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International Certificate of Vaccination or Prophylaxis

Pa, va, montana looking at COVID-19 mandates

Md gov can order doctors to vaccinate

Fl has forced vac provision – form handed out at airport, people sign

"N.J. wants 70% of adults to get COVID-19 vaccine in 6 months once it’s available" (but no mandates) https://www.nj.com/coronavirus/2020/10/nj-wants-70-of-adults-to-get-covid-19-vaccine-in-6-months-once-its-available.html

Proposal about using infrared tattoo with vaccine

ID card with expiration to participate in commerce COVID pass

7th cir march memo will reopen for mandatory vaccination hearings

https://news.mit.edu/2019/storing-vaccine-history-skin-1218


Government health officials and drugmakers plan to roll out extra tools to detect whether Covid-19 vaccines cause any serious side effects... to fill gaps in existing safeguards... .

The measures include surveys tracked through a smartphone app developed by the Centers for Disease Control and Prevention and special monitoring for groups including pregnant women and the elderly... .

CDC plans to send daily texts ... to anyone vaccinated who provides contact information ... daily for the first week post-vaccination, then weekly for six weeks.

"Covid-19 Vaccine Safety Efforts to Feature App Tracking of Vulnerable Groups," Wall Street Journal (November 5, 2020) https://www.wsj.com/articles/covid-19-vaccine-rollout-to-feature-app-tracking-monitoring-of-vulnerable-groups-11604582313.

H.R.2527 - Vaccinate All Children Act of 2019

Dorit Rubinstein Reiss – an index of her vaccine articles on this website

Vaccine Clinical Studies Safeguards, NIAID (October 26, 2011)

https://writtendescription.blogspot.com/

https://writtendescription.blogspot.com/2020/08/why-is-hhs-blocking-fda-from-regulating.html

https://sc.edu/safety/coronavirus/ipledgecolumbia/take_the_pledge/index.php

https://repository.law.umich.edu/mlr_online/vol118/iss1/5/

Mandatory COVID-19 Vaccination: Is It Legal and Is It Right for Your Workplace? (September 4, 2020)

Bioethics in a Pandemic: Vaccine Distribution

COVID-19 vaccines - is a global approach for universal access achievable?

New Guidance Reveals FDA's Thinking on Imposition of Civil Monetary Penalties for Violations of Clinical Trial Reporting Requirements (August 27, 2020)

Robert S. Nichols and Rebecca L. Baker, The COVID-19 Vaccine: Now Is Time for Employers to Plan for Whether They Can, and Should, Require Employees to Be Vaccinated (August 28, 2020)


Christopher T Robertson, K Aleks Schaefer, Daniel Scheitrum, Sergio Puig, Keith Joiner, "Indemnifying precaution: economic insights for regulation of a highly infectious disease," Journal of Law and the Biosciences, Volume 7, Issue 1, January-June 2020, lsaa032, published 30 May 2020 https://academic.oup.com/jlb/article/7/1/lsaa032/5848134

FDA eases some postmarket adverse event reporting deadlines during COVID-19 pandemic

FDA, Guidance for Industry Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic (May 2020)

On June 30, 2020 the CBER issued its nonbinding "Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry".

The Guidance formalizes the allowance of overlapping clinical trial phases, promotes the development of vaccines that are safe and effective for the most highly impacted populations (minorities, the elderly, those with comorbidities), and contemplates the possibility of Emergency Use Authorizations while also noting that full formal approval will ultimately be required for any vaccine sought to be licensed and distributed once the emergency has ended.

See also FDA Releases COVID-19 Vaccine Guidance for Industry

Compulsory licensing under Infection Protection Act: effects on data exclusivity under pharmaceutical law (01 July 2020) (Germany) (check authors)

To Protect or Not to Protect that is the Question : Patent Licensing in times of Covid-19 Pandemic (May 22, 2020) (India) (check authors)

COVID-19: HHS Clarifies Scope of PREP Act COVID-19 Declaration in Advisory Opinion (April 28, 2020)

COVID-19: Tort immunity for vaccines and antivirals – lessons from the swine flu of 1976 (April 8, 2020)

13. May an employer covered by the ADA and Title VII of the Civil Rights Act of 1964 compel all of its employees to take the influenza vaccine regardless of their medical conditions or their religious beliefs during a pandemic?

No. An employee may be entitled to an exemption from a mandatory vaccination requirement based on an ADA disability that prevents him from taking the influenza vaccine. This would be a reasonable accommodation barring undue hardship (significant difficulty or expense). Similarly, under Title VII of the Civil Rights Act of 1964, once an employer receives notice that an employee’s sincerely held religious belief, practice, or observance prevents him from taking the influenza vaccine, the employer must provide a reasonable accommodation unless it would pose an undue hardship as defined by Title VII ("more than de minimis cost" to the operation of the employer’s business, which is a lower standard than under the ADA).(36)

Generally, ADA-covered employers should consider simply encouraging employees to get the influenza vaccine rather than requiring them to take it. *As of the date this document is being issued, there is no vaccine available for COVID-19.

