IL COMPLESSO FARMACO-MILITARE USA COSTRINGE GLI ADDETTI ALLA "VACCINAZIONE"

 

Pharma companies mandate Covid-19 vaccines for staff as Delta variant spreads

By Darcy Jimenez 11 Aug 2021 (Last Updated August 13th, 2021 11:48)

Pharmaceutical giant Gilead Sciences announced it would require all employees and contractors to be fully vaccinated by 1 October.

Pharma companies mandate Covid-19 vaccines for staff as Delta variant spreads
Several pharma companies have mandated staff vaccinations or regular testing. Credit: Ron Adar / Shutterstock.com

This week, pharma giant Gilead Sciences announced it would require all employees and contractors to be fully vaccinated against Covid-19 by 1 October, excepting those with medical or religious reasons for opting out.

The company said its goal is to “safeguard the health of our workforce and to protect the patients we serve” – and it’s not the only industry player to mandate staff vaccinations or regular testing as the Delta variant sends coronavirus cases skyrocketing in the US and elsewhere.

What have been the stances taken on staff Covid-19 vaccination from other players in the pharmaceutical and biotech space, and what is the wider context in which these decisions are being made?

Eli Lilly

Eli Lilly announced yesterday in an email to Endpoints that it would require all US and Puerto Rico staff to be vaccinated against Covid-19, effective 15 November. Employees’ requests for medical or religious accommodations will be considered on an individual basis.

Lilly said: “As a science-based company, we have thoroughly reviewed all the data and options available to us. We believe this decision helps keep our employees, families and customers safe and healthy, and ensures we can continue making life-saving medicines for people around the world.”

Pfizer

Less than a week before Gilead’s announcement, Pfizer said it would require all US staff and contractors to either get vaccinated against Covid-19 or undergo weekly testing.

Pfizer spokesperson Pamela Eisele told CNBC the company is “strongly encouraging” those outside of the US who are able to get vaccinated to do so. She added that individuals with medical conditions or religious objections would be able to seek accommodations.

Novartis

Swiss multinational Novartis told Endpoints that it expects everyone on its campus to either be fully vaccinated or have tested negative for Covid-19 within the last two weeks before each visit.

A spokesperson said: “With the increase of people becoming infected with the highly contagious Delta variant of the virus, and the potential for more variants to develop among the unvaccinated, we strongly encourage all of our associates to be vaccinated as soon as possible.”

Emergent BioSolutions

Emergent is a contract manufacturer that has inked multi-million-dollar deals with AstraZeneca, Johnson & Johnson and Novavax to produce their Covid-19 vaccines.

According to the company’s federal contract, Emergent has permission to hold back a “reasonable quantity” of jabs to vaccinate its “employees and critical subcontractors, and their respective immediate families”.

While some have expressed concern that this could mean Emergent employees are vaccinated before priority groups, the company told NPR in January that its staff would not be jumping the queue for Covid-19 vaccines, and should receive their jabs in line with states’ vaccine distribution plans.

AbbVie

US-based biopharma AbbVie has given employees two options when it comes to being Covid-safe in the workplace: get vaccinated and scrap the masks and social distancing, or keep following anti-coronavirus measures and undergo weekly on-site Covid-19 testing.

In an email to employees, the company said that “vaccination is the most effective way to keep people safe from Covid-19 and stop the spread of the virus”, the Chicago Tribune reported.

Moderna

In December, Moderna announced that it would be making its vaccine available to workers, contractors and board members in the US. The company said the programme would also extend to adult household members of employees to “reduce the risk of absenteeism and disruption due to a Covid-19 infection in an adult household member”.

According to the statement, staff participation in the vaccination programme is entirely voluntary.

The wider debate: can employers mandate staff vaccination?

Employers in industries outside of pharma are also keen to get their workers jabbed. In the UK, several of the nation’s leading employers have encouraged their staff to get vaccinated, with many pledging flexibilities to allow them to attend vaccine appointments during work hours.

Carol Frost, chief people officer at Metro Bank, one of the companies involved in the scheme, said: “The vaccine roll-out is crucial to the health and wellbeing both of the nation and the economy, bringing with it hope for a return to normality.

“We are fully behind the vaccination programme and have encouraged colleagues to get vaccinated in line with government advice, giving them time off, if needed, to get their jabs.”

On Wall Street, Morgan Stanley and BlackRock are opening their office doors to vaccinated employees only, while Goldman Sachs requires its staff to disclose their vaccination status.

