Pharmaceutical Technology Editors

On April 1, 2021, FDA announced two revisions to the Moderna COVID-19 vaccine Emergency Use Authorization (EUA) to increase the number of vaccine doses available.

The first revision further clarifies the number of doses per vial for the vials that are already available, with the maximum number of 11 extractable doses, with a range of 10–11 doses, FDA said in a company press release. The second revision allows for the availability of an additional multi-dose vial which contains a maximum of 15 doses, with a range of 13–15 doses that can potentially be extracted.

Depending on the type of syringe and needle used to extract each dose, FDA warned that there may not be enough volume to extract more than 10 doses from the vial containing a maximum of 11 doses or more than 13 doses from the vial containing a maximum of 15 doses, according to the press release.

“Both of these revisions positively impact the supply of Moderna COVID-19 vaccine, which will help provide more vaccine doses to communities and allow shots to get into arms more quickly. Ultimately, more vaccines getting to the public in a timely manner should help bring an end to the pandemic more rapidly,” said Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, in the press release.

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The first revision further clarifies the number of doses per vial for the vials that are already available, while the second revision allows for the availability of an additional multi-dose vial.

FDA Makes Revisions to Moderna’s COVID-19 Vaccine EUA to Increase Available Doses

At the prompting of the US government, Johnson & Johnson (J&J) will take over responsibility for manufacturing the drug substance for its COVID-19 live viral vector vaccine at Emergent BioSolutions’ Bayview facility in Maryland, following a manufacturing error that led to the loss of 15 million potential doses of the vaccine.

 the company “is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality, and technical operations personnel to work with the company specialists already at Emergent.”

The news of the change in manufacturing responsibility coincides with an 

 that the Biomedical Advanced Research and Development Authority added $23 million to Emergent BioSolutions’s original task order to purchase manufacturing equipment to expand manufacturing of bulk drug substance of the J&J COVID-19 vaccine into a third suite at the Bayview facility.

In 2012, Emergent BioSolutions became part of a public-private partnership designed to facilitate rapid scale up of needed vaccines during public emergencies. In a press statement, the company noted that “Emergent continues to own the facility and perform its contracts consistent with its obligations to all of its customers and in compliance with the regulatory standards promulgated by the FDA and all other applicable regulatory authorities.”

J&J said the company will work closely with FDA toward Emergency Use Authorization of the Emergent Bayview facility.

In addition, manufacturing operations for AstraZeneca’s vaccine candidate AZD1222, another viral vector product, will be moved from the Emergent facility to another location. AstraZeneca said in an 

 that it will relocate production of its vaccine as part of the company’s effort “to maximize and accelerate US production of COVID-19 vaccines.” The company is working with the federal authorities to identify an alternate domestic manufacturing site. 

The AstraZeneca vaccine has not been approved the United States.

Following a manufacturing mix-up, J&J will extend its oversight at Emergent’s Maryland facility; AstraZeneca manufacturing to relocate.

J&J to Take Over Its Product Manufacturing at Emergent Facility

A manufacturing error at an Emergent BioSolutions contract manufacturing facility has reportedly ruined up to 15 million doses of Johnson & Johnson’s (J&J’s) COVID-19 vaccine, according to a 

 report on March 31, 2021 citing unnamed federal officials. The report stated that in February 2021, workers accidentally mixed ingredients for the J&J vaccine with another vaccine manufactured at the facility.

J&J reported in a March 31, 2021 press statement that a batch of drug substance for the company’s vaccine produced at the Emergent facility in Maryland did not meet company’s quality standards and was rejected prior to the fill/finish stage.

J&J said the company has addressed the quality issue with Emergent and shared the information with FDA. Emergent’s Bayview facility, which also produces vaccine drug substance for AstraZeneca, is not yet authorized by FDA to manufacture the J&J vaccine drug substance.

In the statement, J&J said “rigorous quality control” practices, which included test runs and quality checks, were employed to ensure the manufacturing process was validated and product standards are met for each batch of drug substance. Quality specialists from J&J are on site at the Emergent facility to support safety and quality, the company reports.

“Quality and safety continue to be our top priority,” the J&J reported in the statement. “Therefore, as we continue to work with FDA and Emergent toward the Emergency Use Authorization of the Emergent Bayview Facility, Johnson & Johnson is providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct, and support all manufacturing of the Johnson & Johnson COVID-19 vaccine.”

J&J also noted that the company delivered, as committed, 20 million single-shot vaccines by the end of March 2020 for the US market and plans to distribute an additional 24 million single-shot vaccine doses through April. The company also plans to deliver 100 million single-shot vaccines to the United States by the end of May.

