US panel recommends COVID-19 boosters for people 65 and older

US panel recommends COVID-19 boosters for people 65 and older
The panel voted 18-0 for granting emergency authorization for people aged over 65 and those at high risk. (AFP/File)
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Updated 19 September 2021

US panel recommends COVID-19 boosters for people 65 and older

US panel recommends COVID-19 boosters for people 65 and older
  • The panel voted 16-2 against granting a third dose full approval
  • Tens of millions of Americans will soon be eligible for a third shot

WASHINGTON: A panel of leading US medical experts advising the government voted in favor of authorizing boosters of Pfizer’s coronavirus vaccine for everyone aged 65 and up, as well as people at high risk of developing severe COVID-19.
The same committee however rejected an initial proposal, submitted by Pfizer and backed by President Joe Biden’s administration, to fully approve boosters to everyone aged 16 and over.
The decisions came after a day-long meeting full of data presentations and at times charged debate that was convened by the Food and Drug Administration (FDA). Tens of millions of Americans will soon be eligible for a third shot.
“I think this should demonstrate to the public that the members of this committee are independent of the FDA, and that in fact we do bring our voices to the table,” said Archana Chatterjee, dean of Chicago Medical School.
The panel — which included vaccinologists, infectious disease researchers, and epidemiologists — concluded that the benefit-risk balance differed for younger people, especially males at risk for myocarditis.
A clinical trial for the booster involved just over 300 people, which they felt was too small to be able to draw firm conclusions about safety.
The panel voted 16-2 against granting a third dose full approval.
They were then presented with a new motion, and voted 18-0 for granting emergency authorization for people aged over 65 and those at high risk. They agreed this should extend to health care workers and people at high risk of occupational exposure.
Now the issue turns to another committee, this time convened by the Centers for Disease Control and Prevention (CDC) on September 22-23 to further define who is eligible and decide on rollout.
Pfizer will work with the FDA to address the committee’s questions as “we continue to believe in the benefits of a booster dose for a broader population,” Kathrin Jansen, head of vaccine research and development at the company, said in a statement.
Even prior to the meeting, the Food and Drug Administration (FDA) had struck a cautious note.
In its briefing document, the FDA stated: “Data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death.”
Two senior FDA officials meanwhile co-signed a Viewpoint in The Lancet this week opposing boosters for the general population, in what was seen as a rebuke of the White House for taking a decision before consulting its scientific agencies, effectively placing the cart before the horse.
At the meeting, Pfizer officials cited studies that demonstrated waning immunity against infection several months out from the first two doses.
“The demonstrated safety and effectiveness of a third dose support adding a booster dose to the vaccination schedule,” said Donna Boyce, Pfizer’s senior vice president of global regulatory affairs.
But a growing body of US research — including a dataset presented by Pfizer itself at Friday’s meeting — has shown two doses continue to confer high protection against severe outcomes, albeit at slightly diminished levels for the elderly.
Pfizer also presented data showing boosters increased antibody levels against the Delta variant, but an FDA scientist countered that these lab studies could not translate directly to efficacy estimates.
Sharon Alroy Preis, an official with Israel’s health ministry, presented data from her country which ran a booster campaign after experiencing a Delta wave, and has approved boosters for everyone aged 12 and up.
Jay Portnoy, a pediatrician with Children’s Mercy Hospital in Kansas City, said the Israeli experience should serve as a warning beacon and that the United States should follow its lead.
But most of the panel did not see the two countries as closely analogous. Because the US has a much lower overall vaccination rate, the unvaccinated are the primary drivers of spread, rather than breakthrough cases among the vaccinated.


