The Food and Drug Administration (FDA) is expected to approve updated versions of Covid boosters as early as Friday, targeting the XBB.1.5 omicron subvariant. While this strain is no longer dominant, the boosters are designed to protect against current circulating subvariants. However, the timeline for authorization may extend into early next week, causing criticism of the slow rollout. Additionally, there is potential for the boosters to receive a full approval license rather than emergency use authorization, a departure from previous vaccine authorizations. Following FDA approval, the Centers for Disease Control and Prevention and its advisory committee will issue their own recommendations on distribution and usage. The cost of the booster shots will not be covered by the federal government, with Pfizer and Moderna pricing each vaccine dose between $110 and $130. Insurance coverage will determine access to the shots, while uninsured individuals may have access to free boosters through safety net providers or the Biden administration’s “bridge” program. Novavax’s vaccine, available via emergency use authorization, will continue to be covered.
FDA could greenlight new Covid boosters as early as Friday
The Food and Drug Administration (FDA) is expected to grant authorization for updated versions of Covid boosters as early as Friday, according to sources familiar with the agency’s plans. These boosters are specifically designed to target the XBB.1.5 omicron subvariant. Although this particular strain may no longer be dominant, experts believe that the boosters will provide protection against currently circulating subvariants that are closely related. While the Friday timeline for authorization is not set in stone and may be delayed until early next week, there is concern that the slow rollout of boosters by federal health agencies may draw criticism from doctors, especially as Covid cases and hospitalizations continue to rise.
Boosters designed to target the XBB.1.5 omicron subvariant
The updated versions of Covid boosters have been developed to specifically target the XBB.1.5 omicron subvariant. While this strain may no longer be the dominant variant, it is closely related to other circulating subvariants. The drugmakers and experts involved in the development of these boosters believe that they will still provide protection against current subvariants.
Authorization timeline
The FDA is currently planning to grant authorization for the new Covid boosters as early as Friday, although this timeline may be subject to change and could potentially be delayed until early next week. It is essential for the FDA to thoroughly review the safety and efficacy data before granting authorization to ensure that the boosters meet the required standards.
Criticism for slow booster rollout
There has been criticism regarding the slow rollout of Covid boosters by federal health agencies. With Covid cases and hospitalizations increasing once again, some doctors feel that the booster campaign should be expedited to provide greater protection against the virus. It is important for health agencies to address these concerns and work towards a more efficient and timely rollout of booster shots.
Exploring full approval license for boosters
In a departure from the emergency use authorization approach used for previous Covid vaccine authorizations, the FDA is reportedly exploring the possibility of granting the boosters a full approval license. This would involve a more rigorous review process to ensure the safety and efficacy of the boosters. However, it is still uncertain whether this is the intended course of action and further clarification is needed.
CDC recommendations and approval process
Following the FDA’s authorization, the Centers for Disease Control and Prevention (CDC) and its advisory committee will issue their own recommendations regarding the administration and distribution of the boosters. The CDC’s Advisory Committee on Immunization Practices is scheduled to vote on these recommendations at a meeting on Tuesday. If approved, CDC Director Dr. Mandy Cohen could promptly authorize the boosters, paving the way for vaccinations to begin.
Aim to shore up protection as immunity diminishes
While approximately 97% of adults have some level of protective immunity, it is crucial to address the fact that immunity from previous infections and vaccinations diminishes over time. With people spending more time indoors during the fall and winter months, it becomes essential to shore up protection against the virus through booster shots. By targeting specific subvariants, these boosters aim to enhance immunity and minimize the risk of infection.
Cost of the shots not covered by federal government
Unlike previous Covid vaccine administrations, the cost of the booster shots will not be covered by the federal government. Pfizer and Moderna, the manufacturers of the authorized vaccines, have indicated that the list price for the boosters will range between $110 to $130 per dose. It is important to consider insurance coverage and out-of-pocket costs when determining eligibility and accessibility for individuals seeking booster shots.
Insurance coverage and out-of-pocket costs
Most individuals with private and public health insurance should continue to pay nothing out of pocket for the booster shots. However, it is crucial to note that receiving the vaccine out of network may result in additional costs. For individuals without insurance coverage, there may be options to receive boosters for free through safety net providers, such as community health centers. Additionally, the Biden administration has announced a “bridge” program that will offer uninsured individuals access to free boosters at least until the end of 2024.
Coverage of Novavax’s vaccine
Novavax’s Covid vaccine, although not granted full FDA approval yet and instead available through emergency use authorization, will continue to be covered. It is essential to consider the available options for Covid vaccination, and individuals should consult with their healthcare providers to determine the most suitable and accessible choice for them.
In conclusion, the FDA is expected to authorize updated versions of Covid boosters as early as Friday, targeting the XBB.1.5 omicron subvariant. Despite concerns about the slow rollout and potential delays, it is crucial for health agencies to ensure the safety and efficacy of the boosters before granting authorization. The CDC’s recommendations and insurance coverage play a significant role in determining the accessibility and distribution of the booster shots. With the aim of shoring up protection as immunity diminishes, these boosters offer an additional line of defense against the virus.
