Sunday, November 29, 2020

3Q2020 NAND FLASH WorldWide market share: Samsung 33,1%, Kioxia 21,4%, WDC 14,3%, SK Hynix 11,3%, says TrendForce

 



Total NAND Flash revenue reached US$14.5 billion in 3Q20, a 0.3% increase QoQ, while total NAND Flash bit shipment rose by 9% QoQ, but the ASP fell by 9% QoQ, according to TrendForce’s latest investigations. 

The market situation in 3Q20 can be attributed to the rising demand from the consumer electronics end as well as the recovering smartphone demand before the year-end peak sales season. 

Notably, in the PC market, the rise of distance education contributed to the growing number and scale of Chromebook tenders, but the increase in the demand for Chromebook devices has not led to a significant increase in NAND Flash consumption because storage capacity is rather limited for this kind of notebook computer. 

Moreover, clients in the server and data center segments had aggressively stocked up on components and server barebones during 2Q20 due to worries about the impact of the pandemic on the supply chain. 

Hence, their inventories reached a fairly high level by 3Q20. Clients are now under pressure to control and reduce their inventories during this second half of the year. With the scaling back procurement, the overall NAND Flash demand has also weakened, leading to a downward turn in the contract prices of most NAND Flash products.

On the other hand, the latest escalation in the U.S.-China trade dispute saw the U.S. government expanding its export control rules against Huawei in mid-3Q20. Subsequently, Huawei had to pull component shipments forward and stock up as much as possible before the rules came into effect. 

The wave of procurement triggered by this event affected not only MCP and UFS solutions for smartphones but also low-density MLC eMMC solutions for consumer products and NAND wafers for components. Bit shipments for 3Q20, on the whole, grew on account of this event.

Looking ahead to 4Q20, customers in the server segment will continue with their inventory reduction efforts. Hence, the overall demand will still be rather sluggish. Furthermore, the wave of procurement initiated by Huawei has subsided since the stricter export control regime came into force in mid-September. 

Other Chinese smartphone brands are now aggressively building their component inventories in preparation to capture Huawei’s market share. However, their demand together with the demand related to the iPhone 12 series is not enough to reverse the oversupply situation that will be affecting the entire NAND Flash market through 4Q20. 

Also, Samsung and YMTC still intend to continue raising production output, thereby worsening the glut in the NAND Flash market. TrendForce expects the continuing decline in prices to lead to a QoQ decline in total NAND Flash revenue in 4Q20.

Samsung

Samsung’s ASP fell by nearly 10% QoQ for 3Q20 as the overall demand was adversely affected by the inventory reduction efforts that were taking place in the server segment. However, its bit shipments significantly exceeded expectations for the same period and offset the price decline. The tightening of the U.S. export restrictions in the middle of the quarter compelled Huawei to extend its component inventory “one last time” before being cut off from foreign suppliers. 

At the same time, Samsung benefitted from the stock-up demand related to the upcoming release of the iPhone 12 series. Samsung saw a QoQ increase of almost 20% in its NAND Flash bit shipments for 3Q20. Thanks to this, its NAND Flash revenue for the same quarter also rose by 5.9% QoQ to US$4.809 billion.

At the moment, Samsung is proceeding with the second-phase expansion of its Xi’an base as scheduled. As for developments in technology and products, the V5 (92L) process still accounts for the majority share of Samsung’s NAND Flash output. To maintain cost competitiveness, Samsung will be stepping up efforts to get clients to adopt SSDs and UFS solutions featuring V6 (128L) NAND Flash. The transition from the V5 to the V6 will become more pronounced in 2021.

Kioxia

Kioxia’s bit shipments in 3Q20 increased by nearly 25% QoQ thanks to Huawei’s aggressive inventory building and the demand related to the releases of the iPhone 12 series and new game consoles. However, Kioxia’s ASP fell by around 9% QoQ on account of the declining overall demand for NAND Flash products. Despite the drop in prices, Kioxia posted considerable revenue growth for 3Q20 because its earnings report for the period included the revenue from the SSD business unit that it acquired from Lite-On. The supplier’s NAND Flash revenue went up by 24.6% QoQ to US$3.101 billion.