The Financial Times also reported earlier this year that some UK organisations, ranging from care home companies to multinational firms, are looking at drawing up contracts that would make Covid-19 vaccination a condition of employment.

But not all staff are happy with mandated Covid-19 vaccinations. In June, for example, over 150 Houston Methodist Hospital employees resigned or were fired after an unsuccessful lawsuit against the US hospital’s vaccine requirement for staff members.

According to law firm Lewis Silkin, UK employers are allowed to strongly encourage their staff to get vaccinated, and only allow vaccinated employees back into the office. Whether or not employers can mandate vaccination is less clear, as it has never been tested in UK law.

“The key legal problems with mandating the vaccine are the risks associated with dismissing employees who refuse and have over two years’ service, and the potential for discrimination claims from employees with protected characteristics,” the law firm said.

Care home employers are an exception to this rule. The UK government has made vaccination compulsory for all English care home employees, meaning employers will have a legislative basis for dismissing staff members who refuse to get jabbed.

IN GIAPPONE ULTERIORI RITROVAMENTI DI MILIONI DI DOSI DI VACCINI MODERNA CONTAMINATE CON METALLI IGNOTI: DUE MORTI ... E QUANTI SEGUIRANNO?

 

Contaminants found in more Moderna COVID vaccine in Japan

KYODO NEWS KYODO NEWS - Aug 29, 2021 - 22:19 | All, Coronavirus, Japan







The Gunma prefectural government said Sunday that foreign substances were discovered in Moderna Inc.'s COVID-19 vaccine, the latest in a series of contaminants in the company's product reported in Japan over the past several days.

Blackish foreign matter, less than 0.5 millimeters in size, was spotted during pre-inoculation inspections in a vial that has a different lot number from those of the three lots suspended Thursday for use and another found Saturday in Okinawa containing black and pink substances.

About 4,500 people received shots in Gunma under the lot number over the three days through Sunday but no cases of ill health have been reported, the local government said.

Gunma becomes the seventh prefecture to report the discovery of foreign matter in the Moderna vaccine following Ibaraki, Saitama, Tokyo, Gifu, Aichi and Okinawa.

All the seven are among 21 prefectures, out of the total 47, currently under a COVID-19 state of emergency, as Japan is struggling to contain a spike in coronavirus infections.

The same day, the Okinawa prefectural government said it halted inoculations at a mass vaccination site in Naha following the discovery of contaminants in a vial and three syringes filled with vaccine from three different vials.

These four vials fall under the same lot number -- 3005293 -- which is different from the three other lot numbers identified by Japan's health ministry Thursday as potentially contaminated doses.

The Health, Labor and Welfare Ministry said Sunday that rubber pieces have likely fallen into the vials when a syringe needle was inserted into the rubber top of the vials. The ministry has found no major problem in vaccine quality, it added.

The ministry said it consulted with Japanese drugmaker Takeda Pharmaceutical Co., which is in charge of the sale and distribution of the Moderna vaccine in the country, and decided there is no need to halt the use of the batch as there are no major safety issues.

About 880 people received shots in Okinawa under the lot number and the local government has not received any reports of health issues.

The contaminant issue started Thursday when the ministry said foreign substances have been confirmed in 39 unused vials at eight vaccination sites in Ibaraki, Saitama, Tokyo, Gifu and Aichi.

The ministry the same day halted the use of around 1.63 million doses of the three lots, which came from a Spanish manufacturer for Moderna, as a precaution.

Moderna launched a probe into the three lots -- 3004667, 3004734 and 3004956 -- while urging medical institutions and other entities not to administer any vaccine showing abnormalities, even doses not subject to the suspension.

The Okinawa government said it will resume inoculating people at the site on Monday and Gunma restarted vaccination at the center Sunday, both by using unaffected vaccine.


Related coverage:

Contaminants found in Moderna vaccine not belonging to suspended lots

2 men die in Japan after receiving dose of suspended Moderna vaccines

Moderna's contaminated vaccine only shipped to Japan: Spanish maker


Tainted Moderna vaccine found in Okinawa under 4th lot number

THE ASAHI SHIMBUN

August 29, 2021 at 17:00 JST

Photo/Illutration The city center of Naha, capital of Okinawa Prefecture (Asahi Shimbun file photo)

NAHA--A batch of COV19-19 vaccines manufactured by Moderna Inc. not covered by those suspended by the health ministry due to contamination fears turned out to be tainted, Okinawa prefectural authorities said late Aug. 28.

