The pharmaceutical companies Pfizer and BioNTech presented to the United States Food and Drug Administration (FDA) new data that vials of the vaccine against covid-19 can be stored not only at minus 25 degrees, but at minus 15 degrees Celsius for two weeks .
« If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply, » said Albert Bourla, president and CEO of Pfizer.
« Our highest priority was to rapidly develop a safe and effective vaccine and make it available to the most vulnerable people to save lives. At the same time, we have collected data that can facilitate the handling of our vaccine in pharmacies and provide vaccination centers even more flexibility, « said Ugur Sahin, CEO and Co-Founder of BioNTech.
Data submission to the FDA includes stability reports generated on batches manufactured during the last nine months of covid-19 vaccine development, from batches that supplied the first clinical trials to commercial-scale batches currently in production. The data will also be presented to global regulatory agencies in the coming weeks.
Currently, Pfizer-BioNTech’s covid-19 vaccine labels, including those for emergency use in the United States, indicate that the vaccine should be stored in an ultra-cold freezer at temperatures between minus 80 degrees Celsius.
This means that the vaccine can be stored at these temperatures for up to six months. The vaccines are shipped in a specially designed insulated container that can be used as temporary storage for a total of up to 30 days by refilling with dry ice every five days.
Before being mixed with a saline diluent, the vaccine can also be refrigerated for up to five days at standard refrigerator temperature, between two and eight degrees Celsius.
“If approved, the option to store at minus 25-15 degrees Celsius for two weeks would be in addition to this five-day storage option at standard refrigerator temperature. It should be noted that the vaccine is administered at room temperature by medical personnel ”.
As more stability data becomes available, Pfizer and BioNTech anticipate that the shelf life or expiration date could be extended and that short-term storage of the vaccine at another temperature could be considered.
The vaccine is based on mRNA technology and is under an emergency use authorization for active immunization to prevent novel coronavirus disease in individuals 16 years of age or older. The vaccine has not been approved or authorized by the FDA; however, it has been authorized for emergency use by the same organization.
The emergency use of this product is only authorized while there are circumstances that justify the declaration, although it may be terminated or revoked sooner. It should not be administered to people with a history of severe allergic reaction, eg anaphylaxis, and to any component of the biological. Appropriate medical treatment used to manage immediate allergic reactions should be provided immediately.
Recipients of the Pfizer-BioNTech vaccine should be monitored for the occurrence of immediate adverse reactions, according to the guidelines of the Centers for Disease Control and Prevention.
Immunocompromised people, including those receiving immunosuppressive treatment, may have a lowered immune response, and may not protect all vaccine recipients.
In clinical studies, adverse reactions in participants 16 years of age or older indicated injection site pain (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), swelling at the injection site (10.5%), redness at the injection site (9.5%), nausea (1.1%), malaise (0.5%) and lymphadenopathy (0.3%).
Serious allergic reactions, including anaphylaxis, have been reported after the Pfizer-BioNTech covid-19 vaccine during mass vaccination outside of clinical trials. Other adverse reactions, some of which may be serious, may manifest with more widespread use of the Pfizer-BioNTech vaccine.
No data are available on the interchangeability of the Pfizer-BioNTech vaccine with other covid-19 vaccines to complete the vaccination series. People who have received one dose must receive a second to complete the vaccination series.