EEOC, Pandemic Preparedness in the Workplace and the Americans with Disabilities Act, UPDATED IN RESPONSE TO COVID-19 PANDEMIC – March 21, 2020

Jennifer B. Rubin, Vaccinate or Terminate – Mandatory Vaccination As Workplace Policy (July 28, 2020)

WHO, International community rallies to support open research and science to fight COVID-19 (29 May 2020)

Will the COVID-19 pandemic alter the future of patent licensing for vaccines? (July 8, 2020)

In late May, the World Health Organization (WHO) officially launched the COVID-19 Technology Access Pool (C-TAP), a patent pooling initiative first proposed by Costa Rican President Carlos Alvarado.

PANDEMIC INFLUENZA ACT, 2006

  • Immunization Exemption Guidance
    • "Vaccination programs are an important part of military public health and deployment readiness. However, sometimes a particular vaccination is not indicated for an individual to receive. There are 2 main types of exemptions from immunizations: medical and administrative. A medical exemption is a function that can only be validated by a health care professional. An administrative exemption is a non-medical function that is usually controlled by the individual's unit commander".

Parmet

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https://www.northeastern.edu/law/faculty/directory/parmet.html

Pandemic Vaccines — The Legal Landscape (May 27, 2010)

REDISCOVERING JACOBSON IN THE ERA OF COVID-19 (2020)

