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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