FDA’s Revised Covid-19 Vaccines: Only for 65 Plus and High Risk?
In May, the Food and Drug Administration made an unexpected announcement. They decided that revised COVID-19 vaccines would only be approved for adults above 65 and individuals who might be at a higher risk from infection. How this could impact vaccine accessibility for people outside these categories or the question of whether insurance would cover their cost, remains uncertain as fall approaches. The picture is expected to get clearer in the upcoming weeks, but, currently, the situation is predominantly marked by chaos and confusion, which creates an unsettling realm around health matters.
This week saw some noteworthy developments, particularly the American Academy of Pediatrics’ (AAP) resolution on Tuesday to continue endorsing that children between six months and two years old be vaccinated. The AAP also advocates for vaccinating older children that belong to high-risk groups. This contradicts the decision made by the health secretary to stop authorizing COVID vaccinations for healthy children aged 6 months and older, and to stop approving them for pregnant women.
The AAP remained firm in its stance due to the elevated risk of hospitalization for young children and those with high-risk conditions. According to their perspective, the hospitalization rate for children below the age of two is on par with the rate for adults aged 50 to 64—data supported by the Centers for Disease Control and Prevention statistics.
Despite consistent argumentation that healthy children face little to no danger from COVID, above half of the young children admitted to hospitals did not have an underlying health condition. Briefly put, vaccine manufacturers have indeed revamped their COVID vaccines to target the dominant strain of the virus in the United States.
Like flu vaccines, COVID vaccines might not completely eliminate the probability of catching the disease, yet they continue to significantly minimize the risk of severe illness, hospitalization, or death. Nevertheless, the coverage of the revamped vaccines by insurance for healthy adults younger than 65 remains a gray area.
Until now, private insurance and Medicaid have entirely covered COVID vaccines for people aged 6 months and upwards. For the rest, vaccination coverage will depend on their respective insurance policies. Some insurers might opt to continue complete coverage, while others might ask for a copay, and a few might even require individuals to bear the full cost, potentially reaching up to $140.
Once it became apparent that vaccine policy was heading for a shift, a group of public health experts launched a project under the aegis of the University of Minnesota’s Center for Infectious Disease Research and Policy. The project, headed by the Director of CIDRAP, aims to keep assessing the safety and effectiveness of a range of vaccines.
A recent webinar announced the project’s analysis of existing COVID vaccine research, asserting that vaccines continue to be safe and efficacious. The study showcased that there were no signs of sudden safety vulnerabilities or a drop in the effectiveness of these immunizations. There was no scientific base found to back the alterations in COVID recommendations made for pregnant women or children.
The review was executed by 24 infectious disease experts from reputable academic institutions, who examined approximately 600 papers, comprising about 50 randomized controlled trials. The report predicts that other medical associations will likely echo the AAP in the near future and recommend the COVID vaccine for almost all adults, regardless of the CDC’s potentially compromised approvals.
Recommendations from bodies like the Infectious Diseases Society of America, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians might influence insurance companies. However, in contrast to ACIP approval, these opinions will not possess legal force.
In a world of evolving health threats, genuine medical science continues to provide some solace. Despite the uncertainties and ongoing debates, it remains pivotal that public health decisions are guided by rigorous scientifically-backed insights rather than uncorroborated beliefs or fears.