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GAITHERSBURG, Md. , Nov. 9, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company committed to the advancement and commercialization of next-generation vaccines for serious infectious diseases, announced that drugs and fitness products The regulatory firm (MHRA) of the United Kingdom (UK) has extended the conditional marketing authorization (MAC)i for the Nuvaxovid™ (NVX-CoV2373) COVID-19▼ vaccine as a dose of homologous and heterologous booster after the number one series of Nuvaxovid (six months) or mRNA vaccine or adenoviral vector for active immunization to save you from coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults over 18 years of age.
“Our protein-based vaccine, which evolved from cutting-edge technique to classical technology, can play a leading role in stimulating COVID-19,” said Stanley C. Erck, president and chief executive officer of Novavax. “As we continue to explore most productive practices for long-term COVID-19 management, we have ongoing trials further exploring the immunogenicity of Nuvaxovid as a booster dose. The clinical and preclinical knowledge currently available implies that our vaccine induces physically powerful immune responses opposed to Omicron variants, adding BA. 4/5. “
The MHRA resolution was based on knowledge from the Novavax phase 2 trial conducted in the US. The U. S. and Australia (1283 participants), a separate phase 2 trial conducted in South Africa (4404 participants), and the UK-sponsored VOC-BOOST trial (2878 participants). 1,2 In phase 2 trials, a booster dose of Nuvaxovid was administered to single individuals to healthy adult participants approximately six months after their first two-dose series of Nuvaxovid. 1,2 The third dose produced opposite responses to the original ancestral strain of SARS-CoV. -2 comparable or higher grades related to coverage in phase 3 clinical trials. 1,2 In the VOC-BOOST trial, the highest antibody titers of Nuvaxovid when used as a third heterologous booster dose following a two-dose number one vaccination of mRNA or adenoviral vaccine vector. 2
In Novavax-sponsored trials, after withdrawal, local and systemic reactions had a median duration of approximately two days. 1,2 Adverse reactions were mild to moderate in severity. 1,2 Safety reports of reactogenicity occasions showed an increased occurrence of all 3 doses. Medically assisted adverse occasions (AEs), potentially immune-mediated medical conditions, and severe AEs occurred infrequently after the booster dose and were balanced between the vaccine and placebo groups. 1,2
Nuvaxovid is also available for withdrawal use in adults 18 years of age and older in the United States, the European Union, Japan, Australia, New Zealand, Switzerland, and Israel. In addition, several countries have policy recommendations that allow the vaccine to be used as a heterologous or homologous booster dose.
The MHRA in the past awarded a MAC for Nuvaxovid as the number one series in adults 18 and older in February 2022, and in adolescents aged 12-17 years and older in August 2022.
▼This medicine is subject to additional monitoring. This will allow new security data to be temporarily identified. If you are involved in an adverse event, report it on a yellow card. Bureaucracy and reporting data can be discovered on https://coronavirus-yellowcard. mhra. gov. uk/ or search for the MHRA yellow card on Google Play or Apple App Store. When reporting, include the vaccine logo and batch number if available.
Important protection information: United Kingdom
To learn more about Nuvaxovid, add the summary of product characteristics with the package leaflet, instructions for reporting adverse events, or request more information, please visit the following websites:
Nuvaxovid is packaged as a ready-to-use liquid formula in a vial containing ten doses. The vaccination schedule consists of two doses of 0. 5 ml (5 mcg antigen and 50 mcg Matrix-M adjuvant) administered intramuscularly 21 days apart. stored between 2° and 8° Celsius, allowing the use of existing vaccine source channels and bloodless chain. The use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, marketing and distribution of Nuvaxovid worldwide. The existing approvals leverage Novavax’s production partnership with the Serum Institute of India, the world’s largest vaccine manufacturer by volume. Subsequently, they will be complemented by knowledge of other Novavax global production sites. Source Chain
PREVENT-19 (the Novavax PRE|COVID-19 Fusion Protein Subunit Vaccine Efficacy Trial) is a 2:1 observer-blind, placebo-controlled, randomized trial to assess efficacy, protection, and safety. Immunogenicity of the Novavax COVID-19 vaccine with the adjuvant Matrix-M in 29,960 participants older than 18 years at 119 sites in the United States and Mexico. The number one PREVENT-19 endpoint was the first occurrence of symptomatic PCR-confirmed COVID-19 (mild, moderate, or severe) with onset at least seven days post-dose at the time in adult participants who were serologically negative (a SARS-CoV). -2) at the beginning of the study. The statistical criterion of good fortune included a decrease limit of 95% CI >30%. A momentary endpoint was prevention of moderate or severe symptomatic COVID-19 confirmed by PCR. Both parameters were evaluated at least seven days after the time of examining vaccination in volunteers who had not been infected with SARS-CoV-2 in the past. In the trial, the Novavax COVID-19 vaccine achieved an overall efficacy of 90. 4%. It was well tolerated and elicited a physically powerful antibody reaction after the point dose in any of the studies. The full effects of the trial have been published in the New England Journal of Medicine (NEJM).
The pediatric extension of PREVENT-19 is a randomized, 2:1, placebo-controlled, blinded, observer-controlled trial to compare the safety, efficacy, and efficacy of the Novavax COVID-19 vaccine with the Matrix-M adjuvant in 2247 adolescent participants aged 12 to 17 years at 73 sites in the United States, compared with placebo. In the pediatric trial, the vaccine met its number one efficacy endpoint (non-inferiority of neutralizing antibody reaction compared to young adults 18 to 25 years of age of PREVENT-19) and demonstrated 80% overall efficacy at a time when Delta variant, the main strain circulating in the United States, of concern. In addition, immune reactions were two to three times higher in adolescents than in adults unlike all variants studied.
In addition, a UK trial of 14,039 participants aged 18 years and older, designed as a randomised, placebo-controlled, observer-blind study, achieved an overall efficacy of 89. 7%. onset of symptomatic COVID-19 (mild, moderate, or severe) with onset at least seven days after vaccination was examined in serologically negative adult participants (SARS-CoV-2) at baseline negative. The full effects of the trial were published in NEJM.
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References
SOURCE Novavax, Inc.