FDA Delays Approval Of Novavax COVID-19 Vaccine

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Updated Apr 6, 2025 | 07:51 AM IST

FDA Delays Approval Of Novavax COVID-19 Vaccine

SummaryThe delay follows leadership changes within the FDA. Dr. Scott Steele has been appointed acting director of the agency’s vaccine division.

The U.S. Food and Drug Administration (FDA) has postponed granting full approval to Novavax’s COVID-19 vaccine. The decision, which was anticipated by April 1, has been deferred as the agency says it requires additional information before proceeding.

While the Novavax vaccine is currently available under emergency use authorization, full approval by the FDA would pave the way for broader use and potentially reassure individuals seeking alternatives to mRNA vaccines, according to CNN.

This delay coincides with efforts by Republican lawmakers in at least seven U.S. states to restrict or ban mRNA vaccines. As reported by KFF Health News, some of these legislators are also urging federal regulators to revoke approval for mRNA-based COVID vaccines—shots that former President Donald Trump highlighted as a major achievement of his administration.

Unlike the mRNA vaccines developed by Pfizer and Moderna, Novavax uses a protein-based platform, a more traditional vaccine approach.

“As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe that our [Biologics License Application] is ready for approval,” the company stated. Novavax added that the application “included robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of COVID-19.”

The company also said it remains confident its “well-tolerated vaccine represents an important alternative to mRNA COVID-19 vaccines for the U.S.”

The delay follows leadership changes within the FDA. Dr. Scott Steele has been appointed acting director of the agency’s vaccine division after Dr. Peter Marks stepped down last month.

Meanwhile, U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.—a longtime vaccine opponent—has continued to circulate false claims about COVID vaccines and recently shared misleading information about the measles vaccine amid a deadly outbreak.

An HHS spokesperson told CNN that the FDA’s evaluation of the Novavax vaccine, like all vaccines, is undergoing an independent review process.

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Menstrual Blood-Based Self-Sampling Cervical Cancer Test Gets Patent-Know Everything About It

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Updated Apr 9, 2025 | 12:24 AM IST

Menstrual Blood-Based Self-Sampling Cervical Cancer Test Gets Patent-Know Everything About It

SummaryM-Strip, the self-sampling kit for cervical cancer (HPV) and STI screening, provides a non-invasive alternative to traditional cervical screenings.

A medtech startup IOTA Diagnostic, has received an Indian Patent for its M-Strip, an innovative cervical cancer screening test that uses menstrual blood as a biospecimen. This follows regulatory approval from the Central Drugs Standard Control Organization (CDSCO) and successful clinical validation. It is pertinent to note that cervical cancer is the second most common cancer among women in India, causing around 80,000 deaths annually.

How Does This Work?

M-Strip, the self-sampling kit for cervical cancer (HPV) and STI screening, provides a non-invasive alternative to traditional cervical screenings. This allows women to collect menstrual blood using a sanitary pad-based device. This sample is then sent to a lab for analysis to detect the presence of Human Papillomavirus (HPV), a major cause of cervical cancer.

Cervical cancer recently gained widespread attention when model and actress Poonam Pandey sparked headlines by creating a hoax about her death to raise awareness about this chronic disease. While she received a lot of flak for her actions, cervical cancer became a trending search on the internet. But what is this and is it treatable?

What Is Cervical cancer?

Cervical Cancer is a type of cancer that deveops in layers of the cervix. It is caused by abnormal cell growth that can spread to another part of your body. There are two main types of cervical cancer. These are squamous cell carcinoma and adenocarcinoma.

Where Is The Cervix Located?

Cervix is located in the pelvic cavity, about 3 to 6 inches inside the vaginal canal. It serves as the entrance to the uterus to the vagina. As per the World Health Organization (WHO), almost all cervial cancer are linked to human papillomaviruses (HPV) which are transmitted through sexual contact.

What Are The Symptoms Of Cervical Cancer?

Cervical cancer has no symptoms in the early days and therefore, is hard to detect until it has spread.

Early-Stage Cervical Cancer Symptoms

  • Vaginal bleeding after sex
  • Vaginal bleeding post-menopause
  • Vaginal bleeding between periods or unusually heavy/long periods
  • Watery vaginal discharge with a strong odour or containing blood
  • Pelvic pain or pain during intercourse
Advanced Cervical Cancer Symptoms (when cancer has spread beyond the cervix):

  • Persistent symptoms of early-stage cervical cancer
  • Painful or difficult bowel movements or rectal bleeding
  • Painful or difficult urination or blood in the urine
  • Persistent dull backache
  • Swelling of the legs
  • Pain in the pelvis or lower abdomen

Treatment Options

Treatment options for cervical cancer vary based on the cancer’s stage, size, and whether it has spread. Early-stage cervical cancer is often treated with surgery, such as a hysterectomy, to remove cancerous tissue. Radiation therapy, which uses high-energy beams to destroy cancer cells, is frequently combined with chemotherapy in more advanced stages. Chemotherapy involves cancer-killing drugs that circulate throughout the body. Targeted therapy is also emerging as an option, using drugs that focus on specific cancer cell markers while sparing healthy cells. The choice of treatment depends on multiple factors, including the patient’s overall health and desire to preserve fertility.

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Women Have Sharper Hearing Skills Than Men, New Study Finds

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Updated Apr 8, 2025 | 09:26 PM IST

Women Have Sharper Hearing Skills Than Men, New Study Finds

SummaryA recent study has discovered that women can hear up to 2 decibels higher than men.

