The conclusion reached by the Medicines and Healthcare products Regulatory Agency is that Nuvaxovid is both secure and efficient for this age range.
Today, the Novavax COVID-19 vaccine, Nuvaxovid, received an extension of its current UK clearance for 12- to 17-year-olds. The Medicines and Healthcare products Regulatory Agency has approved this extension (MHRA).
The Commission for Human Medicines, the government’s independent scientific advisory agency, provided expert recommendations after reviewing the vaccine’s quality, efficacy, and safety in this age range.
MHRA Chief Executive Dr. June Raine said:
I’m happy to inform that Nuvaxovid has now been approved for use in children aged 12- to 17 as a result of our examination of the vaccine’s quality, efficacy, and safety in this age range. We consulted the independent scientific advisory body of the government, the Commission on Human Medicines, before making our choice.
The MHRA accepted the Conditional Marketing Authorization (CMA) extension via the European Commission (EC) Decision Reliance Route, which is exclusively effective in Great Britain. This is the case when the company’s marketing authorization application makes reference to the EMA’s Committee for Medicinal Products for Human Use judgment (CHMP).
In Northern Ireland, Nuvaxovid is approved for use in children aged 12 to 17 years under the CMA extension given by the European Medicines Agency on July 1, 2022.
Editor’s Notes
On February 3, 2022, the MHRA approved the use of Nuvaxovid for persons who were 18 years of age and older.
Nuvaxovid has not been used in the UK’s COVID-19 immunization program as of August 26, 2022. Whose vaccinations are administered and which age groups are given a vaccination are decided by the Joint Committee on Vaccination and Immunization (JCVI).
All medications and medical equipment in the UK are governed by the Medicines and Healthcare products Regulatory Agency. To guarantee that the benefits outweigh any dangers, every effort is supported by solid, fact-based judgments. The Department of Health and Social Care’s executive arm is the MHRA.
Ministers and the MHRA are advised on the security, effectiveness, and quality of pharmaceutical goods by the Commission on Human Medicines (CHM). The Department of Health and Social Care sponsors the CHM, a non-departmental public advisory organization.
The product information has further details.