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.”
That marks the fifth batch of drug substance that has been freed up after a mishap that led to 75 million total doses being destroyed and tens of millions more held back for testing. This brings the number of J&J batches released to about 50 million.
A batch of the vaccine doses cleared last week had not yet been bottled, The New York Times reported, and US President Joe Biden’s administration has not yet revealed what it will do with the doses. They could be headed elsewhere, as the US has just pledged 1 million doses of J&J’s jab to Bolivia by Thursday, according to CNN.
Pfizer and Vietnam discuss tech transfer: report
As Vietnam sees a record number of new Covid-19 infections, the country’s government says it’s in talks with Pfizer about the possibility of a technology transfer or opening a Pfizer plant, Reuters reported Wednesday.
In June, the country’s health ministry said a local company was lined up to manufacture the jab after a transfer deal was negotiated with “an unidentified US partner.” It did hint that the vaccine would be mRNA based and Pfizer’s vaccine is approved for use in the country, along with China’s Sinopharm and AstraZeneca’s jab.
The country had successfully staved off the virus for much of the pandemic, but since April, has battled a stubborn outbreak, which has applied pressure on its government to ramp up its vaccine inoculation. Fewer than 300,000 people in the country have gotten the shot, Reuters said.
Over 90% of the country’s cases have been reported since May.