Vaccine candidate now expected to continue to be stable at standard refrigerator temperatures of 2° come 8°C (36° come 46°F) for 30 days, increase from previous calculation of 7 days
Shipping and long-term storage problems at typical freezer temperature of -20°C (-4°F) because that 6 months
mRNA-1273 come be spread using widely obtainable vaccine delivery and storage infrastructure
No dilution compelled prior to vaccination
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 16, 2020--Moderna, Inc. (Nasdaq: MRNA), a biotechnology agency pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation the transformative drugs for patients, today announced new data mirroring that mRNA-1273, its COVID-19 vaccine candidate, remains stable at 2° to 8°C (36° to 46°F), the temperature that a standard residence or clinical refrigerator, for 30 days. Stability experimentation supports this expansion from an previously estimate of 7 days. MRNA-1273 remains stable in ~ -20° C (-4°F) for up to 6 months, at refrigerated problems for as much as 30 days and also at room temperature for as much as 12 hours.
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“We believe that our invest in mRNA delivery technology and manufacturing procedure development will allow us come store and ship our COVID-19 vaccine candidate in ~ temperatures generally found in readily obtainable pharmaceutical freezers and also refrigerators,” said Juan Andres, Chief technological Operations and also Quality Officer in ~ Moderna. “We are pleased to send these extended stability conditions for mRNA-1273 to regulators for approval. The capability to store our vaccine for as much as 6 months at -20° C consisting of up come 30 work at normal refrigerator conditions after thawing is an important development and would permit simpler circulation and much more flexibility come facilitate wider-scale vaccination in the joined States and other components of the world.”
Shipping & long-term Storage: because that shipping and longer-term storage, Moderna expects the mRNA-1273 will be maintained at -20°C (-4°F), same to most home or clinical freezer temperatures, for approximately 6 months. Using traditional freezer temperature of -20°C (range of -25° come -15°C or -13° come 5°F) is an much easier and an ext established method of distribution and storage 보다 deep freezing and also most pharmaceutical circulation companies have the capacity to store and ship products at -20°C (-4°F) worldwide.
Refrigeration Storage: ~ thawing, to facilitate storage at point out of administration, Moderna expects the mRNA-1273 will remain stable at standard refrigerated conditions of 2° come 8°C (36° to 46°F) for as much as 30 days within the 6-month shelf life. The security at refrigerated conditions allows for warehouse at most pharmacies, hospitals, or physicians’ offices.
Room Temperature for Vaccination: as soon as the vaccine is gotten rid of from the refrigerator for administration, it have the right to be kept at room temperature conditions for as much as 12 hours.
No Dilution required at vaccination Site: The vaccine will certainly not require onsite dilution or one-of-a-kind handling, i beg your pardon facilitates vaccination across a range of settings including pharmacies and physicians’ offices.
The company anticipates that it will proceed to gather extr stability details over the coming months to assess whether mRNA-1273 can be shipped and stored under increasingly flexible conditions, which will certainly be described in information following regulation approval.
The mRNA-1273 COVID-19 vaccine candidate is Moderna’s tenth mRNA vaccine to enter the clinic. With its experience in prophylactic vaccine breakthrough and invest in mRNA platform and delivery technology, Moderna has developed enhanced manufacturing processes, leading to proprietary lipid nanoparticle an innovation that Moderna believes will enable the vaccine to it is in stored at traditional pharmaceutical distribution temperatures.
