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Moderna Submits Application Before US Regulator For Covid Booster Shot

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<div class="ins_instory_dv_cont"><img alt="Moderna Submits Application Before US Regulator For Covid Booster Shot" src="https://c.ndtvimg.com/2020-11/qcdf72r8_moderna-vaccine_625x300_17_November_20.jpg" title="Moderna Submits Application Before US Regulator For Covid Booster Shot" /></div>
Moderna's booster shot is 50 micrograms (Representational)
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Washington:
Moderna on Wednesday announced it had begun submitting an application to the US Food and Drug Administration to authorize a booster of its Covid vaccine after trial data showed a significant increase in antibodies against variants.
The third shot of the vaccine, known as mRNA-1273, was given to 344 participants in a study six months after their second dose.
The first two doses were 100 micrograms, while the booster was half that at 50 micrograms.
An analysis showed the booster increased neutralizing antibody levels against variants of concern, including Delta by more than 42.3-fold, Gamma by 43.6-fold, and Beta by 32-fold, with similar gains seen across age groups including over-65s.
Ultra-contagious Delta, first identified in India, is now the dominant strain globally.
"We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2," Stephane Bancel, the company's CEO, said in a statement.
The company said it was also planning submissions to the European Medicines Agency (EMA) and other regulatory authorities in the coming days.
While Moderna is submitting data for a repetition of its first vaccine, which was developed against the original strain first identified in Wuhan, China, the company has previously tested a variant-specific booster against Beta, which was first identified in South Africa but has faded considerably in recent months.
US President Joe Biden's administration has begun offering third Covid vaccine doses to immunocompromised people and plans to widen boosters to everyone eligible, eight months after their second dose, starting September 20.
That decision has left many health experts baffled, because although there is evidence that vaccine efficacy is waning against infection, it has remained largely stable against hospitalization and deaths -- the purpose for which the shots were conceived.
The move has also been criticized on the basis that most developing countries at this time don't even have enough vaccines to give their populations their first or second doses.
Beyond the questionable ethics and politics of failing to provide vaccines to poor countries, leaving these regions under-vaccinated for a prolonged period of time risks incubating new and possibly more dangerous variants that could evade the protective action of the current generation of vaccines.
Also on Wednesday, the FDA announced it would hold a meeting on September 17 to evaluate whether to authorize a third booster dose of Pfizer's mRNA Covid shot.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
 
 
source <a href="https://www.ndtv.com/world-news/moderna-submits-application-before-us-regulator-for-covid-booster-shot-2526815">https://www.ndtv.com/world-news/moderna-submits-application-before-us-regulator-for-covid-booster-shot-2526815</a>

news world Moderna Submits Application Before US Regulator For Covid Booster Shot

Moderna's booster shot is 50 micrograms (Representational) Washington: Moderna on Wednesday announced it had begun submitting an ap...

Texas Abortion Restriction "Blatantly Violates" US Constitutional Rights: Joe Biden

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Washington:
President Joe Biden said Wednesday that tough new legal restrictions on abortion in Texas "blatantly" counter constitutional rights under the Supreme Court's landmark Roe v. Wade ruling.
"This extreme Texas law blatantly violates the constitutional right established under Roe v. Wade and upheld as precedent for nearly half a century," Biden said in a statement.
"My administration is deeply committed to the constitutional right established in Roe v. Wade nearly five decades ago and will protect and defend that right."
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
 
 
source <a href="https://www.ndtv.com/world-news/texas-abortion-restriction-blatantly-violates-us-constitutional-rights-joe-biden-2526665">https://www.ndtv.com/world-news/texas-abortion-restriction-blatantly-violates-us-constitutional-rights-joe-biden-2526665</a>

news world Texas Abortion Restriction "Blatantly Violates" US Constitutional Rights: Joe Biden

Washington: President Joe Biden said Wednesday that tough new legal restrictions on abortion in Texas "blatantly" counter cons...

