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WHITTENHALLJR

11/13/20 3:39 PM

#1166 RE: makinezmoney #1165

That’s why I follow you >> one of the few in otc that knows what the heck there doing!! Looking forward to this barn burner running its butt off to $1.00 $LTMP

WHITTENHALLJR

11/14/20 7:56 AM

#1168 RE: makinezmoney #1165

“Delivering billions of doses of vaccine which must be kept at ultra cold temperatures to the entire world efficiently will involve hugely complex logistical and programmatic obstacles all the way along the supply chain. We look forward to working together with government, vaccine manufacturers and logistical partners to ensure an efficient global roll-out of a safe and affordable COVID-19 vaccine,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance.

Facilities: Vaccines must be handled and transported in line with international regulatory requirements, at controlled temperatures and without delay to ensure the quality of the product. While there are still many unknowns (number of doses, temperature sensitivities, manufacturing locations, etc.), it is clear that the scale of activity will be vast, that cold chain facilities will be required and that delivery to every corner of the planet will be needed. Priorities for preparing facilities for this distribution include:

Availability of temperature-controlled facilities and equipment - maximizing the use or re-purposing of existing infrastructure and minimizing temporary builds
Availability of staff trained to handle time- and temperature-sensitive vaccines
Robust monitoring capabilities to ensure the integrity of the vaccines is maintained
Security: Vaccines will be highly valuable commodities. Arrangements must be in place to keep ensure that shipments remain secure from tampering and theft. Processes are in place to keep cargo shipments secure, but the potential volume of vaccine shipments will need early planning to ensure that they are scalable.

Border Processes: Working effectively with health and customs authorities will, therefore, be essential to ensure timely regulatory approvals, adequate security measures, appropriate handling and customs clearance. This could be a particular challenge given that, as part of COVID-19 prevention measures, many governments have put in place measures that increase processing times. Priorities for border processes include:

Introducing fast-track procedures for overflight and landing permits for operations carrying the COVID-19 vaccine
Exempting flight crew members from quarantine requirements to ensure cargo supply chains are maintained
Supporting temporary traffic rights for operations carrying the COVID-19 vaccines where restrictions may apply
Removing operating hour curfews for flights carrying the vaccine to facilitate the most flexible global network operations
Granting priority on arrival of those vital shipments to prevent possible temperature excursions due to delays
Considering tariff relief to facilitate the movement of the vaccine
Capacity
On top of the transport preparations and coordination needed, governments must also consider the current diminished cargo capacity of the global air transport industry. IATA warned that, with the severe downturn in passenger traffic, airlines have downsized networks and put many aircraft into remote long-term storage. The global route network has been reduced dramatically from the pre-COVID 24,000 city pairs. The WHO, UNICEF and Gavi have already reported severe difficulties in maintaining their planned vaccine programs during the COVID-19 crisis due, in part, to limited air connectivity.

“The whole world is eagerly awaiting a safe COVID vaccine. It is incumbent on all of us to make sure that all countries have safe, fast and equitable access to the initial doses when they are available. As the lead agency for the procurement and supply of the COVID vaccine on behalf of the COVAX Facility, UNICEF will be leading what could possibly be the world’s largest and fastest operation ever. The role of airlines and international transport companies will be critical to this endeavour,” said Henrietta Fore, UNICEF Executive Director.

The potential size of the delivery is enormous. Just providing a single dose to 7.8 billion people would fill 8,000 747 cargo aircraft. Land transport will help, especially in developed economies with local manufacturing capacity. But vaccines cannot be delivered globally without the significant use air cargo.

“Even if we assume that half the needed vaccines can be transported by land, the air cargo industry will still face its largest single transport challenge ever. In planning their vaccine programs, particularly in the developing world, governments must take very careful consideration of the limited air cargo capacity that is available at the moment. If borders remain closed, travel curtailed, fleets grounded and employees furloughed, the capacity to deliver life-saving vaccines will be very much compromised,” said de Juniac.

WHITTENHALLJR

11/14/20 10:09 AM

#1169 RE: makinezmoney #1165

the vaccine's complex and super-cold storage requirements are an obstacle for even the most sophisticated hospitals in the United States and may impact when and where it is available in rural areas or poor countries where resources are tight.

The main issue is that the vaccine, which is based on a novel technology that uses synthetic mRNA to activate the immune system against the virus, needs to be kept at minus 70 degrees Celsius (-94 F) or below.

"The cold chain is going to be one of the most challenging aspects of delivery of this vaccination," said Amesh Adalja, senior scholar at Johns Hopkins Center for Health Security.

"This will be a challenge in all settings because hospitals even in big cities do not have storage facilities for a vaccine at that ultra-low temperature."