In the aspect of capacity planning, Kioxia can add new production capacity at K1 but plans to keep its total wafer starts relatively constant to the end of 2021. Moving to product development, 96L products still account for the majority share of Kioxia’s supply. 

The production of 112L BiCS products is not expected to pick up noticeably until 2H21. It is worth noting that Kioxia just announced this October 29 that it will build a new production facility, designated as Fab7, at its Yokkaichi base. The construction is scheduled to begin in 1Q21, and the facility is set to contribute to the supplier’s output in 2022. With respect to products, Fab7 will probably focus on solutions after the BiCS6 generation.

Western Digital (WDC)

WDC’s bit shipments increased by 1% QoQ due to stronger-than-expected sales of storage products for the retail and gaming markets. However, its shipments of client SSDs and enterprise SSDs dropped noticeably because of inventory adjustments by clients in the PC and server segments. Moreover, its ASP fell by about 9% QoQ because of the change in its product mix and the weakening of the overall demand. As a result, WDC was not able to prevent a decline in its quarterly revenue and recorded a QoQ drop of 7.1% to US$2.078 billion.

Turning to capacity planning, WDC will be collaborating with Kioxia to ready more production capacity at K1 and build the new Fab7 at Yokkaichi. These expansion activities will enhance WDC’s competitive position vis-à-vis the other major suppliers. As for product development, WDC will only begin to accelerate the transition to the BiCS5 (112L) technology in 2021. For now, most of its products are still based on 96L BiCS4 technology. WDC will also be offering BiCS4 SSDs with the PCIe 4.0 interface in the near future.

SK Hynix

SK Hynix gives more weight to mobile solutions in its NAND Flash product mix, so its bit shipments for 3Q20 grew by about 9% QoQ on the backs of the new iPhone devices, new game consoles, and Huawei’s procurement activities. However, SK Hynix was also affected by the inventory reduction efforts in the server segment. The share of SSDs in its NAND Flash product shipments fell under 45% in 3Q20, and its ASP also dropped by around 10% QoQ. Taken these factors all together, SK Hynix’s revenue for 3Q20 dipped by 3.1% QoQ to US$1.643 billion.

SK Hynix will not make any significant changes to its production capacity. The company is expected to maintain its wafer input levels by the end of 2021.

To extend its cost advantage, SK Hynix is pushing clients to adopt 96L and 128L solutions. The 128L process is expected to comprise around 30% of the supplier’s overall NAND Flash output by the end of this year. However, the adoption of 128L solutions by server OEMs requires more time. Regarding SK Hynix’s acquisition of Intel’s NAND Flash business, the deal was announced this October 20. TrendForce points out that the deal will help strengthen SK Hynix in the development of QLC NAND Flash and enterprise SSDs, which are two areas that the company needs to improve. Through the acquisition of Intel’s assets, SK Hynix will also become the world’s second-largest NAND Flash supplier by market share.

Micron

Micron’s revenue for its latest fiscal quarter dropped by 8.1% QoQ to US$1.53 billion. Micron has been optimizing its sales mix with a focus on reducing the share of channel-market wafers. Nevertheless, its ASP fell by nearly 8% QoQ for its latest fiscal quarter (June-August) due to the downturn of the whole NAND Flash market. The temporary wave of procurement initiated by Huawei helped Micron’s bit shipments, which were on par with the previous quarter.

