Rotavirus Infections

HHS Secretary Robert F. Kennedy Jr. claimed that moving forward, all new vaccines will need to be tested in placebo-controlled trials before they can win FDA approval, calling it “a radical departure from past practices.” In reality, experts say, placebo-controlled trials for new vaccines have been standard practice for decades. Kennedy’s statement, given by an HHS spokesperson and first published in the Washington Post Wednesday evening, says, “All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices.” The alleged shift from Kennedy on placebo-controlled trials comes as the FDA’s most recent guidance from October 2023 to Covid vaccine manufacturers makes clear that “later phase trials, including efficacy trials, should be randomized, double-blinded, and placebo controlled.” Kennedy also noted in his statement, which HHS did not provide a timeline on implementing, that “none of the vaccines on the CDC’s childhood recommended schedule was tested against an inert placebo, meaning we know very little about the actual risk profiles of these products.” Aaron Kesselheim, professor of medicine at Harvard, and Paul Offit, a pediatrician and member of the FDA’s vaccines advisory committee, told Endpoints News that physicians actually do know quite a lot about the risk profiles of every one of these vaccines on the recommended schedule for children. “I don’t know if they’re trying to parse words by saying ‘inert’ but the idea that we ‘know very little’ about the risk profiles of vaccines that have been used safely around the world in hundreds of millions or even billions of patients for decades is patently ridiculous,” Kesselheim said. A review of all vaccine approvals from 2006-2020, published in Health Affairs in 2021 and co-authored by Kesselheim, found that more than eight out of 10 vaccines approved by the FDA in that time period were tested against placebo or active comparators in pivotal trials when placebo was unethical. For example, a vaccine for rotavirus for children, Merck’s RotaTeq, was placebo-controlled and the data were published in 2008. On Kennedy’s mention of “inert” placebos, which is how the FDA defines every placebo, Offit added that companies typically use placebos, although that doesn’t preclude the use of some non-active buffering or stabilizing agents that might also be in the vaccine. “Oftentimes vaccine developers use buffering or stabilizing agents in placebos as part of their trials to parse out potential safety issues,” Offit said. “You want to know what the adverse reaction is to, and is it to the vaccine part, or is it to a buffering agent or stabilizing agent, or manufacturing, or what?” Kennedy has also touted the idea of reforming the FDA’s vaccine and drug adverse event database, known as VAERS, which currently has limited use because all of the data are self-reported and don’t encompass all of the adverse event data. But the details of how Kennedy will change the database remain unknown. Offit said he thinks Kennedy might use the updated database to further the disproven idea that vaccines cause autism.

WEDNESDAY, March 26, 2025 -- Three years after the start of the COVID-19 pandemic, coverage for selected routine childhood vaccines remained below prepandemic levels, according to a study published online March 26 in Pediatrics . Malini B. DeSilva, M.D., from HealthPartners Institute in Bloomington, Minnesota, and colleagues examined rotavirus; diphtheria, tetanus, and acellular pertussis; and pneumococcal conjugate vaccine coverage among infants born between Jan. 1, 2018, and May 31, 2023, and assessed factors associated with vaccine uptake. Data were included for 395,143 infants. The researchers found that at 5 months of age, coverage for two doses of all three vaccines was 87.8 and 80.8 percent in February 2020 and October 2023, respectively. At 12 months, vaccine series completion was highest in January 2020 and lower in October 2023 (92.3 and 89.6 percent, respectively). Having a caregiver whose primary language was not English or Spanish, non-Hispanic Black race, and Medicaid were factors associated with lower vaccine uptake. "Three years after the start of the COVID-19 pandemic, coverage for selected routine childhood immunizations remained below prepandemic levels," the authors write. "Although our findings highlight population groups for whom focused interventions are needed to improve vaccine coverage, further understanding of how these factors may be related to other sociodemographic and cultural factors, availability of care, structural barriers to accessing care, and vaccine confidence, is needed." Several authors disclosed financial ties to the pharmaceutical industry.

Bharat currently has five products in its personalized medicine pipeline—two in cell culture and three in the gene therapy segment, the Hindu Business Line reported late last week. With a storied history in vaccine development, India's Bharat Biotech is shaking things up and answering the call of advanced therapeutics. Bharat has unveiled plans to set up its first cell and gene therapy manufacturing facility at the Hyderabad, India, life sciences cluster known as Genome Valley. The drugmaker will lay out around $75 million for the project, multiple local news outlets have reported. The move by Bharat represents (PDF) its foray from vaccines into cutting-edge regenerative and personalized therapies, the company said in a Mar. 20 press release. Although a specific date wasn’t disclosed, the 50,000-square-foot plant is expected to begin full operations with the finalization of regulatory approvals and the completion of a build-out phase.Bharat currently has five products in its personalized medicine pipeline—two in cell culture and three in the gene therapy segment, the Hindu Business Line reported late last week, citing comments from Bharat's executive chairman Krishan Ella. The company is working on a range of CAR-T cell, CAR-NK cell and off-the-shelf gene therapies, Bharat's chief development officer Raches Ella added, as quoted by the Times of India. “Bharat Biotech, with its extensive experience and proven excellence in viral vaccine manufacturing, is uniquely positioned to master these complexities and produce human-grade vectors at the scale and consistency needed for clinical trials,” Krishan Ella said in the company's release. Additionally, Bharat has revealed a new collaboration pact with the University of Wisconsin-Madison that has the potential to expand into commercial deals that include in-licensing. The company is also looking ahead to exporting and the potential of medical tourism in the cell and gene therapy segment.Bharat popped up on the global radar in 2019 when it became the largest supplier of rabies vaccines in the world after acquiring Chiron Behring Vaccines from GSK in an all-cash deal. The price of the purchase wasn’t disclosed.At the time, India-based Chiron Behring had just a single product in the rabies vaccine Rabipur, while Bharat Biotech was selling a Vero cell-based rabies vaccine, Indirab. The acquisition boosted Bharat's annual rabies capacity to 25 million doses.During the pandemic, Bharat also rolled out a COVID-19 vaccine, dubbed Covaxin, which won approvals in multiple countries including India, Malaysia and Mexico. Attempts to introduce the shot in the U.S. with partner Ocugen proved less fruitful, however. Bharat currently boasts a portfolio of more than 19 vaccines and 4 biotherapeutics, with shots in influenza H1N1, rotavirus, Japanese encephalitis, rabies and cholera, among multiple others.