According to documents released online on Monday, the US Food and Drug Administration would like to streamline the production of the Covid-19 vaccine so that it more closely resembles the production of the flu vaccine. Vaccine composition, vaccination schedules, and regular updates for Covid-19 vaccines could all be simplified as part of this process.
Like the procedure to update annual flu vaccines, the FDA has stated that it plans to evaluate circulating strains of the coronavirus at least annually and make a decision in June over which strains to select for the fall season.
The latest Covid-19 vaccine may only require a single dosage in the future, the agency said, regardless of how many times a person has been vaccinated in the past. The FDA’s briefing sheet for its vaccine advisers suggests that two doses may be necessary for persons who are extremely young and haven’t been exposed, who are elderly, or who have compromised immune systems.
A proposed @US_FDA variant-chasing "booster-dependent" approach when their uptake is poor and there's no aspiration to develop better vaccines: nasal to block infections, variant-proof shots with more durability and less side-effectshttps://t.co/ePumEpM3jM by @lauriemcginley2 pic.twitter.com/LksnEGkBu9
— Eric Topol (@EricTopol) January 24, 2023
The FDA is advocating for a switch to a monovalent vaccine for primary vaccinations, which targets a single strain, and a bivalent vaccine, which targets multiple strains, for booster vaccinations.
No information about how many strains, if any, will be included in the annual shot is included in the FDA briefing documents. This year’s influenza vaccine protects against four different types of the virus.
The FDA stated that “this simplicity of vaccine composition should minimize complexity, decrease vaccine administration errors due to the complexity of the number of various vial presentations,” and maybe promote vaccine compliance by permitting clearer communication.
On Thursday, the FDA’s independent vaccine advisors will convene to discuss the future of Covid-19 immunization regimens and vote on whether or not to approve aspects of the FDA’s plan.
There was a conflicting opinion among vaccine specialists.
Mayo Clinic’s Dr. Gregory Poland, who previously served on the FDA’s expert advisory panel, recommends that the agency first define the goals it has for annual immunization.
Poland, who investigates the body’s reaction to vaccines, said, “They’re going to have to define what the purpose of the usage of present vaccines is.” If the goal is to reduce the prevalence of fatal diseases, we’ve already achieved that.
1/ FDA considers major shift in COVID vaccine strategy
by @NPR's @robsteinnews
w/ Deepta Bhattacharya, Gregory Poland, John Moore, @DrPaulOffit, @NEJM's Eric Rubin, @David_RMartinez, @PeterHotez & mehttps://t.co/Fb3Z5JQ5Vl
The FDA is trying to simplify recommendations & more.
— Céline Gounder, MD, ScM, FIDSA 🇺🇦 (@celinegounder) January 23, 2023
He would like to see evidence that the most recent version of the booster is effective against the most recent Omicron subvariants before he would contemplate switching to annual boosters.
Specifically, “the evidence that is getting brought out regarding efficacy is before BQ and XBB subvariants,” Poland added.
He also emphasized the need for the committee demanding full disclosure from the FDA and pharmaceutical companies before making any conclusions. Concerned that the agency had not provided the advisory group with all available information about bivalent boosters at their June meeting, he wrote to express his displeasure.
Dean of the National School of Tropical Medicine at the Baylor College of Medicine Dr. Peter Hotez has commented that he sees the idea for an annual update as a balance between what the science indicates is needed to battle the virus and what is actually possible.
Incorporating what we know from scientific research—namely, the importance of being flexible and adaptable—is, in my opinion, a delicate balancing act. Though in all likelihood, businesses can switch over more frequently than once a year,” he noted.
He acknowledges, however, that there are flaws in this strategy. The virus can be updated once a year if it continues to develop gradually from known strains. However, he wonders if the world is equipped with sufficient genetic surveillance to detect a drastically different variety that unexpectedly emerges as Omicron did.
We need an international system of checks and balances for surveillance. Globally, we lack the infrastructure for genomic sequencing. When it comes to monitoring coronaviruses, “we don’t have the highly planned dance that took decades to develop for influenza surveillance,” Hotez added.
Dr. John Wherry, head of the University of Pennsylvania’s Institute for Immunology, has been examining the efficacy of T-cells, the body’s secondary line of defense, against several coronavirus strains.
The response is that prospects are bright. Antibody levels decline within three months after a booster, but T-cells appear to be staying around for longer (up to nine months so far), and they are assumed to be the component of immunity that protects against catastrophic consequences like hospitalization and death.
Wherry says he agrees with the FDA’s intention for a yearly Covid-19 vaccine despite the lack of evidence for a significant reduction in T-cells over time.
He argued that immunizations should be recommended routinely as part of everyone’s preventative health care. If you have the vaccine every year, your T-cells will stay in shape, up to date, and ready to defend us in the background with your antibodies.
This suggests the boosters may have useful effects both quickly and over time.