By Karen Kier
Pharmacist on behalf of the ONU HealthWise team

Billy Joel is a successful singer, pianist, and songwriter. He is referred to as the “piano man” after his first charting song. He has been nominated for 23 Grammy Awards and has won six. He was inducted into the Rock & Roll Hall of Fame in 1999. In 2013, Joel was recognized at the Kennedy Center Honors. 

In 1978, Joel released 52nd Street, which included his hit Big Shot. The album peaked at No. 1 on the Billboard charts. The single only reached 14. The song describes someone behaving like a big shot and running their mouth all over town.

The news last week described the new “big shot” by the FDA and the CDC ACIP (Advisory Committee on Immunization Practices) for COVID-19. Is it important to spread the word all over town?

The FDA approved the new Omicron-specific monovalent COVID-19 vaccines for Moderna and Pfizer on September 11. This action removes the use of the bivalent vaccines from Moderna and Pfizer.

The bivalent vaccines contained 2 variants of the SARS-CoV-2. One-half was the original Wuhan and the other half was the BA.4 and BA.5 variants. The new monovalent vaccines solely target Omicron variants related to the XBB.1.5. 

The new vaccine should not be confused with the original monovalent, which provided the initial doses. A recent headline indicated the monovalent vaccine additional dose was more effective than the bivalent. This misleading headline was extracted from a Singapore study published in The Lancet Infectious Disease. The study was comparing 4 doses (3 original/1 booster) of the Wuhan monovalent versus 3 original doses with 1 bivalent booster. 

The study concluded that the 4 monovalent doses were superior to the original with bivalent in reducing more severe illness. The study did not evaluate the current Omicron-specific monovalent vaccine. It is easy to see how the headline could be confusing and damaging to public health efforts. The newly FDA-approved monovalent vaccines only contain an Omicron. 

Other aspects of the new vaccines could also be confusing. Some aspects of the vaccines are actually FDA-approved with ACIP recommendations, while other components have emergency use authorization (EUA). The latest actions are for the mRNA vaccines and does not include the protein-based, non-mRNA vaccine from Novavax. Novavax has submitted clinical information to the FDA, who is reviewing data on the company’s new monovalent candidate. 

Pfizer’s brand name mRNA vaccine will remain as Comirnaty for the new 2023-2024 Omicron monovalent edition. The FDA-approved Comirnaty is labeled as a single dose shot for those 12 years and older. Note the FDA is now using dates (2023-2024) to be clear as to the vaccine being administered. This nomenclature is similar to how the FDA labels influenza (flu) vaccines. This is a good indication we may be moving to at least an annual COVID-19 vaccine similar to the flu shot. 

Moderna’s brand name mRNA monovalent vaccine will continue to use Spikevax adding the 2023-2024 labeling. The FDA approved Spikevax for a single dose in those 12 years and older. 

Both Pfizer and Moderna received emergency use authorization for a single dose of the new monovalent vaccine in children 6 months of age to 11 years old. The new labeling lowers the age for a single dose of the vaccine to 5 years of age. Those younger than 5 years or who have a suppressed immune system may be eligible for more than one dose. This information only applies to children who have had a previous COVID-19 vaccine. Those who are unvaccinated would require a 3-dose series. 

Individuals who have received a COVID-19 vaccine in the past are eligible for the new monovalent booster if it has been at least 2 months since their last shot. This is based on studies showing a sharp decline in antibodies after 2-3 months after vaccination. 

The new monovalent vaccines have human clinical studies and the FDA has considered the effectiveness and safety information in the approval of the vaccines. The study reactions of vaccinated individuals was similar to the previous monovalent (original) and the bivalent vaccines. The new monovalent doses will provide some protection against the current circulating variants including EG.5.1, FL.1.5.1, BA.2.86, and XBB.1.16.

Two very interesting things to consider based on new studies. A recent study in eBioMedicine showed a better response to the COVID-19 vaccine if given in the same arm as your last COVID-19 vaccine. Scientifically, it makes sense based on the body’s lymph nodes and immune system. Other studies have shown safety in getting a COVID-19 vaccine at the same time as a flu shot. What has not been studied is the combination of getting a COVID-19, flu, and RSV vaccines at the same time. If you get the COVID-19 and flu at the same time, it would be suggested to wait at least 30 days before getting the RSV vaccine. 

It is time to get the Big Shot!

The pharmacy has ordered doses of the Moderna and Pfizer monovalent vaccines. For more information, please call the pharmacy at 419-772-3784.