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  • Robert Iafolla and Allie Reed, Antibodies Unlikely to Sway Court in Covid Jab Mandate Battle, Bloomberg News (August 5, 2021):
    • But given that prior infection does provide some protection, “it could in fact be a due process violation to require someone to receive the vaccine that will have no demonstrable additional effect” if they have antibodies equivalent to those a vaccine would produce, said Brian Abramson, who teaches vaccine law at Florida International University College of Law.
      Mixed Precedent
      While no lawsuits offer a perfect precedent for this particular case, “many state statutes permit workers in the health-care field to avoid vaccination for diseases like measles and rubella if they are able to demonstrate that they have antibodies,” Abramson said.
      On the other hand, some prisoners who sought early release during the Covid-19 pandemic were “denied release because they have previously had Covid-19 and are presumed to have a certain amount of protection due to the antibodies,” Abramson said.
  • Nonmedical vaccine exemptions 'violate' a 'fundamental right' of children (April 23, 2019)
    • "Each state is responsible for creating its own immunization laws, which tend to be “wildly different” according to Brian Dean Abramson, Esq., LL.M, a vaccine law expert and author of Vaccine, Vaccination and Immunization Law. “Some states have specific language as to what kinds of documentation are needed to support a religious exemption. Some of them just say that a parent has to provide a statement saying that they have religious objections,” Abramson told Infectious Diseases in Children. “Philosophical exemptions are even further along this direction because there is no real test of whether someone genuinely has either a religious or philosophical objection. These exemptions, where they exist, they put the concept in a black box that really cannot be investigated.”
  • Tom Hals, U.S. employers get religion with vaccine mandates, Reuters (August 12, 2021):
    • "As an employer, you can inquire whether an employee has a sincerely held religious belief. It's just kind of a fraught investigation," said Brian Dean Abramson, an author and specialist in vaccine law.
      He said employers have to be careful not to appear to be invading the worker's privacy or harassing them and businesses have to be aware that employees' religious views may change over time.
  • Sarah Pulliam Bailey, Religious exemptions from coronavirus vaccines are expected to become a legal battleground, The Washington Post (September 1, 2021)
    • Religious objections to vaccines go back to the smallpox vaccine, said Brian Dean Abramson, adjunct professor of vaccine law at Florida International University.
      “One of the early arguments was that it’s God’s will to decide who dies and who doesn’t die,” he said. “If you vaccinate, some believed, you’re thwarting divine judgment.”
      However, Abramson said, as vaccines became normalized, most people who were vaccine hesitant were Jehovah’s Witnesses or Christian Scientists.
      “Only in recent decades have people started to say, ‘I have a religious objection,’ ” he said.
  • Scott Gleeson, Is Biden's COVID-19 vaccine mandate a law? What happens to those who don't get the shot?, USA Today (September 10, 2021):
    • "This isn't OSHA's first foray into vaccine law, but Biden's mandate is by far the most extensive in using OSHA as a vehicle for requirement," said Brian Dean Abramson, a leading expert on vaccine law.
      Abramson, a professor at Florida International University and the author of Bloomberg Law's "Vaccine, Vaccination, and Immunization Law," told USA TODAY this is the most sizable federal vaccine mandate in the history of nation. He noted that even smallpox mandates in the 19th century and early 20th centuries were enforced from U.S. states.
  • Brendan Morrow, Biden tells legal challengers to 'have at it' after announcing vaccine mandate, The Week (September 10, 2021):
    • As far as whether the legal challenges will succeed, vaccine law expert Brian Dean Abramson predicted to Insider that "we're not going to see a suspension of this rule," while constitutional law professor Erwin Chemerinsky argued to Law&Crime, "There is no constitutional problem with requiring people be vaccinated."
  • Amanda Kaufman, A Supreme Court case that originated in Mass. could provide a legal precedent for President Biden’s vaccine mandates, experts say, The Boston Globe (September 10, 2021)
    • “I think the Biden administration can clearly point to the fact that there is an ability of governmental entities to mandate vaccination,” Brian Dean Abramson, an adjunct professor of vaccination law at Florida International University, said of the Jacobson case. ... Abramson added that the Biden administration’s mandate is narrower than the requirement employed in the Jacobson case, because the Biden rules contain a testing mechanism and certain exemptions for vaccination. ... “I think that if Jacobson were being decided today, there would be some subtle differences in the outcome, recognizing the tradition that has developed for medical exemptions to vaccination to be provided,” Abramson said. ... In the case at issue in Jacobson, every adult resident of the jurisdiction was required to be vaccinated or face a criminal penalty, while with the Biden vaccine employer mandate, it will be a violation of Occupational Safety and Health Administration standards, Abramson said.
  • Tyler Whetstone, Knox County Mayor Glenn Jacobs says he will refuse to enforce President Biden's mandate on vaccines, Knoxville News Sentinel (September 17, 2021)
    • "Brian Dean Abramson, a leading expert on vaccine law and professor at Florida International University told USA Today while it is legal to enforce the mandate via OSHA, company CEOs can sue to block the measures. Employers could seek a nationwide injunction against OSHA, asking a judge to rule that the vaccine requirement doesn't fall under the realm of other enforcement such as a leaky roof.
      Regardless, Abramson said, OSHA won’t go after individuals for not getting vaccinated but instead would possibly fine a company for not complying".
  • Marina Villeneuve, NY governor vows to fight lawsuit over vaccine mandate, Associated Press (September 16, 2021)
    • “It is conceptually problematic for a state to say we’re requiring private businesses to impose a vaccination mandate on their employees without a religious exemption,” said Brian Dean Abramson, adjunct professor of vaccine law at Florida International University College of Law. “At the same time it matters if there are other routes to avoid vaccination.”
  • Rob Garver, Backlash Against Biden’s Vaccine Mandate Mounts Within GOP, Voice of America (September 10, 2021)
    • “OSHA has fairly broad authority delegated to it to ensure worker safety,” said Brian Dean Abramson, an adjunct professor of vaccine law at Florida International University and the author of the BloombergLaw/American Health Law Association treatise Vaccine, Vaccination, and Immunization Law.
      “The broad strokes of what has been presented — that employers with over 100 employees require employees be vaccinated or have some other measures in place to prevent the spread of infection or face an OSHA fine — I think that is likely to ultimately be upheld,” Abramson said.
  • Tom Hals, Texas vaccine mandate ban likely to be trumped by federal law but could cause uncertainty, KELO (Oct 13, 2021)
    • Brian Dean Abramson, a specialist and author on vaccine law, questioned if Texas would actually enforce the mandate ban by going after employers. But he said the threat was probably enough for most businesses to take action. “The employer will be in a position of having to thread the needle of establishing a vaccine policy that doesn’t run afoul of what Abbott requires and run afoul of what the Biden administration is requiring,” he said. “But ultimately federal law will be supreme.”
  • Rob Garver, World Leaders Struggle to Raise Vaccination Rates as COVID-19 Surges, Voice of America (November 26, 2021).
    • "Brian Dean Abramson, an adjunct professor of vaccine law at Florida International University and the author of the BloombergLaw/American Health Law Association treatise Vaccine, Vaccination, and Immunization Law, told VOA that the fate of the mandate remains unclear. According to Abramson, the Occupational Safety and Health Administration, the bureau within the Labor Department that crafted the mandate, left itself open to a number of challenges. For example, it is claiming that the new mandate is necessary to protect workers from a dangerous disease, but simultaneously claiming that health care workers can continue to observe a standard put in place earlier this year that is considerably less stringent".

“The kind of cautious thing for [the Centers for Medicare & Medicaid Services] to do — and the thing that I’d image they will do — will be to reset those deadlines, perhaps push them back by a month,” Brian Dean Abramson, vaccine law expert, author and adjunct professor at Florida International University College of Law, told McKnight’s Long-Term Care News Thursday. ... “I have said that the enactment and the publication of these regulations by the Biden administration is the first step in the waltz. It’s a waltz that we have seen danced before,” Abramson explained. He noted that employers nationwide will likely see modification to all three federal vaccination mandates in response to pending legal cases.

