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EMA committee recommends expanded conditional marketing approval for Novavax Covid-19 vaccine, Nuvaxovid for adolescents aged 12 through 17

Gaithersburg, Maryland
Saturday, June 25, 2022, 16:00 Hrs  [IST]

Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that the Nuvaxovid (NVX-CoV2373) Covid-19 vaccine has been recommended for expanded conditional marketing authorization (CMA) in the European Union (EU) for adolescents aged 12 through 17.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its opinion on results from the phase 3 PREVENT-19 clinical trial.

"This recommendation brings us closer to offering adolescents in the EU the first protein-based Covid-19 vaccine developed using an innovative approach to traditional technology," said Stanley C. Erck, president and chief executive officer, Novavax.

The CHMP recommendation was based on data from the ongoing paediatric expansion of PREVENT-19, a pivotal phase 3 trial of 2,247 adolescents aged 12 through 17 across 73 sites in the US, to evaluate the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid. In the trial, 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 US.

Preliminary safety data from the trial 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. Fever was seen more frequently in adolescents than in adults. These effects are usually mild or moderate and improve within a few days from the vaccination.

The European Commission (EC) granted CMA for Nuvaxovid to prevent Covid-19 in people 18 years of age and over in December 2021.

In the 12 through 17 year-old population, emergency use authorization has been granted in India.

The Novavax Covid-19 vaccine (NVX-CoV2373) has not yet been authorized for use in the US and the trade name Nuvaxovid has not yet been approved by the US Food and Drug Administration.

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' ™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause Covid-19.

The Novavax Covid-19 vaccine 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.

Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India, the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.

NVX-CoV2373 continues being evaluated in two pivotal phase 3 trials.

PREVENT-19 (the?PRE-fusion protein subunit?Vaccine?Efficacy?Novavax?Trial | covid-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M adjuvant in 29,960 participants 18 years of age and over in 119 locations in?the US?and?Mexico. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) Covid-19 with onset at least seven days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe Covid-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. In the trial, NVX-CoV2373 achieved 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies.

Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

 

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