WHITTENHALLJR

11/16/20 8:44 AM

#1177 RE: makinezmoney #1165

$LTMP refrigerant sales will go bonkers>>>


Moderna's Vaccine approved............ Requires Refrigeration

Thanks makinezmoney


Moderna Announces Longer Shelf Life for its COVID-19 Vaccine Candidate at Refrigerated Temperatures MRNA

****************************************************

Vaccine candidate now expected to remain stable at standard refrigerator temperatures of 2deg to 8degC (36deg to 46degF) for 30 days, up from previous estimate of 7 days

Shipping and long-term storage conditions at standard freezer temperatures of -20degC (-4degF) for 6 months

mRNA-1273 to be distributed using widely available vaccine delivery and storage infrastructure

No dilution required prior to vaccination

CAMBRIDGE, Mass.--(BUSINESS WIRE)--November 16, 2020--

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced new data showing that mRNA-1273, its COVID-19 vaccine candidate, remains stable at 2deg to 8degC (36deg to 46degF), the temperature of a standard home or medical refrigerator, for 30 days. Stability testing supports this extension from an earlier estimate of 7 days. mRNA-1273 remains stable at -20deg C (-4degF) for up to six months, at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours.

"We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators," said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. "We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval. The ability to store our vaccine for up to 6 months at -20deg C including up to 30 days at normal refrigerator conditions after thawing is an important development and would enable simpler distribution and more flexibility to facilitate wider-scale vaccination in the United States and other parts of the world."

Shipping & Long-term Storage: For shipping and longer-term storage, Moderna expects that mRNA-1273 will be maintained at -20degC (-4degF), equal to most home or medical freezer temperatures, for up to 6 months. Using standard freezer temperatures of -20degC (range of -25deg to -15degC or -13deg to 5degF) is an easier and more established method of distribution and storage than deep freezing and most pharmaceutical distribution companies have the capability to store and ship products at -20degC (-4degF) worldwide.

Refrigeration Storage: After thawing, to facilitate storage at points of administration, Moderna expects that mRNA-1273 will remain stable at standard refrigerated conditions of 2deg to 8degC (36deg to 46degF) for up to 30 days within the 6-month shelf life. The stability at refrigerated conditions allows for storage at most pharmacies, hospitals, or physicians' offices.

Room Temperature for Vaccination: Once the vaccine is removed from the refrigerator for administration, it can be kept at room temperature conditions for up to 12 hours.

No Dilution Required at Vaccination Site: The vaccine will not require onsite dilution or special handling, which facilitates vaccination across a range of settings including pharmacies and physicians' offices.

The Company anticipates that it will continue to gather additional stability information over the coming months to assess whether mRNA-1273 can be shipped and stored under increasingly flexible conditions, which will be described in detail following regulatory approval.

The mRNA-1273 COVID-19 vaccine candidate is Moderna's tenth mRNA vaccine to enter the clinic. With its experience in prophylactic vaccine development and investments in mRNA platform and delivery technology, Moderna has developed enhanced manufacturing processes, resulting in proprietary lipid nanoparticle technology that Moderna believes will enable the vaccine to be stored at standard pharmaceutical distribution temperatures.

Moderna is working with the U.S. Centers for Disease Control and Prevention (CDC), Operation Warp Speed and McKesson (NYSE: MCK), a COVID-19 vaccine distributor contracted by the U.S. government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an Emergency Use Authorization and/or similar global authorizations. The Company is also working closely with the U.S. Food and Drug Administration (FDA) to submit data from its ongoing stability testing for approval.

About mRNA-1273

mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID's Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA granted mRNA-1273 Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of mRNA-1273. On July 8, the Phase 2 study completed enrollment.

Results from the second interim analysis of the NIH-led Phase 1 study of mRNA-1273 in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On July 28, results from a non-human primate preclinical viral challenge study evaluating mRNA-1273 were published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of mRNA-1273 was published in The New England Journal of Medicine. mRNA-1273 currently is not approved for use by any regulatory body.

BARDA is supporting the continued research and development of mRNA-1273 with $955 million in federal funding under Contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to provide up to $1.525 billion to purchase supply of mRNA-1273 under U.S. Department of Defense Contract No. W911QY-20-C-0100.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company's development of a potential vaccine (mRNA-1273) against the novel coronavirus, the conditions under which mRNA-1273 can be shipped, stored and administered, and the U.S. government's potential purchases of mRNA-1273. In some cases, forward-looking statements can be identified 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 comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201116005606/en/

CONTACT: Moderna Contacts

Media:

Colleen Hussey

Director, Corporate Communications

617-335-1374

Colleen.Hussey@modernatx.com

Investors:

Lavina Talukdar

Senior Vice President & Head of Investor Relations

617-209-5834

Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

Copyright Business Wire 2020

> Dow Jones Newswires

November 16, 2020 06:52 ET (11:52 GMT)




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