Farmas USA

FDA is set to decline new emergency use authorizations for COVID-19 vaccines

• The FDA has said yesterday it may turn down emergency use authorizations (EUA) for COVID-19 vaccines for the remainder of the pandemic unless the developers have not already begun discussion with the regulator, Reuters reported.
• Under a EUA, the FDA facilitates the availability and use of unapproved medical products including vaccines during public health emergencies, such as a pandemic.
• Currently, three COVID-19 vaccines have received FDA’s emergency use approval: Messenger-RNA-based COVID-19 vaccines from Pfizer (NYSE:PFE)/ (NASDAQ:BNTX) and Moderna (NASDAQ:MRNA), Adenovirus-based vaccine from Johnson & Johnson (NYSE:JNJ).
• Meanwhile, AstraZeneca (NASDAQ:AZN) is reportedly seeking full approval for its vector-based vaccine skipping a EUA.
• Novavax (NASDAQ:NVAX) has previously said, the company has started talks with the FDA for emergency use authorization for its COVID-19 vaccine. However, Novavax has pushed back the timeline for its regulatory submission from Q2 2021 to Q3 2021.