
crkx3egk3ygo (GIF Image, 1 × 1 pixels)
The top US health department plans to require placebo testing for all vaccines in an effort to offer "straightforward" public health information, but experts say such testing could limit availability and raise ethical concerns.
In a statement first given to the Washington Post, the Department of Health and Human Services (HHS) said this week, "All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices".
The agency did not provide details on which "new vaccines" would be included.
But officials have suggested that updated Covid-19 shots may be included, which vaccine experts say could slow down vaccine access.
Peter Lurie, a former official with the Food and Drug Administration (FDA), said "it's hard to tell exactly what is being proposed."
"But, broadly, if they mean that every modification to an existing vaccine would require a new placebo-controlled trial, they are treading in ethically dubious territory and likely to deny Americans life-saving vaccines at some point."
HHS has not offered details on the timing of the placebo plan or specify the vaccines involved.
An HHS spokesperson told the BBC in a statement that health secretary Robert F Kennedy Jr's goal of "radical transparency" means being "honest and straightforward about what we know — and what we don't know — about medical products, including vaccines".
The statement said none of the childhood vaccines recommended in the US - except the Covid shot - had undergone "inert placebo" testing, meaning "we know very little about the actual risk profiles of these products".
But public health experts say the statement is misleading, as childhood vaccinations, including ones for Hepatitis A and B, rotavirus, polio and the mumps, were all initially tested against a placebo. In fact, all new immunizations already go through the trials - a type of random testing where one test group receives the immunization, and the other gets a placebo, like a saline shot.
But newer versions of the shots may not go through the same process, because it is considered unethical to withhold a shot known to be safe from a particular group, and because the shot is only being tweaked in a minor way, vaccine experts said.
The coronavirus shot, for example, already has gone through rigorous safety testing, said Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia.
"We have a lot of information about the safety of the vaccine," he said. "All we're doing this year is using a different Omicron variant that we used last year and the year before that."
Still, FDA Commissioner Marty Makary said this week that the agency was "taking a look" at updated coronavirus shots, telling the BBC's US partner CBS News that there is a "void of data".
An HHS spokesperson told the BBC that "significant updates to existing vaccines" may be considered "new products" requiring additional clinical evaluation.
"A four-year-old trial is also not a blank check for new vaccines each year without clinical trial data, unlike the flu shot which has been tried and tested for more than 80 years," the spokesperson said.
Requiring companies to conduct placebo tests for simple upgrades of established vaccines would be costly - and the drug makers could ultimately decide to forgo making the newer, more effective versions of the vaccine altogether, said Dr Lurie.
Before taking office - and since assuming the role as secretary - Kennedy has spread false claims about vaccine safety. His tenure has coincided with one of the worst measles outbreaks in a decade; two children have died and 660 people have been infected in Texas.
This week, he encouraged parents to "do their own research" about the measles vaccine - which has been considered safe and 97% effective for decades - and raised questions about whether the shot could cause seizures or neurological issues.
For months, he has at times endorsed the MMR shot, and at other times, called it a "personal" decision. Kennedy also promoted alternative treatments, which doctors say patients should not use without medical supervision.

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


Daily Mail
35 minutes ago
- Daily Mail
Urgent nationwide recall for OTC cold meds amid fears they could cause fatal fungal BRAIN infections
Officials have issued a recall for multiple cold remedy nasal swabs over fears of a fungi contamination that can cause deadly infections. The Food and Drug Administration has asked consumers to stop using Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs and Orajel Baby Teething Swabs immediately. According to manufacturer Church & Dwight Co., the cotton swab parts of each individual product may have a 'potential microbial contamination identified as fungi'. Officials warn that if used, the possible fungi contamination can cause serious and life-threatening blood infections in patients. The federal agency also noted that children and adults with compromised immune systems or other underlying medical conditions were at the highest risk of developing a fatal infection. Because the swabs are insert deep in the nose, there is a risk the infection could travel to the brain. While it remains unclear which fungi has been found in the products, they can enter the body through contaminated medical products such as swabs, surgical procedures or simply through air and cause blood infections. The FDA has asked consumers to throw away both Zicam products with lot numbers 732216301205 and 732216301656 and Orajel products with number 310310400002. The agency has also asked consumers to reach out to the manufacturer for a full refund. As of now, no reports of illness or death have been revealed by the agency. The recalled products were distributed nationwide in the United States and in Puerto Rico. While Zicam Cold Remedy Nasal Swabs and Orajel Baby Teething Swabs continue to be sold and available in pharmacies, Zicam Nasal AllClear Swabs were discontinued in December 2024. Additionally, the FDA assured consumers that all other Zicam and Orajel products, including Zicam RapidMelts are safe to use to cure colds. Both of the recalled Zicam nasal swabs are meant to soothe and shorten the duration of a cold by rubbing the gel-covered cotton part of the swab inside each nostril. According to the company's website, the gel formula covering the swabs contain plant-based active ingredients including Galphimia glauca, Luffa operculata and Sabadilla. Similarly, the Orajel Baby Teething Swabs are used to to help soothe infants who may be teething, upset, cranky or fussy. However in this case, rubbing the contaminated part of swab inside your nostril or inside the mouth may introduce the fungi into your bloodstream and cause an infection. To fight the infection, the immune system releases chemicals into the bloodstream that can cause widespread inflammation in the body. This can lead to sepsis - which can cause damage to tissues, organ failure and death. Treatment for a blood infection typically involves antifungal medications. In a statement, the FDA explained: 'Swabs found to contain microbial contamination can potentially present a significant risk to the health and safety of consumers including serious and life-threatening blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries.' Typical symptoms of a fungi-caused blood infection include fever, chills, lethargy, and pain. If left untreated, it can lead to organ failure and in certain cases, death. In the US, the most common fungus known to cause bloodstream infections is Candida. About 25,000 Americans suffer from candida blood infections every year.


