Federal health officials are taking a closer look at the safety of COVID-19 vaccines in pregnant women and children, while also weighing updates to recommendations for older adults.

According to U.S. News, the Food and Drug Administration (FDA) is reviewing reports of possible birth defects following vaccination during pregnancy and is preparing data on deaths in children after receiving COVID shots.

The review will be presented during a September 18-19, 2025, meeting with the Centers for Disease Control and Prevention’s (CDC) vaccine advisory committee, CNN reported. Experts emphasise that the Vaccine Adverse Event Reporting System (VAERS), one of the primary tools being used in the review, is a monitoring system meant to detect potential safety signals. It does not establish that vaccines directly caused the reported health problems.

What Is VAERS?

The Vaccine Adverse Event Reporting System (VAERS) is designed to act as an early-warning tool, flagging potential safety signals that may warrant further study. “VAERS is a system that generates hypotheses,” explained Dr Demetre Daskalakis, who recently stepped down as director of the CDC’s National Center for Immunization and Respiratory Diseases, in an interview with CNN.

So far, large-scale studies have continued to show that COVID-19 vaccines are safe in pregnancy. The CDC has tracked outcomes in more than 23,000 pregnant women through one registry and more than 45,000 in another database, finding no increased risk of miscarriage, major birth defects, or other complications. Similarly, Pfizer reported that rates of birth defects in vaccinated participants during a clinical trial were comparable to those in the general population.

The CDC advisory committee is also expected to discuss whether vaccine guidance for older adults should be revised. While COVID vaccines are currently approved for adults 65 and older, as well as younger adults at high risk of severe illness, the panel may consider recommending them mainly for those 75 and older, or for younger individuals with underlying conditions.

ALSO READ: Is 'Stratus' COVID Variant The Pandemic’s Next Chapter In 2025 With New Symptoms?

New COVID Variant ‘Stratus’ Dominates U.S. Cases

COVID-19 activity remained high across the United States during the first week of September, according to fresh data from the Centers for Disease Control and Prevention (CDC). Despite the confusion around emerging strains, shifting vaccine guidelines, and cuts to vaccine development funding, the agency continues to track cases, hospitalisations, and deaths on a weekly basis.

For the four weeks ending August 30, projections show that a new variant called XFG. nicknamed “Stratus” accounted for 78 percent of infections nationwide. The next most common strains were NB.1.8.1 at 14 percent and LP.8.1 at 3 percent.

ALSO READ: Ozempic Users Found To Age Back By More Than 3 Years, Finds New Trial; Peer Review Pending

What Is the ‘Stratus’ Variant?

XFG is a late-summer Omicron offshoot and a recombinant strain, formed by blending two earlier lineages: F.7 and LP.8.1.2. Scientists say the variant may carry mutations that help it slip past parts of the immune system more effectively, though there is no evidence yet that it spreads faster than previous strains.

The CDC advises people to watch for familiar COVID-19 symptoms, which continue to include:

1. Fever or chills
2. Cough
3. Fatigue
4. Sore throat
5. Loss of taste or smell
6. Congestion
7. Muscle aches
8. Shortness of breath
9. Headache
10. Nausea or vomiting

The Centers for Disease Control and Prevention (CDC), US, has issued a statement recalling an organic baby formula. The company ByHeart Inc's two lots of Whole Nutrition Infant Formula has been recalled, the lots are:

• Lot: 206VABP/251261P2 ("Use by 01 Dec 2026")
• Lot: 206VABP/251131P2 ("Use by 01 Dec 2026")

In a statement, the CDC wrote:

CDC and public health officials in several states, the Infant Botulism Treatment and Prevention Program, and FDA are investigating a multistate outbreak of infant botulism linked to recalled infant formula. Infant botulism happens when swallowed spores from a type of bacteria called Clostridium botulinum infects a baby's large intestine and make toxin in it. Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and loss of muscle tone.

The CDC also notes that 10 states have seen the cases infant botulism. 13 cases have been reported, all of them leading to hospitalization.

The Food and Drug Administration (DA), US has also asked parents and caregivers who have this product to identify the given lot information at the bottom of the packaging and if it matches, they must throw it away. The FDA has said that it is working with retailers to remove "all potentially impacted product" from the store shelves.

FDA has also asked parents who have fed their kids ByHeart's infant formula to keep and eye on them as a precaution and botulism can take two weeks to develop.

The States Which Have Reported The Cases Of Infant Botulism Linked With ByHeart Formula:

• Arizona
• California
• Illinois
• Minnesota
• New Jersey
• Oregon
• Pennsylvania
• Rhode Island
• Texas
• Washington

What Is Infant Botulism?

Most common form of all botulism in babies, who are between 2 to 8 months old. It happens when the bacteria spores grow in a baby’s intestines and produce the toxin. Honey and contaminated soil can be sources of infant botulism. Adults can also get this type, though it’s rare.

What Are The Symptoms Of Botulism In Infants?

As per CDC, the symptoms include:

• Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing
• If untreated, infants with infant botulism experience a progressive flaccid paralysis that can lead to breathing difficulties and required weeks of hospitalization

The CDC has also recommended that if clinical supports infant botulism then parents and caregivers must begin the treatment and should not wait for laboratory confirmation.

What Did The Makers Of The Infant Formula Say?

ByHeart, which is a New York City based company said that the FDA has as of now tracked 83 reports of infant botulism across the nation since August, 13 of them from the formula. In the statement, the company said: "ByHeart is taking the proactive step to remove any potential risk from the market and ensure the highest level of safety for infants. The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism."

