EMERGENT IN THE NEWS: COVID-19 General Coverage

Read the latest news coverage of Emergent's insights and involvement in the fight against COVID-19.
Last Updated: Thursday, November 12, 2020

• CBS News 60 Minutes Overtime
• WUSA9
• Baltimore Fox45 News
• WJZ CBS Baltimore
• FiercePharma
• Washington Business Journal
• CBS Sunday Morning
• Homeland Preparedness News
• WJZ CBS News Baltimore
• The Wall Street Journal
• Baystreet

How anticipated COVID-19 vaccines are bulk manufactured under Operation Warp Speed

CBS News 60 Minutes
November 12, 2020 
Link to News Story

Operation Warp Speed, the U.S. government's crash program to inoculate 300 million Americans against the coronavirus, includes a number of pharmaceutical partners like Emergent BioSolutions in Baltimore. CBS News correspondent David Martin toured one of Emergent's manufacturing suites where the company is producing two COVID-19 vaccines awaiting FDA approval. 

Watch as Sean Kirk takes CBS 60 Minutes Overtime inside Emergent BioSolutions Baltimore Bayview facility.

'It's a mission-critical type of situation' | COVID-19 vaccine produced in Maryland lab

WUSA9
November 10, 2020
Link to Video

BALTIMORE — Right now, nearly 800 people are working on a COVID-19 vaccine in Baltimore. The senior vice president of Emergent BioSolutions told WUSA9 that with rising coronavirus cases in our region and around the country the pressure is on, but he said they're ready.

Search for COVID Vaccine is Boosting Maryland Economy

Fox45 News
July 8, 2020
Link to News Story

BALTIMORE (WBFF) - Finding a vaccine is critical to reopening and doing so safely.

Work here in Maryland is ramping up to find one.

Two Maryland companies have just announced deals to work on a coronavirus vaccine. Between them, they amount to $2 billion dollars that’s going toward manufacturing and development.

We’re told that will lead to hundreds of new jobs in the state.

At a lab in front of Johns Hopkins Bayview, scientists with Emergent Biosolutions have been working on vaccines since March.

"We have 4 active partnerships," says Syed Husain, with Emergent BioSolutions.

The company just announced a $480 million dollar deal with Johnson and Johnson to manufacture a vaccine starting early next year.

"We’re certainly adding to our workforce and adding a significant number of colleagues to join Emergent," Husain says.

They’ll be adding 300 jobs to their two Baltimore locations and in Rockville.

View the full news story here. 

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Maryland Biotech Companies at Forefront of COVID-19 Vaccine Research

WJZ CBS Baltimore
July 7, 2020
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BALTIMORE (WJZ) — The worldwide race is on to find a COVID-19 vaccine, and Maryland is on the forefront of some of that research.

In the state, researchers at three companies are hard at work trying to create the first COVID-19 vaccine.

Among them is Emergent BioSolutions, a Global Life Sciences company headquartered in Gaithersburg, with facilities in Baltimore.

Senior vice president Syed Husain said the company has partnered with four fellow innovators, including Johnson & Johnson, in an effort to come up with a vaccine.

View the full news story here. 

Emergent signs $480M manufacturing deal with Johnson & Johnson for covid-19 vaccine

Washington Business Journal
July 6, 2020
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Emergent BioSolutions Inc. said Monday it has signed a five-year agreement with Johnson & Johnson to manufacture its Covid-19 vaccine candidate, just a couple of months after striking a $135 million deal for the first step of their collaboration.

For the first two years of the deal, valued at $480 million, the Gaithersburg biotech will serve as a contract development and manufacturing organization (CDMO) to Janssen Pharmaceuticals, Inc., part of New Brunswick, New Jersey-based Johnson & Johnson (NYSE: JNJ). Emergent (NYSE: EBS) will produce the drug substance at its Baltimore Bayview facility, beginning in 2021, at large scale for commercial manufacturing. Beginning in 2023, Emergent will support additional batches, and the partners will agree on terms for those last three years of the deal in 2021, according to the company.

“Over the next five years, we are committing our leading CDMO services to advance this important vaccine candidate,” Syed Husain, senior vice president and CDMO business unit head at Emergent, said in a statement. “We have the expertise and capabilities to meet the long-term needs of our customers and provide ongoing commercial manufacturing to benefit patients.”

Read the full article here. 

THE RACE TO FIND A COVID-19 VACCINE

CBS Sunday Morning
June 28, 2020
Link to Video

"It's not an understatement to say that the entire nation's hopes are focused on what's happening in a Maryland laboratory – step one in manufacturing a potential coronavirus vaccine."

Watch as Sean Kirk takes CBS Sunday Morning on a virtual tour of Emergent BioSolutions Baltimore Bayview facility.

Emergent BioSolutions Deploys Long-Standing Expertise To Combat Current Pandemic

Homeland Preparedness News
March 19, 2020
Link to Article

Emergent BioSolutions Inc., world-renowned as a bioterrorism expert, is also utilizing its contract development and manufacturing organization (CDMO) status to help quash the coronavirus disease COVID-19.

