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Sunday, December 04, 2022

Novavax asks EU regulator to approve COVID vaccine for teens

LONDON ( Associated Press) —

Pharmaceutical developer Novavax says it has asked the European Medicines Agency to expand the authorization of its coronavirus vaccine to children aged 12 to 17, amid a rise in the disease across the continent.

In a statement on Thursday, Novavax said its request is based on research data from more than 2,200 adolescents aged 12 to 17 years in the US that found its vaccine to be about 80% effective against COVID-19. The study was done when the delta variant was the dominant virus in the US. The main side effects reported were injection site pain, headache, and fatigue.

The EU drug regulator gave the green light to Novavax’s two-dose COVID-19 vaccine for adults in December; The shot has also been approved by Indonesia, Australia and the World Health Organization, among others. The EMA has previously provided OK’d vaccines made by Pfizer-BioNtech and Moderna for use in children from age 6 onwards.

The Novavax vaccine relies on an age-old technology that has been used for years to create shots for diseases such as influenza and pertussis. Maryland-based Novavax drugmaker uses genetic engineering to grow harmless copies of the coronavirus spike protein in insect cells. Scientists then extract and purify the proteins and then mix in an immune-boosting chemical.

Novavax has repeatedly run into production problems and has relied primarily on other factories to make its vaccine. It has delayed the delivery of its shots to several countries in Europe and has not shared a single vaccine with a UN-backed effort to distribute shots to poor countries, despite a pledge to provide 250 million doses of COVAX.

According to the European Center for Disease Prevention and Control, more than half of adolescents in the European Union have not yet been fully vaccinated against COVID-19. Several countries on the continent have recently seen a surge in coronavirus cases due to the spread of the highly infectious Omicron subvariant BA.2 and the relaxation of almost all COVID-19 protocols.

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