Daily Mail
36 minutes ago
- Daily Mail
EXCLUSIVE Warning over hair loss cream used by millions after doctors discover freaky side effect
Doctors have issued a warning about hair growth treatment minoxidil after a woman grew a beard. The 28-year-old reported using hair growth spray minoxidil to treat her hair loss caused by alopecia, suffered by 7million Americans that causes hair loss. Patients apply the medication, sold as a spray or foam, to the scalp and leave it in to absorb. However, the unnamed woman wore a wig during the day and cap at night, which causes the drug to be absorbed at much higher levels in her blood. It then traveled elsewhere in her body, causing uncontrollable hair growth in her face, arms and legs. Doctors say the 40million Americans who take the drug should be aware of the risks of wearing tight caps while taking it. Minoxidil, sold in the US under brand name Rogaine, is applied to the scalp to stimulate hair growth. It costs around $60 for a six-month supply. Doctors writing in as medical journal said: 'Exceeding this dose does not improve efficacy but significantly increases the risk of systemic absorption and adverse effects.' The FDA approved safe dose of the spray, which the woman used, is one milliter twice per day, or six sprays. While side effects are usually minor, such as scalp irritation or changes in hair texture or color, the drug has been linked to excess hair growth and loss. The woman in the case report was diagnosed with androgenetic alopecia, a form of hair loss caused by genetic predisposition or an imbalance of hormones like estrogen and androgens. Prior to treatment, the woman, from France, had a large bald spot on the top of her head. She had mild anemia and vitamin D, both of which can deprive hair follicles of oxygen and cause hair loss, but had no other health issues. Along with vitamin D and zinc supplements, she used five percent minoxidil spray twice a day for two months. She also had done three monthly sessions of LED therapy and plasma-rich plasma injections (PRP), which are meant to separate plasma from the blood and inject it back into the scalp. Plasma is rich in platelets, which have growth factors. After two months of minoxidil treatment, she returned to doctors with increased hair growth on her face, arms and legs. Doctors found wearing a wig during the day and a tight cap at night after applying minoxidil left the woman's scalp 'constantly occluded, day and night.' This means her scalp was constricted and hair follicles became blocked, leading the body to absorb higher amounts of minoxidil than if her hair follicles were still open. The doctors believe this lead to 'systemic absorption' of the drug and effectively a higher than safe dose. The experts wrote: 'Minoxidil is an effective treatment but can occasionally lead to hypertrichosis, especially when applied in high concentrations or over large areas of the body. 'This case illustrates the critical need for precise patient instruction on the correct application of topical therapies to prevent adverse systemic effects such as hypertrichosis.' The woman had laser hair removal on her face and stopped taking minoxidil. She continued with her other treatments.


Reuters
39 minutes ago
- Reuters
Vaccine actions and policy positions under US Health Secretary Kennedy
June 10 (Reuters) - U.S. Health Secretary Robert F. Kennedy Jr., a long-time vaccine skeptic, has been making sweeping changes to reshape U.S. regulation of vaccines, food and medicine. The most far-reaching of his moves culminated in the layoff of all 17 members of a U.S. Centers for Disease Control and Prevention panel of vaccine experts. Here are some of the policy moves under Kennedy's leadership in recent months, related to vaccines: FDA Recommendations for Influenza Vaccines Date of Announcement: March 13, 2025 Details: The FDA independently recommends virus strains for the 2025-2026 influenza vaccines, deviating from traditional advisory committee voting. This move assures no impact on the timing or availability of vaccines for the public. Environmental Toxin Studies Related to Autism Date of Announcement: April 16, 2025 Details: Kennedy plans studies on environmental contributors to autism, including vaccines, despite lacking scientific evidence. This approach aligns with his longstanding views on vaccines and environmental factors. Launch of US Autism Project Using Medicare and Medicaid Data Date of Announcement: May 7, 2025 Details: Federal agencies will create a database to research autism causes, focusing on Medicare and Medicaid data, as part of a broader effort to explore potential links between vaccines and autism. FDA Tightens Requirements for COVID Vaccine Date of Announcement: May 20, 2025 Details: The FDA plans new trials for annual COVID-19 boosters, limiting them to older adults and those at risk of severe illness. This change aligns with international perspectives on COVID vaccination strategies. US Drops COVID Vaccine Recommendation for Healthy Kids, Pregnant Women Date of Announcement: May 27, 2025 Details: The U.S. stops recommending routine COVID vaccinations for pregnant women and healthy children, bypassing the CDC's traditional advisory process. Cancellation of Moderna Bird Flu Vaccine Contract Date of Announcement: May 28, 2025 Details: The Trump administration cancels a contract with Moderna for the late-stage development of its bird flu vaccine, after determining it did not meet scientific standards. Moderna explores alternatives for its vaccine's development. Kennedy Guts Vaccine Advisory Committee Date of Announcement: June 9, 2025 Details: Kennedy fires all members of the CDC vaccine expert panel, which recommends how vaccines are used and by whom, promising to restore public trust in health agencies. Scientists and experts say the changes would undermine public confidence in health agencies.