Roundup: Welcome Steps on Masks and Concerns about Booster Advice

October 13, 2021
A doctor or nurse wearing a face mask and hair net sticks a hypodermic needle into a vial of COVID-19 vaccinePrasesh Shiwakoti (Lomash)/Unsplash
Liz Borkowski
Managing director, Jacobs Institute of Women’s Health at the Milken Institute School of Public Health at George Washington University

This post is part of a series of quarterly roundups on scientific integrity.

In the COVID-19 response in the third quarter of 2021, the Biden administration put more emphasis on masks and vaccination, and made a premature announcement about availability of vaccine boosters. Meanwhile, the FDA responded to concerns about the approval of Alzheimer’s drug Aduhelm, the EPA rolled back several Trump actions that weren’t based on evidence, the Office of Science and Technology Policy collected input on scientific integrity policies, and advocates encouraged better protections for whistleblowers.

Biden administration’s use of science to combat COVID-19 remains uneven

The US saw a sharp rise in COVID-19 cases over the summer as the more contagious Delta variant accounted for a growing share of cases; the tally of new diagnoses began to decline in September. Vaccinations increased as news spread of deaths among previously healthy unvaccinated young adults, but most state governors failed to (re)issue mask mandates or other such measures to reduce viral spread. Racial and ethnic disparities in vaccination are narrowing but remain, with misinformation and access difficulties contributing.

In July, CDC responded to new evidence of COVID-19 spreading among vaccinated individuals by recommending that fully vaccinated people (as well as unvaccinated people covered by earlier guidance) wear masks in public indoor settings in areas of substantial or high transmission. This was welcome news to the scientists and health advocates disturbed by CDC’s earlier lifting of its masking recommendations for vaccinated individuals, which seemed not to sufficiently recognize inequitable vaccine distribution and the likely problematic consequences of the advice.

After FDA approved the Pfizer vaccine in late August (a step up from the emergency use authorization that had allowed its use), more employers began requiring vaccinations. Weeks later, President Biden laid out the evidence—that vaccines are highly effective at preventing severe COVID-19, but that only three-quarters of those eligible have received them—and, based on that, announced that the Department of Labor would be developing an emergency rule to require that all employers with 100 or more employees require that their workers be vaccinated or tested weekly, and offer paid time off to get the shots. He also issued executive orders and related guidance requiring vaccinations for federal employees and contractors.

More controversial than the vaccine mandate in public health circles is the Biden administration’s promotion of booster shots. In mid-August, the president announced that third doses, or booster shots, would be made available starting September 20 for adults who had received both doses of the Pfizer or Moderna vaccine at least eight months earlier. CDC director Rochelle Walensky cited new research showing the vaccines’ protection wanes over time, though she made a general statement that their effectiveness against hospitalization and death remains high, without pointing out that the Pfizer vaccine’s effectiveness was reduced from more than 90% to 75%.

The fact that the announcement preceded FDA authorization of boosters for the general population—and created pressure for the agency to respond quickly—reportedly frustrated regulators and sparked fear of political pressure overriding the agency’s expertise. Two top FDA vaccine regulators, Marion Gruber and Philip Krause, resigned. Along with colleagues from universities and the World Health Organization, they published an editorial in the medical journal The Lancet arguing that the studies interpreted as indicating waning immunity are “preliminary and difficult to interpret” and that “current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations.” World Health Organization regional director for Africa Matshidiso Moeti warned that less than 4% of that continent’s population is vaccinated, and using vaccines for boosters instead of distributing them to under-vaccinated countries allows areas with low rates of vaccination to serve as incubators for future variants that could be more dangerous. The National Center for Health Research pointed out that Pfizer’s study on booster safety has a short follow-up time and a small sample size, with only 12 patients 65 and older—and that making boosters widely available will interfere with researchers’ ability to conduct better research. Overall, public health supporters worry that the administration’s premature embrace in boosters will harm public confidence that it is following Biden’s pledge to “follow the science.”

In September, the FDA advisory committee rejected the plan to authorize a third dose for all adults, and instead voted for a third dose only for people 65 and older and those at high risk for severe COVID-19. FDA expanded the recommendation and authorized a third dose of the Pfizer/BioNTech vaccine, six months after the second shot, for all people 65 and older, adults at high risk of severe COVID, and those whose jobs and living arrangements place them at higher risk of sever complications from COVID-19—a much larger population than originally recommended by the FDA advisory committee.

CDC largely followed the advice of its advisory committee in recommending third Pfizer doses for those 65 and older, those living in long-term care facilities, and those aged 50-64 with underlying medical conditions; however, the agency also added a category to allow people age 18-49 with underlying medical conditions and those at increased risk because of occupational settings or living conditions to receive a booster “based on their individual benefits and risks.” The occupational and institutional category was not one that the agency’s advisory committee approved; members voted 9-6 against it because of concerns about inadequate evidence about risks and benefits and the inequitable global distribution of vaccines. Walensky’s decision to add frontline workers to the recommendation despite the committee’s advice was highly unusual.

