CVAC - 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 (PFE)/ (BNTX) and Moderna (MRNA), Adenovirus-based vaccine from Johnson & Johnson (JNJ).Meanwhile, AstraZeneca (AZN) is reportedly seeking full approval for its vector-based vaccine skipping a EUA.Novavax (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.Related tickers: Vaxart (VXRT), Inovio Pharmaceuticals (INO), Ocugen (OCGN), CureVac (CVAC)
For further details see:
FDA is set to decline new emergency use authorizations for COVID-19 vaccines