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# Retiring Vaccine Officials Reluctant on Boosters
- URL: https://www.fdaweb.com/retiring-vaccine-officials-reluctant-on-boosters/
- Published: 2021-09-13T12:00:00.000Z
- Updated: 2026-09-14T17:14:22.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150127

Two retiring senior FDA vaccine officials, CBER Office of Vaccines Research and Review (OVRR) director **Marion Gruber** and her deputy **Philip Kraus**e, have joined outside researchers to argue against requiring Covid-19 booster shots until data can show a necessary benefit. Writing in a 9/13 *Lancet* [viewpoint article](https://www.thelancet.com/pb-assets/Lancet/pdfs/S0140673621020468.pdf?ref=fdaweb.com), the FDAers and researchers say current evidence does not show a need for boosters for the general population because efficacy against severe disease remains high.

The two officials raised alarm last month when it became public their departures were related to frustrations from how the Biden Administration has gotten ahead of the agency in announcing Covid-19 booster vaccines’ availability ([see earlier story](https://www.fdaweb.com/two-top-cber-vaccine-officials-leaving-fda/)). The officials also reportedly have been frustrated by CDC and its *Advisory Committee on Immunization Practices for making decisions on issues that should be reserved for FDA, and by a lack of support from CBER director* **Peter Marks** *.*  

The viewpoint article argues that even if vaccine-induced immunity appears to wane, “reductions in neutralizing antibody titre do not necessarily predict reductions in vaccine efficacy over time, and reductions in vaccine efficacy against mild disease do not necessarily predict reductions in the (typically higher) efficacy against severe disease. This effect could be because protection against severe disease is mediated not only by antibody responses, which might be relatively short lived for some vaccines, but also by memory responses and cell-mediated immunity, which are generally longer lived.” They also contend that immune responses against current variants indicates that the variants have not yet evolved to the point they can allude memory immune responses induced by the Covid-19 vaccines.

The authors also believe there is time to take an influenza vaccine approach and devise the booster vaccine antigen to provide protection against the variants now circulating. “A similar strategy is used for influenza vaccines, for which each annual vaccine is based on the most current data about circulating strains, increasing the likelihood that the vaccine will remain effective even if there is further strain evolution,” they wrote.

Additionally, the researchers said that if boosters are not justified by robust data and analysis, it “could adversely affect confidence in vaccines and undermine messaging about the value of primary vaccination. Public health authorities should also carefully consider the consequences for primary vaccination campaigns of endorsing boosters only for selected vaccines. Booster programs that affect some but not all vaccinees may be difficult to implement —so it will be important to base recommendations on complete data about all vaccines available in a country, to consider the logistics of vaccination, and to develop clear public health messaging before boosting is widely recommended.”

Meanwhile, FDA is holding a 9/17 Vaccines and Related Biological Products Advisory Committee meeting to discuss Pfizer-BioNTech’s supplemental BLA seeking approval for a booster dose of Comirnaty (Covid-19 vaccine, mRNA) in individuals 16 years of age and older.

Asked to comment on the *Lancet* article, an FDA spokesperson told ***FDA Webview*** 9/13 that the “views of the authors do not represent the views of the agency. We are in the middle of a deliberative process of reviewing Pfizer’s booster shot supplemental approval submission, and FDA as a matter of practice does not comment on pending matters before the agency. We look forward to a robust and transparent discussion on Friday about that application.”