“For 22 years, Emergent has focused on products and services that address serious public health threats, such as biological and chemical warfare agents, emerging infectious diseases, and opioid overdoses,” said Sean Kirk, executive vice president of manufacturing and technical operations at Emergent.

“Like these threats,” said Kirk, “the current COVID-19 challenge is complex, which requires a multi-faceted response. Emergent is committed to advancing solutions to respond to the COVID-19 pandemic.”

Emergent manufactures its own products, many of which the federal government buys and stockpiles in preparation for an attack or infectious disease outbreak.

At the same time, the company operates a CDMO business to help other drugmakers develop and manufacture products, and recently signed on to provide such services to two companies, each working on experimental oral vaccine candidates for COVID-19.

As part of its CDMO’s integrated network, Emergent also is marshaling resources from its Bayview facility in Baltimore, Md., which is designated as a Center for Innovation in Advanced Development and Manufacturing (CIADM) by the U.S. Department of Health and Human Services (HHS).

CIADMs are part of a national strategy recommended in the August 2010 Public Health Emergency Medical Countermeasures Enterprise Review, which found that the nation needed a nimble, flexible capacity to produce medical countermeasures rapidly for any threat, known or unknown, including a novel, naturally occurring emerging infectious disease, according to HHS.

“Emergent’s CIADM is a result of a public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA) at HHS,” according to Kirk, who said Emergent is “entrusted to play a role in public health emergencies, and we take this responsibility seriously.”

Kirk said that Emergent and BARDA co-invested to build the state-of-the-art facility, which is designed for large-scale manufacturing of medical countermeasures during public health emergencies.

“Our CIADM has the capacity to produce hundreds of millions of doses of vaccine based upon the platform technology being leveraged,” wrote Kirk. “That capability encompasses clinical scale production meant to get vaccine candidates quickly into the clinic and, in parallel, the scaleup to commercial volumes necessary for the vaccine to help prevent the disease in people.”

Since its designation as CIADM in 2012, Emergent has responded to U.S. government task orders to develop therapeutics for viral hemorrhagic fevers, including Ebola, and a Zika vaccine, according to his post.

Currently, Emergent is working on vaccines to address the COVID-19 pandemic in separate collaborations with Novavax Inc., announced on March 10 and most recently with Vaxart Inc., announced on March 18.

“We rapidly deployed the capabilities, capacities and expertise of our Bayview CIADM and continue to be in active discussions with multiple fellow innovators, ranging from small to large pharmaceutical and biotech companies, to offer our CDMO services, specifically our Drug Substance manufacturing capability at the CIADM, as a response,” according to Kirk.

Under terms of the agreement with the Nasdaq-traded Vaxart, a clinical-stage biotechnology company, Emergent will provide development services out of its Gaithersburg, Md., location and manufacture drug substance at its CIADM facility in Baltimore for COVID-19.

Development services will begin immediately, and upon Vaxart’s election, Emergent will produce clinical material that’s expected to enable Vaxart to initiate a Phase 1 clinical study anticipated early in the second half of 2020.

“Emergent is pleased to deploy our nimble CDMO expertise to support fellow innovators, like Vaxart, and advance an experimental COVID-19 vaccine candidate,” said Syed Husain, senior vice president and CDMO business unit head at Emergent BioSolutions. “We look forward to applying our broad molecule-to-market services, including our ability to work with a multitude of delivery systems, execute under expedited timelines, and meet Vaxart’s potential need for future scalability and large-scale capacity for commercial quantities.”

Since identifying the novel coronavirus sequence early this year — which Kirk said is the first step to developing an appropriate vaccine — companies like Emergent have been working diligently to advance solutions for COVID-19.

“Fortunately, we have a multi-faceted approach and are using our decades-long development and manufacturing capabilities in vaccines and plasma-derived treatments to quickly advance solutions,” Kirk wrote.

Emergent also is supporting both preclinical testing and phase 1 safety trials for the COVID-19 vaccine candidate being developed by Novavax, another Nasdaq-traded, clinical-stage biotechnology company.

U.S. Rep. David Trone (D-MD) this week commended Emergent for its efforts.

“Today I spoke with @emergentbiosolu about their vaccine and therapeutic developments to respond to #COVID19,” Rep. Trone tweeted on March 17. My background is in business. I know the importance of working with companies like @emergentbiosolu to help solve this public health crisis. Let’s all work together.”

In its financial results for the quarter and year ended Dec. 31, 2019, Emergent reported on Feb. 20 that its CDMO services brought in $80 million, or 7.2 percent of total revenue.

Kirk said Emergent is especially proud and thankful to its dedicated employees, who are “getting the job done as expeditiously as possible to make a positive impact on this pandemic.”

Emergent, he wrote in his posting, is “focused on finding solutions to beat this pandemic.”

‘Giving It Their All’ | Maryland Company Ready To Manufacture Potential Coronavirus Vaccines

WJZ CBS Baltimore
March 19, 2020
Linke to Article

A Maryland company said it’s ready to manufacture multiple potential coronavirus vaccines.

