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'Too Many, Too Soon'? Debunking A Common Fear About Kids' Vaccines

In 1986, a typical child was recommended to receive 11 vaccine doses — seven injections and four oral. Today, that number has risen to 50 to 54 doses by age 18, depending on whether one or two flu shots are given in the first eligible year, and on a few product- and age-specific factors that determine whether a child receives two or three HPV doses, three or four Hib doses, or two or three rotavirus doses. That's a substantial increase in the number of shots, which is why some are alarmed by the idea of "too many, too soon." But the science should offer worried parents a great deal of comfort.

As an infectious diseases physician who directs an antibiotic stewardship program, I'm constantly weighing the benefits and risks of medical interventions — much like parents weighing vaccine decisions for their children. And as a parent of two young kids myself, I understand why parents don't want their children to receive anything that isn't clearly indicated, and I share that commitment to evidence-based decision-making.

So, when parents ask me whether their kids are getting too many vaccines I take the question seriously and look at the data.

And those data reveal one of the most striking paradoxes in modern medicine, something that most people — including many health care providers — don't know: Despite this significant increase in injections, today's vaccines expose children to a fraction of the immune-stimulating material that previous generations encountered.

To understand why, we need to know what antigens are. An antigen is any protein or molecule that your immune system recognizes as foreign. When you get a vaccine, the antigens in it teach your immune system to identify and fight specific diseases. Think of antigens as the "mug shots" your immune system uses to recognize threats.

One hundred years ago, children received exactly one vaccine: smallpox. That single shot contained approximately 200 different antigens. Today's entire pediatric schedule exposes a child to about 165 — a fraction of the more than 3,200 in a single 1980s pertussis shot.

Six former CDC vaccine advisory committee chairs warn: U.S. Risks losing access to life-saving immunizations

In 1986, children received vaccines protecting against seven diseases. Those vaccines exposed them to over 3,200 antigens — mostly from a single shot of whole-cell DTP (diphtheria-tetanus-pertussis) that contained roughly every protein the pertussis bacterium could produce.

Today's expanded schedule protects against 16-18 diseases, but the total antigen count is about 165. That's about a 95% reduction in antigen exposure, thanks to precision engineering that strips vaccines down to only the components necessary for protection.

Vaccine expert Paul Offit and colleagues calculated that a baby could theoretically respond to 10,000 vaccines simultaneously before using even one percent of circulating B-cells. The real-world schedule barely registers on the immune system's capacity.

Since 1986, we've added vaccines against diseases that were killing and disabling thousands of children annually. Hib was the leading cause of meningitis and severe bloodstream infections in infants. After conjugate vaccines were introduced for all infants in 1990, the disease was virtually eliminated within a few years. Hepatitis B vaccination began in 1991 and has nearly eradicated childhood liver infections that can lead to cancer decades later. Pneumococcal conjugate vaccines introduced in 2000 slashed rates of bloodstream infections and pneumonia in toddlers.

The CDC estimates that vaccinating children born from 1994 through 2023 will prevent approximately 508 million illnesses, 32 million hospitalizations, and 1.13 million deaths, resulting in $540 billion in direct savings and $2.7 trillion in societal costs. Each additional vaccine underwent rigorous testing and addressed a real public health need.

Some who believe in the "too many, too soon" canard might say that the problem isn't the antigens but the aluminum. But that fear is unfounded, too.

Aluminum salts have enhanced vaccine effectiveness since the 1930s, with doses tightly regulated by the FDA at no more than 0.85 mg per shot. In 1986, children received a total of about 1.5 mg of aluminum through their first six months from vaccines (the diphtheria-tetanus-pertussis (DTP) vaccine). Today, they receive approximately 4.4 mg by 6 months and about 6 mg by age 2 — a modest increase over nearly 40 years.

For context, formula-fed infants ingest about 38 mg of aluminum in their first six months, though only about 1% is absorbed. Furthermore, well over half the aluminum from vaccines clears through healthy kidneys within days, more than 70% by two weeks, with the remainder eliminated over months in people with normal kidney function. While it's true that aluminum from vaccines enters the bloodstream more directly than aluminum from food (most of which is not absorbed), the body processes it the same way. Once in the blood, aluminum binds to proteins like transferrin and is filtered by the kidneys, regardless of how it entered. Reassuringly, studies show that routine vaccination does not increase total blood aluminum levels, and total lifetime exposure from vaccines remains far lower than from diet.

Many newer vaccines contain zero aluminum: rotavirus, chickenpox, meningococcal conjugates, annual influenza, and mRNA Covid-19 vaccines, as well as RSV prevention shots, which are not technically vaccines.

The mismatch between perception and reality isn't surprising. Going from about a dozen shots to over 50 feels overwhelming. Parents experience more office visits and naturally assume a greater biological burden. Of course, some parents' hesitation isn't rooted in politics or science. It's the emotional weight of watching their children cry, or their own fear of needles. Those feelings are entirely human. But knowing what today's vaccines actually contain — and what they prevent — can help put that discomfort in perspective.

