Washington [US], June 1: Pharmaceutical company Moderna has just announced that its new Covid-19 vaccine called mNEXSPIKE has been licensed for use by the US Food and Drug Administration (FDA).
According to a statement from Moderna on May 31, the US-based company, this new vaccine will be used for people aged 65 and 12-64 with underlying medical conditions that put them at risk of serious infection.
Moderna CEO Stephane Bancel stressed that Covid-19 remains a serious public health threat, with more than 47,000 deaths in the United States last year. The approval of mNEXSPIKE means an important new tool to protect people at risk of severe illness from Covid-19, Bancel added.
The mNEXSPIKE vaccine is expected to be available as the United States enters the peak respiratory infection season in 2025-2026, which is forecast to begin in the fall.
In a phase 3 trial involving more than 11,400 people, Moderna's new vaccine was more effective than its previous Spikevax vaccine , providing 9.3% protection in people aged 12 to 64 and 13.5% protection in people aged 65 and older.
The FDA has recently raised its standards for Covid-19 vaccines, requiring pharmaceutical companies to conduct more thorough research before licensing them for use on people under 65. Axios reported on May 31 that US Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has issued new regulations, according to which children and pregnant women who are in good health are no longer among the recommended groups for vaccination.
Moderna said mNEXSPIKE will be used in conjunction with Spikevax and the respiratory syncytial virus (RSV) vaccine mRESVIA.
Source: Thanh Nien Newspaper