  • Kimberly Marselas, Providers cautiously accept new COVID vaccine mandate guidance as SCOTUS hearing nears, McKnights Long-Term Care News (January 2, 2022), https://www.mcknights.com/news/providers-cautiously-accept-new-covid-vaccine-mandate-guidance-as-scotus-hearing-nears/
    • “It is widely expected in legal circles that the Supreme Court will rule fairly quickly on this, possibly within a matter of a few days,” said Brian Dean Abramson, vaccine law expert, author and adjunct professor at Florida International University College of Law. “The Court’s focus will be on the question of whether CMS has the statutory authority to impose a vaccination requirement at all, no matter what flexibility accompanies its deadlines.”
  • Erin Snodgrass, What to watch for as the Supreme Court reviews challenges to Biden's federal vaccine mandates on Friday, Insider (Jan. 7, 2022), https://www.businessinsider.com/scotus-vaccine-mandates-what-to-watch-for-according-to-expert-2022-1
    • "They are very different issues," Brian Dean Abramson, an adjunct professor of vaccine law at Florida International University and author of "Vaccine, Vaccination, and Immunization Law" told Insider. "But it's actually common for the Supreme Court to bundle issues that touch on common areas of law."
  • Karena Phan, The Associated Press, NOT REAL NEWS: A look at what didn’t happen this week (February 11, 2022)
    • "Vaccine manufacturers do have special immunity from liability under different programs, including the 2005 Public Readiness and Emergency Preparedness Act. And individuals or organizations involved in the manufacture, distribution, or dispensing of medical countermeasures can’t be sued if a person had an adverse reaction to or is injured by a vaccine, said Brian Dean Abramson, an adjunct professor of vaccine law at the Florida International University College of Law. It is possible to sue a vaccine maker if they demonstrate willful misconduct but it’s very difficult to prove, he added".

Gannon v. Am. Home Prods., Inc.

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Gannon v. Am. Home Prods., Inc., 211 N.J. 454, 48 A.3d 1094 (N.J. 2012)

Plaintiffs Jamie and Rebecca Gannon, asserting that plaintiff Jamie Gannon developed a form of brain cancer because of a series of polio vaccines he was given as a child, pursued various forms of relief in both federal and state courts. In the federal court action, they sought relief from the United States pursuant to the Federal Tort Claims Act, 28 U.S.C. §§ 1346(b), 2671–80, contending that the federal government was negligent in permitting the polio vaccine to be sold to the public. Plaintiffs' federal action was dismissed following a partial bench trial, based on the

        [48 A.3d 1096]

government's motion for judgment on partial findings, Fed.R.Civ.P. 52(c); see Gannon v. United States, 571 F.Supp.2d 615, 616, 641 (E.D.Pa.2007), and that judgment was affirmed by the United States Court of Appeals for the Third Circuit, see Gannon v. United States, 292 Fed.Appx. 170, 175 (3d Cir.2008).

        [211 N.J. 457]Proceeding on a parallel track, plaintiffs sought relief in our state courts. In the state court action, they raised product liability claims against defendants American Home Products, Inc., American Cyanamid Company, Lederle Laboratories, and Wyeth–Lederle Vaccines, which they asserted were the entities that had manufactured or distributed the polio vaccine given to plaintiff Jamie Gannon. In the state court litigation, the trial court granted summary judgment in favor of defendants, R. 4:46–2, basing its decision on two grounds. First, the trial court concluded that plaintiffs lacked sufficient evidence to prove the identity of the manufacturer of the polio vaccine that plaintiff Jamie Gannon was given. Second, the trial court concluded that plaintiffs were collaterally estopped from bringing the cause of action based on the prior judgment entered in federal court.

        The Appellate Division, in a published opinion, reversed both aspects of the trial court's judgment and remanded the matter for further discovery and for trial. Gannon v. Am. Home Prods., Inc., 414 N.J.Super. 507, 511, 999 A.2d 522 (App.Div.2010). The panel first concluded that the trial court had utilized an incorrect standard in evaluating the sufficiency of the product identification evidence because it failed to afford plaintiffs the benefit of the inferences to which they were entitled as the non-moving parties in the context of a summary judgment motion. Id. at 516–18, 999 A.2d 522. The panel then concluded that there were equitable considerations that militated against granting collateral estoppel effect to the judgment of the federal court, including the status of discovery in the state court matter and the pendency of similar state court litigation involving other plaintiffs. Id. at 526–30, 999 A.2d 522. For both of those reasons, the panel reversed the trial court's grant of summary judgment and remanded the matter for further proceedings.

        Because we conclude that the Appellate Division's collateral estoppel analysis was in error, we reverse. Inasmuch as that conclusion resolves this matter, we do not address the arguments [211 N.J. 458]of the parties concerning the panel's product identification discussion. Gannon v. Am. Home Prods., Inc., 211 N.J. 454, 48 A.3d 1094 (N.J. 2012)

Medicare Program; CY 2021 Payment Policies

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Proposed rule Centers for Medicare & Medicaid Services 42 CFR parts 410, 414, 415, 423, 424, and 425 [CMS-1734-P] RIN 0938-AU10

Especially in the context of the current Public Health Emergency (PHE) related to the COVID-19 pandemic, it is evident that consistent beneficiary access to vaccinations is vital to public health. Many stakeholders have raised concerns regarding the reductions in payment rates for vaccine administration services over the past several years. The codes that describe these services have generally been valued based on a direct crosswalk to CPT code 96372 (Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular). Because we proposed and finalized reductions in valuation for that code for CY 2018 and because the reductions in overall valuation have been subject to the multi-year phase-in of significant reductions in RVUs, the payment rate for the vaccine administration codes has been concurrently reduced.

