With widespread distribution of various vaccines against COVID-19 vaccine ongoing, companies are still refining their vaccines and therapies and generating new data. Here’s a look at two recent updates.
With widespread distribution of various vaccines against COVID-19 vaccine ongoing, companies are still refining their vaccines and therapies and generating new data. Here’s a look at two recent updates.
Pfizer’s COVID-19 Vaccine Does Not Require Ultra-Cold Storage During Transport
The U.S. Food and Drug Administration (FDA) no longer requires Pfizer to transport their vaccine at the ultra-cold temperatures. The company submitted data to the FDA to support the alternative temperatures, which were originally between -80 and -60 degrees C (-112 and -76 degrees F).
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, stated, “Pfizer submitted data to the FDA to support this alternative temperature for transportation and storage. This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions. The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites.”
The alternative temperature doesn’t apply to the storage of thawed vials before dilution. These can be held in the refrigerator for up to five days, or on the storage of thawed vails after dilution, which can be held at refrigerator temperature or room temperature for use within six hours.
The FDA has updated its Fact Sheets for Health Care Providers Administering Vaccine.
Regeneron’s Antibody Cocktail Decreased Hospitalization or Death by 70%
Regeneron reported that its REGEN-COV antibody cocktail (casirivimab with imdevimab) decreased the risk of hospitalization or death by 70% in non-hospitalized COVID-19 patients. This cut the duration of symptoms by four days. They found that all doses, 8,000 mg, 2,400 mg and 1,200 mg, had similar efficacy. The FDA updated its Emergency Use Authorization fact sheets for all authorized monoclonal antibody therapies and indicated that REGEN-COV was the only one to retain its efficacy against key emerging variants.
The therapeutic also hit all secondary endpoints in the Phase III outcomes study, including reduction of symptom duration. A companion Phase II trial demonstrated that even the lowest doses tested, 300-mg intravenous and 600-mg subcutaneous, had significant decreases in viral load over the first seven days of the study, comparable to the 2,400-mg and 1,200-mg intravenous doses.
“This is a landmark moment in the fight against COVID-19 as this large well-controlled trial provides conclusive results demonstrating that REGEN-COV can dramatically reduce the risk of hospitalization and death in the outpatient setting,” said Suraj Saggar, trial investigator and Chief of Infectious Disease at Holy Name Medical Center in Teaneck, New Jersey. “With so many people still getting infected, as well as recent data showing that REGN-COV addresses emerging variants, these data underscore the need to rapidly adopt REGEN-COV as standard-of-care to offer high-risk patients their best chance to reduce serious consequences like hospitalization or death.”
George Yancopoulos, president and chief scientific officer of Regeneron, added, “With approximately 60,000 newly diagnosed individuals in the U.S. every day and 40,000 still in the hospital because of COVID-19, we are committed to working with the government, healthcare providers and others to support rapid and widespread adoption of REGEN-COV in appropriate patients. We will discuss the new data with regulatory authorities and request that the 1,200 mg dose be rapidly added to the U.S. Emergency Use Authorization, in order for the anticipated REGEN-COV supply to be available to treat even more patients. These Phase III data will also form the basis of a full Biologics License Application.”
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