COVID-19 Update

Post-inspection report reveals nine sanitary and process problems at Bayview, Md., facility.

FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.

Pending a completed FDA inspection, Emergent BioSolutions halts manufacture of vaccine drug substance at Maryland facility.

The additional doses are a result of the European Commission’s expanded advance purchase agreement, which brings the total number of doses delivered to the EU to 600 million.

The agency revoked EUA status for the monoclonal antibody bamlanivimab to be administered alone to treat mild-to-moderate COVID-19.

The agency will use technology for “voluntary remote interactive evaluations” for pre- and post-approval and other types of inspections.

CDC and FDA are reviewing data from reported cases of a rare type of blood clot in people that received the Johnson & Johnson COVID-19 vaccine.

FDA has accepted Airway’s investigational new drug application for the development of its novel human recombinant protein, AT-100 (rhSP-D), as a treatment for COVID-19.

Eli Lilly has modified its purchase agreements with the US government for its emergency use authorized COVID-19 neutralizing antibody therapies, bamlanivimab and etesevimab, to be supplied and used together rather than individually.

A Phase III clinical trial of anti-coronavirus immunoglobulin did not meet its endpoints, concluding the year-long CoVIg-19 Plasma Alliance, Takeda and CSL Behring announced.

Under the terms of the expanded agreement, Catalent will provide Moderna with a new high-speed vial filling line until June 2023 along with inspection, labeling, cartoning, and final packaging for potential pipeline programs.

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.

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

The availability of materials is a critical factor when it comes to vaccine capacity.

Smart, accurate, science-based messaging is needed to advance bio/pharma science.

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

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.

GSK will provide filling capacity at its Barnard Castle facility in England.

Celonic will manufacture CvnCoV at its facility in Germany.

Celltrion Group has revealed that EMA's CHMP has issued a positive scientific opinion for regdanvimab (CT-P59)—an anti-COVID-19 monoclonal antibody treatment candidate.

EMA has approved the manufacturing of drug product for BioNTech’s COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany.

The agency’s human medicines committee has approved new manufacturing sites for COVID-19 vaccines.

The company has entered into an agreement with the African Vaccine Acquisition Trust for the supply of 220 million doses of its single-shot COVID-19 vaccine for the African Union’s 55 member states beginning in the third quarter of 2021.

AstraZeneca has released the results of its primary analysis of the Phase III trial data evaluating its COVID-19 vaccine.

Roche has revealed the positive topline results from it Phase III trial assessing the investigational antibody cocktail of casirivimab and imdevimab in high-risk non-hospitalized COVID-19 patients.

EFPIA and Vaccines Europe urge the avoidance of any reactionary measures that could disrupt the production and delivery of COVID-19 vaccines.

After releasing US Phase III trial data for AZD1222, more questions have been raised with AstraZeneca concerning potentially outdated information that could provide an incomplete view of efficacy.

Under an expanded agreement with J&J, Catalent Biologics will increase manufacturing capacity at its Anagni, Italy, site to accommodate the large-scale commercial supply of Janssen’s COVID-19 vaccine.

The companies will collaborate at BioCentriq’s GMP facilities to produce Tevogen’s proprietary COVID-19 targeted T cells.

The companies will use capacity at IDT previously reserved for Takeda’s dengue vaccine candidate, TAK-003, to manufacture Janssen Pharmaceutical’s single-shot COVID-19 vaccine.