Vaccines - Bill of Health

Washington, DC, USA - Closeup view of December, 23, 2020: COVID-19 Vaccination Record Card by CDC on blurred documents background.

Private Employer Vaccine Mandates in the Courts

February 22, 2022February 22, 2022 Kaitlynn Milvert Leave a comment

By Kaitlynn Milvert

After the Occupational Safety and Health Administration (OSHA) COVID-19 vaccine mandate for large employers was withdrawn last month, many pronounced private employers to be “on their own” to make decisions about vaccine requirements for their employees.

Until one outlier Fifth Circuit decision last week, federal courts have largely agreed. In lawsuits challenging private employers’ COVID-19 vaccine mandates, federal district courts have routinely denied requests for preliminary injunctions to halt private employers’ vaccination policies from taking effect.

Reconsidering Mask Mandates

February 15, 2022February 15, 2022 Carmel Shachar Leave a comment

By Carmel Shachar

The desire to get back to “normal” is an understandable one. And despite their prevalence for the last two years, masks don’t fit into most people’s concept of normal.

But removing mask requirements means rejecting yet another public health tool to control the pandemic and protect our health care system.

First, some context: most states haven’t had indoor mask mandates in place for many months. As of February 10^th, only Washington, Oregon, California, New Mexico, Hawaii, Illinois, and Delaware had statewide indoor mask mandates. These remaining few states are now taking steps to end mask policies. Some states have narrower mask mandates that apply to schools, and are similarly moving to end such policies.

But the decision to end these mandates is not made in a vacuum. We should be thinking about what other public health initiatives and components should be in place before we lift these protections.

Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

February 8, 2022February 8, 2022 The Petrie-Flom Center Staff Leave a comment

By Fatima Khan

When news broke last week that Pfizer-BioNTech was submitting for Emergency Use Authorization (EUA) a two-dose COVID vaccine regimen for children under 5 to the U.S. Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time.

Up until a few days before, the public was expecting approval to possibly drag into summer. While the regimen would likely require a third dose, it became a possibility that children could start getting some level of protection as early as March. Finally children were acknowledged during a time when their needs have often been neglected or even ignored.

The shift in the FDA’s decision process is a critical moment to reflect on how we got here, and what we should strive for to ensure children aren’t repeatedly left behind amidst our new COVID reality.

New York, USA, November 2021: Pfizer Covid-19 Paxlovid treatment box isolated on a white background.

How to Fairly Allocate Scarce COVID-19 Therapies

January 31, 2022January 30, 2022 Govind Persad Leave a comment

By Govind Persad, Monica Peek, and Seema Shah

Vaccines are no longer our only medical intervention for preventing severe COVID-19. Over the past few months, we have seen the arrival and wider availability of treatments such as monoclonal antibodies (mAbs), and more recently, of novel oral antiviral drugs like Paxlovid and molnupiravir.

The recent Delta and Omicron surges have made these therapies scarce. The Delta variant led the federal government to resume control over mAb supply and promulgate allocation guidelines. The Omicron variant exacerbated scarcity because only one of the currently available mAbs, sotrovimab, appears to be effective against it. While Paxlovid and molnupiravir are effective against Omicron, both will likely be in short supply for many months. Paxlovid is currently constrained by a lengthy manufacturing process. Molnupiravir — which is substantially less effective — is contraindicated for use in patients under 18 and not recommended for use during pregnancy.

To allocate COVID-19 vaccines, the CDC’s Advisory Committee on Immunization Practices, the National Academies of Sciences, Engineering and Medicine (NASEM), and the World Health Organization (WHO) identified ethical goals for prioritization, such as maximizing benefit and minimizing harm, mitigating health inequities, and reciprocity. These committees, particularly the NASEM and WHO committees, included ethics experts as well as experts in social science, biology, and medicine. Current federal guidelines for therapy allocation, in contrast, do not identify ethical objectives or involve ethics expertise.

In an open-access Viewpoint in Clinical Infectious Diseases, we identify ethical goals for the allocation of scarce therapies. We argue that the same ethical goals identified for vaccine allocation–in particular maximizing benefit, minimizing harm, and mitigating health inequities — are also relevant for therapy allocation. Because many people have now taken steps to mitigate pandemic scarcity, for instance by protecting themselves through vaccination, we argue that reciprocity is also relevant.

Remember the Babies: The Need for Off-Label Pediatric Use of COVID-19 Vaccines

January 24, 2022January 24, 2022 Carmel Shachar Leave a comment

By Carmel Shachar

As trials stall and the omicron variant surges, the U.S. Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set.

The cries of frustration, anger, and fear from parents of small children have reached a new pitch amidst the ruckus of 2022. Parents of children under five years old need to navigate omicron-fueled rising pediatric hospitalization rates while their kids remain entirely unvaccinated. They must also juggle childcare and work responsibilities amid unpredictable, lengthy daycare and schooling closures. Give us the vaccine to help protect our kids, shorten quarantines, and keep children in care they all clamor.

But where are the vaccines for the pediatric set — the same vaccines that have been proven safe, both in adult populations and in older children? So far the story has focused on disappointing efficacy results and delays in studies from Pfizer and Moderna. But that is not the entire explanation for why parents of small children are blocked from vaccinating their offspring.

The Supreme Court’s Rulings on COVID-19 Vaccine Mandates, Explained

January 18, 2022January 18, 2022 Kaitlynn Milvert Leave a comment

By Kaitlynn Milvert

In a pair of rulings issued January 13, the Supreme Court put on hold the federal vaccine-or-test requirements for large employers, but allowed federal vaccination requirements for health care workers to take effect while they are litigated in the lower federal courts.

