In a bid to fortify defenses against the ever-evolving COVID-19 variants and to mitigate the potential surge in cases during the upcoming fall and winter, the United States has granted its approval for updated COVID-19 vaccines.
This significant decision by the Food and Drug Administration (FDA) heralds the availability of the latest vaccine formulations from Moderna and Pfizer, in collaboration with BioNTech, to a broader spectrum of the American population. Notably, this eligibility encompasses individuals who have never received a COVID-19 vaccine before. The strategy now aligns more closely with the routine administration of an annual flu shot.
However, one crucial checkpoint remains—the green light from the Centers for Disease Control and Prevention (CDC). An advisory panel convened by the CDC is scheduled to issue recommendations on Tuesday, delineating the groups that would benefit most from these updated vaccines. If all goes according to plan, the administration of these updated COVID-19 vaccines could commence later this week. Moreover, it’s worth noting that individuals can receive both the COVID-19 and flu vaccines during a single visit.
Meanwhile, Novavax, a third prominent vaccine manufacturer, has indicated that its updated vaccine is still undergoing scrutiny by the FDA, awaiting its turn for approval.
Over the late summer months, there has been a gradual increase in COVID-19 hospitalizations. However, this uptick, although concerning, is notably less severe than the corresponding period last year. This can be attributed, in part, to the lingering immunity stemming from prior vaccinations and infections. Nevertheless, immunity tends to wane over time, and the virus continues to mutate, giving rise to new variants that may elude the immunity established against earlier strains. Remarkably, it has been a full year since the last vaccine update, and only about 20% of adults have received this earlier iteration.
In light of these developments,FDA vaccination chief Dr. Peter Marks stressed, “Vaccination is vital to public health and COVID-19 prevention, including hospitalization and mortality.We strongly recommend vaccination for eligible individuals.”
Just as in previous vaccine rollouts, the updated vaccines are authorized for adults and children as young as 6 months old. Remarkably, the FDA has extended the eligibility to include individuals as young as 5 years old, permitting a single dose even if they have no prior COVID-19 vaccination history. Younger children may necessitate additional doses, depending on their vaccination and infection history.
Crucially, the FDA refrains from labeling this latest round of vaccines as “boosters.” Instead, they are described as vaccines fine-tuned to better match the prevailing virus strains. These revamped vaccines target an omicron variant known as XBB.1.5, replacing the older combination vaccines that offered protection against the original coronavirus strain and an earlier iteration of omicron.
Even though the XBB.1.5 variant has lost its dominance, the FDA asserts that it closely resembles the virus strains responsible for the majority of current COVID-19 cases, thereby providing substantial cross-protection. Like their predecessors, these vaccines are expected to be most effective at preventing severe COVID-19 outcomes rather than mild infections.
While the FDA’s approval paves the way for widespread use of these updated vaccines, it’s the CDC that will ultimately determine the level of urgency for different population groups to receive them.
Federal authorities have confirmed that these vaccines will remain free for the majority of Americans, covered by private insurance or Medicare. Additionally, for the uninsured or underinsured population, the CDC is collaborating with health departments, clinics, and select pharmacies to temporarily offer free vaccine shots.
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