'Humiliating': Pfizer cancels COVID vaccine trial for lack of interest as global scrutiny mounts

Five years after their wide deployment, first on a voluntary basis, then under threat of firing for nearly 100 million Americans at the direction of the White House, COVID-19 vaccines for at least low-risk groups may be on the way out amid higher regulatory requirements and indifference to the jabs by the vast majority of Americans.

Pfizer and its COVID mRNA vaccine partner BioNTech abruptly pulled the plug on their trial for healthy 50-64 year-olds, telling trial investigators in a March 30 letter they were coming up short on the 25,000-30,000 enrollment needed to generate enough data to evaluate the jabs, Reuters reported, citing a letter it viewed.

Friday was the last day that Pfizer was scheduled to monitor trial participants for signs of COVID illness, the letter reportedly said. "Two sources from companies" that manage 9% of trial sites told the wire service that Pfizer told them in writing weeks earlier to stop recruitment. 

"This study is not ending as a result of any safety or benefit-risk concerns," Pfizer and BioNTech told the wire service, citing their "inability to generate relevant post-marketing data" with lagging enrollment. They said they already told the Food and Drug Administration, which did not answer a query from Just the News, they were throwing in the towel.

Pfizer appears to see more dollar signs in the first serious vaccine candidate for Lyme disease since GSK's vaccine reportedly crashed and burned in 2002 due to relatively low efficacy and strain coverage, no testing in children and widespread reports of serious adverse events.

The drug maker is planning to seek regulatory approval with its partner Valneva for the Lyme vaccine despite admitting the trial missed its "primary endpoint" because not enough people got the tick-borne illness. Pfizer made the same big bet on its pricey COVID antiviral Paxlovid, which did no better than a placebo against "long COVID."

Pfizer is also losing a purported ally in the Trump administration, Attorney General Pam Bondi, who before being fired last week was trying to tank clinical trial whistleblower Brook Jackson's False Claims Act lawsuit against Pfizer for allegedly using fraudulent data to obtain emergency use authorization for its COVID vaccine and a related massive payout from taxpayers.

The 5th U.S. Circuit Court of Appeals, which heard arguments in December, is expected to rule in the case "any Friday now," Jackson wrote on X Thursday. "You can’t certify a lie. So what is an FDA authorization built on fraud?"

Scrutiny is coming from across the Atlantic as well, with a former Pfizer official telling a German pandemic inquiry the vaccine maker cut corners on its COVID vaccine.

Helmut Sterz, Pfizer Europe's chief toxicologist until 2008, told the inquiry the "carcinogenic risk" from mRNA shots "was not investigated due to time constraints" and the standards lagged for its study on "reproduction, fertility, pregnancy and newborn development," leaving "no reliable estimates" for jabs' effect on pregnancy, the U.K.'s GBNews reported.

Though he wasn't involved in the COVID vaccine development, Sterz said he based his conclusions on his review of Pfizer's licensed vaccine Comirnaty, public evidence and research papers.

Pfizer's analysis of "post-authorization adverse event reports" for the FDA in spring 2021, hidden until Freedom of Information Act litigation exposed it, recorded nearly nine pages of single-space "adverse events of special interest."

'A ruse to force the FDA to rescind its rule'?

A devout minority of Americans continue to take COVID vaccines, according to Centers for Disease Control and Prevention data: about 18% of adults and half that for kids, with the World Health Organization effectively declaring an end to the pandemic in May 2023. 

"Vaccination intent" is also decidedly against inoculation this season, with a plurality of adults (48%) saying they "probably or definitely" won't get one and 60% of kids saying the same.

FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research Vinay Prasad gave fair warning to vaccine makers in the New England Journal of Medicine early in the second Trump administration, requiring placebo-controlled clinical trials for COVID boosters for ages under 65.

Prasad told staff last fall the agency would further tighten approval requirements after identifying at least 10 children who died "after and because of" receiving a COVID vaccine. 

Years before he took over the FDA, as editor-in-chief of MedPage Today, Makary questioned the CDC's claim that COVID has killed "healthy young children," saying he had never seen any such data. 

The duo allegedly made it harder to recruit for the healthy 50-64 year-old trial by banning participants with chronic conditions. A trial contractor executive told Reuters more than 80% of initial participants "fail at pre-screening because they don't meet the health criteria."

The higher approval standards, requiring the trial population to closely match the target population, stand in contrast to the relatively low standards for the jabs' initial approval, which did not require data on how well they stopped transmission. The CDC undercut then-Director Rochelle Walensky when she claimed vaccines initially stopped transmission.

Moderna is also struggling to hit 30,000 enrollment for its COVID vaccine candidate for healthy 50-64 year-olds, "sources at four sites" told Reuters. Neither Pfizer nor Moderna answered Just the News queries.

"Essentially, the market itself is taking the Covid shots off the market," Brownstone Institute President Jeffrey Tucker, who hosted the gathering of epidemiologists that produced the anti-lockdown Great Barrington Declaration, wrote on X. "It amounts to a humiliating repudiation of one of history's largest and most destructive inoculation attempts."

The Vaccine Research Safety Foundation, led by onetime Democratic presidential candidate funder Steve Kirsch, dubbed the plunging COVID vaccination rate "a massive, nationwide recalibration of risk-benefit" and the aborted trial a sign of "trust erosion."

It posted an image of Pfizer as the Titanic hitting an iceberg labeled "public skepticism" and "data transparency."

Not everyone was convinced the vaccine makers were being genuine. 

"I would not be surprised if this is a ruse to force the FDA to rescind its rule requiring trials for new COVID boosters," sociologist Josh Guetzkow, who cowrote a study with FDA and CDC advisers on pregnancy losses after early mRNA vaccination, wrote on X.

Guetzkow noted Prasad was scheduled to leave the agency at month's end following a year of repeated takedown attempts by the media, including the pro-pharma Wall Street Journal editorial board, and MAGA influencers including Laura Loomer, who objected to his heightened regulatory scrutiny and politically liberal views, respectively.

The absence of a COVID vaccine for a specific demographic could again spur congressional Democrats, widely expected to take back the House in fall midterms, to lean on the FDA to lower its approval standards. 

Prasad's predecessor, Peter Marks, agreed not to reject a vaccine for kids under 5 "solely" because it was less than 50% effective, in 2022. Marks' hasty exit prompted severe single-day plunges for gene therapy and mRNA vaccine makers a year ago.

Investors rewarded mRNA vaccine makers following the aborted vaccine trial, however. Pfizer and Moderna shares rose nearly 1%, and BioNTech's went up about 2%, Reuters said.