COVID-19 vaccines have been out there for less than roughly 2 years and have already undergone a number of revisions to the really useful vaccine schedule. Vaccine dosing timelines and composition can fluctuate broadly relying on age, immune standing, and sort of SARS-CoV-2 vaccine acquired. 1 It’s maybe probably the most complicated schedules for a vaccine directed in the direction of a single preventable illness that the common pharmacist has ever needed to handle. Because of this, some well being care suppliers have developed and/or are utilizing tables or flowcharts to stay oriented to the intricacies of COVID-19 vaccine dosing. It’s been instructed that that these complexities have, at the least partially, contributed to difficulties in communication about vaccine profit and vaccine uptake all through the nation.2 Nevertheless, there may be hope {that a} simplified COVID-19 vaccine dosing and administration construction will grow to be a actuality.
On January 26, 2023, the FDA’s Vaccines and Associated Organic Merchandise Advisory Committee voted to advocate harmonizing the SARS-CoV-2 vaccine pressure composition of each the first collection and booster doses to a single composition and with the consideration that every one vaccines administered inside the USA be a bivalent vaccine. The advisory committee spent over 9 hours listening to information introduced by consultants from the FDA, the CDC, and from the producers of at present out there COVID-19 vaccines. Though precise particulars of a simplified COVID-19 haven’t been finalized, the dialog on transferring to a constant pressure composition for all vaccine doses was typically supportive.
Jerry Weir, PhD, director of the Division of Viral Merchandise on the FDA, introduced to the committee a number of advantages that simplification and alignment of the vaccine would produce. These embody improved antibody response with bivalent vaccine, a simplified immunization schedule relevant to all COVID-19 vaccines, elevated capacity to make use of immunogenicity and efficacy information to switch future variations of the vaccine based mostly on evolving variants if wanted, and alignment with suggestions from the European Medicines Company Emergency Activity Power.2
Whereas the advisory committee’s vote could be considered as a step ahead, lots of uncertainties stay. The coronavirus continues to do what comes naturally and evolve, with new variants persevering with to emerge. Virtually all of the variants which have emerged in current months have been variations of the Omicron variant, however that doesn’t essentially translate into cross-immunity among the many subvariants.3 At present, main collection for COVID-19 vaccines stays monovalent and encode or include ancestral SARS-CoV-2 spike protein; bivalent vaccines have been launched to offer safety towards the Omicron variant.
Literature printed via the top of 2022 instructed an indeterminate advantage of a bivalent vaccine in comparison with monovalent vaccines for the BA.4 and BA.5 strains.4 Nevertheless, these 2 subvariants have largely been changed with strains who’re extra in a position to evade the immune system.
For the SARS-CoV-2 Omicron sublineage XBB, a current report evaluating sufferers via mid-January 2023 instructed that the bivalent booster dose present safety towards symptomatic an infection attributable to XBB-related viruses for at the least 3 months following the booster administration in sufferers beforehand receiving 2 to 4 monovalent vaccine doses.5 Continued vaccine efficacy for future variants and lineages stays unsure. In the course of the advisory committee assembly, producers indicated {that a} shift to a single composition would nonetheless permit them to change the vaccine in accordance with the virus’ evolution, analogous to the best way the influenza vaccine is adjusted to modifications in circulating strains.2 Advisory committee members questioned what the FDA’s response could be if a producer didn’t replace their vaccine product based mostly on knowledgeable advice(s); although the FDA indicated that particular response had not but been decided, the company acknowledged {that a} plan for such a state of affairs would have to be addressed within the means of COVID-19 vaccine simplification.2
Different questions and dialogue factors introduced ahead by advisory committee members in the course of the assembly included whether or not the vaccines ought to proceed to make use of the ancestral pressure and ideally suited timing of any future doses in each vaccinated and unvaccinated folks. It was additionally instructed that various methods be explored akin to increased doses, which has confirmed to be helpful in geriatric sufferers for the influenza vaccine.2 Solutions to those questions weren’t addressed in the course of the assembly and it stays unclear when proposals could possibly be anticipated.
The medical influence of COVID-19 vaccine simplification is troublesome to foretell with so many questions nonetheless unanswered. Nevertheless, there are a number of logistical and sensible advantages for pharmacies, akin to provide and stock logistics, administration standardization, and extra simple affected person counseling approaches. The indeterminacy of when and if the advisory committee’s advice will come to fruition makes superior planning virtually unimaginable from the pharmacy perspective. Till the method decided and finalized, pharmacies are nonetheless sure to the present cumbersome course of. Nonetheless, the advisory committee’s vote does present hope that a better technique could possibly be on the horizon.
References
- CDC. Keep As much as Date with COVID-19 Vaccines Together with Boosters. CDC web site. Up to date January 25, 2023. Accessed February 1, 2023. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html#recommendations
- FDA. Vaccines and Associated Organic Merchandise Advisory Committee January 26, 2023 Assembly Announcement. FDA web site. January 26, 2023. Accessed February 1, 2023. https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement#event-materials
- COVID Information Tracker. Atlanta, GA: CDC; January 30, 2023. Accessed February 1, 2023. https://covid.cdc.gov/covid-data-tracker
- Offit PA. Bivalent COVID-19 vaccines – a cautionary story. N Eng J Med. 2023. doi:10.1056/NEJMp2215780
- Hyperlink-Gelles R, Ciesla AA, Roper LE, et al. Early Estimates of Bivalent mRNA Booster Dose Vaccine Effectiveness in Stopping Symptomatic SARS-CoV-2 An infection Attributable to Omicron BA.5– and XBB/XBB.1.5–Associated Sublineages Amongst Immunocompetent Adults — Rising Neighborhood Entry to Testing Program, United States, December 2022–January 2023. MMWR Morb Mortal Wkly Rep. ePub:January 25, 2023. doi:10.15585/mmwr.mm7205e1
