In early December, the Food and Drug Administration is expected to complete its review and approve two new COVID-19 vaccines, meaning a limited number of doses of COVID-19 vaccines may begin to be distributed to states by as soon as December 11, 2020, with distribution to health care workers to begin soon thereafter. On Friday, Pfizer and BioNTech submitted their COVID-19 vaccine for review, the first COVID-19 vaccine to be considered for approval by U.S. regulators. Moderna, which also is developing a COVID-19 vaccine using mRNA technology, is also expected to submit its candidate for FDA review in the coming days.
The FDA’s Vaccines and Related Biological Products Advisory Committee is expected to review both requests at a December 10 meeting. That review, which likely will result in the issuance of Emergency Use Authorizations for the vaccines to be used with specific populations, will be followed quickly by review by the Centers for Disease Control and Prevention’s independent Advisory Committee on Immunization Practices, which also will make recommendations on populations for which the vaccine should be given.
At this time, it is expected that the vaccine would be approved for use in most adults, but not children, as further study is needed to test the vaccine’s safety and efficacy in that population.
The distribution and delivery of safe, effective COVID-19 vaccines (which comes with its own sets of myriad logistical challenges) would be a watershed moment in global COVID-19 response efforts. However, as I discussed in a piece in the New Republic last week, “This is not a silver bullet for the pandemic“:
- These vaccines will only be available in a limited number of doses in the next few months. Many experts believe that it will be May 2021 at the earliest before we see the vaccine distributed to the general public (in other words, those who are not health care or essential workers or those considered at high risk of severe COVID-19 complications, all of whom will be prioritized in most vaccine distribution schemes).
- To be effective, individuals must receive two shots spread out over several weeks, which raises significant logistical and information tracking challenges, and full protection does not occur until 28 days after the first shot is given.
- The Pfizer/BioNTech vaccine is not being distributed under Operation Warp Speed, meaning the distribution channels likely will be different for this vaccine than others.
- The Pfizer/BioNTech vaccine requires ultra-cold storage not typically used as part of the vaccine storage and distribution chain, and has a very short shelf life once defrosted, raising concerns that the vaccine may not be able to be as equitably distributed as other vaccines that are less fragile and rely upon more readily available storage technology.
- While the vaccines will be made available to the public, and cost- and other access-related barriers will be minimized, it is up to the public to find the vaccine acceptable and be willing to take the shots. As the old adage goes, “Vaccines don’t stop infectious diseases, vaccination does.”
- Government and health officials, in addition to running widespread, transparent public education campaigns about the vaccines, must also continue to rely upon robust use of targeted closures, contact tracing, social distancing, and hygiene practices until vaccine-induced herd immunity can be reached. Absent commitment to such measures over the next six months (at least), our communities will continue to risk overwhelming their health systems and health care providers, as well as uncontrolled, widespread COVID-19 outbreaks.
Hospitals Challenged to Integrate Eli Lilly Treatment into COVID-19 Response Efforts
The FDA recently granted an Emergency Use Authorization to Eli Lilly for its new antibody treatment, bamlanivimab, and the federal government has begun distributing the antibody to state health departments. The treatment is meant to keep high-risk patients from developing severe COVID-19 cases that might require hospitalization. However, according to STATNews, many hospitals and infectious disease providers, overwhelmed in current COVID response efforts, are reluctant to take on the logistical challenges of implementing the new treatment protocol in their facilities, and this past week the Infectious Diseases Society of America recommended against the routine use of the treatment with ambulatory patients. According to STATNews,
The questions lie in the details. Doctors can prescribe the drug for anyone who is coronavirus-positive, with mild to moderate symptoms, but who is at high risk of getting really sick. “We have for nine months been telling people, ‘If you have COVID and have mild to moderate symptoms, please stay home and isolate,” said Rochelle Walensky, chief of infectious diseases at Massachusetts General Hospital.
Now, a subset of those people are supposed to come in for an antibody infusion. That isn’t simple. It means having trained staff observe recipients for an hourlong medication drip, and then for another hour to make sure there aren’t side effects. But it can’t necessarily be in regular outpatient infusion centers, where cancer patients, for instance, come for chemotherapy: You don’t want highly infectious people mixing with almost anyone, let alone those who are most vulnerable.
COVID-19 Public Policy “Cliff” Coming
December 31 will not just mark the end of 2020; it also will signal the expiration of numerous federal COVID-19 initiatives that have stabilized the U.S. economic recovery and offered critical lifelines to individuals, businesses and communities nationwide adversely affected by the pandemic. These include the end of:
- CDC’s Eviction Moratorium, which may trigger as many as 6.4 million evictions come January 1, and at a time when “nearly a third of all households (32.9 percent) said they were behind on housing payments and rated the chances of eviction or foreclosure within two months as somewhat or very likely.”
- Expanded unemployment benefits, which may impact as many as 12 million individuals.
- The Earned Income Tax Credit and Child Credit program, meaning more low-income people will see bigger cuts to their incomes
- Forbearance on student loan debt
States may step in to try to fill some of these gaps. For example, over the past week, Oregon legislators took up a provision to implement a 6 month extension to the eviction moratorium and create a landlord assistance fund. The New Jersey Senate is considering a bill that would allow pandemic-affected renters to have up to 30 months to make up missed rental payments.
The Massachusetts Attorney General has released a new report, “Building Toward Racial Justice and Equity in Health: A Call To Action,” which recommends several initiatives that would help bridge health disparities arising in the COVID-19 pandemic and beyond, including:
- expanding state access to high speed internet to both help close the digital divide and to increase access of low income communities to telehealth services,
- the state to require “coverage and payment parity across all carriers for telehealth services over the next two years” and “ensure payment parity between telephonic, video, and in-person visits, where clinically appropriate.”
- expanding access to affordable housing and paid sick leave, which will allow individuals to quarantine more easily, as well as
- recommendations for hospitals, health insurers, and greater investment in data structures that will help identify and address health disparities.
Other COVID-19 Legal News
- U.S. Supreme Court majority rejects request from two elderly Texas prisoners to reinstate COVID-19 protections in state facilities, deferring to state officials as to how best to address infection outbreaks in their jails and prisons.
- Maryland Federal Court rejects “Reopen Maryland” challenge by religious groups, businesses, and citizens, upholding new state orders tightening restrictions due to COVID-19 resurgence.
- Michigan Federal court rejects state restaurant association’s challenge to new state executive order prohibiting indoor dining.