Medical training doesn't help. Most physicians learn about vaccine schedules but not the underlying immunology. We're taught to recommend vaccines, not to explain why a 1980s pertussis shot contained about 20 times more antigens than today's entire schedule.

The public health community bears responsibility, too. We've focused on vaccine safety and effectiveness — both crucial — while neglecting to communicate the engineering advances that make modern vaccines so precise. The solution isn't to dismiss parental concerns but to arm families with actual data. The CDC lists vaccine ingredients online, but this information is often technical or not prominently displayed, making it hard for most parents to easily access or understand. Putting plain-language antigen and aluminum content directly on vaccine information sheets would cost little and build trust through transparency. Innovation continues. Researchers are developing adjuvants using saponins, synthetic molecules, and emulsions that could eliminate aluminum entirely while maintaining vaccine effectiveness. Combination vaccines already reduce both needle sticks and total adjuvant exposure. The numbers tell a remarkable story. Children today receive roughly four to five times as many shots as their 1986 counterparts, yet are exposed to 95% fewer antigens and only modest increases in aluminum. We've achieved far more protection with far less immune burden through decades of scientific precision. This isn't just a medical success story; it's a lesson in how perception can diverge from reality. When parents see more visits and more needles, their instinct to worry is natural and understandable. But when we look at what actually matters to the immune system — the biological load, not the injection count — the data are reassuring. In an era when medical misinformation spreads faster than the diseases vaccines prevent, transparency has become our most powerful tool. Show people that a single 1980s pertussis shot contained more antigens than today's entire schedule, and watch skepticism transform into understanding. Jake Scott, M.D., is an infectious diseases physician and clinical associate professor at Stanford University School of Medicine and curator of the Controlled Vaccine Trial Database. The views expressed are his own and do not necessarily reflect those of Stanford University or Stanford Medicine.

Tonix Pharmaceuticals Announces Oral Presentation On Mpox And Smallpox Vaccine Candidate TNX-801 At The Vaccine Congress 2025

Single dose vaccination with TNX-801 protects animals from a lethal challenge with monkeypox, the causative agent of mpox

TNX-801 confers durable protection after a single dose

TNX-801 is well tolerated in immunocompromised animals, without evidence of spreading to blood or tissues even at high doses

CHATHAM, N.J., July 07, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Sina Bavari, PhD, Executive Vice President of Infectious Disease Research and Development at Tonix Pharmaceuticals, will present new data on TNX-801 (recombinant horsepox virus, live vaccine) at the upcoming Vaccine Congress 2025.

TNX-801 is a minimally replicative, attenuated live virus vaccine candidate designed to generate durable humoral and cellular immunity after a single dose. Preclinical results in animals have demonstrated protection against mpox and other orthopoxviruses, supporting further clinical evaluation. TNX-801 also serves as an orthopoxvirus vaccine platform that can deliver multiple protective antigens against diverse viral pathogens.

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Dr. Bavari will present the safety, immunogenicity, and efficacy findings to date and describe Tonix's plans to advance the TNX-801 platform into clinical trials to protect against mpox and other viral diseases.

Presentation details

Location: Vienna, Austria

Presentation Date / Time: July 10th / 11:20am GMT+2

Title: TNX-801, a single-dose live vaccine platform for Mpox and other emerging viral diseases: Safety, Immunogenicity, and Efficacy  

Speaker: Sina Bavari, PhD, Tonix Pharmaceuticals

A copy of the presentation will be posted in the Scientific Presentations section of the Tonix website following the session.

Tonix Pharmaceuticals Holding Corp.* 

Tonix is a fully-integrated biotech company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix's development portfolio is focused on central nervous system (CNS) disorders. Tonix's priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix's immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix's infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD's Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. 

* Tonix's product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. 

This press release and further information about Tonix can be found at www.Tonixpharma.Com. 

Forward Looking Statements 

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the "SEC") on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. 

Investor Contact 

Jessica Morris 

Tonix Pharmaceuticals 

[email protected]

(862) 799-8599 

Brian Korb 

astr partners 

(917) 653-5122 

[email protected] 

Media Contact 

Ray Jordan 

Putnam Insights 

[email protected]

Indication and Usage

Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information

Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes backsevere tightness, pain, pressure, or heaviness in your chest, throat, neck, or jawpain or discomfort in your arms, back, neck, jaw or stomachshortness of breath with or without chest discomfortbreaking out in a cold sweatnausea or vomitingfeeling lightheaded

Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace or Tosymra if you have:

history of heart problemsnarrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)uncontrolled high blood pressurehemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.Had a stroke, transient ischemic attacks (TIAs), or problems with blood circulationsevere liver problemstaken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.Are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.An allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace and Tosymra may cause serious side effects including:

changes in color or sensation in your fingers and toessudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fevercramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feetincreased blood pressure including a sudden severe increase even if you have no history of high blood pressuremedication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.Serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.Hives (itchy bumps); swelling of your tongue, mouth, or throatseizures even in people who have never had seizures before The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.Tonixpharma.Com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.Fda.Gov/medwatch, or call 1-800-FDA-1088.

