WASHINGTON – The US will limit Covid-19 boosters to people over 65 or those at risk of serious illness, while requiring vaccine makers to run fresh clinical trials before offering shots to younger and healthier individuals, officials said on May 20.
Writing in the New England Journal of Medicine, the Food and Drug Administration’s (FDA) Vinayak Prasad and Commissioner Martin Makary framed the policy shift as “evidence-based” and would align the US more closely with guidance in Europe.
But it comes as Health Secretary Robert F. Kennedy Jr, a long-time vaccine sceptic, pushes to remake federal public health policy.
Dr Prasad and Mr Makary praised the initial Covid-19 vaccine rollout as “a major scientific, medical and regulatory accomplishment”, but argued that the benefits of repeated boosters for low-risk individuals are uncertain.
The FDA said it would rely on lab test results to approve boosters for people who are over 65, or over six months old with at least one underlying condition.
But for healthy individuals between six months and 64 years, regulators will now require data from randomised trials.
Some infectious disease experts welcomed the shift.
Dr Amesh Adalja of Johns Hopkins University said it matched the approach taken by other countries in a population that already carries significant immunity.
“For lower-risk individuals, the goal has always been less clear, as protection against infection is transient and they don’t have a high risk of severe disease,” he told AFP.
But others voiced concern about the practical consequences.
“Any use, say in a healthy 35-year-old, would be considered off-label, and you wonder whether an insurance company would pay for it,” he told AFP.
Under the revised framework, companies like Pfizer and Moderna will be encouraged to test updated boosters in adults aged 50 to 64.
These studies should measure whether the vaccines reduce symptomatic infections, hospitalisations and deaths.
Rather than comparing new shots to earlier formulations, Dr Prasad and Mr Makary suggested placebo-controlled trials – with saline as the comparator – to better evaluate both benefit and potential side effects.
The proposal, first floated by Mr Kennedy earlier in May, has proved divisive. Critics argue that using a placebo – when authorised vaccines already exist – could expose participants to unnecessary harm.
“Imagine if there was a death or two in the placebo group,” said Dr Offit. “I don’t see how your conscience allow that.”
Supporters of continued Covid-19 boosters often draw parallels to annual flu shots.
But Mr Makary and Dr Prasad pushed back on that comparison, arguing the genetic changes in Covid-19 variants have not been significant enough to justify automatically updating the vaccine each year.
The FDA officials also sought to reassure Americans concerned they might lose access to boosters under the new framework.
The Centres for Disease Control and Prevention’s definition of risk factors is “vast, including obesity and even mental health conditions such as depression”, they wrote, noting that between 100 million and 200 million Americans would likely still qualify.
– AFP
Banjir landa New South Wales, penduduk terputus hubungan
SHAH ALAM – Belum pun selesai masalah banjir kilat dan sistem perparitan tidak diselenggara dengan baik, khususnya pasca bah besar sejak 2021, kini penduduk Kampung Sungai Kandis diancam dengan kepadatan kependudukan tidak terkawal.
Ketua Penerangan Persatuan Anak Jati Kampung Sungai Kandis (PAJKSK), Mohd Zulhusni Mohd Noh berkata, projek perumahan baharu pangsapuri mewah 660 unit bakal mengundang ketidaktenteraman dan keselesaan penduduk asal.
Beliau berkata, memandangkan jumlah kediaman sedia ada ketika ini sudah mencecah kira-kira 1,500 unit rumah, sudah tentu kemunculan taman perumahan keenam di kampung tradisi itu hanya mendatangkan ‘bala’ berbanding ‘kebaikan’.
“Projek perumahan baharu ini tidak memberikan manfaat langsung kepada penduduk Kampung Sungai Kandis.
Tinjauan MalaysiaGazette ke tapak projek pembinaan pangsapuri 22 tingkat di Kampung Sungai Kandis di sini mendapati, dari 660 unit kediaman itu, sebanyak 132 unit merupakan Rumah Selangorku jenis trio bakal didirikan di atas tanah seluas 7 ekar.
Berdasarkan papan tanda projek yang didirikan Majlis Bandaraya Shah Alam, MalaysiaGazette mendapati kelulusan infra pembinaan dua blok perumahan itu diperoleh pada 27 September 2024, manakala bangunan pula pada 18 Disember lalu.
MalaysiaGazette dimaklumkan, 528 unit pangsapuri jenis A yang berkeluasan 914 kaki persegi (kps) dijual bermula pada harga RM438,000 seunit, manakala 132 unit Rumah Selangorku Trio pula dijual serendah RM197,370 seunit.
Projek perumahan didakwa atas nama “Kandis Residence” itu dilengkapi dengan pelbagai kemudahan, termasuk gimnasium, dewan serbaguna, kolam renang, kedai runcit, dobi, surau dan tadika.
