Sean Kirk and Members of the Bayview Team

Emergent Rallies to Meet COVID-19 Vaccine Supply Challenge

Emergent BioSolutions’ contract development and manufacturing (CDMO) business is playing a crucial role in supporting the battle against COVID-19. The company has contracted with multiple vaccine makers, including AstraZeneca and Johnson & Johnson, to manufacture the preventative medications.

It’s a critical role not taken lightly by the employees in the company’s two Baltimore-based facilities. Sean Kirk, executive vice president of Manufacturing and Technical Operations at Emergent, said the importance of the work taken on by Emergent, as well as the biopharma industry at large to battle the pandemic is not lost on him.

“We have an opportunity to help save a lot of lives going forward,” Kirk said. “The power of what we’re doing as a group of individuals is not lost on me.”

While Kirk spoke to BioBuzz over a video conferencing call, there was a flurry of activity going on around him as employees, all wearing protective masks, operated equipment that assisted in the manufacturing of the vaccines. Kirk recognized the hard work and dedication of the Emergent employees who have continued to tirelessly work despite the threat of viral infection. When the company first entered into vaccine manufacturing agreements in the spring of 2020, Kirk said he gathered his employees and paraphrased former U.K. Prime Minister Winston Churchill’s World War II speech that never before have so few done so much for so many.

Kirk noted the difficulties the COVID-19 virus has created worldwide and how it has separated families and friends. When he was infected with the virus in December, Kirk was forced to separate from his own wife and children and isolate himself in his basement. Although he could work remotely during that time, the isolation helped crystalize his colleagues’ vital work.

“I deeply appreciate the difference these people are making in the world,” Kirk said. “It’s just a phenomenal thing.”

Kirk related the importance of vaccine development by sharing a story of his own 95-year-old grandmother who received her first dose of one of the two authorized COVID-19 vaccines in the United States. Although Emergent did not manufacture that particular vaccine, Kirk said he was struck by how important a moment this was for her in the waning years of her life. Receiving the vaccine will allow her, and millions of other people, the opportunity to be with friends and family again with added protection from a deadly virus.

Could I ask for a more awesome job to be able to contribute to millions of those moments, the reunification of families,” he said.

Since taking office in January, President Joe Biden has called for administering 100 million doses of COVID-19 vaccines in the first 100 days of office. Although Emergent has not partnered with either Moderna or Pfizer-BioNTech, Kirk expressed confidence that the goal could be met. He touted the work performed by the companies already partnered to produce those vaccines and said when it’s time, his company will be able to contribute upon the granting of emergency use authorization of the vaccines developed by AstraZeneca and Johnson & Johnson by the U.S. Food and Drug Administration.  One day after the interview with Kirk, J&J released late-stage data for its vaccine that showed a 66% efficacy against COVID-19.  [Note since this was written J&J has sought EUA.]

Since the start of the pandemic, Emergent has positioned itself to provide multiple shots on goal against COVID-19. Not only has the company partnered with vaccine makers to manufacture and fill the medications, the Gaithersburg-based company that has five locations in Maryland, is also developing its own therapeutics against the virus. The company is developing two candidates, COVID-HIG, a human polyclonal hyperimmune with antibodies to SARS-CoV-2, being evaluated in a Phase III study as a treatment, and in a Phase I study as prophylaxis, and COVID-EIG, Equine-derived polyclonal hyperimmune with antibodies to SARS-CoV-2. In late January, Emergent partnered with Humanigen to accelerate manufacturing at its Baltimore Camden facility of lenzilumab™, an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to prevent and treat an immune hyper-response called “cytokine storm.” Lenzilumab is currently in a Phase III clinical trial evaluating patients hospitalized with COVID-19. Humanigen intends to file for emergency use authorization in the first quarter of 2021.

Emergent is able to take these multiple approaches because of significant investment dollars by the company and the federal government. Kirk explained that those funds were used to ramp up Emergent’s enterprise to meet the demands facing the company and global population. The funds, coupled with the decades of experience at Emergent, has put the company in a strong position to make a significant impact. Emergent was able to leverage its Baltimore Bayview facility for COVID and the viral threats of Ebola and Zika.

“In many ways, our role in the pandemic is a manifestation of all of our years of experience. We rallied to the call to get the necessary materials and equipment,” Kirk said.

“We’re going to win this.”