Following the discovery, officials canceled a mass vaccination of the Moderna vaccine at a site in Naha planned for late in the afternoon that day. They also called off a scheduled inoculation at the venue set for Aug. 29.

Officials said small black particles were detected in an opened vaccine vial as well as in two syringes loaded with the vaccine during the afternoon of Aug. 28.

They added that a foreign substance with a pinkish hue was detected in another syringe.

The contamination affected a batch with the lot number 3005293.

Nearly 900 doses of the same lot number were administered between Aug. 27 and Aug. 28 after health officials confirmed there was no irregularity in the vaccine.

Officials said they are not aware of any reports of health issues among those who received the shots.

They said 360 Moderna vaccine vials were distributed to the site. Officials have yet to confirm the safety of the vials that were not used.

The development followed the health ministry’s Aug. 26 decision to halt the rollout of the Moderna vaccine with the lot numbers 3004667, 3004734 and 3004956, after contamination was discovered in the vaccine produced under lot number 3004667.

The ministry also suspended the use of the product under the latter two lot numbers, citing fears of possible contamination.

The vaccines under the three lot numbers all came from the same production line of a Spanish factory.

Tainted Moderna vaccine found in Okinawa under 4th lot number

THE ASAHI SHIMBUN

August 29, 2021 at 17:00 JST

Photo/Illutration The city center of Naha, capital of Okinawa Prefecture (Asahi Shimbun file photo)

NAHA--A batch of COV19-19 vaccines manufactured by Moderna Inc. not covered by those suspended by the health ministry due to contamination fears turned out to be tainted, Okinawa prefectural authorities said late Aug. 28.

Following the discovery, officials canceled a mass vaccination of the Moderna vaccine at a site in Naha planned for late in the afternoon that day. They also called off a scheduled inoculation at the venue set for Aug. 29.

Officials said small black particles were detected in an opened vaccine vial as well as in two syringes loaded with the vaccine during the afternoon of Aug. 28.

They added that a foreign substance with a pinkish hue was detected in another syringe.

The contamination affected a batch with the lot number 3005293.

Nearly 900 doses of the same lot number were administered between Aug. 27 and Aug. 28 after health officials confirmed there was no irregularity in the vaccine.

Officials said they are not aware of any reports of health issues among those who received the shots.

They said 360 Moderna vaccine vials were distributed to the site. Officials have yet to confirm the safety of the vials that were not used.

The development followed the health ministry’s Aug. 26 decision to halt the rollout of the Moderna vaccine with the lot numbers 3004667, 3004734 and 3004956, after contamination was discovered in the vaccine produced under lot number 3004667.

The ministry also suspended the use of the product under the latter two lot numbers, citing fears of possible contamination.

The vaccines under the three lot numbers all came from the same production line of a Spanish factory.

Tainted Moderna vaccine found in Okinawa under 4th lot number

THE ASAHI SHIMBUN

August 29, 2021 at 17:00 JST

Photo/Illutration The city center of Naha, capital of Okinawa Prefecture (Asahi Shimbun file photo)

NAHA--A batch of COV19-19 vaccines manufactured by Moderna Inc. not covered by those suspended by the health ministry due to contamination fears turned out to be tainted, Okinawa prefectural authorities said late Aug. 28.

Following the discovery, officials canceled a mass vaccination of the Moderna vaccine at a site in Naha planned for late in the afternoon that day. They also called off a scheduled inoculation at the venue set for Aug. 29.

Officials said small black particles were detected in an opened vaccine vial as well as in two syringes loaded with the vaccine during the afternoon of Aug. 28.

They added that a foreign substance with a pinkish hue was detected in another syringe.

The contamination affected a batch with the lot number 3005293.

Nearly 900 doses of the same lot number were administered between Aug. 27 and Aug. 28 after health officials confirmed there was no irregularity in the vaccine.

Officials said they are not aware of any reports of health issues among those who received the shots.

They said 360 Moderna vaccine vials were distributed to the site. Officials have yet to confirm the safety of the vials that were not used.

The development followed the health ministry’s Aug. 26 decision to halt the rollout of the Moderna vaccine with the lot numbers 3004667, 3004734 and 3004956, after contamination was discovered in the vaccine produced under lot number 3004667.

The ministry also suspended the use of the product under the latter two lot numbers, citing fears of possible contamination.

