The vaccine isn’t yet authorised in the US, after the company missed the window for an emergency authorisation due to the complicated nature of its trial results. Astra is planning to submit the shot for approval to regulators in the first half of next year, according to its quarterly statement.
The company is also in discussions with the US Food and Drug Administration about a paediatric study it will conduct in the US, Mene Pangalos, Astra’s head of biopharmaceutical research, told reporters. Another study started by Oxford in 6-to-17-year-olds this year will readout by year-end, which the company hopes will allow it to start immunising children globally, he said.
The shares dropped as much as 5.9 per cent after earnings in the quarter missed analysts’ estimates.
AstraZeneca has said it will only take a profit from wealthier nations, and it will rely on tiered pricing to make sure the shot is affordable.Credit:AP
The development comes after the company said this week it is creating a new unit to house its COVID-19-19 assets, raising questions over whether it would look to push further into the vaccines space or spin off the business at some point. Astra only had one nasal flu spray before the pandemic. The company also has a monoclonal antibody against respiratory syncytial virus in advanced development, which will sit in the group.
Astra reiterated its outlook for the year following the acquisition of rare-disease specialist Alexion Pharmaceuticals Inc. The company is in the midst of integrating Alexion into the business and will look for other potential acquisitions and collaborations in the rare disease space, Marc Dunoyer, chief executive officer of Alexion, said in a Bloomberg interview.
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“There is so much innovation that is coming out for new modalites in rare diseases,” Dunoyer said from Ireland, where Astra is investing $US360 million to build a new manufacturing facility on the Alexion campus there. We will partner with companies and “envisage all sorts of collaborations.”
Bloomberg
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AstraZeneca moves to start making a profit from its vaccine
Source: Philippines Alive