On the technology front, Micron has started to ship 128L products featuring Replacement Gate, which is its own transistor design. However, the supplier’s focus for next year will be on the market release of its 176L products. Micron intends to have most of its storage products for OEMs directly migrate to 176L technology. These include client SSDs, UFS solutions, etc. The deliveries of 176L samples are scheduled to be completed before 2Q21. Furthermore, Micron is steadily raising the shipment share of QLC products. This indicates that Micron wants to be regarded as the main alternative to Intel in the QLC segment.

Intel

Intel experienced a substantial QoQ decline of almost 25% in its bit shipments for 3Q20. Since Intel has a large market share for enterprise SSDs, the increasing pressure on server OEMs to reduce their component inventories turned this advantage into a disadvantage in bit shipments. Also, Intel suffered a QoQ drop of around 10% in its ASP because of the weakening overall demand. With falling shipments and prices, Intel’s NAND Flash revenue for 3Q20 registered a steep QoQ decline of 30.5% to US$1.153 billion.

In the aspect of capacity planning, Intel has no expansion plan for this year and intends to maintain wafer starts at its Dalian plant. For next year, Intel will undertake capacity expansion, though the long-term benefit of the additional capacity will mostly go to SK Hynix. Looking at plans related to products and technology, Intel remains focused on enterprise SSDs and has sent samples of 144L products to its clients. The production of 144L solutions is expected to begin ramping up in 2021.


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3Q 2020 Western Europe smartphone market share: Samsung 35,6%, Apple 28,5%, Xiaomi 12,8% says IDC.

 


The smartphone market in Western Europe continued to be impacted by lockdowns in the third quarter of 2020, as shipments declined 6.5% year over year to 28.8 million units, according to data from International Data Corporation (IDCWorldwide Quarterly Mobile Phone Tracker.

Although lockdown restrictions were lifted across Europe, the smartphone market continued to be impacted by the economic environment. 

While consumer spending on smartphones improved slightly, sales of smartphones to enterprises dropped 11.5% year on year as enterprises shifted spending from smartphones to notebooks.

"The consumer segment was more resilient in Q3 2020 than the commercial segment, as consumers returned to stores to buy new smartphones," said Francisco Jeronimo, associate vice president at IDC EMEA. 

"Although sales online exploded in the last two quarters, the reopening of brick and mortar stores proved to be particularly important for the latest devices, as four out of the ten most sold devices in Q3 2020 were devices launched in the previous quarter. 

The store continues to be the place where consumers learn and test the latest novelties from vendors. Without that physical experience, consumers tend to choose the products they already know when buying online, making it harder for new brands and new products to succeed."

Among the top five vendors, Apple, Xiaomi, and OPPO were the stars in the third quarter, delivering the strongest growth in the region. Apple benefited from strong sales of the newly launched iPhone SE (2020) and the continuous performance of its iPhone 11 portfolio. The iPhone 11 and the iPhone SE (2020) were the two best sellers in the quarter.

In the midrange, Xiaomi and OPPO continue to gain share from Huawei. Xiaomi became the third largest brand in Western Europe for the first time, while OPPO grew its market share and consolidated its fifth position.

Shipments of 5G devices reached 3 million units, up 123.1% from the previous quarter to represent 10.4% of the total number of smartphones.

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LG to set up a new business unit in the US.

 


LG Electronics, a major home appliance maker in South Korea, on Thursday, said it will set up a new business unit in the United States to seek future growth opportunities.

LG's North American Innovation Center will be based in Silicon Valley, California, with the task of exploring new business opportunities and cooperating with leading tech firms there, the company said.

Rhee Sokwoo, who served as an associate director at the U.S. National Institute of Standards and Technology (NIST), will head the center, it added.

In its latest reconfiguration of business units, LG also announced that it will establish a business incubation center to support various new business opportunities.

LG will also set up "CX Lab" that will be managed directly under the CEO to bolster design capability related to user experience. LG added its robot business center will be now managed under its business solutions unit.

Meanwhile, the electronics giant promoted a total of 56 executives in its annual personnel reshuffle, up from 49 last year.