The vaccines under the three lot numbers all came from the same production line of a Spanish factory.

Tainted Moderna vaccine found in Okinawa under 4th lot number

THE ASAHI SHIMBUN

August 29, 2021 at 17:00 JST

Photo/Illutration The city center of Naha, capital of Okinawa Prefecture (Asahi Shimbun file photo)

NAHA--A batch of COV19-19 vaccines manufactured by Moderna Inc. not covered by those suspended by the health ministry due to contamination fears turned out to be tainted, Okinawa prefectural authorities said late Aug. 28.

Following the discovery, officials canceled a mass vaccination of the Moderna vaccine at a site in Naha planned for late in the afternoon that day. They also called off a scheduled inoculation at the venue set for Aug. 29.

Officials said small black particles were detected in an opened vaccine vial as well as in two syringes loaded with the vaccine during the afternoon of Aug. 28.

They added that a foreign substance with a pinkish hue was detected in another syringe.

The contamination affected a batch with the lot number 3005293.

Nearly 900 doses of the same lot number were administered between Aug. 27 and Aug. 28 after health officials confirmed there was no irregularity in the vaccine.

Officials said they are not aware of any reports of health issues among those who received the shots.

They said 360 Moderna vaccine vials were distributed to the site. Officials have yet to confirm the safety of the vials that were not used.

The development followed the health ministry’s Aug. 26 decision to halt the rollout of the Moderna vaccine with the lot numbers 3004667, 3004734 and 3004956, after contamination was discovered in the vaccine produced under lot number 3004667.

The ministry also suspended the use of the product under the latter two lot numbers, citing fears of possible contamination.

The vaccines under the three lot numbers all came from the same production line of a Spanish factory.

AD OKINAWA MILIONI DI DOSI DI MODERNA CONTAMINATE DA METALLI IGNOTI, MA QUANDO LO DICEVANO MONTANARI E GATTI ERANO SOLO DEI FOLLI IMBECILLI

 

Health and Science

Japan’s Moderna vaccine contamination problems widen as regions put holds on more shots

Reuters
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Key Points
  • A tiny black substance was found in a Moderna vaccine vial in Gunma, an official from the prefecture said, while in Okinawa, black substances were spotted in syringes and a vial, and pink material was found in a different syringe.
  • Japan’s health ministry said some of the incidents may have been due to needles being incorrectly inserted into vials, breaking off bits of the rubber stopper.
  • Japan earlier halted the use of 1.63 million Moderna doses, shipped to 863 vaccination centers nationwide after Takeda received reports of contaminants in some vials.

In this article

Staff members of Tokyo Vaccination Center at Aoyama University look over the vaccination recovery area. (Photo by Stanislav Kogiku/SOPA Images/LightRocket via Getty Images)
Staff members of Tokyo Vaccination Center at Aoyama University look over the vaccination recovery area. (Photo by Stanislav Kogiku/SOPA Images/LightRocket via Getty Images)
Stanislav Kogiku | SOPA Images | LightRocket | Getty Images

Moderna’s Covid-19 vaccine contamination woes in Japan widened after two regions put temporary holds on shots following the discovery of foreign substances in more batches.

The disruption to Moderna supplies comes as Japan battles its worst wave of Covid-19 yet, driven by the contagious delta variant, with new daily infections exceeding 25,000 this month for the first time amid a slow vaccine rollout.

The latest reports of vaccine contamination came from Gunma prefecture near Tokyo and the southern prefecture of Okinawa, prompting temporary holds on Sunday on shots from two new Moderna lots. That followed the nationwide suspension of 1.63 million doses last week.

A tiny black substance was found in a Moderna vaccine vial in Gunma, an official from the prefecture said, while in Okinawa, black substances were spotted in syringes and a vial, and pink material was found in a different syringe.

Japan’s health ministry said some of the incidents may have been due to needles being incorrectly inserted into vials, breaking off bits of the rubber stopper.

The ministry and Takeda Pharmaceutical, which distributes the Moderna vaccine in Japan, said there were no safety issues from the Okinawa and Gunma incidents and that there was no need for nationwide suspensions.

Gunma and Okinawa can resume using vials from the lots in question as long as they do not contain foreign materials, the ministry told a briefing late on Monday.

The contamination cases come on the heels of a government report on Saturday that two people died after receiving Moderna shots that were among lots later suspended.

The government had said that no safety or efficacy issues had been identified and that the suspension was a precaution. The causes of death are being investigated.

