Contaminants Found in Japan's Moderna Vaccine
News that foreign objects were found in dozens of bottles of Moderna's COVID19 vaccine in Japan, may affect people's confidence in the vaccine, but manufacturers and experts downplayed the risks and its effect on world health.
Nadine Hosny 
Further complicating the situation, on 22nd August 2021, more contaminated vaccines were found in Okinawa and Gunma districts, and two men in their 30s died three days after receiving their second dose from affected vaccines.
On Thursday, the Japanese government stated that in eight workplaces and mass vaccination sites in five districts of Aichi, Ibaraki, Gifu, Saitama, and Tokyo, foreign objects were found in 39 unopened vials, all with batch number 3004667. The contaminants were first reported on 16th August 2021.
The Japanese government instantly stopped the use of batch number 3004667 (57,000 bottles, equal to 570,000 doses) and batch numbers 3004734 (52,000 bottles or 520,000 doses) and 3004956 (54,000 bottles or 540,000 doses), although there are no reports of contamination, they were produced on the same production line in Spain at the same time. Vaccines from the three batch numbers have been issued to 900 vaccination centers throughout Japan and 500,000 affected doses have been administered.
There had been no cases of poor health from the affected doses until 28th August 2021, when Moderna and Takeda Pharmaceutical Co., the supplier of the US firm’s COVID vaccine in Japan, obtained the case of the deaths of the two men, aged 30 and 38, who had no history of allergies or any underlying conditions. They died three days after they received their second dose of the Moderna vaccine, both of which were from the batch number 3004734.
Takeda and Moderna said in a joint statement on Saturday 28th August that they had not received reports of foreign objects in the batch used by the two for their vaccinations, adding that they had no evidence that these deaths were caused by the Moderna vaccine. The Japanese government has vowed to conduct a rapid and thorough investigation, with the participation of experts from outside Japan, to determine whether there is a relationship between their deaths and the vaccine.
The affected bottles were manufactured by Laboratorios Farmaceuticos Rovi, which has been dealing with the last step in the manufacturing process of Moderna doses that use Swiss-produced vaccine ingredients and are shipped to countries outside the US. The Spanish pharmaceutical company stated that the only batches with foreign bodies detected were ones supplied to Japan.
Infectious disease experts say that the risk of using a contaminated dose is low because standard health protocols mandate that the vials and syringes are checked for abnormalities before they are used. Takeshi Terashima, an infectious disease expert at the Department of Respiratory Medicine at Tokyo Dental University in Ichikawa, said that even if the foreign body is not found immediately and it enters the body, the possibility of major health problems is low.
On his Facebook page, Professor Masayuki Miyasaka, professor of immunology at Osaka University, agreed with Mr. Terashima and added, “If it’s a minute piece of metal, once injected inside the muscle it will be approached and eaten by phagocytes, so it will not circulate in the whole body, and there is a near zero chance of it causing substantial health damage.”
On 28th and 29th August, Okinawa district stopped vaccination with Moderna at a mass vaccination center in Naha. Four cases of filled syringes with black dot-like particles and a pierced vial were previously confirmed, although the pre-use checking of the doses did not confirm any contaminants in the vials. A total of five foreign bodies from batch number 3005293 have been identified, including a pink substance discovered in a syringe in Okinawa on the 28th, although the Japanese Ministry of Health stated that there is no problem with the safety and effectiveness of the doses from this batch number. On 30th August, Okinawa restarted vaccination at the center.
Takeda conducted an investigation that indicated that the black foreign body was probably rubber that was scrapped off when the syringes punctured through the rubber stoppers of the bottles. The Ministry of Health stated that as for the pink substance, it’s too large to have come from a syringe, so it may have already been inside the bottles.
Japan’s severe COVID19 cases have reached record levels, causing many people to recover at home due to a lack of intensive care beds. Just 44% of the population are vaccinated, which is much lower the vaccination rates of numerous developed countries.
