Author: Gonzalo Alvaro

The deadline for signing up for ROVI’s flu vaccination campaign is 15 October. If you haven’t already done so, you have these options for signing up:

1. Send an email to the mailbox vaccinate@rovi.es with the following information: full name, ID and work centre.
2. Submit a signed written form to the Safety and Environment (SYMA) of your work centre that you will find in the security checkpoints of the plants.

• Julián Camarillo: pfacenda@rovi.es / echamorro@rovi.es
• Pozuelo and Building H: afernandez@rovi.es
• Granada: lnuno@rovi.es / rlanzas@rovi.es
• Alcalá: epalomino@rovi.es / aiborra@rovi.es
• San Sebastián de los Reyes: mnaranjo@rovi.es

The internal flu vaccination campaign for all employees who wish to be vaccinated will take place between 25 October and 12 November 2021. Each employee will be assigned a specific vaccination schedule.

Why is it important to get a flu shot?

• The flu is an infectious respiratory disease caused by a virus. Flu viruses can cause mild or severe illness and can sometimes lead to death.
• Vaccination is the most effective strategy to reduce the chances of infection among the general population, with a special focus on risk groups.
• At ROVI we support this strategy of the authorities and we understand that, in the context of the current pandemic, it is essential to promote compliance with the vaccination objectives of the autonomous communities, reduce the risk of influenza contagion among the most vulnerable population and minimize the care burden of health resources.

Vaccine Information

In the following link you will find all the information about the flu vaccine, how it works, the risk groups, its contraindications, etc. We recommend that you read it so that you can make an informed decision.

https://www.mscbs.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/programasDeVacunacion/gripe/faq/home.htm

If you want to know more about the vaccine that we will provide (quadrivalent and cell culture), you will find all the information in this link, including information on adverse effects:

https://www.mscbs.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/programasDeVacunacion/gripe/faq/home.htm

Likewise, below, we provide you with the relevant information regarding Data Protection:

Laboratorios Rovi, SA and its subsidiaries (hereinafter, “ROVI”; or “GRUPO ROVI”, indistinctly), with registered office at C / Julián Camarillo, 35, 28037, Madrid and CIF A-28041283, will process the identification and contact data (name, workplace and ID) of the workers who sign up for the ordinary flu Vaccination campaign that will take place on day [-], in order to manage it. The processing of these data is necessary for your vaccination.

The legal basis that legitimizes the processing of your data is the consent given by you when registering for the Vaccination campaign. The data will be kept for the duration of the employment relationship and, once it has ended, for the period determined by the applicable legislation at all times.

The above data will be transferred to Quirónsalud Hospital Group, external medical service to which we have arranged to carry out the campaign, to allow you to identify yourself as a ROVI employee. Once received, the Quirónsalud Hospital Group You will be fully responsible for the treatment of the data provided by ROVI and the rest of the data provided by you directly, which will be treated under your sole responsibility and in accordance with the provisions of your own Privacy Policy. Likewise, your data may be transferred to third parties to whom ROVI is obliged to transmit information, such as public authorities.

The worker may exercise their rights of access, rectification, cancellation / deletion, opposition, limitation and portability through written communication to [-], identifying themselves as an employee of one of the ROVI GROUP companies, providing a photocopy of their ID or equivalent document and specifying your request. The cancellation or opposition rights may not be exercised when their granting prevents the proper development and fulfilment of the contractual relationship. Likewise, if they consider their right to personal data protection violated, they may file a claim with the Spanish Data Protection Agency ( www.aepd.es ).

If you wish, you can consult the additional and detailed information on Data Protection by contacting our Data Protection Delegate at: dporovi@rovi.es .

One more year, ROVI joins the recommendation of the health authorities and will facilitate the possibility of getting vaccinated against the common flu to all employees who so wish.

Why is it important to get a flu shot?

• The flu is an infectious respiratory disease caused by a virus. Flu viruses can cause mild or severe illness and can sometimes lead to death.
• Vaccination is the most effective strategy to reduce the chances of infection among the general population, with a special focus on risk groups.
• At ROVI we support this strategy of the authorities and we understand that, in the context of the current pandemic, it is essential to promote compliance with the vaccination objectives of the autonomous communities, reduce the risk of influenza contagion among the most vulnerable population and minimize the care burden of health resources.

For this reason, this year we will carry out an internal flu vaccination campaign for all employees who wish to do so, between October 25 and November 12, 2021.

Those employees who are interested in getting vaccinated can enrol in one of the following ways:

1. Send an email to the mailbox vaccinate@rovi.es with the following information: full name, ID and work centre.
2. Submit a signed written form to the Safety and Environment (SYMA) of your work centre that you will find in the security checkpoints of the plants.

• Julián Camarillo: pfacenda@rovi.es / echamorro@rovi.es
• Pozuelo and Building H: afernandez@rovi.es
• Granada: lnuno@rovi.es / rlanzas@rovi.es
• Alcalá: epalomino@rovi.es / aiborra@rovi.es
• San Sebastián de los Reyes: mnaranjo@rovi.es

Registration must be sent before October 15, so that we can properly organize vaccination shifts.

