In a recent announcement, officials from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) revealed that modified Covid-19 vaccines, tailored to strengthen the body’s defense against the prevailing strains of the virus, are slated to debut in mid-September. The officials, speaking on the condition of anonymity, discussed the US government’s strategic preparations for the upcoming fall and winter respiratory virus season.
The FDA is anticipated to grant approval for the updated vaccines within the coming weeks. Following this, the Advisory Committee on Immunization Practices (ACIP), a panel of independent experts advising the CDC on vaccination decisions, will assess the safety and efficacy of the new vaccine iterations. Upon endorsement by the CDC director, the vaccines will be authorized for administration.
The ACIP is scheduled to convene shortly after the FDA’s decision, with a meeting date set for September 12. This expeditious approach aims to fast-track regulatory processes and expedite the vaccines’ availability to the public.
The announcement comes against the backdrop of a late summer surge in Covid-19 cases. Recent data from the CDC indicates a rise in hospitalizations and emergency room visits due to the virus. Approximately 12,600 Americans are currently hospitalized with Covid-19, reflecting a 22% increase in the past week.
Nevertheless, officials assert that current infection levels are significantly lower than those observed a year ago, owing largely to widespread vaccination and acquired immunity from previous infections.
Given the natural decline in Covid-19 antibodies over time, a substantial proportion of the population is due for vaccine boosters. Only around 17% of eligible individuals received the initial bivalent vaccines last autumn, marking the last update in immunization protocols. The upcoming year is expected to witness the availability of three vaccine options: two mRNA vaccines, developed by Pfizer and Moderna, alongside a protein subunit vaccine from Novavax. The latter employs a conventional approach involving a protein component of the virus and an immune-stimulating agent.
Officials emphasize that both vaccine technologies are well-established and safe, having demonstrated their efficacy in real-world scenarios and clinical trials by reducing the risks of hospitalization and mortality due to Covid-19.
As part of the plan, the FDA intends to grant full licensure for Pfizer and Moderna vaccines for individuals aged 12 and older. Vaccination for children aged 11 and below, as well as the Novavax vaccine, will proceed under emergency use authorization.
The updated vaccines are specifically formulated to enhance the body’s defense mechanisms against the XBB.1.5 coronavirus subvariant while maintaining their potency against closely related strains. All three vaccine manufacturers have reported positive testing outcomes, highlighting the vaccines’ effectiveness against the prevalent EG.5 strain in the US.
Notably, these vaccines will be the first to be commercially available. While vaccines were previously distributed free of charge by the government, the Affordable Care Act mandates most insurance plans to cover vaccination costs without imposing co-pays.
For those without insurance or inadequate coverage, a government bridge program will facilitate free access to vaccines. The program will collaborate with federally qualified health centers, public health departments, and pharmacy partners such as CVS, Walgreens, and Walmart to ensure broad access.
CDC Director Dr. Mandy Cohen emphasized that individuals who have previously been vaccinated or infected with Covid-19 might benefit from waiting for the forthcoming vaccines in September. Opting for the older bivalent vaccines at present could potentially delay the opportunity to receive the updated vaccines. Cohen advises such individuals to consult their healthcare provider to assess their individual risk.
Additionally, an ample supply of Covid-19 tests remains available in the Strategic National Stockpile. The government continues to distribute these tests to various institutions and public spaces, with the option to order tests via the Covidtest.gov website.
As September approaches, expectations are high for the new and modified Covid-19 vaccines, offering renewed hope for bolstering the population’s immunity against the virus’s evolving challenges.