Dr. Peter Marks, one of the top FDA's leaders in vaccine regulation, is stepping down from his position as director of the Center for Biologics Evaluation and Research (CBER). His departure has sparked a debate about the future of vaccine regulation and public health policy. Marks was instrumental in leading vaccine approvals, including during the pandemic brought on by COVID-19. As the FDA makes decisions along this transition, experts wait and monitor how it could potentially affect vaccine safety and public trust.

As the head of the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER), Marks Marks played a crucial role in ensuring vaccine safety and efficacy, especially during the COVID-19 pandemic. With his announced departure, concerns are mounting over about the future of vaccine regulation in the U.S. and its potential to affect global public health.

Dr. Peter Marks' Resignation or A Forced Exit?

Dr. Marks' April 5 resignation was not voluntary, according to several sources. He was reportedly told: resign or get fired. His exit occurs under the tenure of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., a highly publicized vaccine critic.

In his resignation letter, Marks expressed deep concern about the direction of vaccine oversight under Kennedy, writing that undermining confidence in vaccines is "irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety, and security." His letter further suggested that scientific integrity was at risk, accusing Kennedy of prioritizing misinformation over truth and transparency.

Since 2016, Marks has served as the head of the FDA's CBER division, guiding the approval of life-saving vaccines, such as the expedited development and authorization of the first COVID-19 vaccines under Operation Warp Speed. His work introduced mRNA technology into vaccines, which have transformed vaccine development and are being investigated for use against a variety of diseases other than COVID-19, including influenza and cancer.

Under his direction, the FDA also approved the first self-administered flu vaccine, offering a new level of protection against flu season. His time at the agency has been characterized by a focus on scientific integrity and transparency, which experts now worry will be undermined.

Kennedy's Anti-Vaccine Influence

Kennedy has been among the loudest anti-vaccine voices, often issuing inflammatory and widely discredited statements. He has challenged the safety of the COVID-19 vaccine and has been a leading force in attempts to undermine public confidence in vaccination campaigns. In 2021, he submitted a citizens petition requesting that the FDA withdraw COVID-19 vaccine authorizations, deeming them "the deadliest vaccines ever made."

His distrust of COVID-19 vaccines is not an isolated incident. Kennedy has also questioned the measles-mumps-rubella (MMR) vaccine, despite the U.S. experiencing the biggest measles outbreak since 2019. During a recent interview, he asserted that the MMR vaccine "does cause deaths every year," something refuted by the Infectious Disease Society of America, which has identified no deaths attributed to the vaccine in healthy people.

Will Vaccine Safety Be Compromised?

Public health officials are sounding the alarm that Marks' resignation could result in a radical change in vaccine regulation and policy. The FDA's CBER branch regulates not only vaccines but also blood products, gene therapies, and allergenic products. Any loss of its regulatory authority could have sweeping implications.

Issues regarding Kennedy's leadership will result in studies that will misleadingly associate vaccines with autism, a theory consistently disproven by scientific studies. Professionals caution that future research may misleadingly imply a connection between vaccines and autism, which could heighten public fear, reduce vaccination rates, and trigger further disease outbreaks.

Also, Dr. Ashish Jha, dean of the Brown University School of Public Health, characterized Marks' ouster as a loss for the FDA. "To push him out makes the FDA immensely weaker, less effective. This is not how we make America healthy," he posted on X (formerly Twitter).

The Risk of Public Health Setbacks

Marks' resignation can't have happened at a more important time. The U.S. is reeling from the increasing rate of vaccine-preventable diseases. The current multistate outbreak of measles, with its ferocity in Texas, highlights the severity of sliding vaccination rates. According to a report by the World Health Organization (WHO), more than 100,000 unvaccinated children have died last year in Africa and Asia as a result of complications related to measles. These numbers are a hard reminder of how devastating things become when misinformation surrounding vaccines spreads.

At the same time, HHS has allegedly requested the Centers for Disease Control and Prevention (CDC) to reexamine the vaccine-autism connection, in the face of overwhelming scientific agreement that no such connection exists. The action further stoked concern that Kennedy's power might result in policy that negates a half-century of scientific advancement.

What's Next for the FDA and Public Health?

With Marks' departure, the FDA will have a vacuum of leadership at a moment when public health institutions' trust is already weakened. His replacement will have to contend with upholding scientific integrity while dealing with pressures from an administration that seems more and more politicized to counter anti-vaccine sentiment.

