After a months-long halt on production, Emergent is back up and running in Baltimore
It’s been a long time since Emergent BioSolutions has been able to produce Covid-19 vaccines at its Baltimore Bayview plant, but the FDA has given the company the go-ahead to resume production, a company spokesman confirmed Thursday morning in an email to Endpoints News.
The news comes two months after the company said it was near a deal to resume. In a House subcommittee meeting in June, CEO Bob Kramer said that his company was prepared to resume manufacturing immediately after it received the go-ahead from the FDA.
“We are proud to be resuming production of bulk Covid-19 vaccine batches following additional reviews and collaboration with FDA and our manufacturing partners,” Kramer told the Wall Street Journal in a statement late Wednesday. “We are grateful for the opportunity to help bring this global pandemic to an end.”
This means J&J production will resume. The CDMO was previously responsible for making drug substance for the AstraZeneca jab as well, but after President Joe Biden’s administration ordered J&J to take over control of the plant, AstraZeneca engaged in discussions with New Jersey-based CDMO Catalent to move its operations over to its Maryland facility.
Early in the manufacturing process, Emergent was forced to toss drug substance used in AstraZeneca’s jab. In that meeting before the House subcommittee, Kramer blamed the mixup on flawed instructions from the British drugmaker.
Later on, a batch of drug substance intended for the AstraZeneca vaccine came in close proximity with a J&J batch, contaminating it as well. That mixup wasn’t noticed until J&J quality control workers picked up on it at one of its sites.
Before those screw ups, Emergent touted its ability to manufacture more than 1 billion doses a year. Kramer went on CNBC’s “Mad Money” in March to say just that, when it inked a $480 million, two-year deal with the US government.
“The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves,” Emergent CEO Bob Kramer said in a press release. “We have fallen short of those lofty ambitions over the past few months but resumption of manufacturing is a key milestone and we are grateful for the opportunity to help bring this global pandemic to an end. We’d like to thank our government partners as well as Johnson & Johnson for their support.”
AstraZeneca’s vaccine has been approved in several countries around the world, but not the US because of a rare but serious blood clot in the brain that has been reported in some who’ve received that vaccine. Demand for J&J’s single-dose jab has waned domestically, recently, but it remains a viable options for countries oversees that are lacking adequate doses, particularly those trying to inoculate people in rural areas. J&J’s single-dose format makes it easier to administer to those who cannot make multiple trips into a populated area to a clinic or hospital. The US pledged to donate doses of J&J’s shot elsewhere, including 1 million to Bolivia.
There are still around 30 million doses that have been made that the FDA has yet to clear J&J to distribute. Another batch of J&J’s vaccine was released three weeks ago, bringing the total number to 40 million, while roughly 75 million have been destroyed.
“Based upon our current observations of the implemented corrective actions, FDA does not object to the resumption of manufacturing” at the Baltimore plant,” a letter to the FDA, obtained by the WSJ, said.