Selain itu, kata Zulhusni, pembinaan 660 unit kediaman pangsapuri itu jauh lebih besar daripada kapasiti infrastruktur di kampung tersebut, apatah lagi ketika ini sebanyak lima taman perumahan sudah dibina di situ sejak lebih 15 tahun lalu.
“Kami tak boleh bayangkan bila projek perumahan diwujudkan, malah hanya menjejaskan keharmonian dan keselesaan penduduk kampung,” katanya.
Dalam pada itu, Zulhusni memberitahu MalaysiaGazette, pembinaan projek 660 unit pangsapuri itu didakwa dibuat dengan tergesa-gesa tanpa memberi tempoh yang mencukupi kepada penduduk asal untuk membuat bantahan.
“Projek ini telah lulus pada Januari 2024, bagaimanapun kami hanya dimaklumkan mengenai projek ini dalam grup WhatsApp di mana ia mula dibina pada 1 Julai 2024.
“Bagaimanapun kami hanya tahu projek ini diluluskan pada 30 Jun 2024, kami mempunyai beberapa jam sahaja untuk membantah kerana masa yang diberikan amat singkat,” katanya.
Katanya lagi, Zulhusni berharap Majlis Bandaraya Shah Alam (MBSA) dapat mengekalkan status Kampung Sungai Kandis sebagai kampung tradisi dan mengelakkan daripada pembangunan tidak terancang seperti itu berulang.
“Kami berharap agar Kampung Sungai Kandis ini dijadikan kampung tradisi kerana hampir tiada lagi kampung seumpama itu di bawah MBSA yang boleh dijadikan kampung tradisi,” katanya.
Sehubungan itu, katanya, PAJKSK mendesak pihak berkuasa yang bertanggungjawab dalam meluluskan projek tersebut supaya menghentikan kerja-kerja pembinaan pangsapuri 22 tingkat itu dengan serta-merta.
“Saya mengharapkan MBSA, JKR ataupun SUK yang bertanggungjawab di atas projek ini mendengar keluhan kami penduduk Kampung Sungai Kandis, tiada kompromi lagi, kami mahu projek ini dibatalkan segera.
“Tindakan sewajarnya dengan menghalang projek ini daripada berterusan serta mengelakkan jalan raya rosak, mendapan tanah dan menjejaskan sistem perparitan di kampung kami perlu dilakukan segera,” katanya.
Sementara itu, menurut bekas Ketua Kampung Sungai Kandis, Miswan Salleh mendakwa, tiada rundingan dan perbincangan dilakukan pemaju hartanah itu dengan penduduk setempat setakat ini.
“Saya harap pihak berwajib memberi perhatian serius kepada keluhan penduduk Kampung Sungai Kandis, lebih-lebih lagi masalah jalan raya dan banjir belum lagi dapat diatasi.
“Kita kena berbincang dengan penduduk kampung, pertambahan penduduk daripada 660 unit pangsapuri baharu ini memang menjejaskan kampung kita, merosakkan jalan, lebih-lebih lagi sekolah waktu pagi atau petang.
“Jadi kita nak kena fikir sama-sama, ini untuk kebaikan kampung kita, apatah sekarang ini banyak taman perumahan dalam kampung kita ini yang telah didirikan, saya harap kalau boleh dibatalkan,” katanya lagi. – MalaysiaGazette
Indonesia urges vigilance as Covid-19 cases rise in region amid Lady Gaga concert, but says domestic situation remains stable
- Admin UKK
- Berita
JAKARTA, May 20 — Indonesia’s health ministry is closely watching a rise in COVID-19 cases in parts of Asia, including Singapore, Thailand, and Hong Kong, while assuring that the domestic situation remains under control.
The increase comes amid rising public mobility, with many Indonesians travelling abroad for international events, including Lady Gaga’s concert tour, which began on May 18.
Ministry spokesperson Aji Muhawarman said data up to the 19th week of 2025 shows that COVID-19 transmission in Indonesia remains within safe limits.
“Despite global trends, the situation at home is stable. We’re enhancing disease monitoring through sentinel surveillance and screening at points of entry,” he said in a statement.
According to Aji, Singapore has seen a spike in cases, attributed to seasonal patterns, with the dominant JN.1 subvariant not linked to more severe illness.
While Indonesia has not implemented stricter border controls, international entry point surveillance has been strengthened using the SatuSehat Health Pass (SSHP) system.
There are no travel bans, but the ministry advises caution, especially when visiting countries with rising infections.
“Travellers should follow local protocols, stay updated, and postpone non-essential travel if unwell,” he said.
The ministry continues to promote preventive measures such as handwashing, mask use when symptomatic, and seeking care for respiratory symptoms.
COVID-19 booster shots are still recommended for high-risk groups, including the elderly and those with underlying conditions.
“There’s no cause for panic, but vigilance is essential to keep Indonesia safe,” Aji added. — Bernama