The approval of the Pfizer-BioNTech vaccine in 2020 ushered in a hope for stemming the endless tide of death and illness wrought by COVID-19. While the importance of the original vaccines is undeniable, variants continue to prolong the pandemic. From preventative measures such as mask wearing, physical distancing, and hand washing to COVID-19 treatments such as Paxlovid, numerous measures have been instituted over time to lessen the tragic toll of COVID-19. In the continuing COVID fight, the latest tool to be developed to turn the tide of the pandemic are the Omicron specific boosters from Moderna and Pfizer-BioNtech.
According to experts at MD Anderson “[u]ntil now, COVID-19 booster shots have been monovalent or univalent. That means they only contained one version of the mRNA sequence for the SARS-CoV-2 virus’ spike protein—the one that came from the original strain which emerged in late 2019 in Wuhan, China.” The boosters that were recently approved are considered to be bivalent vaccines, meaning they will protect people both from the original COVID-19 strain and the current Ba.4 and Ba.5 Omicron subvariants.
In an interview with the AmNews, Dr. Torian Easterling, the first deputy commissioner and chief equity officer for the New York City Department of Health and Mental Hygiene, stated that “we’re seeing right now with the current monovalent booster that’s available with the current vaccines that are available for our primary series, that cases are decreasing, that hospitalizations are also decreasing.” Easterling went on to state that “during this Omicron wave…we have seen higher rates of infection and reinfection but we did not see a high rate of hospitalization similar to previous waves and I think there are a number of reasons why that may be the case but we certainly know that vaccines have remained effective keeping folks out of the hospital and keeping folks from severe illness.” The theory is that the booster shots will continue to protect people from serious illness and death, and also strengthen the memory of the immune system, thus potentially leading to an ability for the body to recognize variants long-term. While the original vaccines and boosters still provide strong protection, scientists believe that the new boosters designed to target Omicron will be even better at providing protection from infection, hospitalization and death from the evolving COVID-19 virus.
On August 31, 2022, the FDA amended the emergency use authorizations for the Moderna and Pfizer-BioNTech vaccines to allow “bivalent formulations” of their COVID-19 vaccines. In a press release, FDA Commissioner Robert M. Califf, M.D. stated that “[t]he COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19…As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.” This approval was quickly followed by CDC approval on September 1, 2022.
According to the FDA, for the Moderna COVID-19, those 18 years and older are eligible for the bivalent booster at least two months after their primary vaccination completion or most recent booster. For the Pfizer-BioNTech booster, the eligibility age is 12.
While the approval of the boosters is not without questions, it is also important to remember that this process is similar to the flu vaccine process where the flu vaccine is reformulated each year without new additional human clinical trials.
The data submitted by the booster manufacturers is mainly from animal data and European studies. Human clinical trials in the United States are expected to occur later this year and will be necessary for full approval of the vaccines. While clinical trials are not necessary for an emergency use authorization if the manufacturers have not significantly changed the manner in which the vaccine is made, there are concerns regarding public acceptance of such a process.
For those interested in getting the newest booster, New York, like many other states, will rely on a network of pharmacies, health care practitioners, and clinics for distribution as opposed to the mass vaccination sites seen earlier in the pandemic. As for whether people should wait until they become eligible for the new booster or can get access, Easterling encouraged individuals to continue to get their primary series and current booster. According to Easterling, once final procedures are in place at the state level “we’ll have updated revised boosters…available for New Yorkers.”
Updates on the booster can be found at the CDC’s website page entitled “Stay Up to Date with COVID-19 Vaccines Including Boosters”: www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html. For more information regarding vaccines and boosters in New York City, please go to www1.nyc.gov/site/doh/covid/covid-19-vaccines.page. These and other resources can also be accessed on the AmNews COVID-19 page: https://amsterdamnews.com/covid/