Countries halt rollout of AstraZeneca vaccine, FDA streamlines the process for approving COVID-19 tests, and more…
IN THE NEWS
- Some European countries, including France, Germany, Italy, and Spain have halted their rollout of the AstraZeneca COVID-19 vaccine after 37 out of 17 million vaccine recipients reported blood clots. Emer Cooke, executive director of the European Medicines Agency, the agency that previously approved the vaccine, said she is “still firmly convinced that the benefits of the AstraZeneca vaccine at preventing COVID-19 with its associated risks of hospitalization and death outweigh the risk of these side effects.” After a two-day internal review, the European Medicines Agency maintained that the vaccine is safe and effective, but added that “the vaccine may be associated with very rare cases of blood clots.”
- The U.S. Food and Drug Administration (FDA) announced that it will use a streamlined process for granting emergency use authorizations for COVID-19 tests used to screen asymptomatic individuals before they engage in specific activities, such as returning to work or school. Previously, FDA required COVID-19 test developers to evaluate the efficacy of their products on asymptomatic individuals before applying for authorization. Dispensing with this requirement, the agency now reasons that the use of “serial testing,” where individuals are tested several times over a few days, is sufficiently effective in detecting asymptomatic infection. In the announcement, FDA officials Jeffrey E. Shuren and Timothy Stenzel, director of the Office of In Vitro Diagnostics, emphasized the continued importance of COVID-19 screening in the effort to return to in-person schooling and work.
- The Occupational Safety and Health Administration (OSHA) launched a program to protect high-risk workers from COVID-19 as directed by President Joe Biden’s recent executive order. The program targets the industries in which workers are most likely to be exposed to the coronavirus, creates a monitoring and enforcement oversight plan, and protects against employer retaliation when employees raise concerns about their safety due to the pandemic. Jim Frederick, OSHA principal deputy assistant secretary, stated that OSHA has “a moral obligation to do what it can to protect workers, especially for the many who have no other protection.”
- The U.S. Environmental Protection Agency (EPA) issued a final rule designed to reduce interstate smog pollution originating from twelve states. The Clean Air Act’s “good neighbor” provision requires EPA to mitigate the effects of air pollution from sources such as nitrogen oxide emissions that can travel downwind from state to state. Although EPA Administrator Michael Regan said that the rule would significantly enhance air quality for areas impacted by interstate air pollution, Kathleen Riley, an attorney at Earthjustice, argued that the agency did not go far enough to curb ozone pollution. “Communities are expecting more going forward from an Administration that has promised to address environmental injustice,” she said.
- The U.S. Senate confirmed Representative Debra Haaland (D-N.M.) as U.S. Department of the Interior secretary, making her the first Native American to lead the Interior Department. Representative Haaland’s historic confirmation is notable not only because she is a member of Laguna Pueblo, but also because of the Interior Department’s long history of oppressing indiginous communities. Stephine Poston, a Pueblo tribal member, reportedly emphasized the significance of Representative Haaland’s confirmation to tribal communities, stating that “Indian Country has shouted from the valleys, from the mountaintops, that it is time.”
- The National Labor Relations Board (NLRB) withdrew a Trump Administration proposed rule that would have prohibited students who work at private universities, in roles such as teaching and research assistants, from joining labor unions. The NLRB indicated that it withdrew the rule to allocate its limited resources on other agency priorities. Some experts found the move surprising, but William Herbert, executive director of the National Center for the Study of Collective Bargaining in Higher Education and the Professions, reportedly remarked that the “withdrawal reflects the changed political climate” and demonstrates renewed encouragement for “the formation of unions and collective bargaining.”
- A federal judge held that the National Archives and Records Administration must ensure that U.S. Immigrations and Customs Enforcement (ICE) maintain records of deaths and sexual assaults of detainees. Several watchdog groups sued to invalidate the National Archives’s approval of ICE’s plan to dispose of records for which the agency did not have a “business use,” which included documents detailing sexual abuses and reviews of detainee deaths. Noah Bookbinder, president of Citizens for Responsibility and Ethics in Washington, hailed the decision as a step forward, saying that “there have been too many abuses documented in our immigration detention system, but the country cannot fix these problems without knowing what has happened.”
- The U.S. Department of Health and Human Services (HHS) announced that it will invest more than $10 billion to expedite the return to in-person learning for students. Authorized by the U.S. Congress through the $1.9 trillion American Rescue Plan of 2021, HHS will dedicate the money to providing schools with COVID-19 tests for students and teachers to facilitate a safe return to school. Michael Mina, assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, reportedly doubted the usefulness of this funding, as FDA has yet to approve new types of tests that would facilitate a safe return to school.
- The Federal Aviation Administration (FAA) announced that it will extend the “zero-tolerance” policy for unruly passengers as airlines struggle to enforce mask mandates. The FAA instituted a stricter enforcement policy for disruptive or violent passengers following instances of passengers refusing to wear masks and passengers being disruptive while traveling for the January 6 Capitol riot. Sara Nelson, international president of the Association of Flight Attendants, said that the policy “makes all the difference for flight attendants, passenger service agents, and TSA officers who are tasked to ensure travelers comply.”
WHAT WE’RE READING THIS WEEK
- In a new report, the U.S. Government Accountability Office (GAO) evaluated the resilience of the nation’s electricity grid in light of the impending threats posed by climate change. GAO found that changes to rainfall patterns and the increased frequency of droughts and wildfires will put pressure on the generation, transmission, and distribution of electricity across the country. GAO recommended that both the U.S. Department of Energy and the Federal Energy Regulatory Commission develop a comprehensive strategy to protect against the risks of climate change to the electricity grid.
- In an article in The New England Journal of Medicine, Benjamin Barsky, PhD candidate in health policy at Harvard University, and his coauthors argued that decarceration paired with vaccination is the only way to address the COVID-19 crisis in jails and prisons. The researchers noted that vaccination alone will be insufficient because it is unclear if incarcerated individuals will be prioritized for vaccination, and there may be high rates of vaccine distrust that is difficult to combat in carceral settings. Barsky and his coauthors advocated that decarceration efforts combined with Centers for Disease Control guideline compliance are effective in reducing COVID-19 spread in prisons and should be continued nationwide.
- In a report for the Center for American Progress, Samantha Ross, former special counsel at the Public Company Accounting Oversight Board, argued that the U.S. Securities and Exchange Commission should require companies to disclose their climate-related risks, including their greenhouse gas emissions or possible damage to their property or business resulting from climate-related disasters. Ross argued that the Commission can use accounting and auditing tools to collect and publish climate information from companies so that investors can make environmentally informed decisions.
- In an essay in The Regulatory Review, Sarah J. Morath, professor at Wake Forest University School of Law, argued that the COVID-19 pandemic has tested the resolve of several states to uphold bans on single-use plastics. She explained that some states, such as New Hampshire and New York, suspended bans on single-use plastics in response to public fears that reusable grocery bags could become contaminated. Morath saw these policy changes as a victory for the Plastics Industry Association, an industry group representing plastics manufacturers that had been pushing for bans to be lifted across the country. Morath predicted that the pandemic will fundamentally reshape the plastics debate even after the pandemic has officially ended.