Anyone who recalls whispering at the dinner table as a child likely also remembers being overheard and reprimanded by their sharp-eared mother, even as an oblivious father ploughed through his meal. Now, science has an explanation for this long-standing observation. A new study conducted by a team of British and French researchers tested around 450 people across 13 countries and found that women typically have higher hearing sensibility than men.

"Women consistently exhibit higher sensitivity by two decibels," the researchers wrote in a paper published in the journal Scientific Reports. This was true across the entire frequency spectrum tested and for all populations sampled. Surprisingly, the study found that in some groups, women's ears were up to six kilohertz sharper than men's. Women not only exhibit heightened cochlear sensitivity—referring to the fluid-filled part of the inner ear that converts sound waves into signals the brain can process—but also outperform men in other auditory tests.

"This difference stems from women's superior function in both the peripheral auditory system and the central auditory pathway. We were surprised to find that women had two decibels more sensitive hearing across all the populations we measured, and this accounted for most of the variations between individuals," said Turi King of the University of Bath in the UK.

People Living in Forests Can Hear Better

Beyond the gender-based differences, the study also uncovered that people living in forest environments exhibited the highest hearing sensitivity. In contrast, those residing in mountainous areas showed the lowest. The researchers noted that people living at higher altitudes tend to have reduced hearing capabilities.

Environmental factors like population density, natural soundscapes, and pollution levels were found to play a significant role in shaping auditory sensitivity. Language exposure also had a measurable impact.

Why Is This Study Important?

According to the lead researchers, the findings are significant because they challenge long-held assumptions about hearing. The study highlights the importance of considering both biological and environmental influences when examining auditory health.

Here's How You Can Enhance Your Hearing

- Avoid loud environments or use ear protection like earplugs or noise-canceling headphones.

- Keep earphone volume low—follow the 60/60 rule (no more than 60% volume for 60 minutes).

- Exercise regularly to improve blood circulation to the ears.

- Eat a balanced diet rich in omega-3 fatty acids and antioxidants.

- Stay hydrated to support overall ear health.

- Quit smoking and limit alcohol intake, as both can harm hearing.

- Manage stress, which can worsen tinnitus or hearing sensitivity.

- Clean your ears gently—avoid inserting cotton swabs or sharp objects.

- Go for regular hearing check-ups, especially if you notice any hearing changes.

- Seek early treatment if you experience ringing, pain, or hearing loss.

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Novo Nordisk's Diabetes Drug Could Be Beneficial For Heart, Study Shows

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Updated Apr 8, 2025 | 07:44 PM IST

Novo Nordisk's Diabetes Drug Could Be Beneficial For Heart, Study Shows

SummaryRybelsus reduced the risk of cardiovascular-related death, heart attack, and stroke by 14% compared to a placebo over an average follow-up period of four years.

Novo Nordisk on Saturday announced that its diabetes pill, Rybelsus, demonstrated cardiovascular benefits in a late-stage trial. The findings pave the way for the medication to become a new treatment option for people living with both diabetes and heart disease.

In the trial, Rybelsus reduced the risk of cardiovascular-related death, heart attack, and stroke by 14% compared to a placebo over an average follow-up period of four years. The study involved patients with Type 2 diabetes and established heart disease, some of whom also had chronic kidney disease. The Danish drugmaker presented these results at the American College of Cardiology’s Annual Scientific Session in Chicago.

Rybelsus, already approved for Type 2 diabetes, is the once-daily oral formulation of Novo Nordisk’s blockbuster weekly injection, Ozempic. Both drugs, along with the company’s weekly weight-loss injection Wegovy, contain semaglutide as their active ingredient.

According to Stephen Gough, Novo Nordisk’s global chief medical officer, the company has submitted applications in the U.S. and EU to expand Rybelsus’ approval to include reducing the risk of serious cardiovascular events. “We know not everybody wants an injection, whether it is painful or not, they want the option of an oral medication,” Gough told CNBC. “We provide that option, that you can have one or the other, depending on what the patients and the healthcare professional think is right in that joint discussion.”

In March 2024, Wegovy received U.S. approval for lowering the risk of major cardiovascular events in adults who are overweight or obese and have heart disease. The new data on Rybelsus suggests an additional option for patients hesitant about injections, offering a more convenient pill-based treatment.

The phase three trial included over 9,600 participants aged 50 and older, who received either Rybelsus or a placebo, in addition to standard therapies. Nearly half of the participants also received SGLT2 inhibitors—commonly used to lower blood sugar—at some point during the trial. By the end, 12% of those on Rybelsus and 13.8% of those on placebo experienced cardiovascular-related death, heart attack, or stroke, amounting to a 14% overall reduction in risk for the Rybelsus group.

The most significant reduction was seen in non-fatal heart attacks, which were reduced by 26%, followed by a 12% drop in non-fatal strokes and a 7% reduction in cardiovascular-related deaths. These findings align with previous trials of injectable GLP-1s like semaglutide, which mimic gut hormones to regulate blood sugar, reduce appetite, and curb inflammation.

While the study showed no major differences in kidney-related outcomes, Gough clarified that the trial primarily focused on heart health. Ozempic, however, is already approved for treating chronic kidney disease in diabetic patients.

Common side effects of Rybelsus were gastrointestinal issues such as nausea, diarrhea, and constipation—similar to those experienced with injectable semaglutide. These symptoms rarely led to patients discontinuing the drug.

Dr. Darren McGuire, the study’s lead author from UT Southwestern Medical Center, noted that despite needing to be taken on an empty stomach at least 30 minutes before eating, patients successfully adhered to Rybelsus and experienced cardiovascular benefits across all age, sex, and health condition subgroups.

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