Outside Groups Organize To Form Unbiased, Independent Vaccine Panel

In the wake of Health Secretary Robert F. Kennedy Jr.'s decision to shake up a key federal vaccine advisory committee, outside medical organizations and independent experts are looking for alternate sources of unbiased information and even considering forming a group of their own.

A leading contender is a new group led by Michael Osterholm, an infectious disease expert and the director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota.

Osterholm is launching the Vaccine Integrity Project at CIDRAP as a potential alternative to the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

"We've always just taken for granted that routine child immunizations and other vaccines would be readily available and that they would be supported by the public health system," Osterholm said. "Now that's in question."

Earlier this month, Kennedy fired all 17 members from ACIP, appointing in their place eight new members, many of whom have expressed vaccine-skeptical views or questioned pandemic restrictions. Kennedy himself has a long history of anti-vaccination activism.

The American Academy of Pediatrics has called the new ACIP members a "radical departure" from the committee's mission of protecting kids.

ACIP holds a significant amount of influence over vaccinations in the U.S.; the panel is responsible for setting the childhood vaccination schedule and determining what vaccines are given free of charge under the Vaccines for Children Program. Its recommendations guide what vaccinations are required for attending public school and what shots insurance covers.

"The real risk is that families and patients may not have access to vaccines" if the panel makes changes to their recommendations, said Dr. Molly O'Shea, a pediatrician in Michigan.

"The ramifications are deep," said Dr. Michelle Taylor, a pediatrician and the director of the Shelby County Health Department in Memphis, Tennessee. "Any school system that is requiring immunizations for school entry is looking for those ACIP recommendations, either directly from the CDC, from the Department of Education, if they are filtered there, or from their local or state health departments."

CIDRAP is now consulting with multiple medical organizations and public health groups — including the AAP, the American Academy of Family Physicians, the American College of Physicians, the American Pharmacists Association, the National Foundation for Infectious Diseases, as well as insurance providers — to discuss vaccine recommendations.

Insurance companies rely on ACIP's guidance on which vaccines to cover. But if enough reputable public health groups come up with recommendations different from ACIP's, Osterholm said those groups could sway insurance companies on which shots to cover.

Although vaccination rates have been slipping in recent years, the vast majority of American families do vaccinate their kids. The CDC reported that 92.7% of kindergartners in the 2023-24 school year had received their routine childhood vaccines.

Parents depend on guidance from pediatricians on which shots to give and when. Those pediatricians rely on CDC guidance.

"Pediatricians have one goal, and that's to keep every child healthy and safe in every community. That is what we wake up every morning thinking about. That is what we go to sleep thinking about at night," said Dr. Susan Kressly, the president of the AAP. "If pediatricians are not standing up for what children and families deserve and need, then who?"

Some major medical organizations are voicing their concerns about Kennedy's anti-vaccine actions.

The American Medical Association has asked Congress to investigate Kennedy's handling of ACIP.

States are also taking action.

The Wisconsin Department of Health Services defied the HHS declaration that the federal government would no longer recommend Covid shots for healthy children and pregnant women. "The recent changes in CDC guidance were not made based on new data, evidence, or scientific or medical studies, nor was the guidance issued following normal processes," the state's department of health wrote in a press release.

The Illinois Department of Public Health criticized Kennedy's gutting of ACIP, saying on X that the secretary had a "misunderstanding of how vaccine trials work."

ACIP was formed in 1972 as an independent panel of experts to educate the federal government on vaccines. The committee —composed of experts including pediatricians, geriatricians, infectious disease doctors, immunologists and vaccinologists — has three regular meetings a year to pore over the evidence for new or updated vaccines.

All meetings are open to the public and are streamed online.

The panel may also be convened outside of those regular meetings. During the Covid pandemic, for example, the committee reviewed rare reports of a heart problem called myocarditis in some young men who'd had the Covid shot. The committee also recommended against the Johnson & Johnson Covid vaccine after it was linked to rare but potentially deadly blood clots.

Recommendations from ACIP are usually adopted by the director of the CDC.

But there isn't any CDC director at the moment. President Donald Trump's pick for the job, Susan Monarez, has a scheduled confirmation hearing in the Senate on June 25 — the same day Kennedy's new ACIP members will meet for the first time.

As head of the Department of Health and Human Services, Kennedy is the ultimate authority and has the ability to override ACIP recommendations. He flexed this rarely used muscle in May by announcing — without any input from ACIP — that the Covid vaccine would no longer be recommended for healthy children and pregnant women.

ACIP members have historically gone through an extensive vetting process to ensure their expertise. If members have conflicts of interest, they recuse themselves from votes.

An HHS spokesman said its eight new ACIP members were thoroughly vetted, but not did not offer specifics. Two members, Dr. Martin Kulldorff and Dr. Robert Malone, were previously paid experts in trials involving Merck vaccines. Another, Vicky Pebsworth, served as an expert witness in a federal lawsuit brought by activists who sought to outlaw childhood vaccination mandates. The case was dismissed in 2021.

Vaccine skepticism isn't necessarily a bad thing. "True scientists ask critical questions in a way that doesn't presume the answer," the AAP's O'Shea said. "What has made America great, however, is our medical and scientific innovation. To undermine that is gravely concerning to me."

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