Pfizer Inc. and partner BioNTech SE plan to begin soon testing a freeze-dried version of its Covid-19 vaccine, which if proven to work safely could ease storage and handling of the shots in rural U.S. areas and low-income countries.
In April, Pfizer is set to start a clinical trial evaluating a so-called lyophilized formulation in adults 18 to 55 years old in the U.S., according to a government database, clinicaltrials.gov, and confirmed by the company.
The 1,100-subject study would last about two months, with researchers seeking to determine whether the lyophilized version is as safe and effective as the version authorized by regulators beginning late last year. Researchers would administer to subjects either the lyophilized version or the current formulation.
If successful, the new formulation could be ready for use by early next year, Pfizer said on an earnings call last month.
Lyophilized vaccines offer advantages to frozen or liquid vaccines because they only need standard refrigeration. That would help with storage and handling and expand access in rural areas and low-income countries that lack specialized equipment. Examples of vaccines that can be lyophilized include shots for preventing shingles or rotavirus.
Pfizer’s vaccine, which uses a new gene-based technology called mRNA, requires the shots to be stored at ultracold subzero temperatures to work properly. In February, the U.S. Food and Drug Administration said the Pfizer vaccine can be stored at roughly minus 20 degrees Celsius (minus 4 degrees Fahrenheit) for as long as two weeks.
The requirement for expensive ultracold storage has been a hurdle for some providers and local health departments around the world.