In the CY 2020 PFS final rule, we acknowledged that it is in the public interest to ensure appropriate resource cost are reflected in the valuation of the immunization administration services that are used to deliver vaccines and noted that we planned to review the valuations for these services in future rulemaking. For CY 2020, we maintained the CY 2019 national payment amount for immunization administration services described by HCPCS codes G0008 (Administration of influenza virus vaccine), G0009 (Administration of pneumococcal vaccine), and G0010 (Administration of hepatitis b vaccine) in the interim.

The RUC has recently re-submitted recommendations from 2009 regarding the appropriate valuation for the broader range of vaccine administration services, including CPT codes 90460 (Immunization administration through 18 years of age via any route of administration, with counseling by physician or other qualified health care professional; first or only component of each vaccine or toxoid administered), 90471 (Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); 1 vaccine (single or combination vaccine/toxoid)), and 90473 (Immunization administration by intranasal or oral route; 1 vaccine (single or combination vaccine/toxoid)). In its recommendation, the RUC noted that the current RVUs assigned are directly crosswalked from CPT code 96372 (like the vaccine administration G-codes had been) and the resulting payment rates are substantially lower than current Centers for Disease Control and Prevention (CDC) regional maximum charges. The RUC also pointed out that that appropriate payment for immunization administration that reflects resource cost is critical in maintaining high immunization rates in the United States, as well as having the capacity to respond quickly to vaccinate against preventable disease outbreaks.

We agree with the RUC’s assertions regarding the importance of appropriate resource based valuations for vaccine administration services. We also recognize that the importance of these services is increased in the context of the current PHE related to the COVID-19 pandemic, especially should there be a vaccine for this particular disease.

We reviewed and considered the 2009 RUC-recommended direct PE inputs for CPT codes 90460-90474 (as well as the related G-codes) in place of the existing policy based on a crosswalk to CPT code 96372. However, the RUC-recommended direct PE inputs from 2009 would result in significant decreases in valuation for these 6 CPT codes even compared to the current crosswalk. At this time, we do not believe that either the existing crosswalk or the RUC recommendations from over a decade ago reflect the relative resource costs associated with these services. Without updated information to use in developing rates specific to these codes based on direct PE inputs, and in consideration of the import of these services for Medicare beneficiaries, as well as the public health concerns raised by commenters, we believe that it would be most appropriate to value these services using a crosswalk methodology that better reflects the relative resources involved in furnishing all of these services.

Therefore, we are proposing to crosswalk the valuation of CPT codes 90460, 90471, and 90473 and HCPCS codes G0008, G0009, and G0010 to CPT code 36000 (Introduction of needle or intracatheter, vein). CPT code 36000 is a service with a nearly identical work RVU (0.18 as compared to 0.17 for CPT codes 90460, 90471, and 90473) and a similar clinical vignette. We believe that the additional clinical labor, supply, and equipment resources associated with the furnishing of CPT code 36000 more accurately capture the costs associated with these immunization codes. We also note that this crosswalk will result in payment rates for vaccine administration services at approximately the same CY 2017 rates that were paid prior to the revaluation of CPT code 96372, which had previously served as the basis of the crosswalk. We believe that the proposed crosswalk is the most accurate valuation of these services and will also serve to ensure the appropriate relative resources involved in furnishing all of these services is reflected in the payment for these critical immunization and vaccination services in the context of the health needs of Medicare beneficiaries.

Regarding the add-on codes associated with these services, CPT codes 90461 (Immunization administration through 18 years of age via any route of administration, with counseling by physician or other qualified health care professional; each additional vaccine or toxoid component administered), 90472 (Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); each additional vaccine (single or combination vaccine/toxoid)), and 90474 (Immunization administration by intranasal or oral route; each additional vaccine (single or combination vaccine/toxoid)), we note that the previous valuation methodology set their RVUs at approximately half of the valuation for the associated base codes, described above. Absent additional information, we are proposing to maintain that approach by valuing the three add-on codes at half of the RVUs of the aforementioned crosswalk to CPT code 36000.

Finally, we are proposing this valuation to apply to all of these existing vaccine administration codes, using the valuation of CPT code 90471 for base codes and CPT code 90472 for add-on codes. Should a vaccine for COVID-19 or other infectious disease become available during CY 2021, we would anticipate applying the same approach to valuing the administration of such vaccines, regardless of whether separate coding for such services would need to be introduced.

