What has Japan found in Moderna’s vaccines?
It started last Thursday when Japan reportedly disapproved of 1.63 million doses of vaccine from US pharmaceutical company Moderna due to undisclosed contamination in some of the vaccines. Last weekend, contaminated vaccines reappeared in the country. This time it involved black-colored material in a few syringes and in a vaccine vial, and a pink substance in a needle.
This week it happened again: Black particles floating in a Moderna vial, discovered during a check of imported vaccines. Thousands of people in Japan have been vaccinated with vaccines from batches that have since been rejected.
Where does the contamination come from?
The first batches withdrawn were high-quality stainless steel, Japanese vaccine distributor Takeda announced on Wednesday. This is said to have happened at Rovi, the Spanish pharmaceutical company that bottles Moderna vaccines. This process probably created friction between two pieces of metal because machines were not properly adjusted. Fragments were released that ended up in the vaccine.
The cause of the rest of the pollution is still being investigated. In some cases, the hypodermic needle is believed to have been misplaced through the rubber stopper of the vial by the person administering the vaccine, Japan’s health ministry said.
The filling machines are generally very well maintained, but in rare cases something can go wrong, says Gideon Kersten, professor by special appointment of vaccine development at Leiden University. That is why ampoules containing pharmaceutical products are randomly checked for things such as discoloration, unwanted particles and cracks. “If a certain percentage deviates, you have to reject the entire batch.”
Occasionally, however, something is overlooked and a pharmaceutical company has to recall medicines. “That is by no means a common occurrence, but it is more common for products to prevent defects. So in that sense, this is not so exceptional.”
Is this harmful to health?
In the case of the metal particles, it doesn’t look like that, according to vaccine distributor Takena. Doctors use this material for medical procedures such as placing artificial joints and sutures. Japan also continues to vaccinate with Moderna.
Kersten also knows no examples of side effects in comparable accidents. Nevertheless, he thinks it is justified that entire parties have been rejected. “Safety above all. Trust is thin, especially when it comes to vaccines.”
He also approves that Japan is investigating the death of two people who received a vaccine from the now rejected batch in which stainless steel was found. There is now nothing to indicate that this has anything to do with their deaths and the Japanese government is assuming a coincidence, but “you always have to get to the bottom of this”.
The extent to which the incidents damage confidence in vaccines depends on the cause, he says. “If it is quickly clear that it is an incident, I think it is not that bad. But if it remains vague and they can’t properly identify the cause, that could prove damaging to the reputation of vaccines.”
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