Eli Lilly’s weight-loss and diabetes injection, Mounjaro, has overtaken GSK’s antibiotic Augmentin (GSK.L) to become India’s highest-selling drug by value in October, as demand for weight-loss treatments continues to surge in the world’s most populated country. According to new data from research firm Pharmarack, the U.S.-based drugmaker’s popular injectable earned ₹1 billion ($11.38 million) in sales last month, compared to Augmentin’s ₹800 million.

While Augmentin still led in overall units sold—5.8 million doses versus 85,000 of Mounjaro—the latter’s premium pricing pushed it ahead in total value, as per Reuters. Analysts say India is rapidly emerging as a major market for obesity treatments, with the global weight-loss drug sector expected to cross $150 billion annually by the end of this decade.

Eli Lilly’s Mounjaro Becomes India’s Top-Selling Medicine in October

Launched in India in March 2025, Mounjaro which helps regulate blood sugar levels and reduces appetite—has seen its sales double within months, surpassing its rival Wegovy by Novo Nordisk, which entered the Indian market in June. Data from Pharmarack shows that Mounjaro has so far generated ₹3.33 billion in total revenue.

“Mounjaro’s consumption in India by volume was nearly ten times higher than Wegovy in October,” said Sheetal Sapale, Vice President (Commercial) at Pharmarack. Eli Lilly sold around 262,000 doses of Mounjaro last month, compared to 26,000 doses of Wegovy. Both drugs belong to the GLP-1 receptor agonist class, designed to treat obesity and type 2 diabetes.

How Does Mounjaro Work?

Mounjaro is a once-weekly injectable medication developed primarily for managing type 2 diabetes. Its key ingredient, tirzepatide, is the first of its kind to act on two gut hormones—GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide). This dual mechanism makes Mounjaro more advanced than older drugs such as Ozempic (semaglutide) or Victoza (liraglutide), which target only GLP-1, which is thus driving a surge in its sale in india.

Although it was originally approved for diabetes management, Mounjaro has attracted global attention for its strong weight-loss effects. Ongoing studies are evaluating its use for non-diabetic individuals struggling with obesity. The drug mimics the action of GIP and GLP-1, which are hormones released naturally after meals to regulate insulin release, lower blood sugar, and suppress appetite.

Mounjaro for Type 2 Diabetes

For people living with type 2 diabetes, keeping blood sugar in check often requires a combination of medicines, diet adjustments, and regular monitoring. Mounjaro offers a more integrated solution by targeting multiple factors that influence glucose levels. Findings from clinical trials, including the SURPASS-1 to SURPASS-5 studies, show that Mounjaro delivers better outcomes than many existing diabetes treatments, particularly in lowering HbA1c levels—a key marker of long-term glucose control.

Patients using Mounjaro have shown:

• Lower fasting and post-meal blood sugar levels
• Reductions in HbA1c by up to 2.5%
• Improved insulin sensitivity

Mounjaro and Weight Loss

Beyond its use for diabetes, Mounjaro has gained global popularity for its significant role in weight reduction. Clinical studies reveal that people taking the drug often lose between 15% and 20% of their body weight over several months of consistent use. This level of weight loss surpasses that seen with many earlier treatments and even some surgical interventions, making Mounjaro one of the most effective options currently available for managing obesity.

Disclaimer: This article is intended for general information and should not replace professional medical guidance. Always consult your doctor for advice or concerns regarding any health condition.

Following the sharp hike in the H-1B visa fee to $100,000, the Trump administration may soon begin rejecting visa applications from foreigners with certain health conditions, including diabetes and obesity.

While there has been no formal confirmation from U.S. authorities, a report by KFF Health News said a cable from the State Department to embassies and consulates listed new health-related grounds for visa denials.

Trump May Now Deny Entry to Diabetic and Obese Immigrants

According to the report, the guidance instructs visa officers to consider applicants ineligible for entry based on factors such as age and medical conditions, including cardiovascular and respiratory diseases, cancer, diabetes, metabolic and neurological disorders, and certain mental health conditions.

Officers have also been told to evaluate other issues such as obesity — which can contribute to high blood pressure, asthma, and sleep apnea, when assessing whether an applicant might become a “public charge,” or a potential financial burden on the U.S. government.

The guidance further directs officials to determine whether the applicant has sufficient financial resources to pay for their care. “Does the applicant have adequate financial resources to cover the costs of such care over his entire expected lifespan without seeking public cash assistance or long-term institutionalization at government expense?” the cable states.

It adds that individuals who could become a “public charge” — due to age or chronic health problems, may be denied entry for potentially relying on U.S. public resources.

Although the directive applies broadly to most visa categories, it is expected to primarily impact those applying for permanent residency, senior attorney Charles Wheeler told KFF Health News.

Can US Officers Reject Visas Over Health Or Financial Ability?

Visa officers have also been instructed to evaluate whether applicants can afford medical treatment independently, without relying on U.S. public funds.

Wheeler said the new rule gives officers the power to form their own opinions on what might lead to future medical emergencies or financial strain. “That’s concerning because these officers are not medically trained, have no expertise in this area, and should not be making projections based on personal judgment or bias,” Wheeler said.

US Visa Officers To Consider Health Of Applicants’ Family Members

The cable also instructs visa officers to assess the health of applicants’ family members — including children or elderly parents, when determining visa eligibility.

“Do any of the dependents have disabilities, chronic medical conditions, or other special needs and require care such that the applicant cannot maintain employment?” the State Department communication asks.

Currently, immigrant applicants must undergo a medical examination conducted by a doctor approved by the U.S. embassy. The screening includes tests for infectious diseases, an evaluation of mental health history, substance use, and proof of vaccination against illnesses such as measles, polio, and hepatitis B.

However, immigration lawyer Sophia Genovese from Georgetown University noted that the new guidance expands these requirements by directing officials to weigh long-term health conditions, not just communicable diseases, when reviewing visa applications.