The U.S. Food and Drug Administration's ("FDA") approval of the Pfizer vaccine under a new brand name, Comirnaty, created a cascade of legal and regulatory issues for prescribers, pharmacies, and other vaccine administrators. This Q&A answers some of the most common and immediate questions raised by the approval.
Why is off-label use not allowed for this FDA-approved product?
It is critical that the vaccine is not administered in any manner that is inconsistent with the FDA-approved labeling. The rules and considerations related to off-label use and the authority of prescribers to issue prescriptions for off-label uses are not relevant to this product. Off-label use of the Comirnaty vaccine can result in False Claims Act ("FCA") violations.
The vaccine supply is owned by the federal government and it is provided to pharmacies and other vaccine administration sites on consignment. In addition, the federal government pays the cost of the vaccine when it is administered so that people can obtain the vaccine at no cost to the individuals. The payment from the federal government, and federal government ownership of the product, implicates the FCA. Any claims submitted for reimbursement of an off-label use of the vaccine creates risk of FCA violations, exposing the health care providers involved to overpayment risk, and criminal and civil penalties.
The FCA provides for liability if a person or entity “knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim.” A person acts “knowingly” for purposes of the FCA if they: “[have] actual knowledge of that information”; “acts in deliberate ignorance of the truth or falsity of the information”; or “acts in reckless disregard of the truth or falsity of the information.” Proof of specific intent to defraud is not required. Under this standard, off-label use of a product owned by the federal government and paid for by the federal government may be treated by enforcement authorities as a false claim because the claim submitted for payment would be seeking reimbursement for an unapproved use of the product. In other words, the claim for off-label use could be viewed as false because the condition for payment is that the product must be used only consistent with its approved labeling.
Can the newly approved vaccine be administered to children?
The FDA-approved usage for the vaccine allows the vaccine to be administered to children age 16 and older. Children age 12 to 15 can still be vaccinated under the emergency use authorization ("EUA").
For children age 11 and younger, there is no coronavirus vaccine that has been proven safe and effective. Off-label use of the approved vaccine is prohibited.
In the announcements regarding the formal approval of the vaccine, the FDA discussed the reasons that the vaccine should not be given to children 11 and younger. These included:
- There is insufficient data at this time to demonstrate that the vaccine is safe and effective for people younger than 12. The frequency and types of side effects, for example, may vary by age.
- Children are not small adults, and the dosage and other factors have to be evaluated independently to confirm what vaccination will be safe and effective for them.
- Current clinical trials are in process for children ages 5 to 11. Once the clinical trials are completed, the results of those trials will be used to evaluate whether there is a safe and effective vaccine option for children in that age group.
- The FDA discussed this during the media call on August 23, 2021 regarding the vaccine approval.
Can the vaccine be used for booster shots?
The FDA-approved vaccine is not yet available for booster shot use. Despite broad speculation, the process to actually determine who should have a third shot of the vaccine has not yet been completed. Under the EUA, a third shot may be authorized for people age 12 or older who have had solid organ transplants or have been diagnosed with conditions that result in a clinically similar suppressed immune system. This was included in recent updates of the EUA, anticipating that at some point the Centers for Disease Control and Prevention's ("CDC") Advisory Committee on Immunization Practices ("ACIP") would issue guidance allowing the use of the vaccine for an additional shot in very limited situations.
This is a very fluid situation because the work to determine the guidelines and recommendations is ongoing. Additional guidance about this issue should be forthcoming from these public health authorities in the next several weeks.
Patients are bringing in prescriptions for the vaccine for an off-label use. What can we do?
It is urgent and important to have a plan in place for resolving this inevitable situation. In particular, the vaccine administrator (including pharmacies) should decline to administer the vaccine for the off-label use and contact the prescriber. Prescribers who have not had in-office administration of the vaccine, for example, may be unaware of the fact that the vaccine stock is owned by the federal government and cannot be administered in any manner that is inconsistent with the FDA-approved labeling.
What is the difference between the FDA-approved formulation and the Pfizer-BioNTech formulation allowed under the EUA?
There is no difference. After reviewing hundreds of thousands of pages of data on the safety and efficacy of the vaccine, as well as inspecting manufacturing locations and clinical trials, the FDA determined that no change to the formulation was needed. The approved vaccine is identical to the vaccine that has been authorized under the EUA. They can be used interchangeably.
Is the EUA still in force?
Yes. On August 23, 2021, when the FDA granted approval of the Pfizer-BioNtech vaccine, they also reissued an updated version of the EUA. The updated version reflects that the Comirnaty branded vaccine is approved, as well as the continuing authorizations for the same uses that have been in place under the EUA prior to the approval.
If a vaccine administrator has the Pfizer-BioNtech vaccine in stock, are they allowed to administer that vaccine or must people wait until new vaccine stock is manufactured with the updated labeling?
The existing vaccine stock should continue to be used. The FDA is not requiring that the product authorized under the EUA be treated any differently even though there is now going to be vaccine stock under the brand name and labeling Comirnaty.
Are pharmacists and others who administer the coronavirus vaccines under an authority granted by the PREP Act declarations still allowed to administer the approved vaccine?
Yes. The EUAs for all of the vaccines and the PREP Act declarations are still in force.
Does PREP Act liability protection extend to Comirnaty?
Yes. The government invoked the PREP Act in response to the COVID-19 pandemic. Under the terms of that act, "covered persons" are granted certain immunity from liability for activities related to "covered countermeasures." Covered persons include essentially all of the entities involved in the manufacture, distribution, and administration of the countermeasure. The term "covered countermeasures" includes both approved COVID-19 products, as well as unapproved products used under an EUA. The Comirnaty approval does not change the status of the vaccine as a covered countermeasure under the PREP Act, and the approved vaccine should receive equal liability protection compared to the version of the vaccine used under the EUA.
What is the FDA-approved prescribing information (PI) for Comirnaty?
The PI is here: https://www.fda.gov/media/151707/download
What is the current version of the EUA for what has been commonly referred to as the Pfizer vaccine?
The August 23, 2021 EUA is available here: https://www.fda.gov/media/144413/download
I heard that the FDA held a media call to discuss the vaccine approval. Is there a recording of that available?
Yes. The recording is available here: https://www.youtube.com/watch?v=aHAGnDz9F_w
Where can I find clinical guidance regarding additional COVID-19 vaccination scenarios we encounter, such as administering vaccines to people who have had COVID-19, or if we switch brands between the first and second shot?
ACIP's COVID-19 page is a robust resource for clinical reference regarding the vaccines and these types of clinical questions.