The Medicines and Healthcare products Regulatory Agency (MHRA) granted an extension to the existing UK approval of the COVID-19 jab Nuvaxovid (Novavax) to 12- to 17-year-olds.
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Novavax, Inc. announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has granted expanded conditional marketing authorization (CMA) for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17.
The expanded CMA was based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S., to evaluate the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid.
In the pediatric expansion, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.
Preliminary safety data from the pediatric 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.
Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise.
There was no increase in reactogenicity in younger (12 to <15 years old) adolescents compared to older (15 to <18 years old) adolescents. No new safety signal was observed through the placebo-controlled portion of the pediatric expansion.
The next step for the vaccine is a policy recommendation for use from the UK Joint Committee on Vaccination and Immunisation (JCVI). Doses of Nuvaxovid will be made available for use in adolescents based on the JCVI's recommendation.
In the 12 through 17 year-old population, the Novavax COVID-19 vaccine has been granted authorization in the U.S., India, the European Union, Australia, Japan, Thailand, and New Zealand, and is actively under review in other markets.
The MHRA previously granted CMA for Nuvaxovid in adults aged 18 and older in February 2022. The vaccine is given as a primary vaccination in two doses administered 21 days apart. Novavax filed for expanded CMA for use as a booster in adults aged 18 and over in June 2022.
Nuvaxovid (NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
Nuvaxovid contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Nuvaxovid is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart.
The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations. ■