In May, Britain agreed to take 100 million doses of the vaccine, with 30 million doses originally estimated for delivery by September, after UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said that clinical trials of the vaccine candidate were safe to continue. Across the pond, the FDA authorized a trial restart in late October. The exact timing for delivery is uncertain at this point, as it depends on infection numbers.
Bingham, Reuters reports, said that the vaccine was being made initially in bulk (drug substance) but could not yet be transferred into vials until more certainties of the timing of late-stage trial data delivery. She added that once the vaccine is put in vials, the clock for shelf life—and how soon one can use the product—begins.
AZ, in a written statement to Reuters, indicated it was making progress to start supplying hundreds of millions of doses on a rolling basis once it receives regulatory approvals. The Oxford/AZ candidate is likely to be among the first vaccines from big pharma to be submitted for governmental authorization.
For an overall look at the regulatory picture for Covid-19 vaccines, read Pharmaceutical Commerce‘s chat with Dr. Ash Ramzan of Woodley BioReg Ltd.
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