Covid-19 manufacturing roundup: FDA frees up more Emergent vaccine doses; Pfizer and Vietnam discuss tech transfer — report
The FDA has freed up yet another batch of J&J Covid-19 vaccines that were held up due to contamination at Emergent’s Baltimore Bayview plant.
In a letter addressed to J&J’s North American Regulatory leader Ruta Walawalkar, the agency re-issued emergency use authorization to one more batch on July 13. That will free up another 10 million doses Bloomberg reports.
“I am waiving Current Good Manufacturing Practice requirements for this batch, and only this batch, for the duration of this EUA,” the letter, signed by director of vaccines and research Marion Gruber, says. “This concurrence does not add any other batches manufactured at this facility to the EUA at this time and does not add the facility itself to the EUA at this time, nor does the EUA cover vaccine manufactured by combining this batch with different batches of drug substance that are not authorized explicitly under this EUA.”
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