Good Brief on No FDA Approved Vaccine Available
Amicus DTR is a nonprofit organization that is dedicated to defending the Constitution, the rule of law, and protecting individual rights of Americans including medical freedom and religious liberty. DTR represents over thirty military service members in litigation involving the violation of their religious freedoms and their other constitutional and statutory rights to refuse mandatory vaccination with experimental COVID-19 treatments. DTR also expects to file suit soon to challenge the federal contractor vaccine mandate on behalf of individual federal contractors on similar grounds that have led multiple federal district courts to impose a nation-wide injunction and stay.
The COVID-19 vaccine mandate at issue in this case is contrary to the mission and values of DTR. It will subject tens of millions of Americans to an unprecedented federal seizure of power, threatening this nation’s Constitutional system of federalism. It contradicts and violates existing laws and individual rights to make health care decisions, and it violates this Court’s long-standing recognitions of rights to privacy.
In consideration of these interests, DTR seeks to inform the Court that the Pfizer COVID-19 vaccine mandated by the OSHA ETS and described as being the one approved by the FDA, i.e., Comirnaty, is not currently available to anyone in the United States. The United States finally and reluctantly conceded this in a lawsuit DTR brought in Florida. There is no supply of Comirnaty. The only vaccines in production and available are the vaccines approved under the FDA’s Emergency Use Authorization (“EUA”). DTR files this brief to explain why the OSHA COVID-19 vaccine mandate before the Court is an illegal federal mandate to compel Americans to take an experimental vaccine.
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FDA is Pfizer-BioNTech’s Comirnaty, which is not available in the United States. The only COVID-19 products that are available are not FDA approved and instead are subject to an EUA.
As explained below, the distinction between an EUA and an FDA-approved product matters. See infra Section III. In particular, the FDA’s grant of EUA requires little, if any, demonstration that the EUA product is safe and effective. Nor does the EUA include FDA review or approval of manufacturing processes, facilities, storage, distribution, or quality control procedures. This is why the FDA has acknowledged the products are “legally distinct.”6
The unavailability of Comirnaty raises a second question that also has not been asked, much less addressed, by OSHA or in the judicial decisions under review. Federal laws and applicable FDA regulations expressly provide a “right to refuse” experimental or EUA products. See 21 U.S.C. § 360bbb3(e)(1)(A)(ii)(III). Yet, the OSHA Mandate unlawfully overrides or circumvents those laws.
These rights to informed consent and to refuse experimental drugs—embodied not only in federal law, like 21 U.S.C. § 360bbb-3, but also international law and conventions like the Nuremburg Code—should foreclose such a wide-ranging mandate. DTR urges this Court to consider the enormous wrongful consequences of imposing an illegal mandate requiring nearly the entire United States adult workforce to take an experimental and irreversible medical treatment.
The immeasurable ramifications of endorsing a near-universal federal mandate justify granting a stay to give more time for deeper consideration by this Court, the political branches, public health experts, and the citizens of the United States to consider the legal arguments and scientific evidence on the safety and efficacy of the newly manufactured “vaccines,” the rapidly proliferating range of therapies, and alternative federal, state, and local public health measures. Surely a stay to allow this Court to hear the arguments presented by all Parties and Amici is appropriate given the momentous consequences for tens of millions of Americans who face the loss of their rights to work, education, travel, worship and other fundamental constitutional rights unless they submit to an unproven, experimental medical treatment with an unprecendented history of adverse effects including deaths.
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II. The FDA-Approved Comirnaty is Unavailable to the American Public
On August 23, 2021, the FDA approved the PfizerBioNTech mRNA vaccine under the marketed name Comirnaty.12 Soon thereafter, on September 9, 2021, President Biden announced that he would “protect vaccinated workers from unvaccinated co-workers” by having the Department of Labor issue “an emergency rule to require all employers with 100 or more employees . . . to ensure their workforces are fully vaccinated or show a negative test at least once a week.”13
With these marching orders, the Secretary of Labor, through OSHA, issued the OSHA ETS, which mandated that private businesses with 100 or more employees “develop, implement, and enforce a mandatory COVID-19 vaccination policy, with an exception for employers that instead adopt a policy requiring employees to either get vaccinated or elect to undergo regular COVID-19 testing and wear a face covering at work in lieu of vaccination.” OSHA ETS, 86 Fed. Reg. at 61,402. Americans subject to this ETS are in compliance if they receive the recommended minimum doses of COVID-19 vaccines that are “[a]pproved or authorized for emergency use by the FDA.” Id. at 61,479.