Moderna is working with the U.S. Centers for disease Control and Prevention (CDC), procedure Warp Speed and McKesson (NYSE: MCK), a COVID-19 vaccine distributor contract by the U.S. Government, as well as an international stakeholders to be prepared for circulation of mRNA-1273, in the occasion that the receives one Emergency usage Authorization and/or similar an international authorizations. The firm is additionally working carefully with the U.S. Food and Drug management (FDA) to send data indigenous its ongoing stability trial and error for approval.
mRNA-1273 is an mRNA vaccine versus COVID-19 encoding because that a prefusion stabilized kind of the Spike (S) protein, which to be co-developed through Moderna and also investigators native NIAID’s Vaccine research Center. The first clinical batch, which was funded by the Coalition because that Epidemic Preparedness Innovations, was completed ~ above February 7, 2020 and also underwent analytical testing; it to be shipped come the NIH on February 24, 42 days from sequence selection. The very first participant in the NIAID-led step 1 study of mRNA-1273 to be dosed on march 16, 63 days from sequence selection to step 1 study dosing. On may 12, the FDA granted mRNA-1273 fast Track designation. On may 29, the an initial participants in each age cohort: adults ages 18-55 year (n=300) and older adults eras 55 years and over (n=300) to be dosed in the step 2 examine of mRNA-1273. Top top July 8, the step 2 research completed enrollment.
Results from the second interim analysis of the NIH-led phase 1 examine of mRNA-1273 in the 56-70 and also 71+ age groups were published on September 29 in The new England newspaper of Medicine. ~ above July 28, results from a non-human primate preclinical viral challenge study analyzing mRNA-1273 were released in The brand-new England newspaper of Medicine. ~ above July 14, an interim analysis of the initial cohorts in the NIH-led phase 1 examine of mRNA-1273 was released in The new England journal of Medicine. MRNA-1273 currently is not approved for use by any kind of regulatory body.
BARDA is sustaining the continued research and advancement of mRNA-1273 through $955 million in federal resources under Contract no. 75A50120C00034. BARDA is reimbursing Moderna because that 100 percent that the allowable prices incurred by the firm for conducting the program explained in the BARDA contract. The U.S. Government has agreed to carry out up come $1.525 billion to acquisition supply that mRNA-1273 under U.S. Room of Defense Contract No. W911QY-20-C-0100.
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Forward looking Statements
This press release consists of forward-looking statements within the meaning of the exclusive Securities Litigation reform Act the 1995, as amended, including regarding the Company’s breakthrough of a potential vaccine (mRNA-1273) against the novel coronavirus, the conditions under which mRNA-1273 deserve to be shipped, stored and also administered, and also the U.S. Government’s potential to buy of mRNA-1273. In some cases, forward-looking statements can be figured out by terminology such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other similar terminology, although not all forward-looking statements contain this words. The forward-looking statements in this press release are neither assures nor guarantees, and you have to not place undue dependence on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, plenty of of which are past Moderna’s control and which could reason actual results to differ materially from those to express or comprise by this forward-looking statements. This risks, uncertainties, and also other factors include, amongst others: the reality that there has actually never been a advertisement product making use of mRNA an innovation approved because that use; the fact that the fast response modern technology in usage by Moderna is still gift developed and implemented; the fact that the safety and also efficacy of mRNA-1273 has actually not however been established; regardless of having ongoing interactions through the FDA or other regulatory agencies, the FDA or such other regulatory agencies might not agree v the Company’s regulation approval strategies, materials of our filings, such together clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; potential disadvantage impacts as result of the worldwide COVID-19 pandemic such as delays in regulation review, manufacturing and clinical trials, it is provided chain interruptions, adverse impacts on medical care systems and disruption the the an international economy; and also those various other risks and uncertainties explained under the heading “Risk Factors” in Moderna’s most recent Quarterly Report on kind 10-Q filed with the U.S. Securities and also Exchange the supervisory board (SEC) and also in succeeding filings make by Moderna with the SEC, i beg your pardon are easily accessible on the SEC’s website at www.sec.gov. Except as forced by law, Moderna disclaims any kind of intention or responsibility for updating or revising any kind of forward-looking statements had in this push release in the occasion of new information, future developments or otherwise. This forward-looking explanation are based upon Moderna’s current expectations and speak just as that the date hereof.
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Moderna ContactsMedia:Colleen HusseyDirector, that company Communications617-335-1374Colleen.Hussey