Post by marriott on Sept 7, 2021 21:05:56 GMT
On August 7, 2020 , Novavax and Takeda announced a partnership for the development, manufacturing and commercialization of NVX‑CoV2373 in Japan. Novavax would license and transfer manufacturing technologies to enable Takeda to manufacture the vaccine antigen and would supply the Matrix-M adjuvant to Takeda. Takeda would be responsible for regulatory submission to the Ministry of Health, Labor and Welfare (MHLW) and will produce and distribute NVX CoV2373 in Japan. Takeda would receive funding from MHLW to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. Takeda declared the capacity to manufacture over 250 million doses of the COVID-19 vaccine annually . Novavax would receive payments based on the achievement of certain development and commercial milestones, as well as a portion of proceeds from the sale of the vaccine .
On May 21, 2021 , Takeda announced that MHLW granted special approval for emergency use of Moderna’s mRNA COVID-19 vaccine, TAK-919, now known as COVID-19 Vaccine Moderna Intramuscular Injection, in Japan. The approval was based on positive clinical data from Takeda’s Phase 1/2 immunogenicity and safety clinical trial of Moderna’s COVID-19 vaccine in Japan, which showed an immune response consistent with results from Moderna’s pivotal Phase 3 trial conducted in the United States. Takeda began distribution in Japan immediately thereafter.
On July 20, 2021 , Takeda announced an additional agreement with Moderna and MHLW to import and distribute an additional 50 million doses of Moderna’s mRNA COVID-19 vaccine in Japan from as early as the beginning of 2022. This includes the potential to secure and supply vaccines corresponding to COVID-19 variants or booster products, when successfully developed by Moderna and licensed by the MHLW. With the agreement , Takeda would import and distribute the vaccine .
On September 1, 2021 a joint statement from Moderna and Takeda on the Investigation of Suspended Lots of Moderna’s COVID-19 Vaccine in Japan updated the separate announcement on August 26, 2021, JST, in which Takeda announced the suspension of the use of three lots of the Moderna COVID-19 Vaccine for Intramuscular Injection in Japan following reports from vaccination sites of a potential foreign substance found in vials. It also updated the joint statement on August 28, 2021, in which Takeda and Moderna confirmed that they were notified of the deaths of two individuals, both had received Moderna’s COVID-19 vaccine in Japan from one of the three lots. Working with the MHLW, Moderna, the vaccine manufacturer ROVI Pharma Industrial Services, S.A. in Spain, Moderna’s European contract manufacturing organization, and Takeda, the authorized distributor, conducted a thorough investigation . According to the root cause analysis report, conducted by ROVI, the most probable cause of the particulates identified in lot 3004667 is related to friction between two pieces of metal installed in a module of the production line due to an incorrect set-up. Steps were taken by ROVI to correct and prevent future defects .
On Sep 2, 2021 , Moderna and Takeda stated they were working with Japanese authorities to recall three batches of COVID-19 vaccine after an investigation found stainless steel contaminants in some vials. Authorities had suspended use of the three batches of Moderna shots containing 1.63 million doses last week after being notified of the contamination issue. The health ministry stated based on information from the companies' investigation, that it did not believe the particles of stainless steel posed any additional health risk. Moderna said the stainless steel contamination probably occurred during production in Spain .
On September 7 , 2021 Takeda stated that the Japanese government agreed to purchase 150 million doses of the COVID-19 vaccine it will produce using Novavax's formula. The company is preparing to make the vaccine domestically and will distribute it in early 2022, pending approval from regulators, the company said in a statement. Novavax is licensing and transferring manufacturing technologies to enable Takeda to manufacture the vaccine .
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The point of this message is to reinforce the the challenges associated with outsourcing the manufacturing of vaccine products . Yes , Novavax has experienced delays associated with meeting the regulatory manufacturing requirements for EUA approval . As you may read above , Moderna's vaccine for the Japanese market is made in Spain . Novavax's vaccine will be manufactured in Japan by Takeda.
I believe Novavax 's vaccine will be in the Japanese market place Q1 2022 .
As stated in the past, I believe the business relationship between Novavax and Takeda will grow beyond Japan going forward !
On May 21, 2021 , Takeda announced that MHLW granted special approval for emergency use of Moderna’s mRNA COVID-19 vaccine, TAK-919, now known as COVID-19 Vaccine Moderna Intramuscular Injection, in Japan. The approval was based on positive clinical data from Takeda’s Phase 1/2 immunogenicity and safety clinical trial of Moderna’s COVID-19 vaccine in Japan, which showed an immune response consistent with results from Moderna’s pivotal Phase 3 trial conducted in the United States. Takeda began distribution in Japan immediately thereafter.
On July 20, 2021 , Takeda announced an additional agreement with Moderna and MHLW to import and distribute an additional 50 million doses of Moderna’s mRNA COVID-19 vaccine in Japan from as early as the beginning of 2022. This includes the potential to secure and supply vaccines corresponding to COVID-19 variants or booster products, when successfully developed by Moderna and licensed by the MHLW. With the agreement , Takeda would import and distribute the vaccine .
On September 1, 2021 a joint statement from Moderna and Takeda on the Investigation of Suspended Lots of Moderna’s COVID-19 Vaccine in Japan updated the separate announcement on August 26, 2021, JST, in which Takeda announced the suspension of the use of three lots of the Moderna COVID-19 Vaccine for Intramuscular Injection in Japan following reports from vaccination sites of a potential foreign substance found in vials. It also updated the joint statement on August 28, 2021, in which Takeda and Moderna confirmed that they were notified of the deaths of two individuals, both had received Moderna’s COVID-19 vaccine in Japan from one of the three lots. Working with the MHLW, Moderna, the vaccine manufacturer ROVI Pharma Industrial Services, S.A. in Spain, Moderna’s European contract manufacturing organization, and Takeda, the authorized distributor, conducted a thorough investigation . According to the root cause analysis report, conducted by ROVI, the most probable cause of the particulates identified in lot 3004667 is related to friction between two pieces of metal installed in a module of the production line due to an incorrect set-up. Steps were taken by ROVI to correct and prevent future defects .
On Sep 2, 2021 , Moderna and Takeda stated they were working with Japanese authorities to recall three batches of COVID-19 vaccine after an investigation found stainless steel contaminants in some vials. Authorities had suspended use of the three batches of Moderna shots containing 1.63 million doses last week after being notified of the contamination issue. The health ministry stated based on information from the companies' investigation, that it did not believe the particles of stainless steel posed any additional health risk. Moderna said the stainless steel contamination probably occurred during production in Spain .
On September 7 , 2021 Takeda stated that the Japanese government agreed to purchase 150 million doses of the COVID-19 vaccine it will produce using Novavax's formula. The company is preparing to make the vaccine domestically and will distribute it in early 2022, pending approval from regulators, the company said in a statement. Novavax is licensing and transferring manufacturing technologies to enable Takeda to manufacture the vaccine .
___________________________________________________________________________________________
The point of this message is to reinforce the the challenges associated with outsourcing the manufacturing of vaccine products . Yes , Novavax has experienced delays associated with meeting the regulatory manufacturing requirements for EUA approval . As you may read above , Moderna's vaccine for the Japanese market is made in Spain . Novavax's vaccine will be manufactured in Japan by Takeda.
I believe Novavax 's vaccine will be in the Japanese market place Q1 2022 .
As stated in the past, I believe the business relationship between Novavax and Takeda will grow beyond Japan going forward !