CHMP Performs Accelerated Assessment of Booster Dose of Spikevax

News
Article

EMA's CHMP is going to perform an accelerated assessment of data submitted by Moderna regarding the use of a booster dose of Spikevax.

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) is going to perform an accelerated assessment of data submitted by Moderna regarding the use of a booster dose of Spikevax (the company’s COVID-19 vaccine).

According to a Sep. 27, 2021 press release, Moderna has applied to the regulatory authority for the use of a booster dose of Spikevax to be given at least six months after the second dose of the vaccine in people 12 years old and older. Based on its review of available data, CHMP will recommend whether or not updates to the product information are appropriate.

In a separate communication, EMA and the European Centre for Disease Prevention and Control (ECDC) have specified that the need for additional and booster doses of COVID-19 vaccines is not urgent for the general population. However, Moderna’s application is being considered to ensure evidence is available to support further doses as necessary.

Source: EMA

Recent Videos
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.
Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.
Mike Baird from Schlafender Haser discusses industry trends from 2024 and those expected to have an impact in 2025 from the perspective of a software developer.
Preeya Beczek from Beczek.COM gives her thoughts on the areas to watch with the new US administration and how Europe might be finalizing preparations for previous legislative changes