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Pfizer seeks US approval of Covid vaccine for children under 5

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FDA said it will hold a meeting in two weeks, on February 15, to consider the request. "Having a safe and effective vaccine available for children in this age group is a priority for the agency," said interim FDA head Janet Woodcock, who added that the FDA asked for the application "in light of the recent Omicron surge." The companies are seeking authorization for only two doses of their vaccine, but believe a third will be needed "to achieve high levels of protection against current and potential future variants," Pfizer CEO Albert Bourla said in a statement. "If two doses are authorized, parents will have the opportunity to begin a Covid-19 vaccination series for their children while awaiting potential authorization of a third dose," he added.

To limit side effects for this young age group, Pfizer chose to significantly decrease the dosage of its vaccine, opting for only three micrograms per jab versus 30 for those over 12 years old, and 10 for ages five to 11.

The company's researchers concluded last fall that low doses of the vaccine provided protection in children up to two years old but not in those aged two to five, and announced in December they would add a third dose to their trials.

Data on the three-dose regimen is "expected in the coming months and will be submitted to the FDA to support a potential expansion" of this initial request, Pfizer and BioNTech said in the statement.

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Authorities in Germany this week seized a lavish $600 million yacht belonging to a Russian oligarch, according to reports.The Dilbar, a 512-foot vessel belonging to billionaire Alisher Usmanov, was taken over by authorities while it was being refitted in a German shipyard, Forbes reported.The business magazine learned about the move Wednesday, just two days after Usmanov was sanctioned by the European Union as part of its response to Russia’s invasion of Ukraine, the report said.The EU has accused Usmanov of being a close ally of Russian President Vladimir Putin and a supporter of Russia’s 2014 invasion of Crimea, the Washington Examiner reported.Usmanov on Tuesday confirmed that financial actions had been taken against him."On 28 February 2022 I became the target of restrictive measures imposed by the European Union I believe that such decision is unfair, and the reasons employed to justify the sanctions are a set of false and defamatory allegations damaging my honor, dignity, and business reputation," he wrote Tuesday.The statement was posted on the website of the International Fencing Federation, where the former professional fencer served as president since 2008 until stepping down Monday, the Examiner reported.The Dilbar had been undergoing work at a shipyard in Hamburg, Germany, since October, according to Forbes. Employees of Blohm+Voss, the shipbuilding firm overseeing the project, were not at work Wednesday, the report said.German shipbuilder Lurssen, which built the Dilbar, claims it’s the world’s largest motor yacht by gross tonnage, weighing nearly 16,000 tons, according to Forbes.When operating, the ship has a crew of 96 people.
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