Is FDA’s Disappointment Over COVID-19 Vaccine Booster Warranted?

Dr. Adam Tabriz

Vaccination Decision Made Based On Transparency Or Ambiguity!

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COVID-19 NewsPhoto byAuthor using Wonder digital art

Almost three years into the COVID-19 pandemic, 48.2 Million vaccine injections, and over $5 billion cost for U.S. taxpayers, the Corona vaccine booster effectiveness faces another scrutiny.

Earlier this month, the latter topic occupied the headlines of major news media across the United States.

In august 2022 United States Food And Drug Administration (FDA) amended an emergency use authorization of Pfizer-Biontech and Moderna COVID-19 vaccines of their bivalent formulation for booster two months following the primary monovalent or booster vaccination.

In November 2022, the federal agency approved the same vaccines for children five years and older.

It is a surprise that according to a report published by CNN health, some federal adviser group expressed their “disappointment” and anger. The advisers' concern pointed to the lack of transparency of the “infection data” related to the late booster vaccine. And that government scientists and pharmaceutical companies should produce to the advisory board.

According to what was mentioned to CNN FDA advisory group provided advice to the U.S. Center for Disease Control only received a copy of what they refer to as “immunogenicity data” in June 2022. The latter information refers to the blood work-study and how well participants respond to antibody production against the Omnicron-specific vaccine.

Despite positive immunogenicity data produced by the pharma, recently discovered booster vaccine data suggests that those boosters are no more effective at preventing Covid-19 infections than the earlier monovalent vaccines.

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Covid-19 VaccinePhoto byAuthor using Wonder digital art

Advisers blame this inconsistency on the lack of transparency on behalf of the scientists and the parent pharma industries.

The infectivity data revealed that 3.2% of the bivalent booster vaccine trial participants became infected after the inoculation versus the 1.9% infections reported after the primary (monovalent) booster vaccine. The latter finding suggests little or no difference in immunity between those who received bivalent shots and those who only received two doses.

Yet, despite the hostility toward the lack of data transparency, according to an interview conducted by CNN with FDA and CDC advisers, the final decision would have been likely unruffled. That is merely because adviser based their entire decision on limited data.

Then again, some leaders still believe the government agency could have made better decisions. For instance, European countries took a different approach to boosting COVID-19 immunity using similar data availability. Instead of using a bivalent vaccine from the same biotechnology, they used an equal mix of the existing monovalent vaccines plus a design against the new subvariant, Omnicron BA.1.

On January 26, 2023, FDA will hold further meetings to address the future strategies and regimen against COVID-19. Nevertheless, these two questions still need to be answered. One: why did advisers fail to use more diligence to insist on having access to infectivity data? And Two: Why now?

Without a doubt, COVID-19 vaccination has offered protection against the novel virus of this pandemic. Moreover, transparency is always a must, especially regarding public health. Nevertheless, when the long-term side effects of some of these vaccines are still unclear, it becomes even more vital to weigh the risks against the benefit. Not to mention the reported short-term cardiovascular complications associated with COVID-19 vaccines.

If infectivity data were not concealed, it would be more probable than not that people defer the bivalent booster shots altogether. But that did not happen!

Reference

  1. Thomas, E.C., Naomi, 2023. FDA vaccine advisers “disappointed” and “angry” that early data about new Covid-19 booster shot wasn’t presented for review last year | CNN [WWW Document]. CNN. URL https://www.cnn.com/2023/01/11/health/moderna-bivalent-transparency/index.html (accessed 1.16.23).
  2. CDC, 2022. COVID-19 Vaccination for Children [WWW Document]. Centers for Disease Control and Prevention. URL https://www.cdc.gov/vaccines/covid-19/planning/children.html (accessed 1.16.23).
  3. Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose [WWW Document], 2022. . Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose | FDA. URL https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use (accessed 1.16.23).
  4. CDC, 2020. COVID Data Tracker [WWW Document]. Centers for Disease Control and Prevention. URL https://covid.cdc.gov/covid-data-tracker (accessed 1.16.23).
  5. Opinion | The Updated COVID Boosters Could Have Been Better [WWW Document], 2022. . The Updated COVID Boosters Could Have Been Better | MedPage Today. URL https://www.medpagetoday.com/opinion/second-opinions/101432 (accessed 1.16.23).
  6. Coronavirus (COVID-19) Update: FDA to Hold Advisory Committee Meeting to Discuss Future Vaccination Regimens Addressing COVID-19 [WWW Document], 2022. . Coronavirus (COVID-19) Update: FDA to Hold Advisory Committee Meeting to Discuss Future Vaccination Regimens Addressing COVID-19 | FDA. URL https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-hold-advisory-committee-meeting-discuss-future-vaccination-regimens (accessed 1.16.23).
  7. UpToDate [WWW Document], n.d. . UpToDate. URL https://www.uptodate.com/contents/covid-19-cardiac-manifestations-in-adults (accessed 1.16.23).

Illumination Curated initially publicized this article on Medium!

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