Vaccine Information

In the following link you will find all the information about the flu vaccine, how it works, the risk groups, its contraindications, etc. We recommend that you read it so that you can make an informed decision.

https://www.mscbs.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/programasDeVacunacion/gripe/faq/home.htm

If you want to know more about the vaccine that we will provide (quadrivalent and cell culture), you will find all the information in this link, including information on adverse effects:

https://www.mscbs.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/programasDeVacunacion/gripe/faq/home.htm

Likewise, below, we provide you with the relevant information regarding Data Protection:

Laboratorios Rovi, SA and its subsidiaries (hereinafter, “ROVI”; or “GRUPO ROVI”, indistinctly), with registered office at C / Julián Camarillo, 35, 28037, Madrid and CIF A-28041283, will process the identification and contact data (name, workplace and ID) of the workers who sign up for the ordinary flu Vaccination campaign that will take place on day [-], in order to manage it. The processing of these data is necessary for your vaccination.

The legal basis that legitimizes the processing of your data is the consent given by you when registering for the Vaccination campaign. The data will be kept for the duration of the employment relationship and, once it has ended, for the period determined by the applicable legislation at all times.

The above data will be transferred to Quirónsalud Hospital Group, external medical service to which we have arranged to carry out the campaign, to allow you to identify yourself as a ROVI employee. Once received, the Quirónsalud Hospital Group You will be fully responsible for the treatment of the data provided by ROVI and the rest of the data provided by you directly, which will be treated under your sole responsibility and in accordance with the provisions of your own Privacy Policy. Likewise, your data may be transferred to third parties to whom ROVI is obliged to transmit information, such as public authorities.

The worker may exercise their rights of access, rectification, cancellation / deletion, opposition, limitation and portability through written communication to [-], identifying themselves as an employee of one of the ROVI GROUP companies, providing a photocopy of their ID or equivalent document and specifying your request. The cancellation or opposition rights may not be exercised when their granting prevents the proper development and fulfilment of the contractual relationship. Likewise, if they consider their right to personal data protection violated, they may file a claim with the Spanish Data Protection Agency ( www.aepd.es ). If you wish, you can consult the additional and detailed information on Data Protection by contacting our Data Protection Delegate at: dporovi@rovi.es .

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In relation to the relevant information published in recent days on the recall of batches of Moderna’s Covid-19 vaccine because of the detection of particles in some vials distributed in Japan, ROVI reports the conclusions of the investigation carried out in collaboration with the Japanese Ministry of Health, Labour and Welfare, the vaccine’s proprietary laboratory, Moderna, and the authorised distributor in Japan, Takeda. 

On 26 August 2021, three batches of Moderna’s Covid-19 vaccine (batch 3004667, 3004734 and 3004956) were recalled following the discovery of foreign particles in unused vials of batch 3004667.

According to the cause investigation report conducted by ROVI, the most likely cause of the particulates identified in that batch is related to friction between two metal parts installed in the capping module of the production line due to an incorrect configuration during a line changeover prior to the start of production of batch 3004667.

According to ROVI’s analysis, the manufacturing incident only affected the three batches that were suspended and for which Takeda has requested a definitive recall.

ROVI, in coordination and in agreement with Moderna, has taken the appropriate measures to strengthen the processing and control protocols with the process requirements that have been revealed in relation to these new manufacturing activities in order to prevent potential incidents.

From ROVI’s Management we would like to send a message of thanks to the teams involved in the investigation of what happened, who have worked over the last few days with the utmost sense of urgency and displaying their professionalism and commitment.
Likewise, we convey our full support to these professionals who continue to work and offer solutions to ensure that our activity continues as normal.

Particulate analysis and safety assessment

According to the independent analysis carried out by Moderna, the particulate from batch 3004667  has been thoroughly analysed and is confirmed to be 316 grade stainless steel. This is consistent with the determination of the particle origin described  above. Grade 316 is a high grade of stainless steel commonly used in the manufacture and processing of stainless steel in food manufacturing and processing

Following a health assessment conducted by Moderna and Takeda, the rare presence of stainless steel particles in Moderna’s COVID-19 vaccine does not pose an undue risk to patient safety and does not adversely affect the benefit/risk profile of the product.

Metal particles of this size injected into a muscle may cause a local reaction, but are unlikely to cause other adverse reactions beyond the injection site. Stainless steel is commonly used in heart valves, joint replacements and metal sutures and staples. Therefore, injection of the particles identified in these batches in Japan is not expected to pose any major medical risk. 

Investigation into two deaths following vaccine administration

As reported by Moderna and Takeda in their press release, there is currently no evidence that the two tragic deaths that occurred following the administration of Moderna’s Covid-19 vaccine (from lot 3004734) were related to the administration of the vaccine. The link is now considered to be coincidental. However, both companies are conducting an investigation with the utmost sense of urgency to provide conclusions.

ROVI’s ESG (Environmental, Social and Governance) criteria were evaluated by Sustainalytics, a leading company in the evaluation of Corporate Social Responsibility and Corporate Governance at world level, having achieved an ESG risk rating of 18.4 points, which places the company in a low risk position (between 10 and 20 points). This rating improves by 3.4 points on the previous year (21.8 points), when the company reached a medium risk position (between 20 and 30 points).

In this classification, ROVI obtained the second best rating out of 432 companies evaluated in the pharmaceutical industry category and 17th out of a total of 896 companies in the sector, which includes biotechnology, pharmaceutical laboratories and healthcare equipment companies.

You can consult ROVI’s evaluation at THIS LINK