Notwithstanding the jurisdictional issues underlying the OSHA Mandate, there is a significant problem concerning how Americans are forced to comply with the mandate. Specifically, the only FDA approved vaccine – Comirnaty – is not available to the American public. According to the CDC, “COMIRNATY products are not orderable at this time.”14 As of December 16, 2021, “there is not sufficient approved vaccine [i.e., Comirnaty] available for the population for whom it is authorized.” See supra, FDA Pfizer-BioNTech Expansion Letter, note 6 at 5 n.9. In fact, it appears that Comirnaty is not available at all in the United States. Pfizer and the National Institutes of Health confirmed that Comirnaty would be unavailable for months after its approval.15
The Department of Justice (“DOJ”) finally conceded the unavailability of Comirnaty through defense counsel for DOD in Austin, where DTR represents service members challenging the DOD Mandate. While DOD initially claimed that the DOD in fact possessed Comirnaty and was administering it to service members, in oral argument, DOJ defense counsel acknowledged that not only did it not have Comirnaty and did not know when it would it get it, but also “could not say even whether vaccines labeled ‘Comirnaty’ exist at all.” Doe v. Austin, 2021 WL 5816632, at *5 (N.D. Fla. Nov. 12, 2021) (citations omitted).16
DOD is the largest purchasing organization in the United States, and given its priority for national security matters, it would necessarily go to the front of the line for any purchasing COVID-19 vaccines. Yet DOD does not have Comirnaty and to this day the DOD cannot say when it will get Comirnaty. If the DOD cannot obtain Comirnaty, then how can average Americans who are subject to the OSHA Mandate? And perhaps more importantly, how can employees be fired for the failure of their employers to obtain a vaccine that even the DOD cannot procure?
The unavailability of Comirnaty is important. First, while OSHA purports to give employers the option of requiring vaccination or allowing testing and masks, it does not hide its real intent to force employees to choose vaccination to keep their jobs. If an employee opts out of their employer’s mandatory vaccination policy, OSHA believes its ETS and the costs it imposes on that employee – which includes paying for regular testing – “creates a financial incentive for those employees to become fully vaccinated and avoid that cost.” OSHA Mandate, 86 Fed. Reg. at 61,532
As Judge Larsen observed in his dissenting opinion on the emergency motion to dissolve the stay of the OSHA Mandate, the Mandate’s main purpose is to compel vaccination:
Second, and in consideration of OSHA’s coercive policy, workers will only be able to comply with the OSHA Mandate if they receive a vaccine under an EUA.18 This is especially important because EUA vaccines bypass the FDA and PHS Act’s requirements for safety and efficacy.
III. Important Differences Between EUA and FDA-Approved Vaccines
There are significant differences between the FDA’s approval standards and the EUA standards. EUA vaccines require little to no proof of safety or efficacy. FDA vaccine approvals do.
The FDA may grant an EUA where: (1) the HHS Secretary has declared a public health emergency that justifies the use of an EUA, see 21 U.S.C. § 360bbb3(b)(1); and (2) the FDA finds that “there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating” the disease in question. 21 U.S.C. § 360bbb-3(c)(3).
The differences between licensed vaccines and those subject to an EUA render them “legally distinct.” See supra, FDA Pfizer-BioNTech EUA Expansion Letter, note 6 at 2 n.8. First, the requirements for efficacy are much lower for EUA products than for licensed products. EUAs require only a showing that, based on scientific evidence “if available,” “it is reasonable to believe,” the product “may be effective” in treating or preventing the disease. 21 U.S.C. §360bbb-3(c)(2)(A).
By plan, those vaccines that are subject to the OSHA Mandate have relatively little data to support their authorization. The Pfizer-BioNTech Vaccine was granted its EUA after approximately 2 months of follow-up testing. See supra, FDA Pfizer-BioNTech EUA Review Memo, note 10 at 17. The Moderna Vaccine received its EUA after providing its studies to the FDA “with a median of 7 weeks of follow-up after the second dose.”19 And for the Janssen Vaccine, which also received an EUA, “the median follow-up duration for participants in the efficacy and safety analysis populations was 8 weeks after vaccination.”20
Second, the safety requirements are minimal, requiring only that the FDA conclude that the “known and potential benefits … outweigh the known and potential risks” of the product, considering the risks of the disease. 21 U.S.C. §360bbb-3(c)(2)(B). There is no requirement that the FDA know the potential risks of the product.
