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Japan Drops Moderna For Un-Authorized COVID-19 Vaccine

September 9, 2021 • 10:29 am CDT
(Precision Vaccinations)

Takeda Pharmaceutical Company Limited announced on September 7, 2021, the Government of Japan’s Ministry of Health, Labour, and Welfare (MHLW) will purchase 150 million doses of Novavax’s COVID-19 vaccine candidate (NVX-CoV2373, TAK-019 in Japan).

Takeda will be responsible for the Japanese clinical trial and regulatory submission to Japan's Pharmaceuticals and Medical Devices Agency and will distribute TAK-019 in Japan if approved by the MHLW.

Takeda confirmed these COVID-19 vaccines would be manufactured in Japan by Takeda, subject to licensing and approval.

Additionally, Novavax is licensing and transferring technologies to enable Takeda to manufacture the vaccine antigen and supply the Matrix-M TM adjuvant to Takeda to fill/finish together with the antigen.

Previously, Takeda had partnered with the Government of Japan and Moderna to help accelerate the availability of COVID-19 vaccines. 

On July 20, 2021, Moderna announced that the MHLW and Takeda had agreed to purchase and distribute 50 million doses of Moderna’s COVID-19 vaccine known as SpikeVax.

However, on August 26, 2021, Japan's MHLW announced Takeda had started to provide information to vaccination facilities to suspend the use of some lots of Moderna's COVID-19 vaccine.

'Regarding the vaccine... based on reports from multiple inoculation facilities that foreign matter was mixed in an unused state.... we have decided to forgo the use of certain Moderna COVID-19 vaccines,' stated the MHLW press statement.

The target lot was #3004667, containing about 57,000 vaccine doses.

On September 1, 2021, Moderna and Takeda issued a joint statement: 'Takeda, as the Japan Marketing Authorization Holder, is planning to initiate the recall of the three suspended lots 3004667, 3004734, and 3004956 from the market as of September 2, 2021, in consultation with the MHLW. Moderna as the Global Marketing Authorization Holder is in full agreement with this decision.'

'According to Moderna’s independent analysis, the particle from lot 3004667 has been thoroughly analyzed and is confirmed to be grade 316 stainless steel. This is consistent with the root cause determination described above. Grade 316 is a high grade of stainless steel commonly used in manufacturing and in food processing.'

'At this time, there is no evidence that the two tragic deaths following the administration of the Moderna COVID-19 vaccine (from lot 3004734) were in any way related to administration of the vaccine.'

'The relationship is currently considered to be coincidental. It is important to conclude a formal investigation to confirm this. The investigation is being conducted with the greatest sense of urgency, transparency, and integrity and is of the highest priority.'

On September 6th, the MHLW announced, 'A third person in Japan has died after receiving a dose of Moderna's COVID-19 vaccine that was among batches recalled due to being potentially contaminated with foreign materials.'

As of September 9, 2021, Novavax's COVID-19 vaccine candidate remains under review by the European Medicines Agency, the U.S. CDC, and regulatory agencies in India, Indonesia, and The Philippines.

Furthermore, Japan's MHLW confirmed 16,525 people had died during the COVID-19 pandemic.

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