U.S. Health Agency Selects a Novel Strain for Autumn COVID-19 Vaccinations: Implications for Your Upcoming Inoculation
The Food and Drug Administration (FDA) has suggested on Thursday that drugmakers should update Covid-19 vaccines to target the LP.8.1 strain, potentially limiting vaccine access for healthy adults and kids this fall.
This recommendation contrasts with the advice given earlier in the day by the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC), which advocated for maintaining the current vaccines' strains. However, VRBPAC members viewed LP.8.1 as a suitable alternative.
Studies conducted by Moderna and Pfizer indicate that an LP.8.1-targeted vaccine produces a moderately stronger immune response against circulating strains compared to the current vaccines, which target the JN.1 or its descendants, such as KP.2.
LP.8.1 is a descendant of JN.1 and is currently the most prevalent strain in the U.S., accounting for approximately 75% of new Covid cases, according to FDA briefing documents released earlier this week. It differs from the NB.1.8.1 strain, which was recently detected in the U.S. and led to a surge in hospitalizations in China.
Typically, altering the vaccine strain would not raise questions, as it is a common practice in recent years, following a similar model to how the flu shot is updated annually. For Pfizer and Moderna, their mRNA technology facilitates updating their vaccines more easily.
However, this year, the change is anticipated to trigger new rules by the FDA, stipulating that new Covid vaccines for healthy kids and adults must undergo placebo-controlled clinical trials, a process that could take roughly a year, according to FDA Commissioner Dr. Marty Makary's statement to a Senate committee on Thursday.
The updated shots are expected to be available in the fall for adults aged 65 and above, as well as kids and adults with at least one medical condition that puts them at risk for severe illness – exempted groups from the clinical trial requirement.
Over 100 million people in the U.S. are estimated to qualify for a shot based on the extensive list of underlying conditions that raise a person's risk, which includes "physical inactivity."
Dr. Jesse Goodman, a professor of medicine and infectious disease at Georgetown University and a former chief scientist at the FDA, stated that the clinical trial requirement would likely delay and hinder vaccine access for those who want it. However, questions remain about the FDA's policy, including the number of trial participants required and whether a new strain selection would indeed trigger the new trial requirement.
When questioned about the new policy, FDA officials either deemed the questions off-topic or mentioned that the details were still being finalized with drugmakers. The FDA's proposal indicates a preference for drugmakers to update their shots to the LP.8.1 strain, potentially leaving room for manufacturers to stick to their existing formulations.
Questions about insurance coverage and out-of-pocket costs for patients who are ineligible for the shots have arisen. The Centers for Disease Control and Prevention's (CDC) vaccine price list indicates that Pfizer and Moderna are charging up to $150 per dose for a Covid vaccine, while the cost of the Novavax vaccine, which was fully approved earlier this month, is not listed.
In response, the spokesperson for America's Health Insurance Plans stated, "Health plans have prioritized providing affordable access to preventive services, including vaccines." The spokesperson added that they will continue to monitor the forthcoming recommendations and guidance from the CDC's vaccine advisory committee.
Insurance companies have expressed concerns about potential out-of-pocket costs for patients who are ineligible for the updated Covid-19 vaccines, as the Centers for Disease Control and Prevention's (CDC) vaccine price list indicates that Pfizer and Moderna are charging up to $150 per dose. Meanwhile, discussions about the science behind health-and-wellness, particularly fitness-and-exercise, are linked to the FDA's policy, as over 100 million people in the U.S. are estimated to qualify for a shot based on the list of underlying conditions that include "physical inactivity." This highlights the importance of maintaining a balanced lifestyle, not just for individual health, but also for access to certain medical interventions.