The company named Lyu Jae-cheol, who has been leading its living appliance business, as new chief for its home appliance & air solution business division.

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Wednesday, November 25, 2020

Qualcomm to hold the 5th annual Tech Summit Digital 2020 on Dec 1-2, 2020. Snapdragon 875 some specifications.

 



Qualcomm will hold the 5th annual Tech Summit Digital 2020 (virtual) event on 
December 1 & 2, 2020 7am PST / 10am EST / 2pm GMT
and invites you to join their live stream to hear Qualcomm® executives and leaders from across the mobile industry share their views on the global expansion of 5G along with the latest and greatest Snapdragon experiences that will set the bar for 2021. 

Snapdragon 875 is set to power the next range of flagships starting in early 2021. The chipmaker will unveil the chip at the Qualcomm Summit on this event, with availability expected from early 2021

Some specifications have surged:


Leaked Snapdragon 875 specifications:

  • Kryo 685 CPU, will be built on Arm v8 Cortex tech
  • 3G/ 4G/ 5G modem
  • Will use millimeter wave (mmWave) and sub-6 GHz bands
  • Low-power audio subsystem combined
  • Aqstic Audio Technologies
  • WCD9380 and WCD9385 audio codec
  • Adreno 660 GPU
  • Adreno 665 VPU
  • Adreno 1095 DPU
  • Compute Hexagon DSP
  • Hexagon Vector eXtensions
  • Hexagon Tensor Accelerator
  • Qualcomm Secure Processing Unit (SPU250)
  • Spectra 580 image-processing engine
  • Snapdragon Sensors Core Technology
  • External 802.11ax, 2×2 MIMO, and Bluetooth Milan
  • Quad-channel package-on-package
  • LPDDR5 SDRAM


As always, Qualcomm Snapdragon™ is synonymous with premium-tier mobile performance and experiences – this year will be no different. Cristiano Amon, president of Qualcomm Incorporated, will host the event, along with Alex Katouzian, senior vice president and general manager of mobile for Qualcomm Technologies.

You can watch the event on:



Note:
Watch the livestreams daily at qualcomm.com/snapdragonsummit and follow Qualcomm on Twitter for live updates before and during the keynotes. Our live stream will also be shown in China on the iQiYi platform, more info can be found at qualcomm.cn. Please tune in and don’t forget to tag your posts #SnapdragonSummit.

More information on Qualcomm

Tuesday, November 24, 2020

Markets for LG Display Transparent OLED are expanding worldwide.

 

              LG Display’s transparent OLED panel is used for the window of a subway in China.


LG Display has expanded its “transparent OLED” business towards the Japanese market after it did so with the Chinese market.


Panasonic announced that it would begin selling 55-inch transparent OLED modules in Japan, Taiwan, Singapore, Australia, and New Zealand starting from this year. This OLED module is based on LG Display’s transparent OLED panel and is less than one centimeters in thickness.


“Panasonic’s module was developed to target B2B (Business to Business) digital signage market in its native country and the Asia-Pacific market.” said one industry official. “LG Display supplied transparent OLED panels that are the key to the module.”


Not only does Panasonic’s module maintains contrast ratio of video contents even in an environment where the intensity of illumination is strong, but it also assists in providing clear images and videos. Panasonic attached a dimming unit that electrically controls light transmittance on the back of the panel and applied a technology that switches the panel between transparent mode and shading mode.


For example, the shading mode that controls the light that passes through the back of the panel is activated by lowering the transmittance of the dimming unit in an environment where the intensity of illumination is strong.

Panasonic explained that there can be many uses with the module as it can be used in various places such as commercial facilities, transportation infrastructures, and public facilities. It also added that a large display screen can also be made by attaching many panels together.


“Development of communication infrastructures and diversification of contents are taking place rapidly,” said Panasonic. “We have decided to commercialize the module due to a rise in expectations towards transparent display that is able to display new images and videos.”