McKercher v. Sec'y of Health & Human Servs. (Fed. Cl. 2015)

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Notwithstanding her position, respondent's counsel informally provided petitioner's counsel correspondence and other documentation between Mr. McKercher and the Countermeasures Injury Compensation Program ("CICP"), the office which administers compensation to individuals who allege a vaccine injury from the H1N1 monovalent influenza vaccine. Response at 5; see generally Respondent's Exhibit ("Res. Ex.") A. Respondent's counsel noted that her inquiry into the Vaccine Injury Compensation Program ("VICP"), the office of the respondent in this matter, showed that "VICP has no record of any correspondence or conversation with petitioner." Id.

Respondent's exhibit A confirms that petitioner contacted CICP in April 2010 for an alleged injury resulting from an H1N1 vaccination he received on January 18, 2010. Res. Ex. A at 1-2. After a review of his claim, the CICP informed petitioner that he was medically ineligible for benefits as no scientific evidence linked his diagnosis and conditions to the H1N1 vaccine. Id. at 39. Thereafter, at petitioner's request, a panel was convened to reconsider petitioner's claim and it also came to the same conclusion. Id.

Tang v. Vaxin, Inc. (N.D. Ala. 2016)

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Plaintiff De-chu Christopher Tang sued after being fired from his position as a researcher for Vaxin, asserting among other things that they stole his research and vaccine development samples (which he claimed were useless without him being there to interpret them).

Held: research done as an employee is property of the employer.

Tabs

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Darryl Bernstein, Rui Lopes, and Zareenah Rasool, South Africa: The Pathway to Regulatory Approval of the COVID-19 Vaccine, 12 Nov 2020

  • Michael D. Shalhoub, HHS Issues Guidance on Vaccine-related COVID-19 Countermeasures, November 13, 2020: "HSS considers state-licensed pharmacists and pharmacy interns to be qualified persons under the PREP Act. Pharmacists or pharmacist interns who otherwise might not be eligible to administer such vaccinations, are permitted to do so under the PREP Act, provided that the pharmacist has undergone 20 hours of specified training. However, if a state permits such vaccinations with a lesser amount of training, the PREP Act does not preempt state law in that regard. The pharmacist in such a state can vaccinate and still have the PREP Act protection".
    • ADVISORY OPINION 20-03 ON THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT AND THE SECRETARY’S DECLARATION UNDER THE ACT OCTOBER 22, 2020, AS MODIFIED ON OCTOBER 23, 2020
      States or their sub-units may not impose any requirement that would prohibit or effectively prohibit activities authorized by the Secretary in a PREP Act declaration. Accordingly, state-licensing laws that are less stringent than those in the Secretary’s Declaration are not preempted, because they do not prohibit or effectively prohibit the activity in question—namely, vaccination.
      Conversely, any state or local law requiring a pharmacist to enter into a collaborative-practice agreement would be preempted if that requirement prohibits or effectively prohibits a pharmacist from ordering and administering vaccines as set forth in the Third Amendment and related issuances.
      Certain states require a protocol or a collaborative-practice agreement (CPA) to administer vaccinations to children of certain ages. Whether the Third Amendment preempts these state requirements depends on whether those requirements prohibit or effectively prohibit qualified pharmacists from ordering and administering (and qualified interns from administering) ACIP-recommended vaccines to children ages 3-18.
  • COVID-19 VACCINES: CONSIDERATIONS FOR US EMPLOYERS, November 09, 2020:
    OSHA may use "general duty clause to require employers to make the COVID-19 vaccine available to employees.
    Nonunion NLRA implications: "Section 7 of the NLRA grants employees the right to engage in “concerted activities” for the purpose of “mutual aid and protection.” This provision may protect the rights of employees who engage in concerted activities with regard to a mandatory workplace vaccine. Examples of protected activities could include protesting against a mandatory vaccination policy, organized office communications or flyers among coworkers concerning a vaccination mandate, or simply coworker discussions about the vaccine".
    "a significant number of other states—for example, Alabama, Kentucky, Massachusetts, North Carolina, Pennsylvania, and Tennessee—permit an employee to decline the influenza vaccination for any reason, so long as the employee was informed of the health risks beforehand".
    "drug treatment centers and homeless shelters in California, or childcare facilities in Texas and Rhode Island—may be subject to various vaccine requirements on a state-by-state basis".

