Moderna: Teenage vaccine trials 'successful' says Dr Hilary
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The reported “black particles” were discovered by pharmacists in Japan’s Kanagawa prefecture, on the central island of Honshu. More than 3,700 people have already received their shots from this batch of the Moderna vaccine, with the rest being put on hold. The worrying discovery comes off the back of a nationwide ban suspending more than 1.63 million doses of the COVID-19 vaccine, after fears of contamination.
Last week, Moderna had traced the contaminants to a production line in Spain.
The vaccine is being bottled by the biotech company Laboratorios Farmaceuticos ROVI.
According to the company, the issue has been limited to batches bottled specifically for Japan and is presently under investigation.
According to official guidance issued by the US Food and Drugs Administration (FDA), the vaccine is not to be administered if a foreign substance is detected in the vaccine vial.
An FDA fact sheet states the Moderna jab is a “white to off-white suspension” that may contain “white or translucent product-relates particulates”.
The document reads: “Visually inspect the Moderna COVID-19 Vaccine vials for other particulate matter and/or discolouration prior to administration.
“If either of these conditions exists, the vaccine should not be administered.”
Foreign materials inside of the vaccine, including black and pink particles in the liquid, have also been reported in the Gunma and Okinawa prefectures.
Norihisa Tamura, Japan’s Health, Labour and Welfare Minister said on Tuesday the materials may have broken off from the vials’ rubber seal after a needle was incorrectly inserted.
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However, the exact nature of the contaminants has not yet been revealed.
Mr Tamura said: “Whatever the reason we have heard that there is no safety or other issues.”
He added: “We will continue to gather information and report back.”
Japan’s health ministry is also investigating the deaths of two men in their 30s who had received jabs from the suspended batch of vaccines, according to Reuters.
More than 500,000 people are estimated to have received shots from three suspended batches of vaccines.
Takeda Pharmaceutical, the company distributing the Moderna jab across Japan, said: “Currently, no link has been confirmed between these deaths and the Moderna vaccine, but we believe it is important to carry out a formal probe to investigate the matter further.”
The country is presently battling record-high infections as a result of the highly contagious Delta variant.
As of August 31, Japan has reported more than 1.49 million coronavirus infections, as well as more than 16,000 deaths.
Japanese authorities have confirmed more than 17,000 new infections on Tuesday, marking a record spike for the 19th consecutive day.
The spike comes amid the 2020 Paralympic Games which are being hosted in Tokyo.
Researchers at the Tokyo Medical and Dental University have also identified a new variant of the coronavirus, dubbed N501S.
Globally, the coronavirus has already infected more than 216.86 million people and killed more than 4.5 million.
As of August 30, World Health Organization (WHO) data shows nearly 5.1 billion vaccines doses have been administered.
Here in the UK, more than 48 million people have received the first dose of a Covid vaccine and more than 42.7 million people have received their second dose.
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