Restarting production of the J&J shot by Emergent would revive efforts to make the single-dose vaccine available to many Americans. The United States currently relies solely on Pfizer and Moderna vaccines for its vaccination efforts. For the second straight week, the White House told state officials on Tuesday that the J&J vaccine could not be ordered.
“Because the company was unable to deliver, the vaccinations of millions of people around the world have been delayed unnecessarily putting their lives at risk,” Chairman Jim Clyburn (D-S.C.) Said at the hearing.
Meanwhile, it is unclear when millions of AstraZeneca overseas promised cans that have also been dispensed at the Emergent facility will be released for use. Lawmakers also pounded the company over the past year on a number of FDA reports it viewed as warning signs of the vaccines being destroyed.
On Wednesday, Emergent officials accused the government of being unprepared and hiring the company on short notice, and accused AstraZeneca of sending faulty manufacturing processes that required Emergent to make 80 different process changes.
“It was very difficult, very complicated and resulted in the loss of production lines,” Kramer told the panel.
Kramer also shed light on the mishap that resulted in 15 million unusable J&J vaccines and told the panel that the waste from the AstraZeneca manufacturing suite got too close to the materials used in J&J manufacturing, creating the problem led.
But Emergent had received a series of warnings of potential manufacturing problems prior to the vaccines being destroyed this year, argued top Democrats on the committee.
Documents released by the panel on Wednesday show that “Emergent, after ignoring these warnings and contaminating millions of doses of much-needed vaccines, found that its executives earned millions of dollars in rewards for the performance of their executives,” said Clyburn.
Emergent is one of the few contract manufacturers in the US equipped to manufacture large quantities of vaccines. The scarcity of such manufacturers led both J&J and AstraZeneca to win over the company last year as the companies struggled to include vaccine supplies and manufacturing facilities. AstraZeneca has yet to announce any new manufacturing partners, and around 60 million of its overseas doses promised by the Biden administration are still pending and not yet cleared for use.
Kramer argued in his testimony that the government’s chronic unpreparedness for biological threats such as a pandemic fueled the latest scenario and two pharmaceutical giants turned to a relatively small facility in Maryland.
Although Bayview is one of three manufacturers that have been tapped by federal officials to take countermeasures, “Bayview only had about 100 employees on site in late 2019, shortly before the Covid-19 pandemic broke out, and was at least a year away from Bayview License to manufacture its first FDA cleared product, ”said Kramer. “Meanwhile the other two [government-enlisted] Other companies’ facilities had changed hands several times and were not yet ready to undertake major short-term operations for the US government. “