Despite President Biden’s recent admission that the COVID-19 pandemic is over, the White House is making another big push to encourage Americans to get yet another COVID booster shot. This time, the Biden administration is marketing the COVID Bivalent versions of messenger RNA (mRNA) Comirnaty and Spikevax biologics developed by Pfizer/BioNTech and Moderna/NIAID respectively.1 2 3
These experimental “bivalent formulations” of the shots, which contain the original strain of the SARS-CoV-2 virus and the other one in common between the BA.4 and BA.5 lineages of the Omicron variant of SARS-CoV-2, were approved for use as a single booster dose by the U.S. Food and Drug Administration (FDA) on Aug. 31, 2022.4 5
The U.S. government has reportedly secured 105 million doses of the Pfizer/BioNTech Bivalent booster and 66 million doses of the Moderna/NIAID Bivalent booster. These may be the last doses of the shots offered free to the public by the federal government.
According to Assistant Secretary for Preparedness and Response Dawn O’Connell:
Our goal is to transition procurement and distribution of COVID-19 vaccines and therapeutics from a federally managed system to the commercial marketplace in a thoughtful, well-coordinated manner that leaves no one behind. We have always intended to transition this work to the commercial market and have been planning for that transition for some time now. Unfortunately, the timeline to make the transition has accelerated over the past six months without additional funds from Congress to support this work.8
Flu Shot, COVID Bivalent Booster Combo Pushed by Federal Government
In the meantime, the Biden administration is ramping up efforts to promote the Omicron-specific COVID Bivalent boosters along with this year’s flu shot. Perhaps the most memorable (if not just plain odd) choice of words to help kick off the administration’s new double-vaccination campaign came from the White House’s Coronavirus Response Coordinator, Ashish Kumar Jha, MD. Dr. Jha said:
The good news is you can get both your flu shot and COVID Bivalent booster at the same time. It’s actually a good idea. I really believe this is why God gave us two arms—one for the flu shot and the other one for the COVID shot.9
The CDC director, Rochelle Walensky, similarly urged the public get both shots at the same time. “If you are eligible, I strongly encourage you to get your fall COVID-19 shot. And remember, if you’re so inclined, it’s perfectly safe and similarly effective to get your flu shot at the same time,” Dr. Walensky said.9
Dr. Walensky continued her two-shot advocacy on Sept. 22 when she received a dose of Moderna’s Bivalent booster. She urged Americans, “protect yourself” now so you can “prevent getting sick in the future” by also getting a flu shot in addition to the new COVID Bivalent booster.10
Some pharmacies in the U.S. have begun offering the flu shot and the COVID Bivalent booster at the same time. CVS and Walgreens, for example, are offering the shots as a “packaged deal” and people have apparently already started getting the shots at the same time.
Unclear How Safety Flu Shot/COVID Bivalent Booster Assurances Were Reached
Interestingly, despite assurances from government health officials like Dr. Jha and Dr. Walensky that it is safe to take the flu shot and COVID Bivalent booster simultaneously, it’s unclear how they arrived at this conclusion. As Mark Conroy, MD of Ohio State University Wexner Medical Center points out:
In terms of side effects from the Omicron-specific vaccine and the flu shot, there haven’t been any studies specifically looking at those two together.11
But this should come as no big surprise, given that neither of the two COVID Bivalent boosters alone were tested for safety on humans prior to being authorized for emergency use on the U.S. population by the FDA. The only safety data there is for these shots comes from a single clinical study on eight mice. That’s it. And, as John Moore, PhD, professor of microbiology and immunology at Weill Cornell Medical College, noted… testing vaccines on mice “doesn’t mimic the human condition.”4
Based on a recent major study published in the Journal of the American Medical Association (JAMA), we do know that simultaneous administration of a flu shot and a non-Omicron-specific COVID mRNA booster can result in “statistically significant” increases in reports of systemic reactions during the week after vaccination. The cohort study involved 981,099 persons aged 12 years and older vaccinated from Sept. 22, 2021 through May 1, 2022. So that might offer some clues about what to expect.12
But as to whether getting a flu shot and a COVID Bivalent booster at the same is safe or not, the honest answer would be, “We simply do not know.”
If you would like to receive an e-mail notice of the most recent articles published in The Vaccine Reaction each week, click here.
Click here to view References:
1 Archie A. Joe Biden says the COVID-19 pandemic is over. This is what the data tells us. NPR Sept. 19, 2022.
2 Diamond D. Biden’s claim that ‘pandemic is over’ complicates efforts to secure funding. The Washington Post Sept. 19, 2022.
3 Stolberg SG. Biden Says the Pandemic Is Over. But at Least 400 People Are Dying Daily. The New York Times Sept. 19, 2022.
4 Cáceres M. Safety and Effectiveness of New COVID Bivalent Boosters Based on a Study of Eight Mice? The Vaccine Reaction Sept. 12, 2022.
5 Press Release. Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose. U.S. Food and Drug Administration Aug. 31, 2022.
6 Erman M, Steenhuysen J. U.S. FDA green lights Omicron-targeted COVID boosters ahead of revaccination campaign. Reuters Aug. 31, 2022.
7 Fauzia M. What are the side effects of the new Covid-19 bivalent booster? Inverse Sept. 20, 2022.
8 Aboulenein A. U.S. plans to move COVID vaccines, treatments to private markets in 2023. Reuters Aug. 31, 2022.
9 Press Briefing. Press Briefing by White House COVID-19 Response Team and Public Health Officials. The White House Sept. 6, 2022.
10 Mitropoulos A. CDC director weighs in on whether pandemic is over, says bivalent COVID shot is ‘critically important’. ABC News Sept. 22, 2022.
11 Onque R. ‘Should I get my omicron booster and flu shot at the same time?’ and other questions about fall vaccines, answered. CNBC Sept. 23, 2022.
12 Hause AM, Zhang B, Yue X et al. Reactogenicity of Simultaneous COVID-19 mRNA Booster and Influenza Vaccination in the US. JAMA Network July 15, 2022.