In comparison, vaccines that go through traditional FDA review typically take 10 years or more to reach approval.21 And the approval process compiles more information on the risks of the vaccine, gathered through lab testing and clinical trials, “to assess the safety and effectiveness of each vaccine.”22
A. The Right to Refuse an EUA Vaccine
The FDA’s grant of an EUA is subject to informed consent requirements to “ensure that individuals to whom the product is administered are informed” that they have “the option to accept or refuse administration of the product.” 21 U.S.C. § 360bbb3(e)(1)(A)(ii)(III).
For the three COVID-19 vaccines, FDA implemented the “option to accept or refuse” condition described in Section 564(e)(1)(A)(ii)(III) in each letter granting the EUA by requiring that FDA’s “Fact Sheet for Recipients and Caregivers” be made available to every potential vaccine recipient. These include the statement that the recipient “has the option to accept or refuse” the vaccine.23 Moreover, the EUA label itself must expressly state that the recipient has a “right to refuse” administration of the EUA product. Accordingly, the OSHA Mandate contradicts established federal law and will require any covered employer, including state agencies, to violate an express requirement of federal law and the express terms of the FDA labeling and packaging requirements.
B. OSHA Cannot Override Informed Consent Rights
The norm of informed consent has been “firmly embedded” in U.S. law and FDA regulations for nearly 60 years. Adullahi v. Pfizer, Inc., 562 F.3d 163, 182 (2d Cir. 2009). Congress first enacted this requirement in 1962 drawing on the Nuremberg Code and the Helsinki Declaration, “which suggests the government conceived of these sources’ articulation of the norm as a binding legal obligation.” Adullahi, 562 F.3d at 182. Informed consent requirements are a cornerstone of FDA rules governing human medical experimentation. See, e.g., 21 C.F.R. §§ 50.20, 50.23-.25, 50.27, 312.20, 312.120 (2008); 45 C.F.R. §§ 46.111, 46.116-117.
In any case, OSHA has not even acknowledged workers’ informed consent rights, much less explained how its mandate can override these rights or force private and public sector employers into violating these rights. Accordingly, the OSHA Mandate cannot stand.
A helpful analogy when considering forced vaccination is to compare the present case to the DOD’s much narrower Anthrax Vaccination Immunization Program. Courts enjoined that program, as it sought to impose a vaccine mandate on service members using experimental, unapproved anthrax mandates, which were expressly barred by statute. See 10 U.S.C. §§ 1107 and 1107a. Even in those cases, courts recognized the limitations of DOD power over military service members, observing “the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs.” Doe No. 1 v. Rumsfeld, 297 F.Supp.2d 119, 135 (D.D.C. 2003) (granting injunctive relief against DOD for mandating an EUA anthrax vaccine).24 Certainly, OSHA has even less authority over American workers.
IV. EUA and FDA Licensed Products do not have the “Same Formulation” and are not “Interchangeable”
Notwithstanding any potential assertions to the contrary, the EUA and licensed versions of PfizerBioNTech do not have the “same formulation” as revealed by a simple inspection of the Pfizer Vaccine EUA letters and the Summary Basis for Regulatory Action (SBRA) for Comirnaty. Thus, they cannot be treated as “interchangeable,” because there is no legal basis to administer an EUA product as if it were the FDA-licensed product. By definition, they are different.
There is no evidence in the public record for finding that the EUA Pfizer-BioNTech vaccine and FDA-licensed Comirnaty have the “same formulation.” There is, however, ample evidence for finding that they do not. The most detailed information on Comirnaty’s composition, manufacturing process, manufacturing locations and other matters approved by the FDA is included in the FDA Comirnaty SBRA, nearly all of which is redacted,25 while most of this information was never made available in the PfizerBioNTech EUA applications or authorizations. To the extent such information is available, it reveals differences in the composition of the EUA and the licensed product.26 There is also no dispute that the FDA EUA does not address manufacturing processes or locations, which are addressed in the Comirnaty license. See August 23 Comirnaty SBRA at 12-13.
