Available at the time of approval.
When they were approved there weren’t any approved alternatives and there’s no provision that revokes the EUA when alternatives emerge.
>>> there’s no provision that revokes the EUA when alternatives emerge.
Funny how we have not heard any complaints from Maderna, J&J, others about their seemingly unequal treatment or lack of consideration for their “full approval” as well.
Not true, when "approved" alternatives are available.
Section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act (PDF, 142 KB) (21 USC 360bbb-3)
Moderna's "Criteria for Issuance of Authorization" -
I have concluded that the emergency use of Moderna COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:...
C. There is no adequate, approved, and available alternative to the emergency use of Moderna COVID-19 Vaccine to prevent COVID-19.
Jannsen's "Criteria for Issuance of Authorization" -
I have concluded that the emergency use of the Janssen COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:...
3. There is no adequate, approved, and available alternative to the emergency use of the Janssen COVID‑19 Vaccine to prevent COVID-19.
Emergency Use Authorization of Medical Products and Related Authorities - "FDA may revise or revoke an EUA if the circumstances justifying its issuance (under section 564(b)(1)) no longer exist (See "C" for Maderna & "3" for Janssen above), the criteria for its issuance are no longer met, or other circumstances make a revision or revocation appropriate to protect the public health or safety."