EU Approves Novavax COVID-19 Vaccine... "Omicron-Specific Vaccine to Be Produced Starting Next Year"

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] The European Union (EU) has approved the conditional sale of the COVID-19 vaccine developed by the U.S. pharmaceutical company Novavax. This marks the fifth vaccine approval within the EU and is seen as a response to the recent spread of the Omicron variant. However, Novavax has stated that it will be able to produce vaccines targeting the Omicron variant starting next year, so actual vaccinations are expected to begin in the first quarter of next year.

According to foreign media including the Associated Press on the 20th (local time), Ursula von der Leyen, President of the European Commission, posted on Twitter that "the use of the Novavax vaccine has been approved," adding, "With the approval of five vaccines, our portfolio has become more diverse. Vaccination and booster shots are the best protection against COVID-19."

Earlier, the European Medicines Agency (EMA) recommended approval for the use of this vaccine for the prevention of COVID-19 in individuals aged 18 and older during an expert meeting held that day. The Committee for Medicinal Products for Human Use (CHMP) under the EMA evaluated that the data on the Novavax vaccine is robust and meets the EU standards in terms of efficacy, safety, and quality.

According to the EMA, clinical trials involving 45,000 participants conducted in the United States, Mexico, and the United Kingdom estimated the vaccine's efficacy in preventing COVID-19 to be 90%. In the trials conducted in the U.S. and Mexico, the vaccine showed 90.4% efficacy seven days after the second dose, while the trial in the UK showed an efficacy of 89.7%.

The EMA stated, "However, data on the vaccine's efficacy against other variants, including Omicron, is still limited." Novavax has previously announced that it will be able to produce vaccines targeting Omicron starting next year. Accordingly, actual vaccinations within the EU are expected to begin in the first quarter of next year. Novavax is also known to plan to strengthen data on efficacy against the Omicron variant and submit approval requests to the U.S. Food and Drug Administration (FDA) in the future.

This content was produced with the assistance of AI translation services.