More than two years into the COVID-19 pandemic, we’ve seen the virus mutate with stunning regularity as it circles the globe. Currently, the omicron variant of the pathogen, as well as its subvariants—tweaks to the virus’s genetic material that change its composition and can make it more infectious, contagious, or cause more serious disease—are infecting the most people. More than 75% of new U.S. cases are now linked to the BA.5 variant of omicron alone.
Regulators acted at the end of June, with the Food and Drug Administration (FDA) recommending that new COVID-19 booster shots target the BA.4 and BA.5 subvariants specifically. The trouble is, those boosters won’t be ready until the fall, as vaccine manufacturer Pfizer noted following the FDA recommendation. And by then an entirely new coronavirus strain may be the one driving a wave of new cases and hospitalizations.
Case in point: The booster for the original BA.1 omicron variant took an extended period to reach vaccine trials, and the variant still makes up the bulk of clinical booster data that Pfizer and Moderna have collected to date, despite largely vanishing from the actual population. Both companies say they are on the cusp of releasing a BA.1-targeted booster should they receive regulators’ blessing, and the theoretical plan would be that such a booster may at least offer partial protection against BA.4 and BA.5 until another booster arrives, ostensibly by October.
But health experts warn that this dog-chasing-cars approach to COVID-19 boosters is unsustainable, and the lag in launching new booster trials and issuing updated regulatory recommendations is a far cry from the striking turnaround time we saw for the original COVID-19 mRNA vaccines in 2020.
“We will be close to 100% BA.5 within a matter of weeks. And no doubt there will be further troublesome variants that lie ahead, be they more in the omicron family or in a whole new lineage,” wrote Dr. Eric Topol, a precision medicine expert and director of the Scripps Research Translational Institute, on his Substack. “Should we wait for a BA.5 booster? That will take months, and it should be noted it took more than 7 months for the omicron BA.1 booster to be tested, a delay that is exceedingly long and unacceptable relative to the timing of validation and production of the original vaccines in 10 months during 2020.”
The nature of mRNA vaccine technology should, in theory, make it easier to adjust boosters to emerging strains once a new coronavirus variant has been genetically sequenced. And the FDA has taken a slew of other measures in recent days and weeks to combat COVID-19, including authorizing vaccines for infants and approving the first new COVID-19 vaccine in more than a year on July 13 (it’s made by Maryland-based Novavax).
The Novavax jab is a traditional, non-mRNA vaccine more akin to a flu shot, an attribute public health experts hope will sway some of the roughly one-third of Americans who have yet to be fully vaccinated against coronavirus due, in part, to skepticism of the newer biotechnology. Just 32% of the U.S. population has received even one booster shot since they became available to the public in fall 2021, according to the New York Times.
In the meantime, the efficacy of BA.1-based COVID-19 boosters against BA.4 and BA.5 is questionable, as evidenced by both preliminary vaccine trial data and the reinfection rates for people who already caught omicron BA.1 but lost natural immunity against BA.5 in just months.
“Usually, immediately after you’ve been infected, within a period of weeks to a month or so, you’re pretty much protected because of the immune response,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, during an appearance on CNN’s New Day. “But if somebody was infected several months ago, particularly if they were infected with omicron, the protection that’s given to you against BA.5 wanes and diminishes pretty rapidly over a period of several months.”
Early data from Moderna suggests that its own BA.1-directed booster shot produces only one-third the level of neutralizing antibodies against COVID-19 in patients with BA.4 or BA.5 variants. As for the prospect of a newer, highly infectious COVID-19 variant driving more cases by the time BA.4/5 boosters are available? A subvariant dubbed BA.2.75, which can deflect immunity from previous infection and vaccines, is already circulating in India, the U.S., and other countries.
Public health experts still urge the same precautions against COVID-19 variants as they have for the entirety of the pandemic: Wear effective masks in public enclosed settings and get the latest booster shot as soon as you are eligible. The Centers for Disease Control and Prevention (CDC) has already recommended adults 50 and older and individuals 12 and older with compromised immune systems receive a second booster shot (even though it wouldn’t be tailored toward omicron) if it’s been at least four months since they received their first booster.
The lackluster pace of booster uptake in the U.S. may sap some of the urgency companies feel to get ahead of the curve in designing new and updated shots, though Pfizer and Moderna still plan to monitor new variants as they emerge. Fauci and other Biden administration officials have faced calls for a new round of federal vaccine development investments to fund an “Operation Warp Speed Part 2,” though such an effort would require Congressional legislation that seems unlikely in the near future.
But the fact remains that addressing this ever-changing virus will ultimately require much faster action by vaccine makers and regulators going forward—or, preferably, a universal COVID-19 vaccine that protects against all mutations.
According to Topol, “All of this gets back to the vital need for a new generation of vaccines that are universal . . . and the pivotal importance of nasal vaccines to promote mucosal immunity and help block the transmission chain. These goals are paramount, along with more and better antiviral drugs, but they are not getting adequate traction or priority.”
Sy Mukherjee has reported on the healthcare industry for a decade. He is a consultant and communications architect at Idea Pharma.