By Brenda Baletti, Ph.D.

The families of two Black infants who died during a 1960s experimental RSV vaccine trial have filed a federal lawsuit against the U.S., alleging government researchers enrolled the babies in a dangerous medical experiment without their parents’ knowledge or consent, The New York Times reported.

The lawsuit, filed May 22 in the U.S. District Court for the District of Columbia, alleges the National Institutes of Health (NIH) and other researchers, in 1965 and 1966, subjected dozens of infants — most or all of them from low-income Black families — to testing of Pfizer’s Lot 100 experimental vaccine for respiratory syncytial virus, or RSV.

Two infants, Victor Marcellus King and Ross Otto Hambrick, later died after developing vaccine-associated enhanced respiratory disease (VAERD), a severe respiratory illness caused by the vaccine.

VAERD occurs when a vaccinated child who never had RSV is exposed to the virus and develops a more severe case of RSV than they would have if they hadn’t received the vaccine.

The suit was filed by Sharlette Hambrick and Darius King, acting as representatives of the estates of their deceased brothers. They allege federal researchers failed to obtain informed consent from the children’s parents, withheld critical information about prior vaccine failures, and continued the study despite mounting evidence that the vaccine was causing severe reactions in participants.

The complaint also alleges that the tissue samples from the babies who died were later used to develop the RSV vaccines and monoclonal antibody shots that have been approved in the last several years — providing a financial boon for drugmakers.

“Medical research in the United States has a long, troubled racial history,” the complaint states, comparing the alleged conduct to other notorious examples of unethical experimentation involving Black Americans, including the Tuskegee Syphilis Study and the exploitation of Henrietta Lacks.

The infants’ families were unaware the babies had been subjected to the experiment until a reporter from Undark magazine contacted them while investigating the story in 2023.

The reporter found the babies’ names in a doctor’s government-issued laboratory notebook and other paperwork from the clinical trial, the Times reported.

Parents not told infants were being enrolled in trial for experimental vaccine

NIH researchers developed an experimental RSV vaccine in the early 1960s using a method similar to the one used to develop the polio vaccine. They administered the shot to over 50 children at a hospital known for its largely Black patient population.

Nearly half of the babies developed RSV, and 10 of them required hospitalization — which NIH researcher Dr. Robert Chanock, who led the study, later conceded was “possibly outside the range of normal.”

Instead of halting the program, the researchers partnered with Pfizer to create a more concentrated version of the shot known as Lot 100, according to the lawsuit.

Pfizer tested Lot 100 on four mice, four guinea pigs and 25 monkeys — and then concluded it was safe enough to test on babies.

In the winter of 1965-66, the researchers selected 31 of the youngest children from one of the hospital’s clinics. Victor King and Ross Hambrick, who were 4 months old and 2 months old — the youngest babies in the study — were among the infants selected, according to the complaint.

The families weren’t informed the babies were being enrolled in a trial, nor were they told about the previous failed trial or the risks associated with the shot.

The babies received three doses of the shot. The dosing continued even as babies in the trial began to be hospitalized, according to the lawsuit.

Babies died just days after hospital shut down trial

During an RSV outbreak in Washington in late 1966, both infants became seriously ill.

Victor King was hospitalized on Dec. 30, 1966, suffering severe respiratory distress. He died on Jan. 1, 1967. Ross Hambrick was admitted to the hospital the same day and died Jan. 2, 1967, according to the lawsuit

The hospital director had decided to halt the study on Dec. 29, just days before the babies died. “By that time, it was already too late for Victor and Ross Otto,” the lawsuit said.

On Jan. 3, the hospital director sent a letter to the NIH with evidence that the shot was making babies sicker instead of healthier. He also said the results were “entirely unexpected,” despite evidence from the earlier trial that the RSV vaccine could cause VAERD.

Autopsies reportedly found severe lung inflammation, RSV infection and bacterial pneumonia in both children.

Tissue samples from dead infants used to develop today’s RSV shots, suit alleges

The failure of the Lot 100 trial effectively halted RSV vaccine development for decades.

Researchers later used preserved tissue samples from the deceased children to study why the vaccine had produced such devastating results, which they thought would inform the development of an effective RSV vaccine, according to the lawsuit.

Research on the samples with new technology in subsequent decades helped researchers determine that the vaccine altered the structure of a key RSV protein, known as the F protein, causing recipients’ immune systems to respond abnormally when exposed to the virus naturally.

The plaintiffs contend that these findings ultimately contributed to the development of modern RSV vaccines and antibody treatments approved by the U.S. Food and Drug Administration (FDA) in 2023.

The U.S. Department of Justice did not respond to a request for comment on the lawsuit.

New RSV shots may carry the same risks, evidence suggests

The lawsuit says that the research on the babies allowed for the “safe development” of both the RSV vaccine, first approved for adults over age 60 in May 2023, and AstraZeneca and Sanofi’s monoclonal antibody shots for infants approved in July 2023.

Currently, Pfizer makes Abrysvo, approved for adults 60 and older, younger adults at high risk and pregnant women.

GSK manufactures Arexvy, approved for adults 60 and older and high-risk adults ages 18-59. Moderna makes mResvia, an mRNA vaccine approved for adults 60 and older and high-risk adults aged 18-59.

However, clinical trial data and post-marketing analysis show these approved treatments may retain the same safety issues as the original vaccines, in addition to others.

In 2024, Moderna had to shut down its trial for its RSV vaccine in babies — which had been fast-tracked by the FDA — after it found the vaccine likely caused higher rates of severe RSV illness among vaccinated babies. In other words, the same issue that occurred with the original vaccines from the 1960s.

That same year, French scientist Hélène Banoun, Ph.D., analyzed outcomes from the 2023-2024 RSV immunization campaign in four countries. She found a “significant increase in mortality” among newborns between 2 and 6 days old in France, suggesting that VAERD may also be an issue with the monoclonal antibodies.

GSK’s and Pfizer’s vaccines both target the F protein identified through analysis of the early trials.

GSK halted its clinical trials on pregnant women when it linked the shot to preterm births. Pfizer’s vaccine also reported elevated rates of preterm birth among vaccinated women, but said the numbers were not statistically significant.

Post-authorization studies have also linked Pfizer’s shot to preterm birth, preeclampsia and other hypertensive disorders of pregnancy.

Growing evidence of adverse events associated with the RSV vaccine also includes the documented risk of Guillain-Barré syndrome.

That evidence led the Centers for Disease Control and Prevention in June 2024 to walk back its recommendations, narrowing the recommended age group for RSV vaccination from adults 60 and older to adults 75 and older — even though the FDA approved it for adults younger than 75.

Related articles in The Defender 

• RSV Vaccine for Pregnant Women Linked to Preeclampsia, Other Complications
• GSK and Pfizer RSV Vaccines for Pregnant Women Increased Risk of Preterm Births — GSK Ended Its Trials, but FDA Approved Pfizer Shots
• FDA Approves First RSV Vaccine, But Some Experts Say Weak Safety, Efficacy Data Suggest Benefits Don’t Outweigh Risks
• Moderna Shuts Down mRNA RSV Vaccine Trial in Babies After Shots Linked to Severe Side Effects, FDA Document Reveals
• New Study Links Pfizer RSV Vaccine for Pregnant Women to Preterm Births
• Infant RSV Shots May Cause RSV, Other Infections or Death in Some Babies, Study Finds

The post Secret Trial of Pfizer RSV Vaccine Killed Two Infants in the 1960s — Their Families Just Sued the U.S. Government appeared first on Children’s Health Defense.

 

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