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FDA expands warning about rare heart side effect in two leading Covid vaccines

FDA expands warning about rare heart side effect in two leading Covid vaccines

Mint25-06-2025
The Food and Drug Administration has mandated that Pfizer and Moderna expand warning labels on their mRNA COVID-19 vaccines (Comirnaty and Spikevax) to highlight a rare risk of myocarditis and pericarditis, which are heart inflammation conditions, primarily in males aged 16–25. The updated labels now cite an incidence rate of 38 cases per million doses in this demographic, up from prior warnings focused on ages 12–17 (Pfizer) and 18–24 (Moderna).
For all recipients under 65, the overall risk remains low at nearly 8 cases per million doses. This move follows FDA analysis of 2023–2024 vaccine safety data, including insurance claims and a study showing persistent cardiac MRI abnormalities in some patients five months post-diagnosis. The CDC, however, maintains that such cases are rare, typically resolve quickly, and are less severe than those caused by COVID-19 infection itself.
Policy clash and political tensions underpin new warnings
The FDA's decision conflicts with prior CDC assessments that found no increased myocarditis risk in vaccine injury databases since 2022. It also aligns with broader efforts by Health Secretary Robert F. Kennedy Jr.'s administration to tighten vaccine oversight. Kennedy recently replaced all 17 CDC advisory panel members with appointees, including anti-vaccine advocates, and FDA Commissioner Marty Makary, a critic of COVID-19 booster mandates, has restricted annual shots to high-risk groups (e.g., senior citizens).
Also Read | Nestle says it will remove artificial dyes from US foods by 2026
Critics argue the label expansion overlooks context: Studies confirm COVID-19 infection poses a 16-fold higher myocarditis risk than vaccination, and most post-vaccine cases are mild, resolving with anti-inflammatory treatment. Yale researchers note the inflammation is transient, not autoimmune, allowing full recovery.
Expert backlash and global safety perspectives
Medical experts condemn the FDA's approach as misleading. 'They are right to suggest that we need to consider myocarditis risks associated with the vaccine, but what they propose is exactly the wrong solution,' said Dr. Robert Morris of the University of Washington. 'We should be investigating who is prone to myocarditis to see if we can predict and mitigate that risk," according to a report by AP.
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Andhra: Junior doctors support foreign medical graduates over delay in permanent registration
Andhra: Junior doctors support foreign medical graduates over delay in permanent registration

Time of India

time19 minutes ago

  • Time of India

Andhra: Junior doctors support foreign medical graduates over delay in permanent registration

Amaravati: The Andhra Pradesh Junior Doctors Association (APJUDA) on Friday expressed solidarity with nearly 500 foreign medical graduates (FMGs) who have been waiting for over 13 months to receive their permanent registration (PR), an official said. APJUDA noted that the FMGs are yet to receive their PR despite completing internships of one to two years, as required by the Andhra Pradesh Medical Council (APMC). "APJUDA is deeply concerned about the undue delay in granting PR to nearly 500 FMGs who have completed their internships," its general secretary, A Nikhil Singh, told PTI. Singh alleged that despite the constitution of a new APMC three months ago, the issue remains "unresolved due to administrative delays". The registrar's office has yet to begin shortlisting eligible candidates as per the National Medical Commission (NMC) norms, prolonging uncertainty for FMGs in the state, he added. According to an APJUDA press release, FMGs held a silent protest in Vijayawada on July 1, National Doctors' Day, which was "disrupted by police intervention", drawing criticism from the association. Meanwhile, APMC chairman Srihari Rao and registrar Ramesh clarified that FMGs were allotted internships in the southern state as per NMC-issued guidelines and instructions. FMGs who completed courses offline abroad, including those returning during Covid-19 or Ukraine war and later went back, were allotted one-year internship in medical colleges across Andhra Pradesh, said Rao in an official press release. FMGs who studied online from India without returning to their universities abroad were allotted two-year internships, said Ramesh in the press release, adding that NMC later issued guidelines requiring clerkship based on year-wise online study. While some FMGs resumed their two-year internship, others approached the high court, however, it upheld NMC rules, dismissing compensation certificates, and one appeal is subjudice, said Ramesh. "Without waiting for the final court judgment, FMGs began protests on July 2 of which the APMC was unaware and Health Minister Satya Kumar Yadav met protestors at NTR University and assured resolution," said Rao. The minister held a meeting on July 2, instructing APMC officials to visit Delhi and represent FMG grievances before NMC. FMGs, however, continued protests despite assurances, said Rao. APMC said most compensation certificates lacked clarity on online study periods, hence, NMC directed two-year internships, and APMC's allotment orders were fully justified and rule-based. The council appealed to FMGs to stop protests and follow NMC norms, adding that the minister is committed, and clarity will come soon from the court or NMC. Meanwhile, YSRCP chief Jagan Mohan Reddy criticised the government for using "police force" against FMGs demanding PR despite completing their internships and exams. He questioned the police action on FMGs' peaceful march to meet the NTR Health University registrar on June 1, alleging that many were "manhandled, detained, and removed" from the site. Reddy further alleged that over 700 doctors were forced into extended, unpaid internships, preventing them from applying for postgraduate courses and causing severe career "setbacks and emotional distress". "The N Chandrababu Naidu-led administration is exploiting FMGs as unpaid labour for private colleges while deliberately withholding PRs to serve corporate interests," Reddy alleged in a post on 'X' on June 2. Reddy demanded the immediate issuance of PRs to all eligible FMGs as per NMC norms and questioned the government's alleged attempt to "demoralise students" who chose to pursue medical education abroad. PTI

