Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C).
That’s cold but not nearly as cold as the mRNA-based vaccine’s emergency use authorization (EUA) label calls for, which is storage in an ultra-cold freezer at temps of between -112 to -76 degrees Fahrenheit (-80 and -60 degrees Celsius). The data are included in a submission for updating the current prescribing information by allowing the vaccine to be stored at the new levels for two weeks.
Coupled with the Feb. 18 data published in The Lancet showing the vaccine was found to be 85% effective 15 to 28 days after the first dose for Israeli health care workers, the new storage temperatures, if approved, could widen patient access to BNT-162b2. The lipid nanoparticle mRNA vaccine is currently administered as a series of two doses, three weeks apart.
The EUA is based on data from multiple studies, including a phase III trial that found BNT-162b2 to be 95% effective in preventing people from contracting the infection for seven days following the second injection.
Pfizer reported solid earnings for 2020 and said it expects even bigger things this year as the company projects approximately $15 billion in earnings from the COVID-19 vaccine.
Johnson & Johnson, pursuing a single-dose path for its vaccine, has a candidate thought by the company to remain stable for two years at -4 degrees Fahrenheit (-20 degrees Celsius). Janssen-Cilag International NV has now submitted an emergency use listing request to the World Health Organization. The submission includes efficacy and safety data from its phase III Ensemble study, the same study used in the company’s early February request to the FDA seeking an EUA.
At current storage temperature levels, the Pfizer-Biontech vaccine can be stored for up to six months. It is shipped in thermal containers that can serve as temporary storage for up to 30 days, provided containers are refilled with dry ice every five days. The vaccine can also be refrigerated for as many as five days at what is considered a standard refrigerator temperature of 36 to 46 degrees Fahrenheit (2 and 8 degrees Celsius).
Pfizer and Biontech also have dosed the first participants in a phase II/III trial to evaluate the safety, tolerability and immunogenicity of BNT-162b2 administered in about 4,000 healthy pregnant women, 18 and older, receiving two doses of BNT-162b2 or placebo 21 days apart. Participation lasts seven to 10 months. The two companies said they also expect to begin studies in children between the ages of 5 and 11 in the next two months and in children younger than 5 later in 2021.
Dr. Reddy’s Laboratories Ltd., of Hyderabad, India, is seeking an EUA from the Indian government for the Russian vaccine Sputnik V (Gam-COVID-Vac). The request will include safety profile data of a phase II study of the treatment along with interim data from a phase III study that’s expected by Feb. 21. Sputnik V already has EUAs from many countries, including Russia, Argentina, Bolivia and Venezuela.
More COVID-19 development
Atea Pharmaceuticals Inc., of Boston, said Chugai Pharmaceutical Co. Ltd. has in-licensed the rights for AT-527 for treating COVID-19 in Japan from Roche Holding AG. AT-527 is being developed by Roche and Atea, with Roche holding the rights to commercialize AT-527 outside of the U.S. AT-527 is an oral antiviral developmental agent derived from Atea’s purine nucleotide prodrug platform and is in a global phase II study for treating COVID-19 in patients hospitalized with moderate COVID-19 and also in a phase II virology study of patients with mild or moderate COVID-19 in an outpatient setting. The companies said a pivotal phase III trial is in the works for those who are also outpatients.
Fresh preclinical data from Immunoprecise Antibodies Ltd., of Victoria, British Columbia, show its TATX-03 antibody cocktail provides antiviral effects against SARS-CoV-2 in preventive and treatment settings. Also, by incorporating multiple antibodies that recognize different, non-overlapping epitopes on the SARS-CoV-2 spike protein, TATX-03 could prevent mutational escape, the process by which a virus, through mutation, may render vaccines less efficacious, the company added.