Italy imposes new COVID-19 rules on unvaccinated

Italy imposes new COVID-19 rules on unvaccinated
Updated 06 December 2021

Italy imposes new COVID-19 rules on unvaccinated

Italy imposes new COVID-19 rules on unvaccinated
  • Only those who have recently recovered from COVID-19 are exempt from the rules
ROME: People in Italy unvaccinated against COVID-19 can no longer go to the theater, cinemas, live music venues or major sporting events under new rules that came into force Monday.
Only those who have recently recovered from COVID-19 are exempt from the rules, which represent a significant tightening of restrictions in the face of rising infections.
New measures are also being enforced on public transport, with a so-called Green Pass showing proof of vaccination, recent recovery or a negative COVID-19 test now required even on local services.
A man in his 50s was fined $452 (€400) for not having his pass on Monday morning as he got off a bus near Piazza del Popolo in Rome, according to the Corriere della Sera newspaper.
“I don’t have it because I wanted to get vaccinated in the next few days,” he was reported as saying.
A record 1.3 million Green Passes were downloaded on Sunday ahead of the change.
Meanwhile in Rome at the weekend, new rules requiring face masks to be worn outdoors in the busiest shopping streets came into effect.
Italy was the first European country to be hit by coronavirus in early 2020 and has one of the highest death tolls, at more than 134,000.
However, it is currently faring better than many of its neighbors, with 15,000 cases out of a population of 60 million reported on Sunday.
Almost 85 percent of over 12s have been vaccinated, a booster campaign is in full swing and jabs will soon be available for younger children.
The Green Pass was introduced in August for access to theaters and cinemas, museums and indoor dining, and extended to workplaces in October — a move that sparked widespread protests.
From now until January 15, a new “Super Green Pass,” which can only be obtained through vaccination or recent recovery, will be required for cultural activities — although not museums — and inside restaurants.
However, having a coffee at the bar of a cafe and eating outside is allowed without a Green Pass.
The restrictions will be further tightened in regions at higher risk of coronavirus.
Currently most of Italy is classed as the lowest of four levels, which range from white to yellow, orange and red.
Two regions are yellow — Friuli Venezia Giulia and Bolzano, which both border Austria, a country in partial lockdown over the number of cases there.

Omicron spreads in India, full vaccination in focus

Omicron spreads in India, full vaccination in focus
Updated 06 December 2021

Omicron spreads in India, full vaccination in focus

Omicron spreads in India, full vaccination in focus
  • India has fully vaccinated 51 percent of its 944 million adults and given at least one dose to 85 percent
  • Most other cases have been in people who have recently come from abroad

NEW DELHI: Cases of the omicron coronavirus variant have risen to 21 in India over the weekend and people must step up for vaccination, officials said on Monday.
The western state of Rajasthan reported the most number of omicron cases with nine, followed by eight in Maharashtra, two in Karnataka and one each in Gujarat and the capital New Delhi.
“The people of Delhi must get fully vaccinated, wear a mask and maintain social distancing,” its health minister Satyendar Jain said on Twitter.
He said the city’s first omicron patient was being treated at a state-run hospital. Some 94 percent of its adults had received at lease one dose, he added.
The country has fully vaccinated 51 percent of its 944 million adults and given at least one dose to 85 percent. Tens of millions of people, however, are overdue for their second dose despite ample vaccine supplies, government data shows.
India reported its first two omicron cases in the southern state of Karnataka on Thursday, in one person with no recent travel history.
Most other cases have been in people who have recently come from abroad, but doctors said the mutated virus was already spreading in the local population as well.
“omicron is here, community spread is underway,” surgeon Arvinder Singh Soin, who has been treating COVID-19 patients, said on Twitter. “Mask up. Get FULLY vaccinated.”
India reported 8,895 new COVID-19 cases for the past 24 hours, taking the total to 34.64 million. Deaths rose by 211 to 473,537.
Since a record surge in infections and deaths in April and May due to the Delta variant, new cases have hovered around 10,000 in the past few weeks.


27 still missing after Indonesia volcanic eruption kills 15

27 still missing after Indonesia volcanic eruption kills 15
Updated 06 December 2021

27 still missing after Indonesia volcanic eruption kills 15

27 still missing after Indonesia volcanic eruption kills 15
  • Mount Semeru spewed thick columns of ash as high as 12,000 meters into the sky in a sudden eruption triggered by heavy rain

SUMBERWULUH, Indonesia: Rescuers dug out the body of 13-year-old boy with their bare hands on Monday, as improved weather conditions allowed them to resume their search after the highest volcano on Indonesia’s Java island erupted with fury, killing at least 15 people with searing gas and ash and leaving 27 others missing.
Mount Semeru in Lumajang district in East Java province spewed thick columns of ash as high as 12,000 meters into the sky in a sudden eruption Saturday triggered by heavy rain. Villages and nearby towns were blanketed by tons of volcanic debris.
Searing gas raced down the sides of the mountain, smothering entire villages and killing or seriously burning those caught in its path.
National Disaster Mitigation Agency spokesperson Abdul Muhari said 56 people had been hospitalized, mostly with burns. He said rescuers were still searching for 27 villagers reported missing. Nearly 3,000 houses and 38 schools were damaged, Muhari said.
The body of the 13-year-old boy was recovered in the worst-hit village of Sumberwuluh, where houses were buried to their rooftops and cars were submerged. Crumpled roofs, charred carcasses of cattle and broken chairs covered in gray ash and soot dotted the smoldering landscape.
Search and rescue efforts were temporarily suspended Sunday afternoon because of fears that heavy rain would cause more hot ash and debris to fall from the crater.
The eruption of the 3,676-meter-high mountain eased pressure that had been building under a lava dome in the crater. But experts warned that the dome could further collapse, causing an avalanche of blistering gas and debris trapped beneath it.
More than 1,700 villagers escaped to makeshift emergency shelters after Saturday’s powerful eruption, but many others defied official warnings and chose to remain in their homes to tend their livestock and protect their property.
Semeru, also known as Mahameru, has erupted many times in the last 200 years. Still, as on many of the 129 volcanoes monitored in Indonesia, tens of thousands of people live on its fertile slopes. It last erupted in January, with no casualties.
Indonesia, an archipelago of more than 270 million people, is prone to earthquakes and volcanic activity because it sits along the Pacific “Ring of Fire,” a horseshoe-shaped series of fault lines.


