Commonground
Senior Moderator
Posting the Summary below.
6. Summary
A critical component of pandemic preparedness and planning is licensure of prototype
pandemic influenza vaccines. Prior to a pandemic and in the absence of transmission of
non-seasonal influenza A virus subtypes (e.g., H5) sufficient to demonstrate vaccine
effectiveness in pre-licensure clinical studies, licensure of a prototype pandemic influenza
vaccine may be inferred from demonstrated efficacy of a licensed seasonal vaccine made by
the same manufacturing process and supported by clinical studies of safety and
immunogenicity of the prototype pandemic vaccine. Currently three prototype pandemic
Influenza A H5N1 monovalent virus vaccines, containing either H5N1 clade 1 or clade
2.2.1 virus, are licensed in the U.S. via this regulatory pathway. In the event of a pandemic
or declared public health emergency, prior licensure of prototype pandemic vaccines may
permit approval of pandemic influenza vaccines of the same hemagglutinin A subtype as
“strain change supplements” in a process similar to that used for updating seasonal
influenza vaccines. Manufacturers of updated pandemic influenza vaccines would be
expected to work with FDA and other governmental agencies on plans to collect additional
safety and effectiveness data during pandemic vaccine deployment.
FDA is requesting that VRBPAC consider a proposed strain change process and the
expected data requirements for updating the composition of licensed prototype pandemic
influenza vaccines during the inter-pandemic period—that is, subsequent to original
licensure of prototype pandemic influenza vaccines but prior to a pandemic or declared
public health emergency. Specifically, FDA requests VRBPAC to discuss and provide input
on a proposed strain change process for prototype influenza A (H5) monovalent vaccines in
the context of the current inter-pandemic period. When considering an inter-pandemic
composition update to U.S.-licensed prototype influenza A (H5) monovalent vaccines,
VRBPAC discussion topics include: if/when a change is needed to the composition of
10
licensed prototype H5 vaccines; what available evidence is needed to support the selection
of currently available candidate vaccine strains for a possible update to U.S.-licensed
prototype H5 vaccines; and, reconvening VRBPAC to make a final composition
recommendation if/when an influenza A H5N1 pandemic is declared.
Complete Report: https://www.fda.gov/media/182543/download
6. Summary
A critical component of pandemic preparedness and planning is licensure of prototype
pandemic influenza vaccines. Prior to a pandemic and in the absence of transmission of
non-seasonal influenza A virus subtypes (e.g., H5) sufficient to demonstrate vaccine
effectiveness in pre-licensure clinical studies, licensure of a prototype pandemic influenza
vaccine may be inferred from demonstrated efficacy of a licensed seasonal vaccine made by
the same manufacturing process and supported by clinical studies of safety and
immunogenicity of the prototype pandemic vaccine. Currently three prototype pandemic
Influenza A H5N1 monovalent virus vaccines, containing either H5N1 clade 1 or clade
2.2.1 virus, are licensed in the U.S. via this regulatory pathway. In the event of a pandemic
or declared public health emergency, prior licensure of prototype pandemic vaccines may
permit approval of pandemic influenza vaccines of the same hemagglutinin A subtype as
“strain change supplements” in a process similar to that used for updating seasonal
influenza vaccines. Manufacturers of updated pandemic influenza vaccines would be
expected to work with FDA and other governmental agencies on plans to collect additional
safety and effectiveness data during pandemic vaccine deployment.
FDA is requesting that VRBPAC consider a proposed strain change process and the
expected data requirements for updating the composition of licensed prototype pandemic
influenza vaccines during the inter-pandemic period—that is, subsequent to original
licensure of prototype pandemic influenza vaccines but prior to a pandemic or declared
public health emergency. Specifically, FDA requests VRBPAC to discuss and provide input
on a proposed strain change process for prototype influenza A (H5) monovalent vaccines in
the context of the current inter-pandemic period. When considering an inter-pandemic
composition update to U.S.-licensed prototype influenza A (H5) monovalent vaccines,
VRBPAC discussion topics include: if/when a change is needed to the composition of
10
licensed prototype H5 vaccines; what available evidence is needed to support the selection
of currently available candidate vaccine strains for a possible update to U.S.-licensed
prototype H5 vaccines; and, reconvening VRBPAC to make a final composition
recommendation if/when an influenza A H5N1 pandemic is declared.
Complete Report: https://www.fda.gov/media/182543/download