The next few months will tell if the FDA can resist political pressure and remain committed to its mission of safeguarding public health. For the moment, experts are calling for caution, stressing the need to protect the scientific standards that have long shaped vaccine regulation in the U.S.

Marks' exit is not simply a house-cleaning in bureaucratic circles—more importantly, it signals a possible turning point in how vaccine science is weighed, approved, and disseminated to the general public. Will this be a catalyst for public health disaster or not, the struggle for vaccine science is just beginning.

A 42- year-old man with type 1 diabetic begna making his own insulin without daily shots or anti-rejection medication. The breakthrough, published in the New England Journal of Medicine, is being hailed as the most promising advancement on the way to a functional cure for type 1 diabetes, an autoimmune disease that afflicts nearly 9.5 million people globally. It signaled the start of a diabetes revolution. For the first time, researchers have been able to transplant genetically modified islet cells into a human patient, allowing the body to produce insulin naturally and prevent immune rejection—a hurdle that has hampered advances for decades.

Type 1 diabetes develops when the immune system attacks and destroys the pancreatic islet cells that make insulin. In its absence, the body is unable to control blood sugar, and patients must depend on man-made insulin injected or pumped into the body.

Although insulin therapy is life-saving, it cannot duplicate the body's subtle sensitivity to provide insulin in anticipation of meals. That leaves even the most compliant patients with wild swings in blood glucose that heighten long-term risks of heart disease, kidney failure, and nerve damage.

Scientists have been working for a long time to replace natural insulin production with islet cell transplants. But there has always been one obstacle: rejection. The immune system is programmed to recognize donor cells as foreign and destroy them. To avoid this, recipients of transplants have to take immunosuppressive drugs for the rest of their lives. The drugs are effective, but they expose patients to infections, cancer, and organ injury—a trade-off that has kept cell transplantation from becoming mainstream.

Insulin Production Without Immune Suppression

For this new patient, who was diagnosed with type 1 diabetes at the age of 5, a healthy donor islet cells were given. Rather than injected into the pancreas, the cells were given through a series of injections into the muscle of his forearm. This made it easier for doctors to check on the graft and lower surgical risks.

During the 12-week period, the transplanted cells started secreting insulin when there were high levels of glucose, like after meals. Most significantly, the patient did not need any immunosuppressant medications. His immune system merely left the cells alone—a feat that had never previously been achieved in humans.

What Role CRISPR Gene Editing Play?

The breakthrough was dependent on genetic engineering. Scientists applied the CRISPR gene-editing mechanism to make three critical modifications to the cells before they were transplanted:

Diminishing immune "flags": Two edits reduced amounts of antigens that T cells typically employ to recognize foreign cells.

Augmenting defense with CD47: The third edit boosted levels of CD47, a protein assigned the codename "don't eat me" signal, which deters natural killer cells and macrophages from targeting.

Surprisingly, not every cell got the full complement of edits. The unedited ones were rapidly killed by the immune system. The partially edited cells survived a bit longer but were eventually rejected. Only the fully edited cells persisted—and they were the ones that achieved the successful production of insulin. This natural experiment within the body of the patient proved that the three-edit approach was the solution.

How This Means Future of Diabetes Treatment Is Closer Than Ever?

Even though the patient was given a modest amount of the engineered cells and still needs daily insulin, the outcome is a proof of concept that cell transplants are possible without immunosuppression. That in itself is a game changer.

If additional research verifies the longevity and safety of this method, it may drastically increase access to islet cell transplantation. Patients would be able to obtain more stable blood sugar levels, lowering complications and enhancing quality of life. Larger grafts or multiple transplants over time may even render insulin treatment obsolete.

The breakthrough follows a wave of experimental treatments for type 1 diabetes. In 2022, a woman in China underwent insulin-producing cells derived from her own stem cells, which made her able to sustain stable blood glucose without injections for months. Gene-edited islet cells have also produced encouraging results in animal trials.

Due to the massive popularity of magnesium and its potential health benefits, many parents had incorporated it into their kid’s consumption as well. However, the UK government has asked for parents and caregivers to immediately stop giving Nutrition Ignition Kids Magnesium Glycinate Gummies to children.

The Medicines and Healthcare products Regulatory Agency (MHRA) found an unlisted medicine, melatonin, in the product. It's important to safely throw away any gummies you have left and to talk to a doctor if you're worried about your child's health.

