Submitted by Stephanie Paulmeno, Greenwich Health Dept, Submitted by Dr. Stephanie Paulmeno, DNP, RN, NHA, CPH, CCM, CDP, Public Health Promotion Specialist
Last week a panel of Food & Drug Administration (FDA) advisors convened to explore the pros, cons, and merits of updating the current COVID-19 vaccine.
Their desired outcome is for the people of America to have at their disposal an updated vaccine that would offer better and targeted COVID-19 protection in advance of the 2023 fall season. It is during this time of the year when a surge of new cases would be most likely to occur. As cooler weather sets in and activities move indoors we could see another rise in COVID-19 cases, as we do with other respiratory illnesses.
This expert panel voted unanimously to recommend to the FDA ceasing the manufacture of the current bivalent vaccine/booster, which targets both the old and new versions of COVID-19, and to return to a monovalent vaccine structure.
Monovalent refers to a vaccine that targets a particular variant of COVID-19 (SARS-CoV-2). The original monovalent vaccine targeted the earlier variant that impacted us at the start of the outbreak that led to our world-wide pandemic. The newly recommended monovalent vaccine would be designed differently from both the original monovalent vaccine as well as from the more recent bivalent injections. This recommended inoculation would specifically target the Omicron subvariants, especially Omicron XBB.1.5. The Omicron mutations are currently responsible for about 40 % of the new COVID-19 infections that are occurring in the USA at this time. It is Omicron XBB.1.5 that is currently anticipated to be the strain that will circulate later this year and into 2024 in the USA. The vaccine creators’ data is indicating that a vaccine that specifically targets the Omicron XBB mutations (specifically subvariant XBB.1.5) will create a stronger neutralizing antibody response than will the current bivalent vaccine (FDA advisers back updated COVID shots for fall vaccinations).
Aside from recommending a return to a monovalent vaccine designed to target the Omicron mutations, the advisory committee discussed who might need this, or who could benefit from it; noting that not everyone will need it. They identified that many of us have already acquired protection against becoming severely ill from a COVID-19 infection because of having already having been ill, having been vaccinated (in some cases multiple times), or in many cases, both. At the advisory meeting the CDC (http://www.cdc.com) displayed data showing COVID-19 related hospitalizations and deaths to be down over the last two months across the country, but not for everyone. Based on the characteristics of those who became very ill and /or died from a COVID-19 infection, the groups they feel may need this added vaccination protection are those over 75 years old, and those with chronic lung diseases and/or diabetes. Their recommendations to the FDA will now go to the CDC where the final decision is made as to whether or not to create a new vaccine and to issue the FDA recommendations.
The World Health Organization (WHO) has also been engaged in exploring the value of creating an updated monovalent targeted vaccine. It reached a similar conclusion and made similar recommendations which were further supported by yet another group of medical experts and regulators from Europe (EU Regulators Back WHO’s COVID Vaccine Update Recommendation).
Looking at Connecticut’s 6-1-23 figures from the governor (COVID-19 Update June 01, 2023 (ct.gov), the creation of a new monovalent vaccine aimed at the Omicron subvariants seems on target for The Nutmeg state. The Omicron variant was 59.56% of all the COVID cases that were lab-tested here in Connecticut. June 1 st was the last date figures were made available on www.ct.gov as part of the Governor’s COVID-19 Update Reports.
If the CDC moves forward to create a new vaccine and to issue vaccine recommendations; we are in a far better place now than we were when the pandemic began. I urge you to self-assess your health and that of your families and make your best judgement calls. Watch the Greenwich Health Department website for updates/eligibility; https://www.greenwichct.gov/575/Health-Department