For the same reasons, the public record does not support any argument that the two admittedly “legally distinct” products are “interchangeable.” “Interchangeable” and “interchangeability” are specifically defined terms in Section 351 of the Public Health Service Act (“PHS Act”), 42 U.S.C. § 262, in relation to a “reference product,” which is a biological product licensed under Section 351(a) of the PHS Act, 42 U.S.C. § 262(a). For the purposes of determining “interchangeability,” the “reference product” must be an FDA-licensed product; in this case, the FDAlicensed Comirnaty Vaccine. But the “interchangeable” product, the EUA BioNTech Vaccine, must be the subject of a later filed “abbreviated” application under 42 U.S.C. § 262(k), and there is no indication that any such application was ever filed by BioNTech, much less reviewed or approved by the FDA.
Any “interchangeability” determination would therefore reverse the temporal order of the COVID-19 licensed product and the interchangeable product. The reference product under 42 U.S.C. § 262(a) is the first licensed product, and therefore the basis for determining the interchangeability of the later product (i.e., the generic or EUA product). Here, however, the EUA Pfizer-BioNTech Vaccine is the earlier product, while the licensed Comirnaty is the latter product; the earlier EUA product cannot rely on the FDA's safety and efficacy determinations for Comirnaty. Thus, an “interchangeability” determination would be a transparent attempt to retroactively license the earlier EUA Pfizer-BioNTech Vaccine, solely for the purpose of enabling the unlawful vaccine mandate.
Amicus DTR is a nonprofit organization that is dedicated to defending the Constitution, the rule of law, and protecting individual rights of Americans including medical freedom and religious liberty. DTR represents over thirty military service members in litigation involving the violation of their religious freedoms and their other constitutional and statutory rights to refuse mandatory vaccination with experimental COVID-19 treatments. DTR also expects to file suit soon to challenge the federal contractor vaccine mandate on behalf of individual federal contractors on similar grounds that have led multiple federal district courts to impose a nation-wide injunction and stay.
The COVID-19 vaccine mandate at issue in this case is contrary to the mission and values of DTR. It will subject tens of millions of Americans to an unprecedented federal seizure of power, threatening this nation’s Constitutional system of federalism. It contradicts and violates existing laws and individual rights to make health care decisions, and it violates this Court’s long-standing recognitions of rights to privacy.
In consideration of these interests, DTR seeks to inform the Court that the Pfizer COVID-19 vaccine mandated by the OSHA ETS and described as being the one approved by the FDA, i.e., Comirnaty, is not currently available to anyone in the United States. The United States finally and reluctantly conceded this in a lawsuit DTR brought in Florida. There is no supply of Comirnaty. The only vaccines in production and available are the vaccines approved under the FDA’s Emergency Use Authorization (“EUA”). DTR files this brief to explain why the OSHA COVID-19 vaccine mandate before the Court is an illegal federal mandate to compel Americans to take an experimental vaccine.
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FDA is Pfizer-BioNTech’s Comirnaty, which is not available in the United States. The only COVID-19 products that are available are not FDA approved and instead are subject to an EUA.
As explained below, the distinction between an EUA and an FDA-approved product matters. See infra Section III. In particular, the FDA’s grant of EUA requires little, if any, demonstration that the EUA product is safe and effective. Nor does the EUA include FDA review or approval of manufacturing processes, facilities, storage, distribution, or quality control procedures. This is why the FDA has acknowledged the products are “legally distinct.”6
The unavailability of Comirnaty raises a second question that also has not been asked, much less addressed, by OSHA or in the judicial decisions under review. Federal laws and applicable FDA regulations expressly provide a “right to refuse” experimental or EUA products. See 21 U.S.C. § 360bbb3(e)(1)(A)(ii)(III). Yet, the OSHA Mandate unlawfully overrides or circumvents those laws.
These rights to informed consent and to refuse experimental drugs—embodied not only in federal law, like 21 U.S.C. § 360bbb-3, but also international law and conventions like the Nuremburg Code—should foreclose such a wide-ranging mandate. DTR urges this Court to consider the enormous wrongful consequences of imposing an illegal mandate requiring nearly the entire United States adult workforce to take an experimental and irreversible medical treatment.
