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AMERICAN SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Foreign private issuer report
In accordance with article 13a-16 or 15d-16 of
the 1934 Stock Exchange Act
For the month of September 2021
Commission file number: 001-38757
TAKEDA PHARMACEUTICAL COMPANY LIMITED
(Translation of the declarant’s name in English)
1-1, Nihonbashi-Honcho 2-Chome
Chuo-ku, Tokyo 103-8668
(Address of the main executive offices)
Indicate with a check mark whether the declarant is filing or will file annual returns under Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate with a check mark whether the declarant is submitting Form 6-K on paper, as permitted by rule 101 (b) (1) of the ST Regulation: ☐
Indicate with a check mark whether the declarant is submitting the Form 6-K on paper as permitted by Rule 101 (b) (7) of the ST Regulation: ☐
Information provided on this form:
In accordance with the requirements of the Securities Exchange Act of 1934, the declarant has duly caused this report to be signed on his behalf by the undersigned, being duly authorized for this purpose.
|TAKEDA PHARMACEUTICAL COMPANY LIMITED|
|Date: September 1, 2021||Through:||/ s / Norimasa Takeda|
Chief Accounting Officer and Corporate Controller
Moderna and Takeda Joint Statement on Moderna’s COVID-19 Vaccine Suspended Lots Investigation in Japan
Osaka, Japan, September 1 – This statement updates the separate announcement from August 26, 2021, JST, in which Takeda announced the suspension of the use of three lots of Moderna COVID-19 vaccine for intramuscular injection in Japan following reports from sites in Japan. vaccination of a potential foreign particulate matter found in vials. It also updates the joint statement of August 28, 2021, in which Takeda and Moderna confirmed being notified of the deaths of two people, both of whom received Moderna’s COVID-19 vaccine in Japan from one of three batches. .
In collaboration with the Ministry of Health, Labor and Welfare (MHLW), Moderna, the vaccine manufacturer, ROVI Pharma Industrial Services, SA in Spain, the European contract manufacturing organization of Moderna, and Takeda, the authorized distributor, have carried out a thorough investigation, which includes:
•Identification of the root cause of the particles and the corrective and preventive actions taken;
•An evaluation of the nature of a particle from a vial of lot 3004667; and
•An associated medical safety assessment, to determine if the identified particle poses a risk to health or safety.
Root cause investigation and corrective and preventive actions
Three lots of Moderna COVID-19 vaccine (lots 3004667, 3004734 and 3004956) have been suspended following reports of vaccination sites of a potential foreign particulate matter observed in unused vials of lot 3004667.
According to the root cause analysis report, carried out by ROVI, the most probable cause of the particles identified in lot 3004667 is related to the friction between two pieces of metal installed in the plugging module of the production line due to wrong setting. The two parts are the star wheel and the plug feeder part that feeds the plugs into the star wheel. This condition is believed to have occurred during the assembly of the line prior to production of batch 3004667 and was the result of incorrect alignment during a line change prior to the start of this batch.
According to the analysis carried out by ROVI, the manufacturing problem only impacted the batches included in the suspension. The following measures have been taken by ROVI to correct and prevent future defects:
•Complete inspection of the production line;
•Improvement of the standard operating procedure for the change of production line; and
•Definition of alert inspection limits in automatic visual inspection, as internal process control.
Takeda, as the Marketing Authorization Holder in Japan, plans to initiate the recall of the three suspended lots 3004667, 3004734 and 3004956 from the market effective September 2, 2021, in consultation with the MHLW and reported to Osaka Prefecture. Moderna, as the holder of the global marketing authorization, fully agrees with this decision.
Preliminary particle analysis
According to Moderna’s independent analysis, the particle in lot 3004667 was thoroughly analyzed and found to be grade 316 stainless steel. This is consistent with the root cause determination described above. Grade 316 is a high quality stainless steel commonly used in manufacturing and food processing.
Current medical safety assessment
After a health assessment conducted by Moderna and Takeda, the rare presence of stainless steel particles in the Moderna COVID-19 vaccine does not pose an undue risk to patient safety and does not adversely affect the benefit / risk profile of the product.
Metal particles of this size injected into a muscle can cause a local reaction, but they are unlikely to cause other side effects beyond the local injection site. Stainless steel is commonly used in heart valves, joint prostheses, and metal sutures and staples. As such, injection of the particles identified in these lots in Japan is not expected to result in an increased medical risk.
Investigation of two deaths following administration of a vaccine
At this time, there is no evidence that the two tragic deaths following the administration of the Moderna COVID-19 vaccine (lot 3004734) were in any way related to the administration of the vaccine. The relationship is currently considered a coincidence. It is important to conclude a formal investigation to confirm this. The investigation is being conducted with the utmost sense of urgency, transparency and integrity and is of the highest priority.
To date, more than 200 million doses of the Moderna COVID-19 vaccine have been administered to more than 110 million people in 45 countries, which is a critical part of the global fight against COVID-19.
For updates and additional resources on the COVID-19 vaccination program in Japan, please visit the official COVID-19 information center.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502 / NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided through our commitment to patients, our staff and the planet. Takeda focuses its R&D efforts in four therapeutic areas: oncology, rare genetics and hematology, neuroscience and gastroenterology (GI). We also make targeted investments in R&D in plasma-derived therapies and vaccines. We are focused on developing highly innovative medicines that help make a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a pipeline. robust and diverse. Our employees are committed to improving the quality of life for patients and working with our healthcare partners in approximately 80 countries. For more information, visit https://www.takeda.com.
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|Media outside Japan
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This press release and any material distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, goals and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “has the” intention of ”,“ ensure ”,“ will ”,“ may ”,“ should ”,“ would ”,“ could ”“ anticipate ”,“ estimate ”,“ plans ”or similar expressions or the negative thereof . These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: economic circumstances surrounding the global operations of Takeda, including general economic conditions in Japan and the United States; competitive pressures and developments; changes in applicable laws and regulations, including global healthcare reforms; the challenges inherent in the development of new products, including the uncertainty of clinical success and the decisions of regulatory authorities and their timing; the uncertainty of the commercial success of new and existing products; manufacturing difficulties or delays; fluctuations in interest and exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, such as the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in the countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to dispose of assets that are not essential to Takeda’s operations and the timing of such disposal (s); and other factors identified in Takeda’s most recent annual report on Form 20-F and Takeda’s other reports filed with the United States Securities and Exchange Commission, available on Takeda’s website at address: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock market rules. Past performance is not an indicator of future results and Takeda’s results or statements in this press release may not be indicative, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.