The Court decisions each addressed questions of whether federal agencies — the Occupational Safety and Health Administration (OSHA) and the Centers for Medicare and Medicaid Services (CMS) — have authority to set these vaccination-related requirements.

In doing so, the Court drew new and unprecedented lines between the kinds of risks that agencies operating outside of the health care context — such as OSHA — have power to address through federal regulations. The Court’s decisions on these issues are likely to loom large in future litigation as federal vaccine requirements continue to be litigated in the lower courts.

The Beginning of the End of Federalism

January 10, 2022May 6, 2022 Jennifer S. Bard Leave a comment

By Jennifer Bard

Friday’s emergency hearing by the Supreme Court regarding the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate was extraordinary both in that it happened at all and what took place.

The hearing came in a response to a petition by a coalition of states and the National Federation of Independent Business (NFIB) to halt an Emergency Temporary Standard (ETS) issued by OSHA mandating that all employers with over 100 employees “establish minimum vaccination standards” including “vaccination verification, face covering, and testing requirements.”

That the Court heard the case on an emergency basis signaled their concern that OSHA, in issuing the ETS, was overreaching its authority, as they ruled the Centers for Disease Control and Prevention had done in issuing an eviction moratorium.

But what made the colloquies particularly unsettling is that the ETS was carefully crafted to be, as Professors Larry Gostin and Dorit Rubinstein Reiss explain lucidly, well within contemporary standards for an exercise of federal power affecting a health matter usually within the jurisdiction of a state. It applies only to employers already obligated to follow OSHA workplace standards and fell far short of a vaccine mandate. Moreover, however severe the risk of COVID when this was drafted six months ago, the risk from the Omicron variant is many times greater.

Yet the sympathetic ear given by the majority of the Justices to the arguments made by the lawyers seeking a stay made it possible to wonder if the whole thing was happening in either one of DC or the MCU’s multiverse. This is because the questioning, directly and by implication, calls into doubt what past Courts have identified as the framework of federalism — a nickname for the Constitution’s balancing of a strong federal government against the rights of individual states. We cannot know the extent to which the Justices will adopt any of the arguments offered them for limiting federal agency power, but from this hearing we can anticipate substantial strengthening of an individual state’s ability to resist federal regulation.

A Timeline of Biden’s Pandemic Response, Part 4: Winter of Death (December 2021 – Present)

January 10, 2022January 7, 2022 Justin Feldman Leave a comment

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. Read the first, second, and third parts here.

By Justin Feldman

On December 1, 2021, the CDC issued a press release announcing that it had identified a case of the Omicron variant in the U.S. for the first time.

White House insiders admit that they were unprepared for Omicron, just as they were unprepared for Delta. Vice President Harris recently told an interviewer that the administration was caught flatfooted because their scientific advisors never warned that such variants could crop up (at least two of these advisors, Rick Bright and Celine Gounder, begged to differ).

While vaccination still provides powerful protection against hospitalization and death due to infection from Omicron, protection against symptomatic illness is weaker than before, particularly among those who have not received boosters. And though evidence is mounting that the risk of hospitalization and death is lower for each person infected compared to Delta, Omicron’s extremely high transmissibility means that a large fraction of the population will become infected in a short time period, particularly in the absence of additional public health measures.

On December 21, as the highly contagious variant started to sweep the country, President Biden delivered remarks about the new threat. For the hundred million Americans who remain unvaccinated, the president’s speech warned of the imminent risk of hospitalization and death. For the vaccinated and boosted, Biden’s message was: Keep Calm and Carry On, all will likely be fine. And for Wall Street, the speech was meant to provide a crucial piece of reassurance: There would be no federal support for public health measures that restrict commerce.

A Timeline of Biden’s Pandemic Response, Part 3: We Have the Tools (Sept. – Dec. 2021)

January 7, 2022January 7, 2022 Justin Feldman Leave a comment

By Justin Feldman

Over the summer of 2021, concern grew that the vaccines were not providing the near-perfect protection against symptomatic disease and transmission that had first emboldened the administration to jettison other public health measures.

It was initially unclear whether the issue was Delta’s higher transmissibility or waning immunity from vaccines, as the first groups had been vaccinated nearly a year prior. There was noticeable concern from CDC, which acknowledged the “war has changed” in a set of leaked slides from July 29, 2021. Of particular concern were case reports from Massachusetts and internationally of high viral loads observed among those who were vaccinated and infected. In late July, CDC reversed course on its mask guidance and recommended indoor masking for all, including the fully vaccinated, in counties with high transmission. In late September 2021, CDC reversed course on its quarantine guidance, which had previously stated that fully vaccinated people should not quarantine after a known SARS-CoV-2 exposure.

These changing epidemiologic realities could have brought about a course correction and a push for other public health policies to complement vaccination. Instead, the administration mostly adapted by shifting its messaging.

BETHESDA, MD - JUNE 29, 2019: NIH NATIONAL INSTITUTES OF HEALTH sign emblem seal on gateway center entrance building at NIH campus. The NIH is the US's medical research agency.

Will NIH Learn from Myriad when Settling Its mRNA Inventorship Dispute with Moderna?

January 6, 2022January 6, 2022 Jorge Contreras 7 Comments

By Jorge L. Contreras

The National Institutes of Health (NIH) is currently embroiled in a dispute over the ownership of patent rights to Moderna’s flagship mRNA COVID-19 vaccine (mRNA-1273).

The NIH, which funded much of Moderna’s research on the COVID-19 vaccine, should be assertive in exerting control over the results of this taxpayer-funded research. Failing to do so would be a missed opportunity for the public sector to have a say in the distribution and pricing of this critical medical technology.

Category: Vaccines