“It is unlikely, in my opinion, that contamination of foreign substances led directly to sudden deaths,” said Takahiro Kinoshita, a physician and vice chair of Cov-Navi, a vaccine information group.

“If the contaminated substances were dangerous enough to cause death for some people, probably many more people would have suffered from some symptoms after the vaccination.

“However, further investigations are definitely needed to evaluate the harm of the particular doses in question.”

VIDEO59:51
How Moderna and Pfizer-BioNTech developed vaccines in record time

‘Look at the bigger picture’

Japan earlier halted the use of 1.63 million Moderna doses, shipped to 863 vaccination centers nationwide after Takeda received reports of contaminants in some vials.

Some 500,000 people received shots from those supplies, Taro Kono, the minister in charge of the vaccine push, has said.

Moderna and Spanish pharma company Rovi, which bottles Moderna vaccines for markets other than the United States, said at the time that the contamination could be due to a manufacturing issue in one of Rovi’s production lines.

Rovi said, in a statement on Sunday, that an investigation was under way in coordination with Moderna, Takeda and the health authorities. Takeda also said, on Monday, that the investigation was ongoing.

Rovi shares closed down 13.5% on Monday.

Nicholas Rennick, an Australian doctor practicing at the NTT Medical Centre in Tokyo, said the contamination “is a serious problem” and there is need to investigate, but given rising Covid-19 cases, Moderna vaccinations should “continue with appropriate precautions.”

Severe Covid-19 cases are at record levels in Japan, leaving many people to recuperate at home amid a shortage of critical care beds. Only 44% of its population has been fully vaccinated, lagging vaccination rates of several developed countries.

“We’ve got thousands of Delta variant patients around Japan as we speak, spreading the virus, and so many of the population remain unvaccinated and unprotected,” Rennick said.

“We have to look at the bigger picture.”

Contaminants found in more Moderna COVID vaccine in Japan

This June 14, 2021, file photo shows a Moderna COVID-19 vaccine vial that is being administered for flight attendants of Japan Airlines ar Haneda Airport in Tokyo.(AP Photo/Eugene Hoshiko, File)

TOKYO (Kyodo) -- The Gunma prefectural government said Sunday that foreign substances were discovered in Moderna Inc.'s COVID-19 vaccine, the latest in a series of contaminants in the company's product reported in Japan over the past several days.

Blackish foreign matter, less than 0.5 millimeters in size, was spotted during pre-inoculation inspections in a vial that has a different lot number from those of the three lots suspended Thursday for use and another found Saturday in Okinawa containing black and pink substances.

About 4,500 people received shots in Gunma under the lot number over the three days through Sunday but no cases of ill health have been reported, the local government said.

Gunma becomes the seventh prefecture to report the discovery of foreign matter in the Moderna vaccine following Ibaraki, Saitama, Tokyo, Gifu, Aichi and Okinawa.

All the seven are among 21 prefectures, out of the total 47, currently under a COVID-19 state of emergency, as Japan is struggling to contain a spike in coronavirus infections.

The same day, the Okinawa prefectural government said it halted inoculations at a mass vaccination site in Naha following the discovery of contaminants in a vial and three syringes filled with vaccine from three different vials.

These four vials fall under the same lot number -- 3005293 -- which is different from the three other lot numbers identified by Japan's health ministry Thursday as potentially contaminated doses.

The Health, Labor and Welfare Ministry said Sunday that rubber pieces have likely fallen into the vials when a syringe needle was inserted into the rubber top of the vials. The ministry has found no major problem in vaccine quality, it added.

The ministry said it consulted with Japanese drugmaker Takeda Pharmaceutical Co., which is in charge of the sale and distribution of the Moderna vaccine in the country, and decided there is no need to halt the use of the batch as there are no major safety issues.

About 880 people received shots in Okinawa under the lot number and the local government has not received any reports of health issues.

The contaminant issue started Thursday when the ministry said foreign substances have been confirmed in 39 unused vials at eight vaccination sites in Ibaraki, Saitama, Tokyo, Gifu and Aichi.

The ministry the same day halted the use of around 1.63 million doses of the three lots, which came from a Spanish manufacturer for Moderna, as a precaution.

Moderna launched a probe into the three lots -- 3004667, 3004734 and 3004956 -- while urging medical institutions and other entities not to administer any vaccine showing abnormalities, even doses not subject to the suspension.

