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FDA Panel Endorses Updating COVID Jab to Target XBB Strain
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On Jun 15, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously recommended updating the COVID vaccines to target the Omicron XBB lineages, which is currently responsible for the majority of the COVID infections in the country.
The VRBPAC voted 21-0 in favor of using a “monovalent” vaccine to target the currently dominating XBB strain, in contrast to the currently available bivalent vaccines that target multiple strains of the coronavirus.
However, the VRBPAC could not reach a decision on which specific XBB lineage should be targeted, nor did it make a recommendation on a vaccination schedule for this newly updated vaccine shot. An FDA official, Dr. Peter Marks, indicated that the FDA may consider selecting the XBB.1.5 subvariant as the preferred target.
The VRCPAC endorsement comes a month after an advisory group to the World Health Organization (“WHO”) recommended the next wave of COVID vaccines to provide protection against the XBB lineages. Earlier this month, the European Medicines Agency also backed WHO’s recommendation. All these agencies observed that though the currently authorized bivalent vaccines provide protection against the XBB lineages, the protection wanes with time.
COVID vaccine makers Pfizer (PFE - Free Report) /BioNTech(BNTX - Free Report) , Moderna (MRNA - Free Report) and Novavax (NVAX - Free Report) are currently updating their own vaccines to target the XBB lineages. During the VRBPAC meeting, Pfizer/BioNTech, Moderna and Novavax presented their pre-clinical findings supporting the use of their own vaccines which target the XBB.1.5 variant. The preclinical data from these manufacturers indicate that a monovalent vaccine is more effective against a bivalent vaccine.
While Pfizer/BioNTech expects to make their updated vaccine ready for supply by the end of next month, Moderna stated that it is prepared to supply a new variant-containing vaccine for fall 2023. Novavax, on the other hand, stated that it is currently manufacturing its protein-based monovalent XBB.1.5 COVID vaccine candidate at a commercial scale, which is intended to be in the market during the 2023 fall vaccination campaign. However, it is to be noted that these vaccines are yet to be authorized/approved for use by the FDA.
In April, the FDA amended the emergency use authorization (“EUA”) granted to the mRNA-based vaccines developed by Pfizer/BioNTech and Moderna.
Following the EUA amendment, the current bivalent vaccines developed by Pfizer/BioNTech and Moderna would be used for all doses administered to individuals aged six months and older. Subsequently, the monovalent/original vaccines developed by these companies are no longer authorized for use in the United States. This was done with the intent to simplify the COVID immunization schedule for the majority of the country’s population.
Novavax’s vaccine is currently authorized for use in adults and adolescents aged 12 years and older for use as a primary two-dose regimen. The Novavax vaccine is also authorized for use as a booster dose in adults aged 18 years and older.
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FDA Panel Endorses Updating COVID Jab to Target XBB Strain
On Jun 15, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously recommended updating the COVID vaccines to target the Omicron XBB lineages, which is currently responsible for the majority of the COVID infections in the country.
The VRBPAC voted 21-0 in favor of using a “monovalent” vaccine to target the currently dominating XBB strain, in contrast to the currently available bivalent vaccines that target multiple strains of the coronavirus.
However, the VRBPAC could not reach a decision on which specific XBB lineage should be targeted, nor did it make a recommendation on a vaccination schedule for this newly updated vaccine shot. An FDA official, Dr. Peter Marks, indicated that the FDA may consider selecting the XBB.1.5 subvariant as the preferred target.
The VRCPAC endorsement comes a month after an advisory group to the World Health Organization (“WHO”) recommended the next wave of COVID vaccines to provide protection against the XBB lineages. Earlier this month, the European Medicines Agency also backed WHO’s recommendation. All these agencies observed that though the currently authorized bivalent vaccines provide protection against the XBB lineages, the protection wanes with time.
COVID vaccine makers Pfizer (PFE - Free Report) /BioNTech(BNTX - Free Report) , Moderna (MRNA - Free Report) and Novavax (NVAX - Free Report) are currently updating their own vaccines to target the XBB lineages. During the VRBPAC meeting, Pfizer/BioNTech, Moderna and Novavax presented their pre-clinical findings supporting the use of their own vaccines which target the XBB.1.5 variant. The preclinical data from these manufacturers indicate that a monovalent vaccine is more effective against a bivalent vaccine.
While Pfizer/BioNTech expects to make their updated vaccine ready for supply by the end of next month, Moderna stated that it is prepared to supply a new variant-containing vaccine for fall 2023. Novavax, on the other hand, stated that it is currently manufacturing its protein-based monovalent XBB.1.5 COVID vaccine candidate at a commercial scale, which is intended to be in the market during the 2023 fall vaccination campaign. However, it is to be noted that these vaccines are yet to be authorized/approved for use by the FDA.
In April, the FDA amended the emergency use authorization (“EUA”) granted to the mRNA-based vaccines developed by Pfizer/BioNTech and Moderna.
Following the EUA amendment, the current bivalent vaccines developed by Pfizer/BioNTech and Moderna would be used for all doses administered to individuals aged six months and older. Subsequently, the monovalent/original vaccines developed by these companies are no longer authorized for use in the United States. This was done with the intent to simplify the COVID immunization schedule for the majority of the country’s population.
Novavax’s vaccine is currently authorized for use in adults and adolescents aged 12 years and older for use as a primary two-dose regimen. The Novavax vaccine is also authorized for use as a booster dose in adults aged 18 years and older.