Human error at an Emergent BioSolutions facility cited as cause for the loss of a large batch of COVID-19 vaccines.


Ingredient Mix Up Ruins 15 Million Doses of J&J Vaccine

SK Capital Partners, a private investment firm focused on the specialty materials, chemicals, and pharmaceuticals sectors, announced on March 31, 2021 it has completed its acquisition of Catalent’s blow-fill-seal (BFS) sterile contract development and manufacturing organization (CDMO).

The business, which has been renamed Woodstock Sterile Solutions, will operate out of a single site in Woodstock, IL, and will support clinical to commercial stage formulation and manufacturing, SK Capital said in a company press release. The company will also focus on BFS sterile manufacturing and formulation for complex chemistries, including small molecules, biologics, macromolecules, and potent compounds.

Woodstock has appointed Paul Josephs as CEO, according to the press release. Most recently, Josephs served as the head of Contract Development and Manufacturing and Global Business Development at Mylan.

“We are excited to launch Woodstock Sterile Solutions as an independent company, building on its decades of experience in serving commercial and development customers,” said Aaron Davenport, managing director of SK Capital, in the press release. “We are delighted that Paul Josephs is joining to lead the very capable Woodstock team. Paul is a CDMO industry veteran who brings sterile production experience and contemporary leadership skills to ensure an environment committed to operational excellence, customer delight, innovation, and a partnership-driven approach for Woodstock’s customers, suppliers, and employees.”

“I am truly honored and excited to lead an organization with the heritage and potential of Woodstock,” Josephs added in the press release. “I look forward to partnering with SK Capital, the executive team, and all Woodstock associates to leverage the company’s unique sterile manufacturing capabilities, strong market position, and exceptional talent to execute our growth strategy. The BFS and sterile manufacturing markets are significant growth areas in our industry and together we have a great opportunity to positively impact the lives of countless patients, domestically and abroad.”

The business, which has been renamed Woodstock Sterile Solutions, will operate out of a single site in Woodstock, IL, and will support clinical- to commercial-stage formulation and manufacturing.

SK Capital Completes Acquisition of Catalent’s Blow-Fill-Seal CDMO

Pfizer and BioNTech announced on March 31, 2021 that a Phase III trial evaluating the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, in adolescents 12 to 15 years of age showed 100% efficacy and positive antibody responses.

The trial, which included 2260 participants in the United States, observed 18 cases of COVID-19 in the placebo group, compared to no cases in the vaccinated group, and produced SARS-CoV-2–neutralizing antibody geometric mean titers of 1239.5, which resulted in strong immunogenicity in a subset of adolescents one month after the second dose, Pfizer said in a company press release. This response exceeds that of an earlier vaccine trial aimed at participants aged 16 to 25 years old.

“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” said Albert Bourla, chairman and CEO, Pfizer, in the press release. “We plan to submit these data to FDA as a proposed amendment to our [e]mergency [u]se [a]uthorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”

“The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant. It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones,” added Ugur Sahin, CEO and co-founder of BioNTech, in the press release.

A Phase III trial evaluating the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, in adolescents 12 to 15 years of age showed 100% efficacy and positive antibody responses. 

Pfizer-BioNTech COVID-19 Vaccine Shows Positive Results in Clinical Trial for Adolescents

Amgen announced on March 30, 2021 that it has acquired Rodeo Therapeutics, a US-based biopharmaceutical company focused on small-molecule therapy development, for up to $721 million.

Under the terms of the agreement, Amgen will provide an upfront payment of $55 million and future potential milestone payments of up $666 million in cash, Amgen said in a company press release. The acquisition will give Amgen access to Rodeo's 15-prostaglandin dehydrogenase (15-PGDH) program, which will strengthen its inflammation portfolio.

"The enzyme 15-PGDH plays a key role in many disease-relevant processes such as stem cell self-renewal and epithelial barrier repair. Given the encouraging preclinical data to date, we are excited about the opportunity to develop a novel therapy with potential in a range of important inflammatory disease indications," said Raymond Deshaies, PhD, senior vice-president of global research at Amgen, in the press release.

"We are thrilled that Amgen recognizes the potential value and differentiated profile of our 15-PGDH inhibitor program,” added Thong Q. Le, president and CEO of Rodeo, in the press release. “With decades of experience in developing, manufacturing, and commercializing innovative therapies for patients suffering from a broad range of immunologic diseases and conditions, Amgen is ideally positioned to rapidly advance our program into the clinic."

The acquisition will give Amgen access to Rodeo's 15-prostaglandin dehydrogenase program, which will strengthen its inflammation portfolio. 