- Pfizer and BioNTech announced a significant change to their coronavirus vaccine that could have a dramatic impact on shipping logistics and vaccine availability.
- The two companies say the drug can be stored at higher temperatures, which makes it easier to transport and should extend the vaccine’s reach.
- Pfizer and BioNTech say the vaccine can be stored at -25°C to -15°C (-13°F to 5°F) for up to two weeks. The drug can then be stored between 2⁰C and 8⁰C (36⁰F and 46⁰F) for an additional five days before being administered.
The Pfizer/BioNTech coronavirus vaccine currently used in many countries around the world was the first novel coronavirus vaccine candidate to have cleared clinical trials successfully. The drug is highly effective at preventing severe COVID-19 and deaths, according to Phase 3 trial data, and the side effects are minimal. Various studies have already analyzed the vaccine’s efficacy against the new mutations, finding that the drug can still neutralize some of the SARS-CoV-2 mutants that have become dominant in certain regions. But the mRNA vaccine does have a significant disadvantage compared to many other COVID-19 vaccines that have received Emergency Use Authorization (EUA), and it’s an issue that can hinder vaccination campaigns: The drug requires extremely low temperatures for long-term storage.
Ultra-cold freezers are needed to transport and store the drug prior to use, and this can be a logistics nightmare for certain countries and regions that might not have the infrastructure in place to transport and store the drug. But Pfizer and BioNTech just announced a huge change to the way the drug can be stored, revealing the vaccine can be stored at -25°C to -15°C (-13°F to 5°F) for up to two weeks and then at even higher temperatures five days before use.
Pfizer and BioNTech submitted new data to the FDA that shows the stability of the vaccine at -25°C to -15°C (-13°F to 5°F). These are temperatures usually found in pharmaceutical freezers and refrigerators. The companies have proposed an update to the EUA prescribing information, which would allow the institutions involved in COVID-19 vaccination campaigns to make changes to their vaccine distribution protocols and expand the vaccine’s reach.
The two companies explained that the new FDA submission includes stability data generated on vaccine batches manufactured in the past nine months, including batches that were used for clinical trials. Pfizer and BioNTech will also issue the same documentation to other regulators around the world that have authorized the drug for emergency use. Since mid-December, the vaccine has been used in various markets, including the US, UK, Europe, Israel, and more.
The current EUA labels say that the vaccine must be stored in ultra-cord freezers at temperatures ranging from -80ºC to -60ºC (-112ºF to ‑76ºF), where it can remain for up to 6 months. The vaccines are shipped in specially-designed boxes that contain dry ice in order to achieve those low temperatures. The vaccine can be stored in these boxes for up to 30 days if the dry ice is refilled every three days.
According to the proposed changes, Pfizer’s vaccine can be stored for up to five days at average refrigerator temperature between 2⁰C and 8⁰C (36⁰F and 46⁰F) before it’s mixed with a saline diluent and administered to people. The vaccine is then administered to people at room temperature.
If the FDA approves the proposed label change, hospitals, pharmacies, and other centers that might be involved in the vaccination process would be able to store the drug at the proposed -25°C to -15°C (-13°F to 5°F) temperature for two weeks. After that, the drug can continue to be stored for an additional five days between 2⁰C and 8⁰C (36⁰F and 46⁰F) once it’s prepared to be administered. The new temperature recommendation could also help reduce the number of vaccines that are wasted, which is a key issue when supply remains low. The drugs can only be used within a certain window of time after being thawed.
Pfizer and BioNTech did say a few months ago they were studying whether their drug could be stored at higher temperatures than the initial estimates. The announcement highlights Pfizer’s second COVID-19 vaccine “upgrade” in a matter of weeks. Recently, the two companies have announced they can mass-produce the drug almost twice as fast as before.
The Moderna drug, also an mRNA vaccine that showed the same efficacy in the Phase 3 trial as the BioNTech drug, needs low storage temperatures as well. But the Moderna drug remains stable at higher temperatures. The drug can be stored between 2° and 8°C (36° to 46°F) for up to 30 days prior to use. It can be kept at standard freezer temperature of -20°C (-4°F) for six months during shipping and long-term storage.