Greenwich Health Dept: The New COVID-19 Vaccine, Approved Sept 13, 2023

By Stephanie Paulmeno, Greenwich Health Dept

On September 11, 2023, the FDA approved the new vaccine that targets Omicron variant XBB.1.5, for people 12 years of age and older. They issued an Emergency Use Authorization for that vaccine for youngsters between the ages of 6 months and 11 years.

These actions covered the newly revised Pfizer/BioNTech and Moderna mRNA vaccines, both of which were updated to be monovalent, or single-target vaccines, designed to target the Omicron XBB.1.5 mutation. Neither Moderna nor Pfizer’s new vaccine contains components from the earlier injections that were designed to combat the multiple variants that mutated from the original COVID-19 virus, nor from the previous versions of COVID-19’s multiple Omicron mutations. As of 9-11-23 the bivalent Moderna and Pfizer vaccines are no longer authorized for use in the U.S.A.

Dr. Peter Marks, Director of the FDA’s Center for Biological Research offered the public the following
reassurance: “Vaccination remains critical to public health and continued protection against serious
consequences of COVID-19, including hospitalization and death. The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturingquality. We very much encourage those who are eligible to consider getting vaccinated” (FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants | FDA).

The very next day, 9-13-23, the CDC Director, Dr. Mandy Cohen, heeded the advice of her expert advisory panel and has now recommended the Pfizer/BioNTech and Moderna vaccines. Recommending that the public take these vaccines now underlies a CDC-led public health campaign that is advising the vaccines for everyone 6 months of age and older (CDC chief urges Americans to get COVID-19 boosters) (US CDC recommends broad use of updated COVID-19 vaccines | Reuters.

She noted that every eligible person should take advantage of the new vaccine because COVID-19 “continues to evolve (mutate) and to evade human immunity, and the more people who get vaccinated, the fewer illnesses, hospitalizations, and over-capacity hospitals we will have” (CDC chief urges Americans to get COVID-19 boosters New York Times). We have been in the midst of rising COVID-19 related hospitalizations and deaths for now going into the 8th straight week. Dr. Cohen went on to say that.

“While we would all love to leave COVID-19 in the rear-view mirror for good, the virus is still here. And it will probably always be with us,” The CDC’s key takeaway messages to the public about getting vaccinated with the new vaccine are as follows:

• Everyone 6 months and older should get vaccinated with the NEW mRNA monovalent COVID-19 vaccine. The older versions are no longer available.

• Older adults and those with weakened immune systems are at highest risk for hospitalization and death. Healthy children and adults can still experience severe disease from COVID-19.

• The new COVID-19 mRNA single target (monovalent)t vaccine aimed at Omicron XBB.1.5 is expected to also be effective against other currently circulating Omicron mutations, (e.g.: BA.2.86, which is being carefully monitored and is described as “a master of immune escape”. This variant has 30 additional mutations over XBB.1.5).

• The CDC continues to advise that the best way to self-protect against severe COVID-19 disease is to get yourself and your family vaccinated.

• Experts at the CDC note that the benefits of being COVID-19 vaccinated continue to outweigh any potential risks, saying that serious reactions following a COVID-19 vaccination are rare.

• Responding to on-going disinformation campaigns, in a cited study the CDC detailed that the risk of cardiac problems, including myocarditis in young males between the ages of 12-17, was higher following a COVID-19 infection than after a COVID-19 vaccination. People get myocarditis for many reasons separate and apart from COVID-19 vaccinations. Updated COVID-19 Vaccine Recommendations Now Available CDC.

• The new COVID-19 mRNA monovalent vaccines are covered by insurance, private insurance, and both by Medicare and Medicaid plans. Uninsured children can access the Vaccines for Children Program; Uninsured adults can access the Bridge Access Program to obtain vaccines.

As is the case each Fall, as people and activities begin to move indoors, respiratory illnesses will increase. Again this year we will be facing the same triple threat we have faced over the last several years; COVID-19, influenza, and Respiratory Syncytial Virus otherwise known as RSV. While vaccines to minimize the impact of getting COVID-19 or the flu have been in use for years, this year, for the 1 st time, we have FDA/CDC-approved new weapons to fight RS, (i.e.: RSV vaccines and targeted monoclonal antibody products). Here are links in English and Spanish about all three of these potentially deadly respiratory conditions that can affect infants, young adults, adults and seniors, including their symptoms, vaccines, and who is at highest risk (COVID-19, Flu and RSV and El
COVID-19, la influenza y el virus respiratorio sincitial (VRS)
| FDA).

Learn your own hereditary and personal risk factors, heed public health guidance, and get vaccinated to protect yourself, your families, and others at risk whom you may unwittingly expose.