COVID authorizations vs. NOC/c
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I've noticed that several of the COVID-19 vaccines have a black box warning on the cover of the Product Monograph that states that the product has been authorized with Terms & Conditions, and that patients should be advised of the nature of the authorization.
But they aren't actually NOC/c, listed on the NOC database as without conditions.
How would the PAAB review these vaccines -- are they required to disclose their Terms & Conditions approval with a black box as with NOC/c products?
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I've noticed that several of the COVID-19 vaccines have a black box warning on the cover of the Product Monograph that states that the product has been authorized with Terms & Conditions, and that patients should be advised of the nature of the authorization.
But they aren't actually NOC/c, listed on the NOC database as without conditions.
How would the PAAB review these vaccines -- are they required to disclose their Terms & Conditions approval with a black box as with NOC/c products?
Hi @stet
The term “black box warning” is used in reference to FDA in the USA. In Canada and in reference to the boxed content you are seeing on the cover of the COVID vaccines, this is boxed disclosure of a commitment to continue research on the products efficacy and safety.
During the introduction of COVID vaccines early in the pandemic, PAAB applied a risk-based approach consistent with the NOC/c guidelines in consideration of the TMA I/O warnings and limited information. As more scientific literature/evidence has accumulated, we have shifted to the standard NOC approach. Note that this means that this important disclosure content from the cover should be presented along with the first mention of the indication in marketing pieces so as to be accurate and complete about the nature of the authorization.
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Hi @stet
The term “black box warning” is used in reference to FDA in the USA. In Canada and in reference to the boxed content you are seeing on the cover of the COVID vaccines, this is boxed disclosure of a commitment to continue research on the products efficacy and safety.
During the introduction of COVID vaccines early in the pandemic, PAAB applied a risk-based approach consistent with the NOC/c guidelines in consideration of the TMA I/O warnings and limited information. As more scientific literature/evidence has accumulated, we have shifted to the standard NOC approach. Note that this means that this important disclosure content from the cover should be presented along with the first mention of the indication in marketing pieces so as to be accurate and complete about the nature of the authorization.
@jennifer-carroll Thank you!
