Unveiling data disclosure in the process of vaccine authorisation for contagious ailments
Hamburger (dts Nachrichtenagentur) - Amidst the ongoing discussions surrounding the potential approval of a COVID-19 vaccine, infectious diseases specialist Marilyn Addo has called for the public disclosure of study data.
In an interview with Deutschlandfunk, Addo, head of infectious diseases at the University Medical Center Hamburg-Eppendorf, emphasized the importance of having these data from large studies with over 30,000 to 40,000 participants. She questioned, "What percentage of participants experienced headaches? What percentage has this side effect occurred?" Addo noted these transient side effects usually resolve within one to two days if they occur. She further stated, "This information is vital for us to be transparent about these aspects."
At present, there are eleven different vaccines in various stages of Phase III clinical trials, employing diverse vaccine strategies and categories. Addo believes this diversity is advantageous, as it provides a solid foundation for the COVID-19 vaccine development process.
Addo also highlighted how immune responses in different population groups might necessitate different vaccine formulations. For instance, she explained that influenza vaccines often show weaker immune responses in older populations compared to younger ones. As a result, various vaccine formulations may be needed for various population groups.
Preliminary data suggests current frontrunners, such as mRNA vaccines, are showing promising results due to their swift production times. However, Addo urged caution and emphasized the significance of waiting for results from other trials as well. She noted, "We will likely need more than one vaccine to vaccinate the world population."
Relevant Background: Current approved COVID-19 vaccines continue to shield against severe illness and deaths. Studies, like those on the 2024-2025 BNT162b2 vaccine, display significant protection, particularly for older adults. Monitoring the genetic and antigenic evolution of SARS-CoV-2 is ongoing to ensure vaccine effectiveness.
The complete vaccination data for 2024 is being collected and will be released in mid-July 2025. Further research focuses on understanding immune responses and clinical endpoints in diverse human populations, including those with different immune statuses and age groups. Continued epidemiological and virological surveillance will help identify emerging variants and guide the development of vaccines that improve protection across various populations.
In the ongoing COVID-19 vaccine discussions, Marilyn Addo, a leading infectious diseases specialist, suggests the need to disclose study data, including the occurrence of side effects like headaches in large health-and-wellness studies. She stresses that this transparency is essential for understanding the medical-conditions related to the vaccines. Furthermore, as the scientific community explores multiple vaccine possibilities to cater to diverse population health-and-wellness needs, Addo underscores the importance of considering immune responses and potential side effects in different age groups and populations with different immune statuses.