The immeasurable ramifications of endorsing a near-universal federal mandate justify granting a stay to give more time for deeper consideration by this Court, the political branches, public health experts, and the citizens of the United States to consider the legal arguments and scientific evidence on the safety and efficacy of the newly manufactured “vaccines,” the rapidly proliferating range of therapies, and alternative federal, state, and local public health measures. Surely a stay to allow this Court to hear the arguments presented by all Parties and Amici is appropriate given the momentous consequences for tens of millions of Americans who face the loss of their rights to work, education, travel, worship and other fundamental constitutional rights unless they submit to an unproven, experimental medical treatment with an unprecendented history of adverse effects including deaths.
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II. The FDA-Approved Comirnaty is Unavailable to the American Public
On August 23, 2021, the FDA approved the PfizerBioNTech mRNA vaccine under the marketed name Comirnaty.12 Soon thereafter, on September 9, 2021, President Biden announced that he would “protect vaccinated workers from unvaccinated co-workers” by having the Department of Labor issue “an emergency rule to require all employers with 100 or more employees . . . to ensure their workforces are fully vaccinated or show a negative test at least once a week.”13
With these marching orders, the Secretary of Labor, through OSHA, issued the OSHA ETS, which mandated that private businesses with 100 or more employees “develop, implement, and enforce a mandatory COVID-19 vaccination policy, with an exception for employers that instead adopt a policy requiring employees to either get vaccinated or elect to undergo regular COVID-19 testing and wear a face covering at work in lieu of vaccination.” OSHA ETS, 86 Fed. Reg. at 61,402. Americans subject to this ETS are in compliance if they receive the recommended minimum doses of COVID-19 vaccines that are “[a]pproved or authorized for emergency use by the FDA.” Id. at 61,479.
Notwithstanding the jurisdictional issues underlying the OSHA Mandate, there is a significant problem concerning how Americans are forced to comply with the mandate. Specifically, the only FDA approved vaccine – Comirnaty – is not available to the American public. According to the CDC, “COMIRNATY products are not orderable at this time.”14 As of December 16, 2021, “there is not sufficient approved vaccine [i.e., Comirnaty] available for the population for whom it is authorized.” See supra, FDA Pfizer-BioNTech Expansion Letter, note 6 at 5 n.9. In fact, it appears that Comirnaty is not available at all in the United States. Pfizer and the National Institutes of Health confirmed that Comirnaty would be unavailable for months after its approval.15
15 On September 13, 2021, the National Institutes of Health (“NIH”) posted an announcement by Pfizer that Pfizer “does not plan to produce any product with these new [Comirnaty] NDCs and labels over the next few months while the EUA authorized product is still available and being made available for U.S. distribution.” See NIH-Pfizer Announcement of Comirnaty Unavailability (Sept. 13, 2021), available at: https://www.cdc.gov/ vaccines/programs/iis/COVID-19-related-codes.html (last visited Dec. 27, 2021). S
The Department of Justice (“DOJ”) finally conceded the unavailability of Comirnaty through defense counsel for DOD in Austin, where DTR represents service members challenging the DOD Mandate. While DOD initially claimed that the DOD in fact possessed Comirnaty and was administering it to service members, in oral argument, DOJ defense counsel acknowledged that not only did it not have Comirnaty and did not know when it would it get it, but also “could not say even whether vaccines labeled ‘Comirnaty’ exist at all.” Doe v. Austin, 2021 WL 5816632, at *5 (N.D. Fla. Nov. 12, 2021) (citations omitted).16
DOD is the largest purchasing organization in the United States, and given its priority for national security matters, it would necessarily go to the front of the line for any purchasing COVID-19 vaccines. Yet DOD does not have Comirnaty and to this day the DOD cannot say when it will get Comirnaty. If the DOD cannot obtain Comirnaty, then how can average Americans who are subject to the OSHA Mandate? And perhaps more importantly, how can employees be fired for the failure of their employers to obtain a vaccine that even the DOD cannot procure?
The unavailability of Comirnaty is important. First, while OSHA purports to give employers the option of requiring vaccination or allowing testing and masks, it does not hide its real intent to force employees to choose vaccination to keep their jobs. If an employee opts out of their employer’s mandatory vaccination policy, OSHA believes its ETS and the costs it imposes on that employee – which includes paying for regular testing – “creates a financial incentive for those employees to become fully vaccinated and avoid that cost.” OSHA Mandate, 86 Fed. Reg. at 61,532
As Judge Larsen observed in his dissenting opinion on the emergency motion to dissolve the stay of the OSHA Mandate, the Mandate’s main purpose is to compel vaccination:
Here, employers, not employees, control any non-vaccine option in the first instance; and OSHA has been candid that it has stacked the deck in favor of vaccination … OSHA has alerted us to no prior attempt on its part to mandate a solution that extends beyond the workplace walls— much less a permanent and physically intrusive one, promulgated on an emergency basis, without any chance for public participation. But that it is what OSHA has done here. A vaccine may not be taken off when the workday ends; and its effects, unlike this rule, will not expire in six months.17
Second, and in consideration of OSHA’s coercive policy, workers will only be able to comply with the OSHA Mandate if they receive a vaccine under an EUA.18 This is especially important because EUA vaccines bypass the FDA and PHS Act’s requirements for safety and efficacy.
