In a highly anticipated development in the ongoing fight against the COVID-19 pandemic, the U.S. Centers for Disease Control (CDC) recently made a significant update to the vaccine schedule. The CDC’s vaccine committee has recommended that everyone, regardless of age, should receive another booster shot to enhance their immunity against the virus.
This decision was endorsed by CDC director Dr. Mandy Cohen and was based on the expert recommendations of the agency’s committee. The newly recommended booster shot is the most recent vaccine to receive approval from the Food and Drug Administration (FDA), which gave the green light for the use of mRNA vaccines developed by Moderna and Pfizer-BioNTech. These vaccines are specifically designed to target the XBB.1.5 variant and are approved for individuals aged 12 and older. The FDA also granted emergency use authorization for mRNA vaccines in children aged six months to 11 years. As a result, the updated vaccine is currently the sole authorized and approved option for combating COVID-19, with the previous booster for the BA.4/5 variant no longer authorized.
The CDC’s panel of vaccine experts voted overwhelmingly in favor of recommending near-universal vaccination for all individuals aged six months and older. This decision was driven by the goal of providing the most robust protection against a potential surge in infections during the upcoming fall and winter seasons. Notably, COVID-19 hospitalizations have been on the rise since mid-July, with a notable portion of these cases involving young children and older adults. Alarmingly, approximately half of the children under the age of five who were hospitalized had no underlying health conditions, serving as a stark reminder that even individuals without pre-existing health issues can suffer severe illness from COVID-19.
Despite the broad consensus on recommending the vaccine for most people, some committee members raised valid concerns. First and foremost, the new vaccines target the XBB.1.5 variant, which is no longer the dominant strain causing infections in the U.S. Although it was prevalent earlier in the summer when the FDA made its decision to switch to a new vaccine, it has since been replaced by a variety of new strains, including EG.5.1 and BA.2.86. Moderna, Pfizer, and Novavax all presented data showing that their XBB-targeted vaccines produced robust antibody responses against these newer variants. However, Moderna’s data was unique in that it involved human cells, while Pfizer and Novavax relied on animal studies for their data.
The debate also centered around whether the updated vaccine should be recommended universally or only for those at the highest risk of COVID-19 complications, such as the very young, the elderly, and those with compromised immune systems. Dr. Matt Daley, the head of the CDC’s work group that assessed vaccine safety and effectiveness data, emphasized that their discussions began with the assumption that the updated vaccine might not be recommended for everyone. Their comprehensive review sought detailed data on hospitalizations, the severity of the disease, and mortality rates related to COVID-19, in order to better identify populations at higher risk of complications and who could benefit from vaccination. The data revealed that serious illness from COVID-19 affected individuals across all age groups, even those without underlying medical conditions, making a compelling case for universal vaccination.
The decline in overall immunity against SARS-CoV-2 was also a concern due to the fact that many people did not receive the most recent booster. Dr. Sandra Fryhoffer, representing the American Medical Association, noted that with reduced immunity, the population as a whole becomes more susceptible to the virus.
While most committee members were in favor of a universal recommendation, Dr. Pablo Sanchez was the sole member to vote against it. He stressed the importance of acknowledging the lack of data on children and suggested a more targeted approach, focusing on the most vulnerable groups, including individuals over 65, the immunocompromised, and pregnant people. He advocated for individualized discussions between healthcare providers and patients to make informed decisions about vaccination.
Some committee members echoed Sanchez’s concerns about data limitations but argued that without a universal recommendation, disparities in vaccine access would worsen, particularly for those without access to healthcare.
An important change accompanying the updated vaccine is its commercial availability, which marks a departure from the previous distribution model used during the pandemic. These vaccines will be available on the commercial market, with an estimated cost of $120 to $130 per dose. Pharmacies and medical offices will purchase the vaccines at their own expense and then seek reimbursement for administering the shots. Most insurance plans, including Medicare and private companies, will continue to cover the vaccine without requiring co-pays, as it is recommended by the CDC.
For uninsured or underinsured children, the Vaccines for Children program will supply the necessary shots. As for older children and adults without adequate insurance coverage, the CDC plans to purchase vaccines and make them available through state and local health departments and retail pharmacies participating in the Bridge Access Program until 2024. To extend the program for adults beyond that timeframe, the agency seeks additional funding to establish a permanent Vaccines for Adults program, which will offer a wider range of vaccines beyond COVID-19 to promote public health and safety.
Appointments for individuals aged five and above are made available at CVS.com and via the CVS Pharmacy app, and walk-ins will be accepted as individual locations receive the vaccines. MinuteClinic locations will also begin offering the new COVID-19 vaccine for patients aged 18 months and above in the coming weeks, with appointments available at MinuteClinic.com.