LG Display’s transparent OLED supply chain is expected to expand continuously as there are growing demands for transparent OLEDs globally.


It is reported that Xiaomi’s 55-inch transparent OLED TV, which is the first in the world, is also equipped with LG Display’s transparent OLED panel. It is likely that the same panel is used for Panasonic’s OLED module.


LG Display’s transparent OLED panels are also used for windows of subways in Beijing and Shenzhen. Disney plans to build a space for experimenting with transparent OLED panel within its establishment with LG Display.

Korea IT News.


Monday, November 23, 2020

SPACE: StarShip coming into our atmosphere, filmed from the ISS. Video.

 






According to Gina Maria Colvin Hill, who posted the above video on Youtube, Mia Schopen has captured several images of what appears to be a Starship (UFO) and it is  coming into our atmosphere as filmed from the ISS. The ship is coming in and it is not a camera reflection.

IMHO the starship arrived in our atmosphere coming out from some kind of portal. Who knows.

Every kind of UFO or extraterrestrial visits have been happening for thousands of years, but maybe they are intraterrestrials who live underneath or underwater or inside a volcano. Just guessing.

Gina has a wonderful youtube channel where you can find a long playlist of her experiences finding  UFO presence https://www.youtube.com/c/GinaMariaColvinHill555/about





Wednesday, November 18, 2020

SCIENCE: PFIZER/BIONTECH Primary efficacy analysis demonstrates BNT162b2 vaccine to be 95% effective against COVID-19. Press Release.

 




PFIZER AND BIONTECH CONCLUDE PHASE 3 STUDY OF COVID-19 VACCINE CANDIDATE, MEETING ALL PRIMARY EFFICACY ENDPOINTS

Wednesday, November 18, 2020 - 06:59am

  • Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group
  • Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94%
  • Safety data milestone required by U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved
  • Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled; no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%
  • Companies plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe
  • The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021
  • Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints. Analysis of the data indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201118005595/en/

There were 10 severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group.

To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. A review of unblinded reactogenicity data from the final analysis which consisted of a randomized subset of at least 8,000 participants 18 years and older in the phase 2/3 study demonstrates that the vaccine was well tolerated, with most solicited adverse events resolving shortly after vaccination. The only Grade 3 (severe) solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following dose 2. Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination.

In addition, the companies announced that the safety milestone required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved. Pfizer and BioNTech plan to submit a request within days to the FDA for an EUA based on the totality of safety and efficacy data collected to date, as well as manufacturing data relating to the quality and consistency of the vaccine. These data also will be submitted to other regulatory agencies around the world.

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”

“We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose, underscoring the power of BNT162 in providing early protection,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities. I want to thank all the devoted women and men who contributed to this historically unprecedented achievement. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.”

The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in United States, Germany, Turkey, South Africa, Brazil and Argentina. The trial will continue to collect efficacy and safety data in participants for an additional two years.

Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021. Four of Pfizer’s facilities are part of the manufacturing and supply chain; St. Louis, MO; Andover, MA; and Kalamazoo, MI in the U.S.; and Puurs in Belgium. BioNTech’s German sites will also be leveraged for global supply.

Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world. The companies have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of -70°C±10°C. They can be used be as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes leveraging Pfizer’s broad distribution network.

Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer NewsLinkedInYouTube and like us on Facebook at Facebook.com/Pfizer.

 


Monday, November 16, 2020

SCIENCE: MODERNA COVID-19 vaccine Phase 3 study met statistical criteria with an efficacy of 94.5%. Press Release.

Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study.

The first interim analysis included 95 participants with confirmed cases of COVID-19

Phase 3 study met statistical criteria with a vaccine efficacy of 94.5% (p <0.0001)

Moderna intends to submit for an Emergency Use Authorization (EUA) with U.S. FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 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 that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This study, known as the COVE study enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001).

A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.