How a silver revolution is taking place in Indian gyms
How a silver revolution is taking place in Indian gyms

India Today

timean hour ago

  • India Today

How a silver revolution is taking place in Indian gyms

The moment you enter a gym, you're mostly greeted by loud, thumping music. The mecca of movement is always abuzz with commotion. While some are busy clicking mirror selfies to announce their gym attendance on social media, others are sweating it out on the treadmills, with many struggling to lift weights. The oohs and aahs of pushing the body for just one more rep echo throughout. So do the clangs of iron as barbells and dumbbells are finally released after a strenuous bulked-up men further chiselling their frames, women striving to be in their best shape, or young teens working on their physique metamorphosis, gyms, over the years, have become more inclusive. It is obviously no longer a workout arena for young men. Women are now equally serious about their fitness game. And it is no more limited to the so-called fat-melting cardio sessions.A new set of fitness enthusiasts is finally hitting Indian gyms: people in their 50s and 60s. View this post on Instagram A post shared by Ashu Jain (@ revolution in Indian gyms When I re-entered the gym this month, years after first trying it, something felt different. In the cardio section, a man in his early 70s, crowned with a head of shining silver hair, was cycling with the other side of the gym, a 57-year-old woman was performing weighted squats. That day, she had brought her daughter along to get her a gym membership too.I could easily spot four to five more elderly individuals around – including my 60-year-old father, who has been a regular at the gym for over a month reason for hitting the gym at 60 was to manage a few health issues that surfaced earlier this year. Alongside medication, he consulted a nutrition and lifestyle coach, who recommended some basic dietary changes, fixed his meal timings, and strongly encouraged him to start weight training. It is not uncommon to see elderly people working out in gyms now. (Photo: Unsplash) Sandeep, a Noida-based gym trainer with over three decades of experience, says that earlier, even doctors used to discourage the idea of going to the gym. 'Now, doctors themselves advise their patients, even older ones, to make strength training a part of their routine. It helps prevent muscle loss, controls many diseases, and supports a pain-free life,' he Singh, a fitness instructor based in Raipur, also acknowledges the rise in the number of elderly people joining gyms.'There is increased awareness, especially after Covid-19, because of which more people in their 50s and 60s are beginning their gym journeys,' Singh tells India the beginning – a long way to goMeanwhile, many fitness trainers also believe that this silver revolution in Indian gyms has just begun, and has a long way to go.'When I began my fitness journey almost 15 years ago, there were hardly any elderly people in gyms. 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Many of them now see gym routines as a preventive and lifestyle necessity rather than a reactive measure,' Dr Richa Mishra, personal trainer and VP, Operations at Anytime Fitness India, tells India lifestyle disorders like hypertension, diabetes and fatty liver are among the key reasons why there is a silver influx in gyms.'Strength training improves insulin sensitivity, cardiovascular health, and mental well-being, all of which are especially relevant after 50. It also supports healthy ageing by reducing the risk of falls, fractures, frailty, and lifestyle diseases like type 2 diabetes and hypertension,' says Dr Suranjit Chatterjee, senior consultant, internal medicine, Indraprastha Apollo Hospitals, New media leading the movementAshu Jain, a fitness influencer known as 'Not Just A Grandma' on Instagram, began her fitness journey at the age of 54 after being diagnosed with hypertension and high cholesterol. She started with regular walks and home workouts, eventually transitioning to gym Mohan, a popular model, was also 54 when he began his fitness journey, battling a host of health issues at the time. Choosing fitness as a way to fight back and reclaim his life, he is now 66, a professional model, and confidently flaunts his enviable physique on the ramp. View this post on Instagram A post shared by dinesh mohan silverfox India (@ Jain and Mohan have been vocal on social media about starting their fitness journeys late in rise of fitness influencers and health experts championing strength training for the elderly for an improved quality of life is also pushing this silver Ramprasad is one such influencer championing senior fitness, both online and offline. Through video content featuring his parents, he encourages young followers to take charge of their own parents' fitness journeys. 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Look for a trainer with experience in training people of your want someone who understands your health issues and works on an approach to build strength gradually, improve flexibility, and ensure heart-friendly endurance without every elderly member undergoes an initial fitness assessment to create a personalised plan, supervised closely by our fitness is never too late to start working out. Fitness experts as well as doctors agree with it. But having a personal trainer should be non-negotiable.'Many people have had the luxury of exercising and getting into weight training while they were young. They carry it forward into old age. But just because you didn't do it earlier doesn't mean you can never start,' celebrity fitness trainer Shivohaam told India too, emphasises the importance of personal need someone to correct the form and posture. It will ensure you don't get injured. 'As you are above a certain age, the risk of injury is higher. 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Docs seek action as post-Covid neurological disorders rise in Mysuru
Docs seek action as post-Covid neurological disorders rise in Mysuru

