Emergent BioSolutions Asked to Halt Covid-Vaccine Production by FDA

Emergent BioSolutions Asked to Halt Covid-Vaccine Production by FDA

Emergent BioSolutions (NYSE: EBS) has been asked by the Food and Drug Administration to stop production for Covid-19 vaccines. According to the company, the halt comes amid a botched batch of Johnson & Johnson shots within its Baltimore plant. Shares fell 9% following the news.

The FDA commenced an inspection on April 12 and asked that production be paused just four day later. Within a filing, the company said it has quarantined all products manufactured at the establishment.

Johnson & Johnson announced it will be working with Emergent and FDA “to address any findings at the conclusion of the FDA inspection.”

“Our goal remains ensuring all drug substance for our COVID-19 vaccine meets our high-quality standards and securing Emergency Use Authorization for drug substance manufactured at Emergent Bayview,” the company said. “At this time, it is premature to speculate on any potential impact this could have on the timing of our vaccine deliveries.”

The Biden administration had charged J&J with the Baltimore plant at the beginning of the month, when U.S. officials found out that the J&J and AstraZeneca manufacturer had mixed up ingredients for the two vaccines. AstraZeneca vaccines have also been halted.

“We recognize the confusion these recent events may have caused our customers, our employees and the public,” Emergent said in its statement. “We are steadfastly committed to full compliance with the FDA’s strict requirements. We acknowledge that there are improvements we must make to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes.”

Though Johnson & Johnson’s one-shot vaccines have been paused within the United States due to six cases of a rare blood clot in patients, the shot could return to the market this week. J&J asked rivals Pfizer and Moderna to participate in a study that would investigate blood clots, however, both companies declined according to The Wall Street Journal.

Emergent’s share price fell from USD92.91 on March 31 to USD72.23 on Monday.