Why Do You Need To Stop Giving These Supplements?

The MHRA discovered that the gummies, sold online as a food supplement, contain melatonin, even though it is not on the label. Each gummy has 1.5 to 1.7 milligrams of melatonin. This is a lot, especially since the recommended starting dose for children who need melatonin is only 1 milligram. The gummies were marketed for "calm, focus, and digestion" for kids ages four and older, but they contain a powerful, unlisted drug.

What Are The Potential Side Effects of The Magnesium Supplements?

Taking too much melatonin can cause side effects like drowsiness, headaches, dizziness, and nausea. While these issues are not expected to cause lasting harm and the body typically clears the drug within 12 hours, the MHRA has already removed the product from online stores. Dr. Alison Cave, the MHRA's Chief Safety Officer, also pointed out that other possible side effects from melatonin in children can be hyperactivity and stomach pain.

What Is The Safest Way To Dispose The Supplements?

It is very important that you do not throw these gummies in the regular trash. Instead, you should store them securely in a container that children cannot open and keep them out of their reach. When you can, take the gummies to any local pharmacy for safe disposal. If you think your child had a bad reaction to the product, stop giving it to them right away and talk to a doctor. You can also report the side effect to the MHRA's Yellow Card scheme.

Nepal has officially been verified for rubella elimination. This makes it a milestone in global public health and putting the country among six in the World Health Organization’s (WHO) South-East Asia Region to achieve this feat.

The announcement was made at the 10th meeting of the Regional Verification Commission for Measles & Rubella Elimination, held from July 22 to 24, 2025, where progress across all 10 member states was reviewed.

The WHO has set 2026 as the target year to eliminate both measles and rubella from the region, a goal it described as ambitious but attainable if countries sustain momentum and strengthen cooperation.

Nepal’s Path to Elimination

Nepal’s achievement was the result of decades of determined efforts, robust immunization campaigns, and innovative community-level outreach.

The country introduced the rubella-containing vaccine in 2012 through a nationwide campaign that reached children between nine months and 15 years of age.

In 2016, a second dose was added to the routine immunization schedule, further boosting protection.

Regular follow-up campaigns, conducted every four years in 2012, 2016, 2020, and 2024, helped plug immunization gaps, even during times of crisis.

For instance, vaccination drives continued during the devastating earthquakes of 2015 and 2023, ensuring that immunization momentum was not lost.

By 2024, Nepal had achieved more than 95% coverage with at least one dose of the rubella vaccine, creating herd immunity levels strong enough to halt the spread of the virus.

The country also introduced innovative strategies, such as an annual “Immunization Month,” mobile outreach programs to reach missed children, and the declaration of “fully immunized districts” to hold local leaders accountable.

On the surveillance front, Nepal has been equally rigorous. Laboratory-supported rubella case surveillance began as early as 2004, while congenital rubella syndrome (CRS) surveillance started in 2014.

These systems consistently exceeded elimination targets. Most recently, Nepal introduced a robust laboratory testing algorithm, the first of its kind in the region—that allows more accurate detection of true rubella cases.

What Is Rubella?

Rubella, often called “German measles,” is a viral infection that spreads through droplets from coughs and sneezes. While symptoms are usually mild in children and adults, fever, rash, and swollen lymph nodes, the disease can have devastating consequences during pregnancy. Infection in expectant mothers can cause miscarriage, stillbirth, or congenital rubella syndrome, a condition leading to lifelong disabilities including hearing and vision impairment, heart defects, and developmental delays.

According to WHO, before the widespread introduction of vaccines, rubella was a leading cause of preventable congenital disabilities worldwide. Elimination is defined as the absence of endemic transmission for at least 12 months, supported by a high-performing surveillance system.

Regional and Global Push

The South-East Asia Region has made significant strides, but challenges remain. Six countries, including Nepal, have eliminated rubella, while four have eliminated measles. However, WHO cautioned that setbacks caused by global geopolitical crises, funding shortages, and disruptions during the COVID-19 pandemic have slowed progress.

At the regional commission meeting, experts urged governments and international partners to redouble efforts, ensure sustainable funding, and strengthen collaboration if the 2026 elimination target is to be met.

“The region has shown what is possible with political will and community participation,” the Commission said in a statement, commending Nepal for its achievement. “But urgent, accelerated actions are needed to protect these gains and prevent resurgence.”