Looking ahead: Decisions from both agencies on Moderna and Johnson & Johnson boosters are expected in the coming months. 

FDA responds to concerns about approval of Alzheimer’s drug

In June, FDA approved Biogen’s Alzheimer’s drug Aduhelm despite its advisory committee having voted unanimously against it (with one abstention). The advisory committee did not find that the drug’s trials provided convincing evidence of slowing cognitive decline, whereas the studies found frequent serious side effects, such as brain swelling. FDA’s approval was based not on improvements in patient outcomes, but on a marker believed—not proven—to be associated with cognitive health; also, they approved it for all Alzheimer’s patients rather than the patients with mild disease who made up the clinical trial’s population.

On July 7, a group of scientific integrity supporters sent a letter to the Department of Health and Human Services (HHS) criticizing the unscientific basis of FDA’s approval of Aduhelm and urging that FDA revise Aduhelm’s indications to be for mild Alzheimer’s only, and require well-designed confirmatory studies within the next two years rather than the nine years the agency allowed in its approval. On July 8, FDA announced that the agency was “updating” the label for Aduhelm to be approved for mild Alzheimer’s only, an unprecedented action for a label that was only one month old. The advocates’ letter also requested an HHS inspector general investigation into whether the approval decision was consistent with FDA’s scientific integrity policies and other agency standards. On July 9, FDA Acting Commissioner Janet Woodcock requested an inspector general investigation into whether interactions between Biogen and FDA review staff were inconsistent with policies and procedures—a narrower question, and one that is likely to reflect the lower scientific rigor that FDA has experienced in recent years.

Looking ahead: The HHS inspector general will examine the approval pathway FDA used to approve Aduhelm. Two House committees have requested documents from FDA related to Aduhelm and asked the agency to explain why the drug’s original label applied to all Alzheimer’s patients, the timeline for follow-up study completion, and other issues. 

Undoing Trump administration damage and strengthening scientific integrity infrastructure

Work to undo Trump administration actions that disregarded evidence continues, particularly at EPA. That agency announced that it will publish a new rule to prohibit agricultural use of the neurotoxic pesticide chlorpyrifos, the continued use of which the Trump administration allowed despite its scientists’ recommendations. A federal district court judge threw out a Trump administration “waters of the United States” rule (used to implement the Clean Water Act) because it ignored a large body of evidence EPA had assembled. And EPA announced a reconstituted Science Advisory Board characterized by members’ diversity and independence as well as expertise.

At the same time, journalists continue to uncover information about how Trump administration officials tried to suppress and distort data—and often succeeded. At The Intercept, Sharon Lerner reports on Trump administration officials’ suppression of a formaldehyde draft risk assessment that links the chemical to myeloid leukemia. For the New York Times, Emily Bazelon and Michael Wines reveal how Census Bureau employees stood up to Trump administration pressure to release insufficiently vetted figures on undocumented immigrants.

A series of disturbing reports from Sharon Lerner about EPA’s new chemicals division indicates that some problems persist. The Intercept series “EPA Exposed” uses information from four EPA whistleblowers represented by Public Employees for Environmental Responsibility and describes how the Trump administration’s EPA approved dangerous chemicals despite evidence of health harms. Lerner also reports that some career staff have continued to disregard evidence of health harms when approving chemicals under the Biden administration, and that whistleblowers have continued to be disappointed by responses from the agency’s scientific integrity office and inadequate protections.

Work to better guard against such abuses in the future is underway. The White House Office of Science and Technology Policy (OSTP) received feedback from a wide range of organizations, via written comments and multiple listening sessions, about how it should protect government science from political meddling. Stakeholder input is one step in a process Biden established in one of his first acts as president to ensure that all agencies establish and enforce scientific integrity policies that prohibit improper political interference.

One area where advocates urge additional safeguards is protection for whistleblowers. Zena Wolf of the Revolving Door Project warns that several Biden appointees have failed to protect whistleblowers in the past and urges the president to “ensure that his administration prioritizes good policy and transparency over its own power.” Melissa Wasser of Project on Government Oversight and Andrew Lautz of National Taxpayers Union call on Congress to pass the Whistleblower Protection Improvement Act, which would protect federal whistleblowers from retaliatory investigations and give them access to jury trials. It has been approved by the House Committee on Oversight and Government Reform and can now come to a vote on the House floor.

Looking ahead: OSTP will soon deliver its review of existing scientific integrity policies, and then will have another 120 days to develop a framework to inform and support assessment and improvement of scientific integrity policies and practices.

Also:

New resources: