Pfizer, BioNTech Seek Full FDA Approval for COVID-19 Vaccine

Pfizer and BioNTech recently announced the initiation of a Biologics License Application for full FDA approval of their mRNA COVID-19 vaccine

With the application, the companies submitted data t from an analysis of the company’s Phase 3 clinical trial, which found that the Pfizer-BioNTech vaccine was 91.3 percent effective against the coronavirus six months following the second dose.

Additionally, the vaccine was 100 percent effective against severe disease as defined by the CDC and 95.3 percent against severe COVID-19 as defined by FDA. 

The data will be submitted on a rolling basis over the next few weeks, with a request for priority review. 

“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” Albert Bourla, chairman and chief executive officer at Pfizer said in the announcement. 

“We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months,” Bourla continued. 

Pfizer noted that the Prescription Drug User Fee Act (PDUFA) goal date for a decision by FDA will be set once the Biologics License Application is accepted for review by the agency. 

Currently, the Pfizer-BioNTech vaccine is available in the US under emergency use authorization, which was granted by FDA in December.  At the time, available data showed that the vaccine was effective in preventing COVID-19 in individuals 16 years of age and older.

Along with the Biologics License Application, the companies also submitted an application to expand the current emergency use authorization for their vaccine to include individuals 12 to 15 years of age.

GSK, Vir Biotechnology Announce European Review of COVID-19 Treatment 

GSK and Vir Biotechnology recently announced that the European Medicines Agency (EMA) has begun the rolling review of data on its COVID-19 antibody treatment

The antibody, sotrovimab, is intended for the treatment of adults and adolescents with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe coronavirus. 

The EMA will evaluate all data on sotrovimab, including available evidence from all clinical trials. The agency will also look at the safety, efficacy, and quality of the antibody with usual standards. 

The decision to start the rolling review is based on the Phase 3 COMET-ICE trial, which found that sotrovimab reduced hospitalization or death by 85 percent in patients who received the antibody as monotherapy compared to placebo. 

Currently, sotrovimab is under review by other global regulators, such as Health Canada under the Interim Order application pathway for COVID-19 drugs. 

Moderna Expands its Manufacturing Technology Center in Massachusetts

Moderna recently announced that it is more than doubling the space at its manufacturing facility in Massachusetts, Moderna Technology Center (MTC).

The expansion will allow the company to transform the facility from a production and lab space of 30,000 square feet to an industrial technology center of 65,000 square feet.

This will be done through renovation of existing space and acquisition of a 240,000 square foot building located on the same campus. Ultimately, the initiative will support a 50 percent increase in production of Moderna’s COVID-19 vaccine.

Vaccine manufacturing is anticipated to increase in late 2021 and early 2022. Global capacity for the vaccine is also expected to increase to 3 billion doses. 

“We believe that this investment and expansion at our technology center will allow us to continue to optimize our mRNA products as we explore new pharmaceutical delivery forms such as prefilled syringes and lyophilized products. As we grow, we are committed to minimizing our environmental footprint,” said Stephane Bancel, chief executive officer of Moderna. 

The expansion will also include an increase in Moderna’s technical development capacity and preclinical production capability. Currently, there is capability to produce thousands of preclinical samples per month for research and development, the company explained.