More tabs

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  • Helen H. Mao and Shoubai Chao, "Advances in Vaccines" (2019) ** Newly licensed = Shingrix Vaccine; Ebola Vaccine: Ad5-EBOV ("clinical trial permit from the Chinese Food Drug Administration (NMPA, formerly CFDA) and from the Government of Sierra Leone"); Meningococcal Subgroup B Vaccine (MenB); HPV; Dengue; EV71 Vaccine (approved by the Chinese Drug Administration); HBV Recombinant Vaccine
    • Under development = RSV Vaccine; Ebola; Malaria

NJ

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3-11 restart

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4-14 restart

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  • The COVID-19 Vaccine Rollout: What Employers Need to Know (April 6, 2021)
    • "no laws expressly prohibit employers from mandating COVID-19 vaccinations as a condition of employment"; bills to this effect proposed in Alabama, Arizona, Connecticut, Illinois, Iowa, Kansas, Kentucky, Maryland, Minnesota, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas and Washington
    • Title VII, ADA, Pregnancy Discrimination Act
    • To get around ADA prohibited inquiries, EEOC oks "strictly voluntary vaccine programs" and "vaccines from a public vaccination site, or a health care provider, without employer involvement"
  • CDC Issues Guidance on Workplace Vaccination Programs, Lee Tankle (April 7, 2021)
    • "CDC recommends offering on-site vaccinations for companies with (a) large workforces at one physical location on a predictable schedule and (b) sufficient space to set up a vaccine clinic with appropriate social distancing".
    • Also recommends "a diverse group of respected organizational leaders obtain the vaccine and publicize their stories".
    • Also recommends paid leave for vaccinations and "flexible, non-punitive sick leave options (e.g., paid sick leave) for employees with signs and symptoms after vaccination".
    • Suggests providing transportation to off-site vaccination sites.
    • Suggests staggering vaccination schedules to avoid worker shortages.
  • EEOC Updates COVID-19 Technical Assistance with Vaccination Guidance (Part II) (March 16, 2021)
    • ADA confidentiality for medical info obtained pursuant to COVID-19 vaccination program
    • Employer can ask for proof of vaccination (non-vaccination may not indicate disability); can't ask why not unless there is a business necessity
    • Must try to accommodate per ADA/Title VII
    • Does not implicate GINA unless screening questions do

Added 4-15

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  • Kelly A. Bauer, Christian J. Litwiller and Timothy Fry, Rural FQHC Can Provide Free Space for COVID-19 Vaccinations (April 13, 2021)
    • HHS OIG was asked whether a federally qualified health center (FQHC) with a location in a rural area can provide free space to a retail pharmacy that administers COVID-19 vaccinations to FQHC patients and the general public
    • Response was yes, because "vaccine administration is crucial to the COVID-19 pandemic response and that individuals in rural areas may face heightened challenges in accessing vaccines"

Added 4/26-30

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  • Andrew C. Karter, Mandatory Versus Voluntary Vaccinations: An Employer Guide (April 26, 2021)
    • FD&C Act says individuals must be informed of “the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and of the option to accept or refuse administration of the product”; but also “of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.” 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III).
  • Ryan P. Blaney & Krusheeta R. Patel, Federal Vaccination Tracking Raises Privacy Concerns (April 14, 2021)
    • CDC has asked for data-sharing
    • " HHS exercised its enforcement discretion to announce it will not enforce penalties in connection with the good faith use of online scheduling applications for COVID-19 vaccinations"
  • Additional PREP Act Amendments Accommodate Vaccination Administration Needs (April 20, 2021)
    • Fifth Amendment (February 2, 2021) "ensures that healthcare professionals can cross state lines to administer vaccinations"; must complete CDC COVID-19 Vaccine Training modules
    • Sixth Amendment expands protection to "any federal government employee, contractor, or volunteer who would distribute or dispense COVID-19 vaccines", if not otherwise covered
    • Seventh Amendment (March 16, 2021) covers administrations by "midwives, paramedics, advanced or intermediate emergency medical technicians (EMTs), physician assistants, respiratory therapists, dentists, podiatrists, optometrists, and veterinarians"

OSHA FAQ

Q. Are adverse reactions to the COVID-19 vaccine recordable on the OSHA recordkeeping log?

A. In general, an adverse reaction to the COVID-19 vaccine is recordable if the reaction is: (1) work-related, (2) a new case, and (3) meets one or more of the general recording criteria in 29 CFR 1904.7 (e.g., days away from work, restricted work or transfer to another job, medical treatment beyond first aid).

Q. If I require my employees to take the COVID-19 vaccine as a condition of their employment, are adverse reactions to the vaccine recordable?

A. If you require your employees to be vaccinated as a condition of employment (i.e., for work-related reasons), then any adverse reaction to the COVID-19 vaccine is work-related. The adverse reaction is recordable if it is a new case under 29 CFR 1904.6 and meets one or more of the general recording criteria in 29 CFR 1904.7.

Q. I do not require my employees to get the COVID-19 vaccine. However, I do recommend that they receive the vaccine and may provide it to them or make arrangements for them to receive it offsite. If an employee has an adverse reaction to the vaccine, am I required to record it?

A. No. Although adverse reactions to recommended COVID-19 vaccines may be recordable under 29 CFR 1904.4(a) if the reaction is: (1) work-related, (2) a new case, and (3) meets one or more of the general recording criteria in 29 CFR 1904.7, OSHA is exercising its enforcement discretion to only require the recording of adverse effects to required vaccines at this time. Therefore, you do not need to record adverse effects from COVID-19 vaccines that you recommend, but do not require.