Tainted Covid Vaccines Sent To Japan Contained Steel: Moderna Amid Furore

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<div class="ins_instory_dv_cont"><img alt="Tainted Covid Vaccines Sent To Japan Contained Steel: Moderna Amid Furore" src="https://c.ndtvimg.com/2021-04/9hgrsbm8_moderna-covid19-vaccine-reuters_625x300_14_April_21.jpg" title="Tainted Covid Vaccines Sent To Japan Contained Steel: Moderna Amid Furore" /></div>
Moderna said the contamination had been traced back to production line flaws (File)
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Washington:
Moderna said Wednesday that tainted batches of its Covid-19 vaccine sent to Japan were contaminated with stainless steel particles, but the company did not expect it posed "an undue risk to patient safety."
The US biotech firm is facing major setbacks in Japan, with hundreds of thousands of doses suspended following reports of foreign substances detected in vials.
Authorities are also investigating the deaths of two men who received doses from a tainted batch, but the cause of their deaths is so far unknown.
In a joint statement with its Japanese partner Takeda, Moderna said the contamination in one of three suspended lots had been traced back to production line flaws at a factory run by its Spanish contractor, ROVI Pharma Industrial Services.
"The rare presence of stainless steel particles in the Moderna Covid-19 vaccine does not pose an undue risk to patient safety and it does not adversely affect the benefit/risk profile of the product," the statement said.
Metallic particles of this size injected into a muscle may cause a site reaction, but are unlikely to go beyond that, it added.
"Stainless steel is routinely used in heart valves, joint replacements and metal sutures and staples. As such, it is not expected that injection of the particles identified in these lots in Japan would result in increased medical risk."
Moderna added that for the time being, there was no evidence that the two deaths were related to administration of the vaccine and "the relationship is currently considered to be coincidental." An investigation is ongoing.
Last week, Japan suspended 1.63 million Moderna doses across the country.
Around 46 percent of Japan's population has been fully vaccinated, as the country battles a record surge of coronavirus cases driven by the more contagious Delta variant.
Some 16,000 people have died from Covid-19 in Japan, and large parts of the country are under strict virus restrictions.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
 
 
source <a href="https://www.ndtv.com/world-news/tainted-covid-vaccines-sent-to-japan-contained-steel-moderna-amid-furore-2526649">https://www.ndtv.com/world-news/tainted-covid-vaccines-sent-to-japan-contained-steel-moderna-amid-furore-2526649</a>

news world Tainted Covid Vaccines Sent To Japan Contained Steel: Moderna Amid Furore

Moderna said the contamination had been traced back to production line flaws (File) Washington: Moderna said Wednesday that tainted bat...

A Third Of Global Tree Species Threatened With Extinction: Report

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Well-known trees such as magnolias were among the most threatened (Representational))
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Paris:
Around a third of all the world's tree species are threatened with extinction, according to a global index published Wednesday, warning that climate change could tip some forests into ecosystem collapse.
Land clearance for farming -- both crops and livestock -- and logging are by far the biggest threats to trees, the State of the World's Trees report said, adding that climate change was also "having a clearly measurable impact".
The study looked at the risks to 58,497 tree species worldwide and found that 30 percent (17,500) are threatened with extinction, with a further seven percent listed as "possibly threatened".
For 21 percent of species there was not enough data for an evaluation, and just over 40 percent were listed as "not threatened".
Well-known trees such as magnolias were among the most threatened, while oaks, maples and ebonies were also deemed at risk.
Some 142 tree species were found to be extinct, and more than 440 have fewer than 50 individual trees in the wild.
"Many tree species are on the brink of extinction, some represented by one last living individual," said Jean-Christophe Vie, Director General of Fondation Franklinia, in a foreword to the report.
He said it was "shocking" that deforestation rates remain so high, given the crucial role that trees play -- providing habitat for a huge proportion of the world's animals and plants, slowing climate change by absorbing carbon, and providing ingredients for medicines.
Brazil, home to large swathes of Amazon rainforest that is increasingly under threat from massive agricultural expansion and logging, has the most tree species (8,847) and also the largest number of threatened trees (1,788).
But the highest proportion of threatened species was found to be in tropical Africa, especially in islands like Madagascar and Mauritius where 59 percent and 57 percent of tree species respectively are threatened.
- Ecosystem collapse -
The report also raised concerns that the destruction can cascade across ecosystems affecting communities of trees.
Notable examples include the loss of a million hectares of spruce species in Alaska and some ten million hectares of lodgepole pine in British Columbia.
Forest ecosystems can collapse when they are subjected to multiple stressors -- like fire, logging and the break up of habitat -- that have the potential to interact and "drive abrupt ecological change", the report said.
"However, climate change has the potential to become the principal driver of collapse in most, if not all, types of forest ecosystem," said Adrian Newton, Director of Conservation Ecology at Bournemouth University, in the report.
The impacts of a changing climate and severe weather -- listed as a direct threat to more than a thousand species -- include shifting habitats, increasing storms and floods, as well as more fires, pests and disease.
- 'Huge opportunity' -
The five-year assessment was coordinated by Botanic Gardens Conservation International and specialists from the International Union for Conservation of Nature (IUCN), which holds a key biodiversity conference in France this week.
Vie said that the strong focus on restoring forests to mitigate the effects of climate change was a "huge opportunity to change this dire picture".
But he said it was crucial to make sure the right trees are planted in the right places.
"Tree species that have evolved over millions of years, adapting to changing climates, can no longer survive the onslaught of human threats," said Vie.
"How short-sighted are we to allow the loss of tree species on which global society is ecologically and economically dependent. If we could only learn to respect trees, undoubtedly many environmental challenges would greatly benefit."
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
 
 
source <a href="https://www.ndtv.com/world-news/a-third-of-global-tree-species-threatened-with-extinction-report-2526590">https://www.ndtv.com/world-news/a-third-of-global-tree-species-threatened-with-extinction-report-2526590</a>

news world A Third Of Global Tree Species Threatened With Extinction: Report

Well-known trees such as magnolias were among the most threatened (Representational)) Paris: Around a third of all the world's tree...

