Nuvaxovid, also known as NVX-CoV2373, is the first protein-based COVID-19 vaccine authorized for use in
urope.
Local test and release procedures were completed and Nuvaxovid doses are shipping from Novavax' Netherlands distribution center to EU member states beginning this week.
The first wave of shipments includes several countries, such as Germany, France and Austria. Shipments to additional EU member states are expected to quickly follow.
The European Commission (EC) granted conditional marketing authorization (CMA) for Nuvaxovid for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The authorization followed the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation to authorize the vaccine and is applicable in all 27 EU member states.
Novavax expects to submit its regulatory filing for a pediatric indication in adolescents aged 12 through 17-years to global regulatory authorities, including EMA, during the first quarter of 2022.
Novavax and the EC have an advance purchase agreement for up to 100 million doses of Nuvaxovid with the option for an additional 100 million doses (up to 200 million doses total). Through the second quarter, Novavax has received a commitment for orders from the EC totaling 69 million doses.
The initial doses were manufactured by Novavax' partner, the Serum Institute of India, the world's largest vaccine manufacturer by volume. Information about dose administration will be available through each member state.
The brand name Nuvaxovid has not yet been authorized for use in the U.S. by the FDA.
Nuvaxovid is contraindicated in persons who have a hypersensitivity to the active substance or to any of the
xcipients
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.
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress–related reactions may occur in association with vaccination as a 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.
In individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) bleeding or bruising may occur following an intramuscular administration in these individuals. The efficacy of Nuvaxovid may be lower in immunosuppressed individuals.
The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical
rials.
Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients.
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
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. NVX-CoV2373 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. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
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. ■