III. Important Differences Between EUA and FDA-Approved Vaccines
There are significant differences between the FDA’s approval standards and the EUA standards. EUA vaccines require little to no proof of safety or efficacy. FDA vaccine approvals do.
The FDA may grant an EUA where: (1) the HHS Secretary has declared a public health emergency that justifies the use of an EUA, see 21 U.S.C. § 360bbb3(b)(1); and (2) the FDA finds that “there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating” the disease in question. 21 U.S.C. § 360bbb-3(c)(3).
The differences between licensed vaccines and those subject to an EUA render them “legally distinct.” See supra, FDA Pfizer-BioNTech EUA Expansion Letter, note 6 at 2 n.8. First, the requirements for efficacy are much lower for EUA products than for licensed products. EUAs require only a showing that, based on scientific evidence “if available,” “it is reasonable to believe,” the product “may be effective” in treating or preventing the disease. 21 U.S.C. §360bbb-3(c)(2)(A).
By plan, those vaccines that are subject to the OSHA Mandate have relatively little data to support their authorization. The Pfizer-BioNTech Vaccine was granted its EUA after approximately 2 months of follow-up testing. See supra, FDA Pfizer-BioNTech EUA Review Memo, note 10 at 17. The Moderna Vaccine received its EUA after providing its studies to the FDA “with a median of 7 weeks of follow-up after the second dose.”19 And for the Janssen Vaccine, which also received an EUA, “the median follow-up duration for participants in the efficacy and safety analysis populations was 8 weeks after vaccination.”20
Second, the safety requirements are minimal, requiring only that the FDA conclude that the “known and potential benefits … outweigh the known and potential risks” of the product, considering the risks of the disease. 21 U.S.C. §360bbb-3(c)(2)(B). There is no requirement that the FDA know the potential risks of the product.
In comparison, vaccines that go through traditional FDA review typically take 10 years or more to reach approval.21 And the approval process compiles more information on the risks of the vaccine, gathered through lab testing and clinical trials, “to assess the safety and effectiveness of each vaccine.”22
A. The Right to Refuse an EUA Vaccine
The FDA’s grant of an EUA is subject to informed consent requirements to “ensure that individuals to whom the product is administered are informed” that they have “the option to accept or refuse administration of the product.” 21 U.S.C. § 360bbb3(e)(1)(A)(ii)(III).
For the three COVID-19 vaccines, FDA implemented the “option to accept or refuse” condition described in Section 564(e)(1)(A)(ii)(III) in each letter granting the EUA by requiring that FDA’s “Fact Sheet for Recipients and Caregivers” be made available to every potential vaccine recipient. These include the statement that the recipient “has the option to accept or refuse” the vaccine.23 Moreover, the EUA label itself must expressly state that the recipient has a “right to refuse” administration of the EUA product. Accordingly, the OSHA Mandate contradicts established federal law and will require any covered employer, including state agencies, to violate an express requirement of federal law and the express terms of the FDA labeling and packaging requirements.
B. OSHA Cannot Override Informed Consent Rights
The norm of informed consent has been “firmly embedded” in U.S. law and FDA regulations for nearly 60 years. Adullahi v. Pfizer, Inc., 562 F.3d 163, 182 (2d Cir. 2009). Congress first enacted this requirement in 1962 drawing on the Nuremberg Code and the Helsinki Declaration, “which suggests the government conceived of these sources’ articulation of the norm as a binding legal obligation.” Adullahi, 562 F.3d at 182. Informed consent requirements are a cornerstone of FDA rules governing human medical experimentation. See, e.g., 21 C.F.R. §§ 50.20, 50.23-.25, 50.27, 312.20, 312.120 (2008); 45 C.F.R. §§ 46.111, 46.116-117.
