FDA Expert Committee Votes to Update Annual COVID-19 Vaccine Strains Without Safety Data

The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously on June 5^th to recommend that the FDA update the COVID-19 vaccine to include a SARS-CoV-2 JN.1 lineage strain to replace the XBB1.5 strain. The vaccine's update is thought to be necessary due to evidence demonstrating the lack of effectiveness of the current COVID XBB1.5 vaccine formulation in neutralizing JN.1 SARS-CoV-2 lineage variants circulating within the U.S. population, as well as waning vaccine protection.¹

Committee Votes in Absence of Safety Data

No safety data was presented for any vaccine under discussion during the meeting; however, the committee was provided with an update on vaccine effectiveness for COVID-19 vaccines currently in use.^{2 3} Some VRBPAC members expressed concern about the absence of safety data. Dr. Peter Marks of the FDA responded that safety data would be presented at future meetings and that there were no new findings.

The health status of individuals hospitalized with COVID was also discussed after the U.S. Centers for Disease Control’s presentation  (CDC) on COVID-19 vaccine effectiveness.⁴ The CDC was unable to provide the information and additionally stated that more granular data on the health status and underlying conditions of COVID hospitalized individuals would be published in the CDC’s quasi-journal Mortality and Morbidity Weekly Report (MMWR) this summer.

Circulation of JN.1 Variant in Decline

Notably, dominant variant data presented by CDC officials and vaccine manufacturers during the meeting indicated that the JN.1 variant circulating within the U.S. population is declining, and its related sublineage variants, KP.2 and KP.3, appear to be increasingly dominant.^{5 6} The World Health Organization’s (WHO) Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) presented additional global data to the committee that echoed much of the U.S. data.⁷

Vaccine Manufacturers Ready to Produce Updated COVID Vaccines

Vaccine manufacturers Moderna and Pfizer presented non-human preclinical data, demonstrating that their JN.1 and KP.2 mRNA vaccine candidates were superior in neutralizing all JN.1 lineage variants compared to the current XBB1.5 strain. Notably, there were no significant differences in the neutralization of JN.1 lineage variants when comparing JN.1 and KP.2 vaccine candidates. Both manufacturers were ready to provide either vaccine lineage option, depending on the FDA’s strain decision.^{8 9}

Novavax also presented data on its JN.1 vaccine candidate; however, it is not offering a KP.2 candidate due to timing limitations associated with meeting FDA requirements related to its protein-based vaccine product. Similar to pre-clinical data presented for the mRNA vaccine candidates, Novavax’s clinical (human) data demonstrated a similar ability to neutralize all JN.1 variants of concern. Novavax also promoted that their vaccine candidate was the only non-mRNA vaccine option and was already in production.¹⁰

SARS-CoV-2 Variants May Evolve and Evade FDA Vaccine Strain Choice

During committee discussions, it was noted by several members that variants can quickly evolve/mutate and become dominant. The VRBPAC did voice more support for a JN.1 variant formulation over the KP.2 variant option amid vast uncertainty of how JN.1 lineage variants (KP.2 and KP.3) will mutate and potentially evolve further away from the JN.1 variant between the time of the FDA’s strain choice and vaccine distribution.¹¹ Such a mutation could potentially impact the effectiveness of the newly updated vaccines. Data presented during the meeting revealed that the FDA’s XBB1.5 choice last year was not the dominant strain in circulation when those vaccines received FDA approval roughly three months later.¹²

The CDC reported on June 7^th that the KP.3 variant was now the dominant strain circulating in the U.S. and that the updated vaccines may not protect as well against this variant.¹³ Data presented during the VRBPAC meeting echoed CDC’s report.¹⁴

On June 13^th the FDA updated their guidance to vaccine manufacturers to use the KP.2 sublineage variant for the 2024-2025 monovalent COVID-19 vaccine, if feasible.¹⁵ Notably, during the June VRBPAC meeting, Dr. Peter Marks of the FDA stated that should the FDA choose a sublineage strain, the choice would not preclude the approval of a COVID-19 vaccine using the JN.1 parent lineage. Such a scenario would mean that the Novavax JN.1 2024-2025 vaccine candidate already in production will also be available for use in the U.S.

Natural Immunity on the Rise

While the VRBPAC meeting aimed to select the annual COVID-19 strain, epidemiological data presented by CDC officials demonstrated that hospitalization rates and deaths are at their lowest point since 2020.¹⁶ Additionally, data demonstrated that high rates of natural immunity (90 to 99 percent) existed in children ranging from infancy to 17 years of age by the end of 2022.¹⁷ Similarly, data noted that for individuals from age 16 to over 65 years of age had also attained high rates of natural immunity (72 to 89 percent) by the summer of 2023,¹⁸ which some committee members later lamented as influencing low COVID-19 vaccine uptake.

The CDC’s Advisory Committee on Immunization Practices (ACIP) will review the updated COVID-19 vaccine data and vote on use recommendations during their June 27, 2024 meeting.¹⁹

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2 Responses to "FDA Expert Committee Votes to Update Annual COVID-19 Vaccine Strains Without Safety Data"

Louise

Posted: 6/21/2024 5:02:37 PM

There was a number of the population who stupidly took the first round of shots but will not take any more which helps the immunity population. This is ticking off the fear mongering, poison pushing doctors and pharma because their tackics aren't working as well this time. Makes me happy and makes me laugh......

Margaret

Posted: 6/21/2024 7:08:32 PM

Dr. Jim Meehan was a beautiful & shining light who made this world a better place! He is deeply missed by by so very many!