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17% of U.S. Toddlers Falling Short on Childhood Vaccinations
Most early-childhood vaccinations require multiple doses, but about 1 in 6 toddlers — 17% — are not getting all of the needed doses, according to a study published in the journal Pediatrics.
Their findings stem from an analysis of vaccination data on 16,365 U.S. children, 19 to 35 months old — considered a nationally representative sample. The data was gathered by the Centers for Disease Control and Prevention, focusing on seven series of vaccines that require one to four doses and protect against multiple diseases.
Overall, almost 73% of the children got all required doses, about 10% failed to start one or more of the vaccine series, and some 17% started but did not complete all their vaccinations. In this last group, most children fell one to three doses short of completing their vaccinations.
The reasons varied but included family moves (especially to a different state), insurance problems and lack of transportation to medical providers. Also, children in large families (four or more children) and those in lower-income households were more likely not to have gotten all required doses. The study also notes that some children may have missed vaccine doses because of parental hesitancy.
Gardasil Caused Lupus, Other Autoimmune Diseases After Young Boy Received HPV Vaccine: Lawsuit
Although families and medical providers were led to believe that Gardasil was safe and carried few serious side effects, a Florida woman indicates in a recently filed lawsuit that her young child was diagnosed with lupus and other serious autoimmune diseases after receiving the HPV vaccine.
The complaint was brought late last month by Rebecca Sullivan, on behalf of herself and her minor son, identified with the initials A.S. in the lawsuit, seeking damages from Merck & Co. for failing to warn parents and the medical community about the risks caused by Gardasil.
A growing number of parents and young adults are now pursuing a Gardasil lawsuit against Merck, claiming the drug maker has withheld critical safety information about the risk of autoimmune diseases from Gardasil, such as lupus, postural orthostatic tachycardia syndrome (POTS), idiopathic thrombocytopenic purpura (ITP) and other debilitating conditions, which leave otherwise healthy and active young children with serious disabilities.
Since the injections, A.S. has been diagnosed with systemic lupus erythematosus, the most common form of lupus, as well as lupus nephritis class IV & V, alopecia, cutaneous vasculitis, leukopenia, transaminitis, abnormal weight loss, positive ANA, normocytic anemia, sedimentation rate elevation, TSH elevation, polyarthritis, early satiety, immune-suppressed status, and h-pylori infection. The lawsuit indicates the boy continues to need to see specialists, receive regular medical testing and treatments for the numerous autoimmune disorders.
Antibiotic Resistance Is on the Rise, Doctor Warns: ‘This Is an Enormous Problem’
A growing number of Americans are building immunity to antibiotics, which can make them more vulnerable to illnesses and infections.
There are about 2.8 million antibiotic-resistant infections per year, according to the Centers for Disease Control and Prevention (CDC), which cause at least 35,000 annual deaths. And those numbers are likely an understatement, according to Dr. Marc Siegel, a professor of medicine at NYU Langone Medical Center and a Fox News medical contributor.
The World Health Organization (WHO) describes antibiotic resistance as “one of the biggest threats to global health, food security and development today,” according to its website. “I’m famous for saying the WHO usually over-exaggerates things, but in this case, they’re right,” said Siegel.
One of the biggest drivers of antibiotic resistance is the lack of any new medications in recent decades, the doctor said. “The drug companies don’t have an incentive to do this, because people only use antibiotics when they get sick, so there’s not much of a profit margin.”
Study by Former FDA Advisors Finds Agency Is Biased Towards Approving New Drugs
A new study highlights how federal drug regulators are more likely to approve new drugs than in years past, even when scientific advisors recommended against allowing the new treatment onto the U.S. market.
The U.S. Food and Drug Administration (FDA) followed the advice of its scientific advisory committee nearly every time the advisors recommended approval of a new drug. However, the agency only followed those recommendations two-thirds of the time when it recommended the agency reject a new drug approval request.
Researchers from the Brigham and Women’s Hospital and Harvard Medical School, including former FDA advisory committee members, conducted a manual review of summaries prepared by FDA staff for 409 drug advisory committee meetings from 2010 to 2021.
FDA OKs First Pill for Postpartum Depression — in One Trial, More Than Twice as Many Women Achieved Remission After 2-Week Treatment Course
The FDA approved zuranolone (Zurzuvae) as the first oral treatment for postpartum depression, the agency announced late on Friday.
Until now, brexanolone (Zulresso) has been the only other treatment with an indication for postpartum depression, but that drug requires a continuous IV infusion administered by a healthcare provider.
Underpinning zuranolone’s approval were two phase III trials in the NEST clinical program. Trial participants included women with postpartum depression who met DSM-5 criteria for a major depressive episode with symptom onset in the third trimester or within 4 weeks of delivery.
The most common side effects in trials (occurring in 5% or more of patients) were drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection. Zuranolone also may cause suicidal thoughts or behavior, the FDA noted.
New Vaccine Research Center in U.K. to Help Scientists Prepare for ‘Disease X’
Ministers have opened a new vaccine research center in the U.K. where scientists will work on preparing for “disease X”, the next potential pandemic pathogen.
The state-of-the-art Vaccine Development and Evaluation Center is based at the U.K. Health and Security Agency’s (UKHSA) Porton Down campus in Wiltshire.
Live viruses will be kept onsite in specialist containment facilities where scientists can assess pathogens that do not yet have a vaccine or ones where immunization could be improved, for example, the flu or mpox.
The health secretary, Steve Barclay, said: “This new center cements the U.K.’s global position spearheading pandemic preparedness, vaccine development, and scientific discovery. This state-of-the-art complex will also help us deliver on our commitment to producing new vaccines within 100 days of a new threat being identified.”
Echoing Pfizer, BioNTech Says It’s ‘Carefully Watching’ Costs as COVID Vaccine Sales Sink
As Pfizer eyes possible cost cuts, its COVID vaccine partner BioNTech is “carefully watching” its spending, the German company’s finance chief Jens Holstein said Monday.
Despite uncertainty around seasonal demand for COVID vaccines, BioNTech maintained its full-year revenue projection of 5 billion euros.
That target puts pressure on the company to deliver during the upcoming fall and winter seasons. In the second quarter, BioNTech’s Pfizer-partnered COVID vaccine Comirnaty returned BioNTech 168 million euros ($185 million) in revenues, bringing the first-half total to 1.4 billion euros. That was down from 9.6 billion euros in the first six months of 2022.
While COVID vaccine volumes are declining, a commercial market is opening in the U.S., allowing the companies to charge a higher price, Ryan Richardson, BioNTech’s chief strategy officer, said on the call.
Why Big Pharma Might Think Twice About Running Away to America
Is Big Pharma crying wolf? In the six months since the EU’s plans to reform its rules for medicines were leaked, CEO after CEO has lined up to warn that the legislation will sabotage the European pharma market and force companies to invest elsewhere. Their threat, not always veiled, is that they’ll take their business to America.
But with the United States undergoing its own radical clampdown on drug pricing, things aren’t quite that simple.
New measures, contained within the Biden administration’s Inflation Reduction Act (IRA), are set to cut the prices of medicines in the government’s Medicare services for older and vulnerable patients by at least 50%, says industry — dramatically cutting into companies’ bottom lines. Medicare accounts for a third of U.S. spending on retail prescription drugs, at some $126 billion.
The EU’s proposed overhaul of its rules around medicines will fundamentally change the competitiveness of the European pharma market, the industry says.
The current plans will squeeze pharma’s market protections for new drugs unless they are necessary, game-changing treatments and are quickly made available to all EU citizens.