Time of India

time4 hours ago

  • Time of India

Docs seek action as post-Covid neurological disorders rise in Mysuru

1 2 3 Mysuru: Following the state govt's move to form an expert committee to investigate a surge in sudden cardiac deaths, Mysuru-based neurologists have urged similar action to address the alarming rise in neurological disorders post-Covid-19. Dr Shushrutha Gowda, an American board-certified neurologist, reports a 30% increase in such cases, aligning with international findings that indicate a multifold rise in cities like Mysuru. He said that even though brain-related disorders are increasing, there is no effort to address them. Dr Gowda highlighted a significant uptick in conditions such as migraines, neuropathy, stroke, and dementia compared to pre-Covid times. "Neurological disorders are often more severe than cardiac issues, with higher morbidity rates. The urgency to conduct comprehensive studies and implement interventions cannot be overstated," he said. He emphasized the need for immediate action to understand and mitigate these health challenges. Citing recent cases, Dr Gowda noted treating an 18-year-old diabetic smoker for stroke, one of the youngest such patients, and dementia cases in individuals as young as 45. Diabetic persons with smoking habits are more vulnerable to neuro disorders. There is a need to take up a drive to educate society on brain health, he said. To tackle this growing crisis, he proposed statewide epidemiological surveys, regional neurology registries, and funding for research into dementia risk factors and treatments. He advocated for an integrative approach to develop effective solutions. Dr Mohamed Ataulla Shariff, consultant-neurology, Narayana Hospital, Mysuru, observed that post-Covid-19, neurological conditions like Guillain-Barré syndrome and ischemic strokes have seen an increasing trend. Many patients have shown cognitive decline (brain fog), fatigue, muscle aches, and pains. Due to steroid usage in the treatment of Covid, patients developed diabetes leading to a few neurological complications like sensory changes such as numbness and tingling, he explained. Dr Sucharitha MV, associate consultant-neurology, Manipal Hospital, Mysuru, said initially post-Covid, they did see a spike in acute ischemic strokes, cerebral haemorrhage, cerebral venous thrombosis, and encephalitis. Other common problems encountered by many patients were anosmia (loss of smell), altered taste, fatigue, headaches, dizziness, and myalgia. Over a span of a year, many patients recovered completely, while others did not return to their near normal but have shown gradual improvement. There hasn't been a drastic spike in new cases, but patients with pre-existing neurological disorders, such as Parkinson's disease, dementia, and epilepsy, who worsened during Covid have often not returned to their pre-Covid baseline. As a delayed complication of Covid, many patients suffer from memory loss, behavioural issues, depression, and fatigue, she said. In the acute phase, patients had an increased risk of ischemic stroke, intracerebral haemorrhage, and cerebral venous thrombosis, she said. According to health department officials, the rise in the number of neurological disorders can be ascertained only when the cases are reported to the hospitals, and till now no sudden spike in the cases has been reported. Mysuru district health officer Dr PC Kumaraswamy stated that the mental health programme currently includes brain health initiatives focusing on disorders like dementia. However, he claimed no significant spike in neurological cases has been observed locally.

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