PORTAL RASMI
JABATAN PERDANA MENTERI
AGENSI PENGURUSAN BENCANA NEGARA
JABATAN PERDANA MENTERI
AGENSI PENGURUSAN BENCANA NEGARA
US limits Covid boosters to over-65s or those at high risk
- Admin UKK
- Berita
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.
They criticised the US approach of recommending boosters for all adults regardless of age or health status, calling it a “one-size-fits-all” model based on the mistaken belief that Americans could not handle more nuanced, risk-based advice.
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