The Okinawa government said it will resume inoculating people at the site on Monday and Gunma restarted vaccination at the center Sunday, both by using unaffected vaccine.

Contaminants found in more Moderna COVID vaccine in Japan

This June 14, 2021, file photo shows a Moderna COVID-19 vaccine vial that is being administered for flight attendants of Japan Airlines ar Haneda Airport in Tokyo.(AP Photo/Eugene Hoshiko, File)

TOKYO (Kyodo) -- The Gunma prefectural government said Sunday that foreign substances were discovered in Moderna Inc.'s COVID-19 vaccine, the latest in a series of contaminants in the company's product reported in Japan over the past several days.

Blackish foreign matter, less than 0.5 millimeters in size, was spotted during pre-inoculation inspections in a vial that has a different lot number from those of the three lots suspended Thursday for use and another found Saturday in Okinawa containing black and pink substances.

About 4,500 people received shots in Gunma under the lot number over the three days through Sunday but no cases of ill health have been reported, the local government said.

Gunma becomes the seventh prefecture to report the discovery of foreign matter in the Moderna vaccine following Ibaraki, Saitama, Tokyo, Gifu, Aichi and Okinawa.

All the seven are among 21 prefectures, out of the total 47, currently under a COVID-19 state of emergency, as Japan is struggling to contain a spike in coronavirus infections.

The same day, the Okinawa prefectural government said it halted inoculations at a mass vaccination site in Naha following the discovery of contaminants in a vial and three syringes filled with vaccine from three different vials.

These four vials fall under the same lot number -- 3005293 -- which is different from the three other lot numbers identified by Japan's health ministry Thursday as potentially contaminated doses.

The Health, Labor and Welfare Ministry said Sunday that rubber pieces have likely fallen into the vials when a syringe needle was inserted into the rubber top of the vials. The ministry has found no major problem in vaccine quality, it added.

The ministry said it consulted with Japanese drugmaker Takeda Pharmaceutical Co., which is in charge of the sale and distribution of the Moderna vaccine in the country, and decided there is no need to halt the use of the batch as there are no major safety issues.

About 880 people received shots in Okinawa under the lot number and the local government has not received any reports of health issues.

The contaminant issue started Thursday when the ministry said foreign substances have been confirmed in 39 unused vials at eight vaccination sites in Ibaraki, Saitama, Tokyo, Gifu and Aichi.

The ministry the same day halted the use of around 1.63 million doses of the three lots, which came from a Spanish manufacturer for Moderna, as a precaution.

Moderna launched a probe into the three lots -- 3004667, 3004734 and 3004956 -- while urging medical institutions and other entities not to administer any vaccine showing abnormalities, even doses not subject to the suspension.

The Okinawa government said it will resume inoculating people at the site on Monday and Gunma restarted vaccination at the center Sunday, both by using unaffected vaccine.

AD OKINAWA SOSPESE LE VACCINAZIONI PER LA PRESENZA DI METALLI NEI VACCINI MODERNA ... MILIONI DI DOSI ... NESSUN "ERRORE DI CAMPIONAMENTO" ...

 

COVID-19: Japan’s Okinawa reports Moderna jab impurities

  • AFP, Tokyo

Japan’s Okinawa Prefecture yesterday suspended the use of the Moderna COVID-19 vaccine after contamination was found, the prefecture government said.

It comes a day after the Japanese Ministry of Health Labor and Welfare said it was investigating the death of two men who received shots from tainted Moderna batches — although the cause of their death is unknown.

Okinawa authorities said that yesterday’s vaccination program has been partially postponed.

People wait in the post-inoculation observation area of a COVID-19 vaccination site in Naha, Japan, on June 12.

Photo: Bloomberg

“We are suspending the use of Moderna’s COVID-19 vaccines as foreign substances were spotted in some of them,” the prefecture government said in a statement.

The lots affected by the contamination spotted in Okinawa are different from the 1.63 million doses suspended after the two deaths, local media reported.

That suspension came after the health ministry said that two men, aged 30 and 38, died earlier this month after getting their second Moderna doses.

Those doses were drawn from one of three batches suspended by the Japanese government on Thursday after several vials were found to be contaminated.

The ministry said that it was investigating the cause of death.

It is unknown if there is a causal link with the vaccine.

“At this time, we do not have any evidence that these deaths are caused by the Moderna COVID-19 vaccine, and it is important to conduct a formal investigation to determine whether there is any connection,” Moderna and its Japanese distributor Takeda said in a joint statement on Saturday.

