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Law360 (August 13, 2020, 5:44 PM EDT) --
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| Leah Durant |
Now, with over 12 million confirmed cases worldwide, and over 166,000 deaths just in the U.S. alone, the race is on to find a safe and effective vaccine that will aid in preventing new cases and potentially eradicate the virus altogether.[1]
It is important for the public to know that while vaccines are an important part of national health policy, as with any pharmaceutical, a small percentage of injuries or adverse reactions can occur. Many injuries are quite minor, but others can be more serious.
Physicians and pharmacists are required to report all adverse vaccine reactions to the Vaccine Adverse Event Reporting System, a database maintained by the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration. The reporting system was established in 1990 and is intended to be a national early warning system to detect possible safety problems with vaccines licensed in the U.S.
Each year, 30,000 adverse events following vaccination are reported.[2] Although the reporting system collects data on adverse events that occur during or following vaccination, the reports tell little about whether the vaccine caused the injury, and whether an incident is reported at all can vary widely based on many factors.
In order to address the growing number of lawsuits filed against vaccine manufacturers and to ensure the availability of vaccines in the U.S., in 1986 Congress created the National Vaccine Injury Compensation Program, or NVICP, as part of the National Vaccine Injury Compensation Act.[3]
The goal of this legislation was to shield both vaccine administrators and vaccine manufacturers from liability from lawsuits arising from injuries that result from vaccines. At the time, vaccine manufacturers and administrators were being sued in civil court by those injured by vaccines and both the manufacturers and administrators threatened to stop manufacturing or administering vaccines.
The act was passed by Congress to ensure that vaccines, especially childhood vaccines, would continue to be produced by the manufacturers and administered by health professionals.
The Vaccine Act's key provision is the vaccine injury table. The vaccine table lists injuries that are scientifically associated with a host of vaccines. The vaccine injury table allows petitioners in vaccine claims to gain a presumption that any vaccine listed on the table caused the injury on the list if the onset of the injury occurred within a prescribed time frame.
While Congress enacted the initial table in consultation with many health professionals, manufacturers and administrators, the vaccine act provides that Alex Azar, the secretary for the U.S. Department of Health and Human Services, can periodically revise the vaccine injury table based on current medical thinking.
Since its inception, the vaccine program has paid out $4.3 billion in claims. By far, most claims filed under the vaccine program involve the annual flu vaccine. Flu vaccine claims account for 6,315 claims since added to the table in 2005.[4]
In recent years, the most common injury alleged in the vaccine program is a condition called shoulder injury related to vaccine administration, or SIRVA, which can result after needle administration of any vaccine.
Medical literature supports the potential for inducing a prolonged immune-mediated inflammatory reaction if a vaccine antigen is injected into tissue structures underlying the deltoid muscle. Shoulder injuries such as bursitis, tendinosis, adhesive capsulitis, rotator cuff injuries and others are associated with SIRVA.
Since the original study on SIRVA was conducted by HHS in 2010, numerous other scientific studies have similarly found a causal link between receiving a vaccine and experiencing SIRVA.[5] However, due primarily to the workload issues, HHS now proposes to remove SIRVA from the vaccine injury table.
Under the Vaccine Act, anytime that the secretary of HHS proposes to revise the vaccine injury table, the proposal must first seek the advice of the Advisory Commission on Childhood Vaccines. On May 18, the commission unanimously voted to reject HHS' proposed rule seeking to remove SIRVA from the vaccine injury table.[6]
Despite the commission's unanimous recommendation rejecting the secretary's proposal to revise the vaccine injury table to remove SIRVA, on July 16 the secretary of HHS moved forward and had the final rule published in the Federal Register.[7] In the 34 years since the inception of the vaccine program, the secretary's action to move forward with a revision to the vaccine injury table without first getting the approval of the commission is unprecedented.
The rule that HHS published in the Federal Register on July 16 addresses SIRVA and the development of future COVID-19 vaccines. The rule states:
In other words, since the vaccine injury table currently includes all vaccines intended for routine administration to children, assuming children will also receiving COVID-19 vaccines in the future, there is some possibility that COVID-19 vaccines could end up being heard in the NVICP.Because COVID-19 and a potential COVID-19 vaccine are not currently on the Table, the Department does not believe this rule would have an impact on patients with COVID-19 or a COVID-19 vaccine. However, HHS requests public comment on this determination.
