UK MHRA Approves Novavax COVID-19 for Ages 12-17

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has given expanded conditional marketing authorization (CMA) to use the Novavax COVID-19 vaccine in people ages 12-17. The decision was made based on data from the PREVENT-19 phase 3 trial. Early data showed that it had an 80% clinical efficacy during the US’s delta wave.

According to Emily Kimber, “Preliminary safety data from the paediatric expansion showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine, the company reported.”

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(Source: PM Live, August 31, 2022)