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Paraguay's Almiron sent off under new FIFA 'mouth-covering' rule
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Ancelotti hails 'complete game' as Brazil sink Haiti at World Cup
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Tunisia ask how Sweden World Cup star Ayari slipped its net
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Scotland remain bullish despite Morocco World Cup setback
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USA down Australia to reach World Cup knockout rounds, Brazil swat Haiti
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Brazil cruise past Haiti to re-ignite World Cup campaign
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Australia detects first case of contagious H5 bird flu
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Scheffler career Slam chances blowing in Shinnecock winds
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Iran's treatment at World Cup 'a dark point' for football: official
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McIlroy seven back but likes his chances at US Open
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Nagelsmann eyes same German lineup against I. Coast after Curacao trouncing
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Clark leads US Open by four with major champs in the hunt
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Saibari early strike gives Morocco World Cup win over Scotland
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Archaeologists discover 'never before seen' pre-Hispanic ruins in Mexico
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Pochettino backs 'high IQ' players to block out World Cup hype
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James Burrows, prolific innovator in US TV comedies, dead at 85
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Douglass breaks 50m free world record at Indy Pro Swim
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World Cup warning with Sweden star Isak 'getting stronger and stronger'
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'Like China': Cubans welcome reforms but exiles remain skeptical
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Tunisia coach says 'I am no wizard' after World Cup SOS call
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USA down Australia to reach World Cup knockout rounds
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USA beat Australia 2-0 to reach World Cup knockouts
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Imperious Dupont guides record-breaking Toulouse to Top 14 final
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Qatar-gifted Air Force One replacement unveiled
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Venezuelan opposition figure heads to US after transition talks
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Niemann fires 65 at US Open after upsetting two-shot penalty
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Canada star Kone to miss rest of World Cup after surgery: team
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Spain's Yamal says 'too soon' to play full match at World Cup
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Confident Fitzpatrick makes a run at another US Open title
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Neymar? He is working remotely at the World Cup, jokes Lula
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England captain Stokes strikes for Durham as Test recall looms
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Three-time Stanley Cup champion Toews retires
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Clark wants to win back fans as well as US Open title
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Japan wary of fired up and wounded Tunisia for World Cup landmark game
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Clark leads as fellow major winners charge at US Open
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'Like a fridge': France cave homes offer lucky few respite from heat
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Ton-up Nicholls turns the screw for New Zealand against England
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Hormuz ship traffic climbs after war deal: trackers
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Sun shines on jockey Lee at Royal Ascot
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Kane hails World Cup 'Wonderwall' singalong as England highlight
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Sabalenka roars back to make Berlin WTA semis
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Europe swelters as more heat records set to tumble
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Narvaez takes Swiss Tour third stage after 100km breakaway
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'There's no soul': Tony Leung weighs in on AI in filmmaking
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Europe swelters as temperature records tumble
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From Versailles to a Swiss mountain: a week of dizzying Iran diplomacy
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French mountain lodges worry over strained water supply
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Coach tells S. Korea to move on fast with World Cup knockouts in reach
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Heatwave hits more than one in two people in France
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Henry strikes as New Zealand strengthen grip against England
Moderna says infant Covid vaccine succeeded in trial
US biotech firm Moderna on Wednesday said it was pursuing regulatory approval for its Covid vaccine in children aged six months to six years after the two-shot regimen was found to be safe and produced a strong immune response.
Specifically, two doses of 25 micrograms given to this age group generated similar levels of antibodies to two doses of 100 micrograms given to young people aged 18-25, indicating there would be similar levels of protection.
Based on the data, Moderna said it would submit authorization requests to the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulators in the coming weeks.
The results "are good news for parents of children under six years of age," said CEO Stephane Bancel in a statement.
"We now have clinical data on the performance of our vaccine from infants six months of age through older adults."
The company did however find relatively low vaccine efficacy against infection, with its trial taking place during the Omicron wave.
Vaccine efficacy in children six months to two years was 43.7 percent, and vaccine efficacy was 37.5 percent in the two to under six years age group.
Moderna said this was consistent with what had been observed among adults and the company was evaluating a third dose to lift efficacy levels.
The trial comprised 11,700 pediatric volunteers in the United States and Canada, including 4,200 aged two to six years and 2,500 aged six to two months.
The company added that, after consulting with the FDA, it is also applying to be authorized among children six to 11 for two-doses of 50 micrograms, and updating its application for authorization in kids aged 12 through 17.
The EMA and other regulators have already authorized the Moderna vaccine in these age groups.
Last month, the FDA postponed a meeting of a panel to consider the Pfizer-BioNTech Covid vaccine for children younger than five, saying it required additional data on third doses. The companies said they expected that data to be ready by April.
X.Matos--PC