Spreeha Choudhury and Richard H. Hughes, IV, attorneys in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, co-authored an article in Healthcare Business Today, titled "Quadrivalent vs Trivalent Influenza Vaccines: Not a Simple Switch."
Following is an excerpt:
On October 5, 2023, the Vaccines and Related Biologic Products Advisory Committee (VRBPAC), an advisory panel to the Food and Drug Administration (FDA), voted unanimously to remove the B/Yamagata viral strain from future influenza vaccines “as soon as possible.” This change will not be effectuated overnight and, without clearer regulatory guidance, may lead to consumer and provider confusion over the appropriate flu vaccine. While VRBPAC acknowledged that flu vaccine manufacturers would need time to make this transition, FDA has begun telling them it must occur sooner. …
Currently, most influenza vaccines are quadrivalent formulations, meaning that they are manufactured to protect against four viral strains: two alphainfluenza strains and two betainfluenza strains. Of the betainfluenza strains, a particular strain called B/Yamagata, has not been detected in circulation for three years. No strain has been identified to replace the B/Yamagata strain.
For some time, VRBPAC has considered removal of the B/Yamagata strain, but the decision was not made until September of this year after the WHO influenza vaccine composition advisory committee recommended its exclusion.
