Pfizer reduces ultra-low temperature requirements for COVID-19 vaccine

According to new data submitted by Pfizer to the US Food and Drug Administration, the mRNA COVID-19 vaccine is stable for longer periods of time at warmer temperatures than previously thought. The new recommendations suggest that the vaccine is stable for 2 weeks in a freezer around -15 ° C (5 ° F), greatly increasing shipping and storage flexibility.

The first COVID-19 vaccine approved for emergency use in the United States last year was based on state-of-the-art mRNA technology. Developed by German company BioNTech with the support of pharmaceutical giant Pfizer. Vaccine showed incredible effect However, be careful. The vaccine had to be kept very cold to prevent degradation.

Standard drug freezers offer temperatures from -25 ° C to -15 ° C (-13 ° F to 5 ° F). Ultra-low temperature freezers, on the other hand, can keep items at temperatures between -80ºC and -60ºC (-112ºF to -76ºF).

The main challenge in effectively distributing Pfizer’s COVID-19 vaccine is the lack of a super cold chain delivery infrastructure in many parts of the world to keep the vaccine at the required temperature. Pfizer has developed a new dry ice package to help distribute the vaccine widely, but the requirement for ultra-low temperature storage has inevitably been a difficult and costly problem to overcome.

Currently, the company suggests that new data indicate that the vaccine is stable at more normal freezer temperatures between -25 ° C and -15 ° C (-13 ° F to 5 ° F) for at least two weeks. Claims to be. This new data was provided to the FDA in the hope of updating the Emergency Authorization details.

BioNTech CEO Ugur Sahin suggests that this new recommendation stems from ongoing stability studies that have been underway since mass production of the vaccine began late last year. The mRNA technology behind this vaccine is so new that the company has understated its storage recommendations until further data are collected.

“Our top priority was to quickly develop safe and effective vaccines and make them available to the world’s most vulnerable people to save lives,” says Sahin. “At the same time, we continuously collected data that would allow storage at approximately -20 ° C (-4 ° F). The data submitted facilitated the handling of vaccines in pharmacies and further to the vaccine center. It can provide great flexibility. “

Pfizer’s candidate is not the only mRNA COVID-19 vaccine on the market.Another shortly after Pfizer’s emergency FDA approval last year Moderna RNA vaccine, Did not require comparable ultra-low temperature storage.

Moderna’s RNA vaccine is said to be stable for up to 6 months at normal freezer temperatures from -25 ° C to -15 ° C (-13 ° F to 5 ° F). Explaining the storage condition mismatch between two similar mRNA vaccines, Moderna argues that its unique lipid nanoparticle formulation improves stability at high temperatures compared to Pfizer candidates.

Talk to NPR In November last year, a Moderna spokeswoman also explained that the company has gained significant experience over the years in the development of many other mRNA vaccines. This probably gives us a deeper insight into how stable the mRNA vaccine is at different temperature conditions.

“I don’t need it now [ultra-cold conditions] Product quality is improved, [it] It does not need to be highly frozen to avoid degradation of mRNA, “said Moderna spokeswoman Colleen Hussey.

Peter English, a former chairman of the British Medical Association’s Public Health Commission, said that as Pfizer learns over time, it may further increase the storage temperature requirements for the COVID-19 vaccine. ..

“I wouldn’t be surprised if they could increase this period over time and as the pre-test storage period increased,” says English. “This can significantly ease infrastructure requirements.”

Source: Pfizer