Do bivalents have human trial data?

Due diligence on the question. Short answer: Moderna yes, Pfizer no?

Much excitement regarding covid bivalent vaccines, which promise to be rather more up to date in terms of matching the actual circulating strands/variants of covid. For my part, I have followed the rapidly-dwindling size of covid vaccine trials since 2020 - when tens of thousands of subjects were involved in Pfizer, Moderna, and Astra-Zeneca trials; to 2021, when a couple of thousand youths were involved in Pfizer trials; to 2022, when a few hundred Israelis were involved in Pfizer booster trials —

— and now to late 2022, when it appears that human trials are not considered necessary for bivalent vaccines.

However, let us perform some due diligence checks to confirm whether or not there might be human trials data that is simply not well publicized.

First check: U.S. government clinical trials database:

There are no completed studies of covid bivalent vaccines in the NIH Clinical Trials Database.

Second Check: DR. ANTHONY FAUCI

In an interview on Canadian TV on September 6, 2022, Dr. Anthony Fauci also indicated that human trials had not been done (2:20-2:27 on this video) :

“It hasn’t been proven in a clinical trial because we don’t have time to do a clinical trial because we need to get the vaccine out now…”

Third Check: FIERCEPHARMA

Pharmaceutical industry website FiercePharma contends there is no human trial data:

Fourth Check: YOUR LOCAL EPIDEMIOLOGIST

One of the emerging bivalent enthusiasts on social media is the esteemed epidemiology Professor Katelyn Jetelina, who has a large presence on Substack and has been invited to the White House for her work on informing the public throughout covid. This is completely independent of any funding whatsoever. Her epidemiological perspective on bivalents is found here.

I have read through this post twice, and have found no reference to human trials data, or in fact any data at all, with reference to covid bivalent vaccines. However, the conclusion is:

(YLE= Your Local Epidemiologist)

Fifth Check: POPULAR SCIENCE

The CDC and FDA said that they recommended the bivalent boosters based on the “totality of evidence.” In translation, the decision was made using a combination of safety and efficacy data from trials of slightly different bivalent Omicron vaccines, and mouse trials involving the newly authorized updates.

“Part of this is because the Omicron variant mutates rapidly. Just weeks after the variant emerged last November, Pfizer, Moderna, and other vaccine manufacturers began developing strain-specific shots. But by the time the companies began to submit data to federal regulators for approval, Omicron had changed shape. When an independent panel of FDA advisors convened in April, it largely agreed that updated boosters should target the most recent BA.4 and BA.5 strains. That forced pharmaceutical companies to begin work on a second Omicron formulation of which human trials are still ongoing.”

Sixth check: Substack readers

One correspondent points out that Moderna has human trial data on their bivalent vaccine. A search for “spikevax bivalent” yields this preprint, funded by Moderna and published to preprint on June 25, 2022. It does not appear to be peer-reviewed as yet. Also unclear why this trial does not appear to be indexed in the NIH Clinical Trials database.

Conclusion: There is one human trial from Moderna regarding the bivalent vaccine in pre-print