Note that for this discretion to apply, the vaccine must be truly voluntary. For example, an employee’s choice to accept or reject the vaccine cannot affect their performance rating or professional advancement. An employee who chooses not to receive the vaccine cannot suffer any repercussions from this choice. If employees are not free to choose whether or not to receive the vaccine without fearing adverse action, then the vaccine is not merely “recommended” and employers should consult the above FAQ regarding COVID-19 vaccines that are a condition of employment.

Note also that the exercise of this discretion is intended only to provide clarity to the public regarding OSHA’s expectations as to the recording of adverse effects during the health emergency; it does not change any of employers’ other responsibilities under OSHA’s recordkeeping regulations or any of OSHA’s interpretations of those regulations.

Finally, note that this answer applies to a variety of scenarios where employers recommend, but do not require vaccines, including where the employer makes the COVID-19 vaccine available to employees at work, where the employer makes arrangements for employees to receive the vaccine at an offsite location (e.g., pharmacy, hospital, local health department, etc.), and where the employer offer the vaccine as part of a voluntary health and wellness program at my workplace. In other words, the method by which employees might receive a recommended vaccine does not matter for the sake of this question.

Added 5/1-5/5

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  • Lara D. Compton, Bridgette A. Keller, The Ongoing US Vaccine Passport Debate (April 29, 2021)
    • "Biden administration announced that vaccination credentials or “passports” would not be mandated at the federal level and that there would be no centralized universal federal vaccinations database"; federal government will only facilitate standards.
    • Lots of private solutions are being implemented without standardization.
    • HIPAA allows patients to voluntarily share information, so these solutions may cause privacy headaches.

5/12 restart

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After 5/12

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June

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  • Vaccine injuries are not OSHA recordable unless the vaccine is required - DOL and OSHA, as well as other federal agencies, are working diligently to encourage COVID-19 vaccinations. OSHA does not wish to have any appearance of discouraging workers from receiving COVID-19 vaccination, and also does not wish to disincentivize employers’ vaccination efforts. As a result, OSHA will not enforce 29 CFR 1904’s recording requirements to require any employers to record worker side effects from COVID-19 vaccination through May 2022. We will reevaluate the agency’s position at that time to determine the best course of action moving forward.
  • May 2021 EEOC/OSHA updates
    • Eric Amdursky, et al., EEOC and OSHA Release Updated Vaccine Guidance (May 29, 2021)
    • Susan F. Eandi, Robin Samuel & Autumn Sharp, EEOC Updates its COVID-19 Technical Assistance: Employers Administering Vaccines Can Offer Non-Coercive Incentives to Employees (May 28, 2021)
    • Fiona W. Ong, OSHA Changes Its Recording Requirements for Adverse Reactions to the COVID-19 Vaccine (May 24, 2021)
    • Jim Paretti, Barry Hartstein, Philip Gordon, David Gartenberg, and Dane Steffenson, Key Takeaways from the EEOC’s Updated Guidance Regarding COVID-19 Vaccinations, Incentives (June 1, 2021)
      • "EEOC's revised guidance makes clear that, subject to certain limitations... an employer can lawfully require that its employees obtain a COVID-19 vaccination as a condition of returning to the workplace".
      • EEOC points to CDC as "important source of current medical knowledge about COVID-19".
      • EEOC says "direct threat" assessment should consider "the type of work environment, such as whether the employee works alone or with others or works inside or outside; the available ventilation; the frequency and duration of direct interaction the employee typically will have with other employees and/or non-employees; the number of partially or fully vaccinated individuals already in the workplace; whether other employees are wearing masks or undergoing routine screening testing; and the space available for social distancing".
      • Accommodations can include masking/social distancing, limiting contact with others, modified shifts, telework, testing, reassignment to another workplace.
      • ADA/GINA not implicated by incentives (but no clarification on availability of incentives to non-vaccinating)
      • Employers "should not assume that an employee does not require an accommodation relating to COVID-19 simply because the employee is fully vaccinated".

August–September

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  • Colorado Issues COVID-19 Vaccination Mandate for Many Healthcare Settings: "On August 30, 2021, the Colorado Board of Health (the “Board”) adopted an emergency rule, 6 CCR 1101-1, Chapter 2 Part 12, mandating that all employees, direct contractors, and support staff (“covered employees”) in licensed healthcare settings in Colorado receive their first dose of the COVID-19 vaccine by September 30, 2021 and be fully vaccinated no later than October 31".
  • COVID-19 VACCINATIONS IN THE WORKPLACE (NZ): "The New Zealand Bill of Rights Act 1990 (BORA) protects the right of everyone to refuse to undergo any medical treatment. ... However, an employer could require those working with a high risk of contracting and transmitting Covid-19 to be vaccinated in order to comply with the employer’s obligations under the Health and Safety at Work Act 2015 (HSWA)".

October-December

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