The temperature limit on storage, known as the biggest vulnerability of the novel coronavirus infection (Corona 19) vaccine jointly developed by Pfizer and Bioentech, is expected to be slightly improved.
The two companies recently submitted new data to the US Food and Drug Administration (FDA) demonstrating the stability of their Corona 19 vaccine when stored from -25°C to -15°C.
-25℃ ~ -15℃ is generally the standard refrigeration temperature for medicine storage. If this provides an additional option to store the vaccine vial for two weeks, the company claims that it will improve handling convenience and make the vaccine supply plan more flexible.
Currently, Pfizer/Bioentech’s Corona 19 vaccine must be stored in a cryogenic freezer at a temperature of -80°C to -60°C in the permit, and can be stored at that temperature for up to 6 months.
Transport to the inoculation site is also delivered in a specially designed container (stored for up to 30 days) in a manner that is refilled with dry ice every 5 days, and the vaccine before saline dilution is delivered for up to 5 days at a normal refrigeration temperature of 2℃ to 8℃. Storage is possible.
If the US FDA accepts the safety data submitted by the company and reflects it in the approval of the vaccine, the vaccine can be stored at -25℃ to -15℃ for up to two weeks at an inoculum equipped with a refrigeration facility exclusively for medicines. .
The data submitted are stability data for batches manufactured during the last nine months of vaccine development, and vaccines produced from those batches are being used from initial clinical trials to the production of commercial products.
The company plans to submit the data to regulators around the world within a few weeks.
“We are continuing to conduct stability studies to maximize vaccine access and support commercial scale production, and working with the US FDA and CDC to make vaccines increasingly flexible,” said Pfizer Chief Executive Officer, Albert Bourla. “We are working hard to ensure that they can be shipped and stored in condition,” he said. “If this new storage option is approved, it will provide greater flexibility in your vaccine delivery strategy.”
Meanwhile, in Korea, the first expert advisory meeting will be held for Pfizer/Bioentech’s approval of the Corona 19 vaccine.
The Ministry of Food and Drug Safety held a meeting on the 22nd of the’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Group’ meeting on the Corona 19 vaccine (product name Cominati), which Pfizer Korea applied for product permission, on January 25. He said it would be public.
The Ministry of Food and Drug Safety said, “We are carefully reviewing the data on non-clinical, clinical, quality, etc. submitted at the time of application for permission, and we plan to receive advice from external experts on safety, effectiveness, and clinical significance at this verification advisory meeting.” .