The COVID-19 injectable vaccines will undoubtedly result in SIRVA injuries and whether these claims are ultimately heard in the NVICP will likely be decided in the courts through hard-fought litigation. If the secretary adopts his notice of proposed rulemaking, it is likely that lawyers will challenge in federal court whether the rule violates the express provisions of the Vaccine Act and its legislative history.
Whether those who receive a COVID-19 vaccine will be covered by the NVICP is further complicated by the secretary's proposed rule to revise the vaccine injury table to remove automatic inclusion of certain vaccines. The current table includes a provision that "[a]ny new vaccine recommended by the CDC for routine administration to children, [are included in the NVICP] after publication by the Secretary of a notice of coverage."
However, if the secretary's proposed rule passes, it would reverse more than three decades of public policy, as the secretary's proposed rule as published in the Federal Register eliminates this table provision from the vaccine injury table and leaves it to the sole discretion of the secretary as to what vaccines may be added to the NVICP. This means that all vaccines routinely administered to children, like a possible COVID-19 vaccine, may no longer be covered by the NVICP.
For those who are injured by a coronavirus vaccine, there appears to be some recourse available, but it may or may not be through the NVICP. In 2005, Congress enacted the Public Readiness and Emergency Preparedness Act, which authorizes the secretary of HHS to issue a declaration in response to a public health emergency.
The PREP Act was enacted to encourage the expeditious development and deployment of medical countermeasures during a public health emergency and authorizes the secretary of HHS to limit legal liability for losses relating to the administration of medical countermeasures, including diagnostics, treatments and vaccines. On Feb, 4, the secretary issued a PREP Act declaration concluding COVID-19 to be a public health emergency warranting liability protections for covered countermeasures.
The secretary's PREP Act declaration of Feb. 4 regarding COVID-19 indicates that manufacturers and administrators of COVID-19 vaccines are generally immune from legal liability for losses relating to the administration or use of covered countermeasures against COVID-19, except for willful misconduct resulting in death or serious physical injury.
This high standard will be exceptionally difficult for COVID-19 injured individuals to meet. Individuals who are injured or die as a result of receiving a COVID-19 vaccine may seek compensation through the Countermeasures Injury Compensation Program. Unlike the NVICP, this administrative process administered by HHS does not allow petitioners to recover any award for pain and suffering nor are claimant's attorney fees paid for by the program. Under the program, claimants must bear the cost of their own legal fees for bringing a claim.
At this point, it is unclear whether the program will be the sole recourse for persons injured from the coronavirus vaccine. It is likely that the secretary of HHS has not yet made a decision on this issue. Given that the proposed rule requests public comment as to whether COVID-19 vaccines should be covered by the NVICP, perhaps even the secretary is unsure whether one or more COVID-19 vaccines should be added to the NVICP.
As it stands now, if an individual receives a COVID-19 vaccine that results in SIRVA, they may be forced to bring their claim to the injury compensation program, but the program does not cover all forms of SIRVA injuries. Of course, SIRVA is just one possible adverse reaction to a coronavirus vaccine. Other adverse reactions may involve serious neurological conditions similar to those associated with the flu vaccine.
Although the instance of adverse vaccine reactions is very low, for those considering whether to obtain the COVID-19 vaccine there are things individuals can do to protect themselves to ward against adverse vaccine reactions.
If and when they become available, COVID-19 vaccines will become an effective tool in preserving public health. The development of these vaccines will also bring about a host of medical, ethical and legal issues. These issues will no doubt play out in courtrooms for many years to come.
Leah V. Durant is the principal and founder of The Law Offices of Leah V. Durant PLLC.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
[1] Johns Hopkins Coronavirus Resource Center.
[2] CDC.gov/vaccine safety.
[3] 42 U.S.C. § 300aa-1 et seq.
[4] https://www.hrsa.gov/sites/default/files/hrsa/vaccine-compensation/data/data-statistics-report.pdf.
[5] Martín Arias, K.H., et al., Risk of Bursitis and Other Injuries and Dysfunctions of the Shoulder Following Vaccinations,Vaccine,2017; 35: 4870-4876.
[6] The recorded meeting can be found here: https://hrsa.connectsolutions.com/pyw8twt062me/?proto=true.
[7] https://www.federalregister.gov/documents/2020/07/20/2020-15673/national-vaccine-injury-compensation-program-revisions-to-the-vaccine-injury-table.
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