Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, is proud to announce that its partner SK bioscience has received expanded approval from the Korean Ministry of Food and Drug Safety (KMFDS) for Nuvaxovid™ (NVX-CoV2373) as a booster to protect adults aged 18 and older from COVID-19. This decision follows the recommendation of the Korean Centers for Disease Control and Prevention in September 2022 that Nuvaxovid could be used as a booster in adults aged 18 and older.
We are thrilled to partner with SK bioscience to make our highly-effective protein-based vaccine, Nuvaxovid, available as a booster for adults regardless of their previous vaccine history. This is a monumental step in ensuring that everyone has access to a wide range of vaccine options that could protect them from disease.
Novavax’s Nuvaxovid vaccine has been approved for use following a series of successful trials conducted in the United States, Australia, South Africa, and the United Kingdom. Results showed that a single booster dose of Nuvaxovid, administered six months after the initial two-dose vaccination, produced immune responses on par with or exceeding those seen in Phase 3 clinical trials. Additionally, the COV-BOOST trial demonstrated a significant antibody response when Nuvaxovid was used as a booster dose after other authorized COVID-19 vaccines. With this approval, Nuvaxovid has proven to be a safe and effective vaccine for protecting against the virus.
Following administration of the booster dose of Novavax’s Nuvaxovid vaccine, local and systemic reactions had a median duration of just two days, with a low incidence of Grade 3 or higher events. Reactogenicity events increased in frequency after each dose, but medically attended adverse events, immune-mediated medical conditions, and severe adverse events were rare, and the same across both vaccine and placebo recipients.
Novavax’s COVID-19 vaccine has rapidly become a global success story, with authorization for use as an adult booster in over 35 countries and further recommendations allowing its use in other countries. As trials continue to explore its efficacy and safety as a booster, the vaccine is set to become an integral part of the fight against the virus worldwide.
In January 2022, the Korean Food and Drug Safety Ministry (KFMDS) gave their approval for Nuvaxovid to be used as a primary series in adults aged 18 and older. Following this, SK Bioscience signed a licensing agreement with Novavax to manufacture the drug substance and drug product of Nuvaxovid for use in the country. Finally, in August 2022, the KFMDS approved the use of Nuvaxovid for adolescents aged 12 through 17 as a primary series.
Trade Name in the U.S.
The U.S. Food and Drug Administration (FDA) has yet to give its approval to the trade name Nuvaxovid™.
Important Safety Information: South Korea
Nuvaxovid should not be used by those with an allergic reaction to its active ingredient or any of its inactive ingredients. Those with a known hypersensitivity must avoid this medication to prevent any adverse reactions.
Be aware that anaphylaxis has been reported as a side effect of receiving COVID-19 vaccines. If an anaphylactic reaction occurs after vaccination, medical attention and supervision are essential. To ensure safety, it is recommended that individuals be monitored for at least 15 minutes after the vaccine is administered. Those who experience anaphylaxis after receiving the first dose of Nuvaxovid should not receive a second dose.
Vaccination can be a nerve-wracking experience for some people, leading to anxiety-related reactions such as vasovagal reactions (syncope), hyperventilation, or stress-related reactions. To avoid injury from fainting, it’s essential to take the necessary precautions.
When it comes to vaccinations, it’s important to remember that those who are suffering from an acute severe febrile illness or acute infection should delay getting their shot. However, having a minor infection or low-grade fever should not delay vaccination.
Nuvaxovid should be used with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia). In these cases, intramuscular administration may lead to the risk of bleeding or bruising, so extra care must be taken.
The efficacy of Nuvaxovid may be diminished in individuals whose immune systems are compromised, making it even more important for those with weakened immune systems to take extra precautions when using this medication.
Considering Nuvaxovid in pregnancy should be approached with caution, as the potential benefits must be carefully weighed against the potential risks for both mother and baby.
The temporary effects of Nuvaxovid may cause a disruption in your ability to drive or operate machinery. Be sure to take extra precautions when engaging in activities that require alertness and attention.
After receiving two doses of Nuvaxovid, individuals may not be fully protected for up to seven days. However, this vaccine is still a great way to help protect yourself and those around you, as it has proven to be effective in providing protection to many of those who have received it.
Patients reported a range of side effects during clinical studies, such as headaches, nausea, muscle or joint pain, tenderness or pain at the injection site, fatigue, and malaise.