The 95 COVID-19 cases included 15 older adults (ages 65+) and 20 participants identifying as being from diverse communities (including 12 Hispanic or LatinX, 4 Black or African Americans, 3 Asian Americans and 1 multiracial).

The interim analysis included a concurrent review of the available Phase 3 COVE study safety data by the DSMB, which did not report any significant safety concerns. A review of solicited adverse events indicated that the vaccine was generally well tolerated. The majority of adverse events were mild or moderate in severity. Grade 3 (severe) events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%). These solicited adverse events were generally short-lived. These data are subject to change based on ongoing analysis of further Phase 3 COVE study data and final analysis.

Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.

As more cases accrue leading up to the final analysis, the Company expects the point estimate for vaccine efficacy may change. The Company plans to submit data from the full Phase 3 COVE study to a peer-reviewed publication.

“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, Chief Executive Officer of Moderna. “This milestone is only possible because of the hard work and sacrifices of so many. I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus.

They are an inspiration to us all. I want to thank the NIH, particularly NIAID, for their scientific leadership including through years of foundational research on potential pandemic threats at the Vaccine Research Center that led to the discovery of the best way to make Spike protein antigens that are being used in our vaccine and others’. I want to thank our partners at BARDA and Operation Warp Speed who has been instrumental in accelerating our progress to this point. Finally, I want to thank the Moderna team, our suppliers and our partners, for their tireless work across research, development and manufacturing of the vaccine. We look forward to the next milestones of submitting for a EUA in the U.S., and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study. We remain committed to and focused on doing our part to help end the COVID-19 pandemic.”

Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least 2 months). Moderna also plans to submit applications for authorizations to global regulatory agencies.

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 the distribution of mRNA-1273, in the event that it receives a EUA and similar global authorizations. By the end of 2020, the Company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. The The company remains on track to manufacture 500 million to 1 billion doses globally in 2021. On November 10, the American Medical Association (AMA) issued a Current Procedural Terminology (CPT) code to report vaccination with mRNA-1273 (code: 91301). Moderna recently announced further progress towards ensuring the distribution, storage, and handling of the vaccine can be done using existing infrastructure.

To learn more about Moderna’s work on mRNA-1273, visit www.modernatx.com/COVID19.

About the Phase 3 COVE Study

The Phase 3 COVE trial is a randomized, 1:1 placebo-controlled study testing mRNA-1273 at the 100 µg dose level in 30,000 participants in the U.S., ages 18 and older. The primary endpoint is the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2. The trial will continue to accrue additional data relevant to safety and efficacy even after a EUA is submitted. The final estimates of vaccine efficacy for both primary and secondary endpoints will depend on the totality of data that will accumulate to inform the final analysis. Moderna worked closely with BARDA and the NIH, including NIAID’s COVID-19 Prevention Network (CoVPN), to conduct the Phase 3 COVE study under Operation Warp Speed. Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory, and lifecycle management services, has also been essential to the successful execution of the COVE study.

The Phase 3 COVE study was designed in collaboration with the FDA and NIH to evaluate Americans at risk of severe COVID-19 disease and completed enrollment of 30,000 participants ages 18 and older in the U.S. on October 22, including those at high risk of the severe complications of COVID-19 disease. The COVE study includes more than 7,000 Americans over the age of 65. It also includes more than 5,000 Americans who are under the age of 65 but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity, and cardiac disease. These medically high-risk groups represent 42% of the total participants in the Phase 3 COVE study. The study also included communities that have historically been under-represented in clinical research and have been disproportionately impacted by COVID-19. The study includes more than 11,000 participants from communities of color, representing 37% of the study population, which is similar to the diversity of the U.S. at large. This includes more than 6,000 participants who identify as Hispanic or LatinX, and more than 3,000 participants who identify as Black or African American.

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 was 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 MedicineOn 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 a supply of mRNA-1273 under the U.S. Department of Defense Contract No. W911QY-20-C-0100.

 


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