Long Covid Affects Up To 1 In 7 Children Months After Infection: Study

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The study was conducted by University College London and Public Health England. (File)
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London:
As many as 1 in 7 children may have symptoms linked to the coronavirus months after testing positive for COVID-19, the authors of an English study on long COVID in adolescents said on Wednesday.
Children rarely become severely ill with COVID-19 but they can suffer lingering symptoms, and the study is one of the largest of its kind on how common so-called long COVID is in the age group.
The study, led by University College London and Public Health England, found that 11- to 17-year-olds who tested positive for the virus were twice as likely to report three or more symptoms 15 weeks later than those who had tested negative.
Researchers surveyed 3,065 11- to 17-year-olds in England who had positive results in a PCR test between January and March, and a control group of 3,739 11- to 17-year-olds who tested negative over the same period.
Among those who tested positive, 14% reported three or more symptoms such as unusual tiredness or headaches 15 weeks later, compared with 7% reporting symptoms by that time among the control group.
The researchers said that while the findings suggested as many as 32,000 teenagers might have had multiple symptoms linked to COVID-19 after 15 weeks, the prevalence of long COVID in the age group was lower than some had feared last year.
"Overall, it's better than people would've guessed back in December," Professor Terence Stephenson of the UCL Great Ormond Street Institute of Child Health, told reporters.
The findings were a pre-print which had not been peer-reviewed. The authors said that any decision to extend vaccination to 12- to 15-year-olds in Britain was unlikely to be based on this study as there was not enough data on whether vaccination protects against long COVID.
"We are getting increasing evidence on the safety of the vaccine in the 12- to 15-year-olds and that's more likely to be taken into consideration," Liz Whittaker, a paediatrician at Imperial College London, told reporters.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
 
 
source <a href="https://www.ndtv.com/world-news/coronavirus-long-covid-affects-up-to-1-in-7-children-months-after-infection-study-2526531">https://www.ndtv.com/world-news/coronavirus-long-covid-affects-up-to-1-in-7-children-months-after-infection-study-2526531</a>

news world Long Covid Affects Up To 1 In 7 Children Months After Infection: Study

The study was conducted by University College London and Public Health England. (File) London: As many as 1 in 7 children may have symp...

"Only Tragedies, Only Losses": Vladimir Putin On US Exit From Afghanistan

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<div class="ins_instory_dv_cont"><img alt="'Only Tragedies, Only Losses': Vladimir Putin On US Exit From Afghanistan" src="https://c.ndtvimg.com/2021-08/bcmcsarg_putin_625x300_22_August_21.jpg" title="'Only Tragedies, Only Losses': Vladimir Putin On US Exit From Afghanistan" /></div>
Afghanistan: Russia has been cautiously optimistic about the new leadership in Kabul. (File)
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Moscow:
Russian President Vladimir Putin said Wednesday that the United States' 20-year campaign in Afghanistan ended in "only tragedies, only losses."
The Russian leader has a track record of criticising Western countries for trying to impose their values on non-Western nations.
Moscow has regularly slammed the US policy in Afghanistan, which is now controlled by the Taliban after their takeover this month ahead of the American pullout on August 31.
Putin said Wednesday that the US army tried to "engrain their norms" in war-ravaged Afghanistan for two decades, which he characterised as a futile exercise.
"The result is only tragedies, only losses for those that did it -- for the US -- and even more so for the people who live on Afghan territory," he said.
It is "impossible to impose anything from outside", he said.
He was speaking at a meeting with teenagers in the Russian far eastern city of Vladivostok to mark the start of the school year.
Last week, Putin said Russia would not interfere in Afghanistan and that Moscow had learned from the Soviet occupation of the country.
He has also complained about Western countries trying to place Afghan refugees in Moscow-allied Central Asian states.
Moscow has been cautiously optimistic about the new leadership in Kabul, saying it would not meddle in domestic affairs.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
 
 
source <a href="https://www.ndtv.com/world-news/vladimir-putin-says-us-presence-in-afghanistan-ended-in-tragedies-losses-2526037">https://www.ndtv.com/world-news/vladimir-putin-says-us-presence-in-afghanistan-ended-in-tragedies-losses-2526037</a>

news world "Only Tragedies, Only Losses": Vladimir Putin On US Exit From Afghanistan

Afghanistan: Russia has been cautiously optimistic about the new leadership in Kabul. (File) Moscow: Russian President Vladimir Putin s...