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Drones hit Moscow as Russians go to the polls
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Myanmar win first Asian Games teqball gold as Spain great Puyol watches
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New England boss Fleming says 'wrong' to ask Stokes to end retirement
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China's 13-year-old Yu scorches to first major gold at Asian Games
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Germans vote in elections threatening fresh blow to Merz
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Russians vote on last day of parliamentary elections
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US fears rapid escalation in Mideast after Houthis attack Riyadh
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Hong Kong pays final respects to former city leader Tung
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Japan triathlete Hojo wins first gold of Asian Games
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China's 13-year-old Yu cruises as Asian Games swimming begins
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AI 'warning shots' focus Beijing on national security risks
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Leo XIV, first US pope transcends his restrained style
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Republicans find transgender issues a powerful political weapon in midterm campaigning
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In 'Tenzing', a Sherpa mountaineer gets his due
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German state elections threaten new shock waves for Merz
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Ed Sheeran set to return to stage after Palestinian controversy
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Chile's Bachelet quits race to be next UN chief
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Toulouse edge Vannes, Lyon beat Pau to take Top 14 summit
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Raphinha treble fires perfect Barca to win at Sevilla
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Germans arrested for Louvre stunt in Mona Lisa hall
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Thiam makes winning heptathlon return at Decastar meet
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Saudi-led coalition says Houthis fired ballistic missile at Riyadh
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Czechs beat USA to qualify for Davis Cup finals
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France's debt climbs to highest since 1978: ministry
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Dortmund sink Stuttgart to climb to Bundesliga summit
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McIlroy two shots off the lead at Wentworth after eagle on 18
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Trump says will not tolerate attempts to slow AI growth
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Martinez brace saves Inter in Serie A top-two clash with Roma
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'It has to stop': runners protest women's murders in S.Africa district
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Rosenior abused but guides Paris FC past old club Strasbourg
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Fire erupts near Riyadh airport as Houthis claim strikes
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Seven-try Lyon beat Pau, climb to Top 14 summit
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Cuba works to restore power after another blackout
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Brighton defeat a 'big lesson' against complacency for Arsenal, says Arteta
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England thrash Sri Lanka again to return to top of T20 rankings
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Thousands protest inaction over climate crisis in Switzerland
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Arsenal thrashed by Brighton, sorry Spurs lose again
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Carapaz out of cycling world championships
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South Korea, Austria qualify for Davis Cup finals
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'Fragile' Tottenham beaten by Aston Villa despite late rally
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Seare shocks Ingebrigtsen to win world 5km gold
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Mourinho hails Real Madrid grit before Atletico derby clash
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