The nature of the particles found in the vials, which were manufactured by a Moderna contractor in Europe, is also not known yet.

“The vials have been sent to a qualified lab for analysis, and initial findings will be available early next week,” Moderna and Takeda said.

The contractor, Spanish pharmaceutical firm ROVI, on Thursday said in a statement that it was investigating the cause of the contamination in the batch, which was only distributed in Japan.

It added that the issue might have originated on one of its manufacturing lines.

About 44 percent of Japan’s population has been fully vaccinated, as the country battles a record surge of COVID-19 cases driven by the more contagious Delta variant of SARS-CoV-2.

More than 15,800 people have died from COVID-19 in Japan, and large parts of the country are under strict virus restrictions.

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Japan vows quick and transparent probe after deaths of two who had Moderna shots

The Okinawa Prefectural Government said it had found foreign matter in an unused vial of the vaccine not belonging to batches already suspended


  • Bloomberg, KYODO, staff report

Japan is investigating the deaths of two people who were given Moderna Inc.’s COVID-19 shots from vaccine batches which have since been suspended.

While the relationship between the deaths and the shots is currently unclear, the health ministry will swiftly conduct the investigations together with external experts, health minister Norihisa Tamura said during an NHK program on Sunday.

“(The) investigation is still ongoing, but we will quickly disclose what we find out,” Tamura said. “We would like the experts to examine under what circumstances the deaths occurred, and whether there were any causal relations” with the vaccine, he said.

Doses from three lots have been halted following reports that foreign particles were found in one of the batches. The two people received their second shots from a lot that didn’t have any foreign particles reported, but it was suspended because the batch was produced at the same facility at around the same time, the health ministry said.

The deaths of the two men in their 30s were confirmed three days after they received their second Moderna vaccines this month, the health ministry said. Neither man had a history of allergies or other underlying conditions.

The health ministry said Thursday that foreign substances had been confirmed in 39 unused vials at eight vaccination sites in five prefectures — Ibaraki, Saitama, Tokyo, Gifu and Aichi.

The same day, it halted the use of around 1.63 million doses, or three lots, which came from the same production line at a Spanish factory, as a precaution.

A health care worker administers a dose of Moderna Inc.'s COVID-19 vaccine at a mass vaccination site in Saitama on Aug. 23. | BLOOMBERG
A health care worker administers a dose of Moderna Inc.’s COVID-19 vaccine at a mass vaccination site in Saitama on Aug. 23. | BLOOMBERG

Takeda Pharmaceutical Co. Ltd., the local distributor of the Moderna shot, and the vaccine manufacturer said it’s important that the relationship between the deaths and the shots is officially investigated. No link has been detected so far, they said in a joint statement on Saturday.

“The investigation is being conducted with the greatest sense of urgency, transparency and integrity and is of the highest priority,” the companies said. “Takeda and Moderna will keep the public informed as we learn more.”

Separately, Okinawa Prefecture suspended some Moderna vaccinations Saturday evening after observing suspected foreign particles in doses that did not come from the three halted batches, said Atsushi Mizuta, an official overseeing the prefecture’s vaccination program. The prefecture said it was discussing next steps with the health ministry.

The prefecture said it found black particles and pink particles in vials before use at a mass vaccination center in Naha on Saturday. Moderna vaccinations at the same site were also suspended Sunday.

Takeda has requested that Moderna and the company’s European contract manufacturing organization “urgently” conduct a thorough investigation to determine the nature of the foreign substance, according to the joint statement.

Takeda has said there have been no safety concerns tied to the halted vials, and vaccinations using Moderna’s shots in Japan will proceed as usual.

The presence of the foreign substances had been known since Aug. 16, but Takeda only reported the problem to the ministry on Wednesday.

Taro Kono, the minister in charge of the vaccination rollout, said Friday that over 500,000 shots have already been administered from the potentially contaminated batches.

About 124.5 million vaccine doses have been administered in Japan, and about 43.5% of the population is fully inoculated, government data shows.

So far, more than 1,000 people in total have died in Japan after being administered a COVID-19 vaccine, but no causality has been established between the shots and the deaths, according to the health ministry.




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Ranieri Guerra mentions the name of Massimo D'Alema to the magistrates –  Libero Quotidiano

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German Finance Minister Reveals the Conditions for Germany to Support  Eurobonds

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