind the enrollees in the placebo arm of the Pfizer/Biontech vaccine study, but Mina said he hoped that those in the control arm have an option to stay in blinded fashion at least for a few more months. This is particularly important given that the human immune system reaction to vaccines is generally quite vigorous in the first few months, but that this reaction tends to ebb over time for most vaccines. Ergo, there is still a question about the efficacy of the vaccine out to five months or so following administration. This lack of certainty would suggest a need to sustain the blinding for at least part of the placebo arm, thereby providing some critical information as the first quarter of 2021 gives way to summer.

Mina predicted Congress will soon pass a pandemic relief bill with a dollar value close to the $908 billion currently under discussion on Capitol Hill, but he advocated a more serious amount of funding for testing. He said that $1 billion for nondiagnostic testing would do much to restore the U.S. economy without incurring an undue risk of a massive new outbreak of COVID-19.

However, Mina also said there should be an uproar over the testing of nonessential personnel. “The rich and wealthy of our country,” such as athletes and Hollywood stars, are being tested despite that these are anything but critical economic functions, he said, while the anonymous millions of schoolchildren and restaurant operators go without and suffer as a result.