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| Moderna's Covid-19 jab given green light by EU drugs regulator for use in adolescents | Moderna's Covid-19 jab given green light by EU drugs regulator for use in adolescents |
| (about 1 month later) | |
| The EU's medicines regulator has given its backing for Moderna's Covid-19 vaccine to be administered to minors aged between 12 and 17, citing positive results in trials involving 3,732 participants. | The EU's medicines regulator has given its backing for Moderna's Covid-19 vaccine to be administered to minors aged between 12 and 17, citing positive results in trials involving 3,732 participants. |
| In a statement on Friday, the European Medicines Agency (EMA) gave its recommendation for the Spikevax Covid-19 shot to be administered to adolescents aged 12-17. The Moderna vaccine, which is taken in a two-shot-regimen, is now the second Covid-19 jab which has been approved by the agency for use in those under the age of 18. | In a statement on Friday, the European Medicines Agency (EMA) gave its recommendation for the Spikevax Covid-19 shot to be administered to adolescents aged 12-17. The Moderna vaccine, which is taken in a two-shot-regimen, is now the second Covid-19 jab which has been approved by the agency for use in those under the age of 18. |
| In its statement, the EMA recommended that the administration of the vaccine to adolescents should be the same as for those over the age of 18. Citing a trial which incorporated 3,732 children, the body said that the antibody response in adolescents appeared similar to that of 18-25-year-olds. | In its statement, the EMA recommended that the administration of the vaccine to adolescents should be the same as for those over the age of 18. Citing a trial which incorporated 3,732 children, the body said that the antibody response in adolescents appeared similar to that of 18-25-year-olds. |
| The trial suggests that adolescents are prone to the usual, most common side-effects to the jab, including pain at the injection site, tiredness, headache, muscle and joint pain, as well as nausea, vomiting and fever. "These effects are usually mild or moderate and improve within a few days from the vaccination," the EMA said. | The trial suggests that adolescents are prone to the usual, most common side-effects to the jab, including pain at the injection site, tiredness, headache, muscle and joint pain, as well as nausea, vomiting and fever. "These effects are usually mild or moderate and improve within a few days from the vaccination," the EMA said. |
| The agency added that it understands the trial size was not large enough to isolate new uncommon side effects, or the risk associated with known side effects such as myocarditis (inflammation of the heart muscle). | The agency added that it understands the trial size was not large enough to isolate new uncommon side effects, or the risk associated with known side effects such as myocarditis (inflammation of the heart muscle). |
| The agency's statement on Friday noted that it will continue to evaluate the vaccine's safety and effectiveness as it is administered, and beyond. | The agency's statement on Friday noted that it will continue to evaluate the vaccine's safety and effectiveness as it is administered, and beyond. |
| Prior to Friday's backing, the Pfizer vaccine was the only Covid-19 jab approved by the EMA for use on minors. | Prior to Friday's backing, the Pfizer vaccine was the only Covid-19 jab approved by the EMA for use on minors. |
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