Emergent BioSolutions manufactures drugs like Narcan and was involved in the Ebola response. Now, the Baltimore manufacturing facility will be involved with two companies hoping to develop a coronavirus vaccine.

“Our people certainly feel that level of responsibility and they’re giving it their all,” Emergent’s senior vice president Syed Husain said.

The company’s Gaithersburg site will work on development for two companies that may be vaccine candidates, while its Baltimore plant will manufacture the drugs.

“We’ve been built for this,” Husain said. “The sense of urgency has always been there and it’s heightened at this time, and this is where our experience really comes together.”

Emergent’s first step is providing clinical trial materials. Regulatory agencies will make sure any vaccine is safe.

“(We’re working) as fast as possible, but what’s most important to make sure the vaccine, in this case, is safe and it’s efficacious,” Husain said.

Researchers caution, though, that it will likely be at least a year before any vaccine is available to the public.“

Everyone wants to ensure a timeline is done as fast as possible. There’s been indications of 12-18 months. I think that is an appropriate and fair timeline for what the experts have provided,” Husain said.

An experimental coronavirus vaccine was administered earlier this week to human subjects in Seattle, CBS News reports, one of dozens of projects underway worldwide.

The Top Ways To Ward Off Infection, According To Health Experts [Excerpt]

Baystreet
March 19, 2020
Link to article 

Vaxart Inc. (NASDAQ:VXRT) announced that it has entered into an agreement with Emergent BioSolutions Inc. (NYSE: EBS), whereby Emergent will deploy its molecule-to-market contract development and manufacturing (CDMO) services to help develop and manufacture Vaxart’s experimental oral vaccine candidate for coronavirus disease (COVID-19). Vaxart’s oral recombinant vaccine candidate is based on its proprietary VAAST™ platform. “I’m pleased that we are joining forces with an experienced manufacturer such as Emergent to help advance our oral COVID-19 vaccine to the clinic,” said Wouter Latour, MD, chief executive officer of Vaxart. “We believe an oral vaccine administered using a room temperature-stable tablet may offer enormous logistical advantages in the roll-out of a large vaccination campaign, and Emergent is a great partner to help in this endeavor.”

U.S. Moves To Expand Array Of Drug Therapies Deployed Against Coronavirus

The Wall Street Journal
March 19, 2020
Link to Article

President Trump said Thursday he is directing the Food and Drug Administration to expedite testing and possible broader use of some investigational medicines to help treat patients diagnosed amid the pandemic of the new coronavirus disease.

“Nothing will stand in our way as we pursue any avenue to find what best works against this horrible virus,” Mr. Trump told reporters at a White House news conference.

Mr. Trump specifically mentioned two drugs, chloroquine and hydroxychloroquine, that have long been used for malaria but aren’t approved for the coronavirus, as well as an antiviral drug, remdesivir, that is currently being tested in clinical research on Covid-19, the coronavirus disease.

Some physicians are already using hydroxychloroquine and chloroquine to treat patients with the disease. These therapies were approved decades ago and are off-patent.

“If things don’t go as planned, it’s not going to kill anybody,” Mr. Trump said, arguing that the drugs pose less risk because two of them have been approved for other uses.

That approach is a departure from the FDA’s normal procedure, which is to measure whether a drug achieves a balance of safety and effectiveness against a specific disease. This is done through clinical studies, often with some patients getting a study drug while others are randomly assigned to a control group.

However, the FDA has allowed compassionate use of unproven investigational drugs, such as when a patient is otherwise on the verge of death.

There is no known drug to combat the coronavirus, and pharmaceutical industry officials say it could take months to find an effective treatment.

The timing of whether drugs are effective and safe has less to do with regulatory decisions and more about how long drug development takes. Studies must be designed properly to assess whether an experimental medicine works, then patients must be enrolled in the study and tested.

Mr. Trump specifically touted drug company Gilead Sciences Inc., which produces remdesivir, as offering promising therapies.

In addition to Gilead, Emergent Biosolutions Inc. and Takeda Pharmaceutical Co. are also developing experimental therapies. The companies and industry officials have said that it will be several months before there is an indication of whether the drugs are effective and can be applied broadly to patients infected with the disease.

Takeda said if testing is successful, the company aims to make the therapy available to patients between nine months and 18 months from now.

FDA Commissioner Stephen Hahn, in the news briefing, emphasized that his agency is trying to move as quickly and scientifically as possible.

“FDA’s responsibility to the American people is to ensure that products are safe and effective and we are continuing to do that,” Dr. Hahn said during the news conference. “We are looking at everything that’s coming across our desks as possible treatment options for the coronavirus.”

Dr. Hahn said Mr. Trump had directed the FDA to test chloroquine, adding that the agency wants a “large, pragmatic clinical trial” to test possible benefits of the drug for treating coronavirus.

Former FDA commissioners Drs. Scott Gottlieb and Mark McClellan called for the FDA to work with manufacturers in a paper published Thursday. The two said the agency should create two task forces to develop therapeutics and vaccines, exempt from some regulatory requirements.

Some in the Trump administration are arguing for allowing experimental drugs to get broader use in the country.