J&J Sees Delays in Coronavirus Vaccine Production as It Approaches Regulatory Finish Line
As Johnson & Johnson (J&J) nears the release of critical phase 3 trial results and potential emergency authorization for its promising COVID-19 vaccine, the company has reportedly hit speedbumps in manufacturing doses.
The company yesterday declined to confirm or deny reports that it is falling behind its goal of manufacturing 12 million shots of the single-dose vaccine by the end of February by as much as two months and may need until April to hit its target, but told FDAnews it believes it will ultimately meet its supply agreements for 2021.
“It is premature to get into the specifics of the supply of our vaccine candidate, as we do not yet have phase 3 data, nor have we filed for or been granted Emergency Use Authorization (EUA),” a J&J spokesperson said. “[We] are confident in our ability to meet our 2021 supply commitments signed with governments, and we expect to share more detail after some of these steps are achieved.”
Operation Warp Speed’s (OWS) chief adviser Moncef Slaoui, who is resigning from the project next month at the Biden administration’s request, appeared to refer to the reported delays Tuesday, saying that OWS anticipates seeing “single-digit million number of doses available in the second half of February.”
“We’re trying to make that number get as close to a double-digit number as possible, and then a larger number in March and a much larger number in April,” he said.
Slaoui, who has previously called the vaccine a potential “game changer,” said that OWS and the J&J “are very clear” that the company will file for EUA by the end of the month after the FDA’s analysis of phase 3 data. He projected that emergency clearance could come in the middle of February. An EUA for J&J’s vaccine would give the U.S. a crucial third inoculation option for COVID-19.
Though the company may be seeing manufacturing hiccups, its viral-vector vaccine, Ad26.COV2.S, offers a huge advantage in that a vaccination requires just one dose. Coupled with the vaccine’s moderate temperature needs — shipping and storage at -4 degrees Fahrenheit — this would simplify distribution and global vaccination efforts.
The U.S. government has a $1 billion advance order in place with the company to make and deliver 100 million doses, with a provision for 200 million more if needed (DID, Aug. 6, 2020). — James Miessler