FDA greenlights Novavax's updated COVID-19 vaccine targeting the JN.1 variant, with doses expected to roll out next week. (Representational image: Unsplash) 
Medicine

FDA Authorizes Novavax's Updated COVID-19 Vaccine Targeting JN.1 Variant

Ankur Deka

Bengaluru: The U.S. Food and Drug Administration (FDA) granted emergency use authorization on Friday for Novavax's updated COVID-19 vaccine. The new version of the vaccine is approved for individuals aged 12 and older and specifically targets the JN.1 strain of the virus.

Following the announcement, Novavax's stock rose by 2.2% in after-hours trading, adding to an 8.6% gain earlier in the day.

"This authorization provides another option for COVID-19 vaccination," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. Novavax indicated that doses of the updated vaccine could be available as soon as the end of next week.

John Jacobs, CEO of Novavax, emphasized that the updated vaccine is designed to target the "parent strain" of currently circulating variants. He noted that it has demonstrated strong cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1, and LB.1.

Novavax's latest COVID-19 vaccine, targeting the JN.1 strain, receives emergency use authorization from the FDA. The company's shares surge as it prepares to launch the new shot by the end of next week. (Wikimedia commons)

Earlier in August, the FDA approved updated COVID-19 vaccines from Pfizer and Moderna, which are designed to target the KP.2 variant. The JN.1 strain, although once dominant in the U.S. earlier this year, now accounts for only 0.2% of cases as of the two-week period ending August 31, according to data from the Centers for Disease Control and Prevention (CDC).

In contrast, the KP.2 subvariant currently accounts for 3.1% of cases, while KP.3.1.1 has become the dominant strain, making up 42.2% of cases. In June, the FDA instructed COVID-19 vaccine manufacturers to focus on the KP.2 strain for the 2024-2025 vaccines.

Novavax's vaccine, based on traditional protein-based technology, offers an alternative to the mRNA-based vaccines developed by Moderna and Pfizer-BioNTech, such as Spikevax and Comirnaty.

Despite an increase in COVID-19-related hospitalizations and deaths in the U.S. over the past three months, demand for COVID-19 vaccines has significantly declined from the pandemic's peak. However, Novavax remains optimistic, expecting overall demand in the U.S. to be similar to last year, while anticipating stronger performance for its own vaccine.

(Input from various sources)

(Rehash/Ankur Deka/MSM)

Also read:Nigeria Receives 10,000 Mpox Vaccine Doses from USAID

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