AstraZeneca to Create Distinct Vaccine and Antibodies Business

AstraZeneca is setting up a new business unit dedicated to overseeing its vaccines and antibody therapies as it looks to rebound from pandemic-era disappointments related to its COVID-19 jab co-developed with Oxford University.

The new group will oversee the company’s COVID-19 shot Vaxzevria and its long-acting COVID-19 combination therapy AZD7442, currently under review for Emergency Use Authorization by the FDA and under a rolling review by the European Medicines Agency. The unit will also continue development on experimental shots meant to address coronavirus variants and be responsible for the drugmaker’s other current respiratory viral disease treatments.

“In order to optimize the management of our existing portfolio of vaccines and antibodies … We are creating a dedicated Vaccines and Immune Therapies Unit that brings together R&D, manufacturing, commercial and medical teams,” a spokesperson told FDAnews. The division will be led by Iskra Reic, AstraZeneca’s executive vice president of Europe and Canada.

The spokesperson didn’t specify when the new unit would formally launch, but AstraZeneca is set to publish third-quarter earnings on Friday and is expected to delve into the matter on the investor conference call.

The news arrives as the Anglo-Swedish drugmaker has faced numerous setbacks in recent months.

First, AstraZeneca and the European Commission squared off earlier this year after the drugmaker scaled back its initial supply and the 27-member bloc sought to force the company to make good on its commitments (DID, Jan. 28).

Then, the AstraZeneca shot was linked to rare blood-clotting events, prompting a temporary halt in inoculations in Europe, and was later associated with Guillain-Barré syndrome, a rare nerve disorder. The shot now requires a warning for both in the EU, as does Johnson & Johnson’s COVID-19 jab (DID, March 16).

But, lately, AstraZeneca appears confident, touting positive phase 3 data for AZD7442 and expecting to launch the product in the U.S. by year’s end. The company has said the therapy could offer protection for those unable to mount a proper immune response after receiving a COVID-19 vaccine. That includes its own shot, which, while authorized in the UK and EU, has yet to receive any approval in the U.S. (DID, Oct. 6). ― Jason Scott