Pfizer to Test Covid-19 Vaccine That Doesn't Need Ultracold Storage
March 30 2021 - 3:05PM
Dow Jones News
By Jared S. Hopkins
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.
A powdered formulation would still require Pfizer's vaccine to
be mixed with diluent agents before administration, but would
reduce the number of cold-chain hurdles. Currently, health workers
at vaccination sites must actively manage freezing, refrigeration
and thawing times.
Peter Loftus contributed to this article.
(END) Dow Jones Newswires
March 30, 2021 14:50 ET (18:50 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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