EU regulator OKs Moderna vaccine for teens

Data showed the Moderna jab produced a comparable antibody response in 12- to 17-year-olds as it did in young adults.

EU regulator OKs Moderna vaccine for teens

The European Medicines Agency has approved the Moderna vaccine for children ages 12 and over, making it the second vaccine green-lit for teens in the EU after BioNTech/Pfizer’s jab in May, the regulator announced Friday.

Previously, Moderna was authorized for use in people aged 18 and above. The recommendation Friday came from the EMA’s human medicines committee, which found that the vaccine could be used in the same way as it was in adults. The recommendation will still need to be formally accepted by the European Commission.

The ongoing study that informed the recommendation found that the Moderna jab produced a comparable antibody response in 12- to 17-year-olds as it did in young adults. None of the 2,163 children receiving the vaccine developed COVID-19, whereas four children in the control group contracted the virus. The committee concluded that the efficacy of the vaccine was similar to that seen in adults. 

Children experienced similar side effects to adults, such as pain in the site of the injection, tiredness and headache. 

The committee found that the benefits of Moderna in children outweighed the risk, “in particular in those with conditions that increase the risk of severe COVID-19.”

The authorization means that countries will need to decide whether to offer Moderna to their teens. While many European countries are offering BioNTech/Pfizer to children who meet the age requirement, experts advising the governments in Germany and the U.K. have recommended the jab only for those with comorbidities. 

Source : Politico EU More   

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US warns Poland over broadcaster spat

Amendments to Polish media law would restrict ownership of foreign companies.

US warns Poland over broadcaster spat

Future American investment could be in jeopardy if Poland refuses to renew the license of a U.S.-owned broadcaster, Washington warned Warsaw.

Poland’s ruling coalition, led by the Law and Justice (PiS) party, has proposed a media bill that would see licenses granted only to broadcasters that aren’t majority-owned by entities from outside the European Economic Area. Critics warn the law is an attempt to void the license of TVN24, a television station owned by Discovery of the U.S. that is often critical of the government and which is seeking to renew its broadcast permit before it expires in September.

Speaking to TVN24 on Thursday, U.S. State Department Counselor Derek Chollet said: “This is a very significant American investment here in Poland. And there will be knock-on effects perhaps, if the [TVN24] license is not renewed, to future U.S. investments.”

Poland plunged in the 2021 World Press Freedom Index, compiled by the NGO Reporters Without Borders, falling to 64th position out of 180 countries, down from 18th place in 2015.

Source : Politico EU More   

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