Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorization (CMA) for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older in Great Britain. The vaccine, also known as NVX-CoV2373, is the first protein-based vaccine to be authorized for use in Great Britain.
"We are proud that Nuvaxovid will be the first protein-based vaccine option authorized by MHRA as the United Kingdom tackles this next phase of the pandemic," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We thank the agency for its thorough review process and are tremendously grateful to the clinical trial participants and trial sites in the U.K., as well as the Vaccines Taskforce, for their ongoing support and vital contributions to this program."
The MHRA decision was based on the totality of preclinical, clinical, and chemistry, manufacturing and controls (CMC) data reviewed by the agency. This includes two pivotal ongoing Phase 3 clinical trials: PREVENT-19 which enrolled approximately 30,000 participants in the U.S. and Mexico, the results of which were published in the New England Journal of Medicine (NEJM)i; and a trial with almost 15,000 participants in the U.K., the results of which were also published in NEJMii. In both trials, the vaccine demonstrated efficacy with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed. The vaccine is stored at 2° - 8° Celsius and has a current assigned shelf life in Great Britain of 9 months.
Novavax previously announced an agreement with the U.K. Vaccines Taskforce for up to 60 million doses of Novavax' COVID-19 vaccine.
For more information on Nuvaxovid, including a full listing of where it has been authorized for use, please visit the following websites:
MHRA Regulatory approval of COVID-19 vaccine Nuvaxovid
Novavax global authorization website
The brand name Nuvaxovid™ has not yet been authorized for use in the U.S. by the FDA.
Conditional Marketing Authorization of Nuvaxovid™ in Great Britain
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorization for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
Important Safety Information
Nuvaxovid is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients.
Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Nuvaxovid.
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress–related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. M...
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