Next pandemic could be more lethal than COVID-19, Oxford vaccine creator says

Next pandemic could be more lethal than COVID-19, Oxford vaccine creator says
Updated 06 December 2021

Next pandemic could be more lethal than COVID-19, Oxford vaccine creator says

Next pandemic could be more lethal than COVID-19, Oxford vaccine creator says

LONDON: Future pandemics could be even more lethal than COVID-19 so the lessons learned from the outbreak must not be squandered and the world should ensure it is prepared for the next viral onslaught, one of the creators of the Oxford-AstraZeneca vaccine said.
The novel coronavirus has killed 5.26 million people across the world, according to Johns Hopkins University, wiped out trillions of dollars in economic output and turned life upside down for billions of people.
"The truth is, the next one could be worse. It could be more contagious, or more lethal, or both," Sarah Gilbert said in the Richard Dimbleby Lecture, the BBC reported. "This will not be the last time a virus threatens our lives and our livelihoods."
Gilbert, a professor of vaccinology at the University of Oxford, said the world should make sure it is better prepared for the next virus.
"The advances we have made, and the knowledge we have gained, must not be lost," she said.
Efforts to end the COVID-19 pandemic have been uneven and fragmented, marked by limited access to vaccines in low-income countries while the "healthy and wealthy" in rich countries get boosters, health experts say.
A panel of health experts set up by the World Health Organisation to review the handling of the SARS-CoV-2 pandemic has called for permanent funding and for greater ability to investigate pandemics through a new treaty.
One proposal was for new financing of at least $10 billion a year for pandemic preparedness.
The COVID-19 outbreak was first detected in China in late 2019. Vaccines were developed against the virus in record time.
Gilbert said the omicron variant's spike protein contained mutations known to increase the transmissibility of the virus.
"There are additional changes that may mean antibodies induced by the vaccines, or by infection with other variants, may be less effective at preventing infection with omicron," Gilbert said.
"Until we know more, we should be cautious, and take steps to slow down the spread of this new variant." 


UN rights chief deplores Aung Suu Kyi conviction in ‘sham trial’

UN rights chief deplores Aung Suu Kyi conviction in ‘sham trial’
Updated 45 min 27 sec ago

UN rights chief deplores Aung Suu Kyi conviction in ‘sham trial’

UN rights chief deplores Aung Suu Kyi conviction in ‘sham trial’
  • For inciting dissent against the military and breaching COVID-19 rules
  • Former president Win Myint was also jailed for four years under the same charges

GENEVA/YANGON: United Nations human rights chief Michelle Bachelet on Monday deplored the sentencing of Myanmar’s ousted leader Aung San Suu Kyi to four years in prison by a military court and called for her immediate release.

The conviction of Suu Kyi “closes another door to political dialogue” in Myanmar, where the military took power on Feb. 1, and “will only deepen rejection of the coup,” she said in a statement issued by her Geneva office.

“The conviction of the State Counsellor following a sham trial in secretive proceedings before a military-controlled court is nothing but politically-motivated,” Bachelet added.

A Myanmar court jailed ousted civilian leader Aung San Suu Kyi for inciting dissent against the military and breaching COVID-19 rules, a spokesman for the ruling junta said.

Suu Kyi “was sentenced to two years’ imprisonment under section 505(b) and two years’ imprisonment under natural disaster law,” junta spokesman Zaw Min Tun said.

Former president Win Myint was also jailed for four years under the same charges, he said, adding that they would not yet be taken to prison.

“They will face other charges from the places where they are staying now” in the capital Naypyidaw, he added, without giving further details.

The 76-year-old Suu Kyi has been detained since the generals ousted her government in the early hours of February 1, ending Myanmar’s brief democratic interlude.

The junta has since added a slew of other indictments, including violating the official secrets act, corruption and electoral fraud. The Nobel laureate faces decades in jail if convicted on all counts.

Journalists have been barred from proceedings in the special court in the military-built capital, and Suu Kyi’s lawyers were recently banned from speaking to the media.

More than 1,300 people have been killed and over 10,000 arrested in a crackdown on dissent since the coup, according to a local monitoring group.