Novavax COVID vaccine now for emergency use in Thailand
GAITHERSBURG, Md., and PUNE, India, April 10, 2022 — Novavax, Inc. (Nasdaq: NVAX) and Serum Institute of India Pvt. Ltd. are granted emergency use authorization by the Thai FDA for Novavax’ protein-based vaccine.
The vaccine is for active immunization to prevent COVID-19 caused by the SARS-CoV-2 in individuals 18 years of age and older. The vaccine, also known as NVX-CoV2373, is manufactured and marketed by SII under the brand name Covovax.
“Novavax looks forward to delivery of the first protein-based COVID-19 vaccine option for the people of Thailand,” says Stanley C. Erck, President and Chief Executive Officer, Novavax.
“We remain committed to helping fight the global pandemic by offering an additional vaccination option built on a well-understood platform used in other vaccines for decades.”
Clinical trial data
The Thai FDA decision was based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the U.S. and Mexico and was published in the New England Journal of Medicine (NEJM); and a trial with almost 15,000 adult participants in the U.K. which was also published in NEJM. In both trials, the vaccine demonstrated efficacy and a reassuring safety and tolerability 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. NVX-CoV2373 will continue to be analyzed using real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.
Covovax
Covovax has received Emergency Use Listing (EUL) from the World Health Organization, as well as EUA in India, Indonesia, the Philippines, and Bangladesh. It is also authorized for use in adolescents aged ≥12 to <18 years in India. For additional information on Covovax, please visit the following websites:
Novavax in Thailand
The Thai FDA has issued Emergency Use Authorization for Covovax/Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg to induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years old and above.
Authorization in the U.S.
NVX-CoV2373 has not yet been authorized for use in the U.S. by the U.S. FDA.
Important Safety Information
- NVX-CoV2373 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. Close observation for at least 15 minutes is recommended and a second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of NVX-CoV2373.
- 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. The presence of a minor infection and/or low-grade fever should not delay vaccination.
- NVX-CoV2373 should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
- The efficacy of NVX-CoV2373 may be lower in immunosuppressed individuals.
- Administration of NVX-CoV2373 in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
- The effects with NVX-CoV2373 may temporarily affect the ability to drive or use machines.
- Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with NVX-CoV2373 may not protect all vaccine recipients.
- The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. /PRNewswire/