In any case, OSHA has not even acknowledged workers’ informed consent rights, much less explained how its mandate can override these rights or force private and public sector employers into violating these rights. Accordingly, the OSHA Mandate cannot stand.
A helpful analogy when considering forced vaccination is to compare the present case to the DOD’s much narrower Anthrax Vaccination Immunization Program. Courts enjoined that program, as it sought to impose a vaccine mandate on service members using experimental, unapproved anthrax mandates, which were expressly barred by statute. See 10 U.S.C. §§ 1107 and 1107a. Even in those cases, courts recognized the limitations of DOD power over military service members, observing “the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs.” Doe No. 1 v. Rumsfeld, 297 F.Supp.2d 119, 135 (D.D.C. 2003) (granting injunctive relief against DOD for mandating an EUA anthrax vaccine).24 Certainly, OSHA has even less authority over American workers.
IV. EUA and FDA Licensed Products do not have the “Same Formulation” and are not “Interchangeable”
Notwithstanding any potential assertions to the contrary, the EUA and licensed versions of PfizerBioNTech do not have the “same formulation” as revealed by a simple inspection of the Pfizer Vaccine EUA letters and the Summary Basis for Regulatory Action (SBRA) for Comirnaty. Thus, they cannot be treated as “interchangeable,” because there is no legal basis to administer an EUA product as if it were the FDA-licensed product. By definition, they are different.
There is no evidence in the public record for finding that the EUA Pfizer-BioNTech vaccine and FDA-licensed Comirnaty have the “same formulation.” There is, however, ample evidence for finding that they do not. The most detailed information on Comirnaty’s composition, manufacturing process, manufacturing locations and other matters approved by the FDA is included in the FDA Comirnaty SBRA, nearly all of which is redacted,25 while most of this information was never made available in the PfizerBioNTech EUA applications or authorizations. To the extent such information is available, it reveals differences in the composition of the EUA and the licensed product.26 There is also no dispute that the FDA EUA does not address manufacturing processes or locations, which are addressed in the Comirnaty license. See August 23 Comirnaty SBRA at 12-13.
26 See Doe v. Austin, 2021 WL 5816632, at *3 n.5. Compare Summary Basis of Regulatory Action, BLA 125742/0 at 9 (Aug. 23, 2021) (“August 23 Comirnaty SBRA”) (listing 11 components, including .450 ml per vial of a redacted excipient) (this document has been scrubbed from the FDA website, but was filed as an exhibit in the Doe v. Austin and Crosby v. Austin proceedings and can be filed with the Court if the amicus motion is granted), with FDA BioNTech EUA Expansion Letter, supra, note 6 at 7 (listing 10 components, all of which also appear on the Comirnaty SBRA) and November 8 Comirnaty SBRA at 7-8 (listing 11 components, but removing .450 ml per vial of redacted excipient and replacing with unspecified amount of water as 11th component).
For the same reasons, the public record does not support any argument that the two admittedly “legally distinct” products are “interchangeable.” “Interchangeable” and “interchangeability” are specifically defined terms in Section 351 of the Public Health Service Act (“PHS Act”), 42 U.S.C. § 262, in relation to a “reference product,” which is a biological product licensed under Section 351(a) of the PHS Act, 42 U.S.C. § 262(a). For the purposes of determining “interchangeability,” the “reference product” must be an FDA-licensed product; in this case, the FDAlicensed Comirnaty Vaccine. But the “interchangeable” product, the EUA BioNTech Vaccine, must be the subject of a later filed “abbreviated” application under 42 U.S.C. § 262(k), and there is no indication that any such application was ever filed by BioNTech, much less reviewed or approved by the FDA.
Any “interchangeability” determination would therefore reverse the temporal order of the COVID-19 licensed product and the interchangeable product. The reference product under 42 U.S.C. § 262(a) is the first licensed product, and therefore the basis for determining the interchangeability of the later product (i.e., the generic or EUA product). Here, however, the EUA Pfizer-BioNTech Vaccine is the earlier product, while the licensed Comirnaty is the latter product; the earlier EUA product cannot rely on the FDA's safety and efficacy determinations for Comirnaty. Thus, an “interchangeability” determination would be a transparent attempt to retroactively license the earlier EUA Pfizer-BioNTech Vaccine, solely for the purpose of enabling the unlawful vaccine mandate.
