The FDA has put a planned phase 1 clinical trial of Altimmune’s intranasal COVID-19 vaccine on clinical hold. Altimmune attributed the setback to the need for protocol modifications and additional chemistry, manufacturing and controls (CMC) data. Maryland-based Altimmune is one of a number of companies working on COVID-19 vaccines that are delivered by means other than injection. Altimmune’s candidate, AdCOVID, is an adenovirus type 5-vectored vaccine that is designed to provide protection against SARS-CoV-2 after administration of a single intranasal dose.
Altimmune’s plans to test the vaccine in humans hit a snag late last year when the FDA issued a clinical hold on the IND filing. The FDA asked Altimmune to make protocol modifications and submit additional CMC data to get the clinical hold lifted. Altimmune has moved quickly to resolve the situation. Having received the letter on Dec. 22, the company had submitted its response to the FDA by the time it publicly disclosed the setback the next day. Altimmune said it has agreed to each of the FDA’s requests.
EU Drug Regulator Recommends Authorization of Moderna Covid-19 Vaccine
The European Union drugs regulator has recommended granting Moderna’s Covid-19 vaccine a conditional marketing authorization, a move that will soon pave the way for the drug to become the second coronavirus vaccine to be distributed in the bloc.Following the recommendation by the European Medicines Agency (EMA), the shot now must be formally authorized by the European Commission, which is expected to do so quickly.On Wednesday, the European Parliament Committee on
Environment, Public Health and Food Safety said on Twitter that they are “expected to follow the (EMA) recommendation and grant the authorization shortly after which the roll-out of the vaccine in the EU can begin.”Emer Cooke, EMA executive director, said on Wednesday that “this vaccine provides us with another tool to overcome the current emergency.” The EU has secured the purchase of up to 160 million doses of the Moderna vaccine — enough to vaccinate 80 million people of its 448 million citizens — as part of a joint vaccine strategy aimed to ensure equitable access across the bloc.It has also purchased up to 300 million doses of the Pfizer/BioNTech vaccine, which was authorized for use on December 21 and rolled out to all EU countrie