FDA Approves Updated COVID Vaccine as Cases Rise

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A new COVID vaccine that targets the most recent variants is being rolled out this week. Many pharmacies are scheduling appointments now. Jill Stryker
A new COVID vaccine that targets the most recent variants is being rolled out this week. Many pharmacies are scheduling appointments now. Jill Stryker

By Sunayana Prabhu

Ready for another jab this fall? The updated 2023-2024 COVID-19 vaccine targeting the most recent variants – XBB, EG5 and BA286 – will be available at most area pharmacies and health care centers as soon as this week.

With the persistence of long COVID and several strains of the XBB variant increasing in circulation, both the U.S. Food and Drug Administration (FDA) and the Centers For Disease Control and Prevention (CDC) have officially recommended nearly every American get the updated COVID-19 vaccine “to protect against potentially serious outcomes of the virus this fall and winter,” according to the CDC’s press announcement Sept. 12.

Following the CDC’s recommendations, most pharmacies have opened up appointments for the updated mRNA vaccines, currently manufactured by Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax), including Bayshore Pharmacy in Middletown, said owner and pharmacist Richard Stryker. However, there is one caveat: the new vaccine is priced around $185 and is not covered by the federal government like the previous formulations.

Most commercial insurance plans, Medicare and Medicare D plans will be covering it with no copay, but “the unfortunate part,” Stryker said, is “for anyone who’s uninsured. There’s really nothing set up for them yet.”

Stryker shared resources for patients meeting income requirements whom he said should be covered under the Vaccines for Children and the Federal Vaccines for Adults Program, but “the best bet,” he said, is “probably to reach out to the Monmouth County Board of Health and they’ll be able to arrange for those vaccinations.”

The “fall dose” season is quickly ramping up with an onslaught of several respiratory diseases, like the flu, RSV and others, including COVID-19. As expected, the COVID-19 vaccine is likely to become an annual affair like flu shots, said Stryker.

Coronaviruses cause the common cold, but the COVID-19 version mutates more rapidly than the influenza virus that causes the flu. Offering a bit of hope amidst the concern, Stryker said the virus currently seems to have “peaked in how dangerous it is. It is becoming less virulent with every mutation.”

The CDC maintains that vaccination is the best protection against a constantly changing virus. The latest vaccine is reworked to target the XBB variants that are a descendant of the Omicron strain that peaked last winter, threatening a “tripledemic” – the convergence of the flu, COVID and RSV (respiratory syncytial virus), a respiratory disease that causes mild, cold-like symptoms but can be severe for infants and older adults. Omicron was part of the evolution of SARS-CoV-2, the original strain that caused the COVID-19 pandemic.

“We have more tools than ever to prevent the worst outcomes from COVID-19,” said CDC director Mandy Cohen, M.D., M.P.H., in the release. “CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones.”

“This is the first fall and winter virus season where vaccines are available for the three viruses responsible for most hospitalizations – COVID-19, RSV, and flu,” according to the CDC.

The CDC’s decision to roll out the revised vaccine came after the FDA authorized and approved the new mRNA formula to closely target the XBB strains currently found to be most dominant in the country, according to an FDA statement Sept. 11. The new vaccine has been “updated to include a monovalent (single) component that targets Omicron variant XBB.1.5,” based on the data evaluation and evidence found by their expert advisors. The new vaccine is not considered a booster shot but rather is a separate preparation. The vaccine will most likely be reworked every year like the flu shot to target the most prevalent strains of the virus.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in the release. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

The FDA approved the selection of the XBB strain to be included in updated COVID-19 vaccines based on the analysis of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) that periodically convenes in open session to discuss and make recommendations on the selection of strain(s).

Citing the CDC data tracker of variant proportions, the FDA, in another statement on behalf of its advisory committee, further explained why it chose to target the XBB strain. The CDC reported details on the evolution of the original COVID-19 strain (SARS-CoV-2) and stated that its current trajectory indicates the most dominant spike is found in XBB sublineages, “accounting for more than 95% of the circulating virus variants in the U.S. as of early June 2023.”

“XBB.1.16 could be dominant by fall 2023,” according to the advisory committee report.

The new formula will replace the bivalent Moderna and Pfizer-BioNTech COVID-19 (original plus Omicron BA.4/BA.5) vaccines that “appear less effective against currently circulating variants,” the FDA confirmed in its statement, noting the bivalent vaccines “are no longer authorized for use in the United States.”

Several pharmacies, including national chain CVS, have advised of the availability of the new vaccine on their websites. CVS indicated the updated mRNA vaccines are approved for “individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age. For individuals aged five and above the new vaccines are authorized regardless of previous vaccinations but must be administered two months following the last dose of any COVID-19 vaccine.”

According to the CDC “COVID-19 continues to be a major cause of serious respiratory illnesses in the United States, with more than 200,000 deaths (including more than 600 in children and adolescents 0-19 years old) reported since January 2022. Vaccination is the most effective tool to protect yourself from severe illness this fall and winter.”

The article originally appeared in the September 21 – 27, 2023 print edition of The Two River Times.