Health
The FDA will consider whether the COVID booster will be vaccinated against the next flu
According to the report, the impact of the regular COVID booster program will be the most important agenda item at the FDA Advisory Board meeting on Wednesday. Briefing document Released by agency staff.
and April 6th meetingThe FDA has given the Vaccine and Related Biopharmaceutical Advisory Board (VRBPAC) parameters on how often and how to apply it to both approved, as well as how to determine when the composition of the COVID booster needs to be updated. I am asking you to present it. Approved vaccine.
In a document released on Monday, FDA staff appear to be fine-tuning VR BPAC for a structure similar to the flu vaccine. This is an “approach that can support strain changes with manufacturing information alone” supported by clinical immunogenicity and safety data. In contrast to current policies that require clinical data.
Agency staff argued that, as with influenza, the scope of COVID vaccines needs to be expanded to a more global scale through “adjusted strain selection.” They also find that while the World Health Organization and the FDA coordinate annual selection of strains of the seasonal influenza vaccine, there are some important differences to consider between influenza and SARS-CoV-2. Also mentioned.
The most important difference is that unlike influenza, COVID has no “predictable winter seasonality”. In this case, manufacturers can implement recommendations based on the Northern or Southern Hemisphere influenza pattern. In contrast, “a predictable pattern of SARS-CoV-2 has not yet emerged,” FDA staff said.
“At this time, it is not clear if, or when, the SARS-CoV-2 epidemiology will fall into a pattern that manifests or requires global recommendations for an updated COVID-19 vaccine composition.” They are writing.
Agency staff recommended three criteria for possible changes in the composition of COVID vaccine strains.
- Sufficient data exist to “suggest the need for a more suitable vaccine”
- Evidence that the new vaccine “provides significantly better results than the current vaccine”
- Manufacturers have the ability and ability to produce these new vaccines
Manufacturing was listed as another commitment to changing COVID booster stocks. The influenza vaccine is on a similar platform and is easy to update, and agency staff said, “The various platforms used for the approved and approved COVID-19 vaccine correspond to the updated composition in a similar time frame. It’s not clear if it can be done. “
Finally, FDA staff discuss the timing and population of future boosters, and additional boosters should “optimally prevent hospitalization and death of those at greatest risk” and these future variants. Thought that it could essentially appear between the 2022 and 2023 flus. Seasons or “at least a significant part” of them.
They also emphasized the importance of preventing symptomatic illnesses in the hope of preventing long-term COVID. It also addresses the potential associated risks of additional booster immunity, such as vaccine-related myocarditis, while “potentially generate a broader immune response that may address new mutations across the population. Benefits may be determined to outweigh the known ones. ” And potential risks. “
FDA staff also asked VRBPAC to discuss topics related to COVID epidemiology, vaccine efficacy, and “practical aspects and goals of public health vaccination programs.”
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