Value of Vaccines IE - Q3 2021 by Mediaplanet UK&IE

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Our strategy starts with our people and we are outperforming through operational excellence.

A Martin McAuliffe MD and Head of Cork Operations, Merck Group

Brandon Viner Site Director, Arklow Merck Group WRITTEN BY Virginia Blackburn

s the world begins to find a new normal, the fight against COVID-19 and indeed other diseases continues, with constant work on updating and developing vaccines. Not least through companies such as Merck, which has been on the frontline of the fight against the disease. The Life Science business of Merck is helping to respond with products and solutions at its two sites in Cork and Arklow that help scientists detect and characterise viruses and ultimately to develop vaccines and therapies. Developing vital membrane Martin McAuliffe is MD and Head of Cork Operations at Merck. “It is a centre of excellence for membranes, chromatography and analytical devices used by customers in the pharma and biopharma sectors for research and manufacturing applications,” McAuliffe says. “The Cork site produces millions of feet of all types of membrane on an annual basis. The lateral flow membrane is the key component in rapid diagnostic antigen tests, typically used in pregnancy tests and tests for infectious diseases like dengue fever, ebola and malaria. The membrane is also a key component in the rapid antigen tests for COVID-19.” McAuliffe points out that with the onset of the pandemic, the facility’s main duty was to keep colleagues safe, but its second was to see how, following protocols on site, the company could continue to supply its essential products. “The customer demand for this type of membrane has significantly increased since the onset of COVID-19,” McAuliffe explains. “As a result, Merck’s Cork site has completed a €36 million expansion to double its output of lateral flow membrane annually. We have extensive experience in collaborating with our partners to support the production of rapid antigen tests, as a key supplier of lateral flow membrane.” Merck has been based in Cork for over 30 years

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The world is beginning to recover from the pandemic with a global vaccine rollout. Ireland is in line to get 14 million doses of different vaccines in the course of 2021, with over 90% of people over 18 now fully vaccinated.

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Working behind the scenes in the fight against COVID-19

and has grown from a relatively small operation to now employing over 750 staff. As the site continues to expand, opportunities will arise in engineering, quality, process and technology operations areas in the next 12 months. Increasing cholesterol production Brandon Viner is Arklow Site Director, which is primarily known for its production of cholesterol. “Merck Arklow is the primary centre for cGMP bulk manufacturing of commercial and late-stage APIs (active pharmaceutical ingredients) and advanced intermediates, high purity solvents, buffer solutions and excipients,” Viner says. “We have expertise in new process evaluation, process development and technology transfer and we currently have over 100 employees supporting the operation here.” But it is cholesterol that is the key component and demand was exacerbated by the onset of the pandemic. “Our site is producing cholesterol, a key lipid which may be used as a component of mRNA therapeutics and vaccines,” says Viner. “Global demand for our product increased rapidly with the pandemic. We significantly scaled up our volumes over ten-fold in order to supply the global market. We are proud to be a collaborative partner in the development and supply of potenially life-saving therapies and vaccines.” Working behind the scenes Viner emphasises the importance of work behind the scenes and the commitment to providing vaccine development products. “Our strategy starts with our people and we are outperforming through operational excellence,” Viner says. “We.. recognise the power of operational excellence when it is pervasive in the culture. Our lean manufacturing principles and support from our partners enabled us to successfully increase our cholesterol output by ten-fold.”

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Merck – Solving the toughest problems in life science by collaborating with the global scientific community. Merck empowers its employees to fulfil their ambitions and its diverse businesses offer various career moves to seek new horizons. The company offers flexible working conditions and competitive remuneration packages including annual bonus, pension, healthcare and subsidised canteen and gym facilities. merckgroup.com

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Pharmacies gearing up for COVID booster and flu vaccination effort Irish community pharmacies are preparing to play an active role in the COVID booster and flu vaccination campaigns which are due to begin in the coming weeks.

Dermot Twomey President, Irish Pharmacy Union

easonal flu vaccination and COVID-19 booster shots are set to be made available as we approach the winter, providing dual protection against these two serious respiratory viruses. Dermot Twomey, President of the Irish Pharmacy Union (IPU) says, “Pharmacies have administered almost 300,000 COVID-19 vaccinations in recent months. We are ready to play our part in ensuring that our older and more vulnerable citizens are provided with this extra level of protection against COVID-19.

We have all seen the damage a virus can do when it takes hold in our community. Flu remains a serious threat and we all have a duty to protect against it. Protecting the community Mr Twomey also urges everyone to register for a flu vaccine in the coming flu season, “We have all seen the damage a virus can do when it takes hold in our community. Flu remains a serious threat and we all have a duty to protect against it. “Pharmacists have been administering the flu vaccine for the last 10 years. Last flu season, over 300,000 people were vaccinated by their local pharmacist. Just as Irish people registered in their millions for COVID-19 vaccines, we hope to see a strong level of enthusiasm to protect against this perennial flu threat.

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Local vaccination services “As many people will have already experienced, pharmacies offer a highly convenient vaccination service. They are available in local communities, without the need to travel or join long queues. Pharmacies offer services from early morning to late evening and on weekends. They are consistently rated as the easiest to access component of our health system. This convenience will be an asset in these vaccination campaigns.” Value of pharmacists in COVID-19 response Mr Twomey commends the role played by pharmacies in the COVID-19 vaccine rollout since they began vaccinating last June, “Pharmacies across Ireland have proven their immense value to their communities by their success in the vaccination programme. Since the first vaccines were approved, we have been calling for them to be available in pharmacies and, when called upon by the HSE, the community pharmacy sector has delivered and will continue to do so. “The gradual return to normality has come about thanks to the success of the COVID-19 vaccine rollout, helped by the participation of pharmacies across the country. Pharmacies are delighted to be playing a central role in vaccinating communities. We look forward to playing a central role in the rollout of both the COVID-19 booster vaccine and the influenza vaccine ahead of the winter flu season” concludes Mr Twomey.

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Community pharmacists: ready, willing and able Pharmacy doors remained open throughout the COVID-19 pandemic. Pharmacists quickly stepped up to assume a role in the National Vaccination Plan. Two community pharmacists share their perspectives.

Pharmacies step up

P Séamus Burke MPSI Pharmacist, Haven Pharmacy Burke’s, Macroom, Co. Cork

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harmacy teams have shown consistent dedication, determination and flexibility since the outbreak of COVID-19. Members of the Haven and totalhealth Pharmacy groups benefitted from the assistance of our support office in meeting the challenges of the pandemic, enabling us to focus on our patients’ needs, including COVID-19 vaccination. Despite proving an effective resource in community vaccination programs, pharmacy involvement in the COVID-19 roll-out came later than expected. Throughout months of uncertainty about what role we would play, we prepared ourselves with additional vaccine training and pharmacy refits to facilitate vaccine clinics. Our support office assisted with procedures and policies, patient communication, and online registration. Our vaccine service is well underway, though it has not been without challenge: delivery delays, vaccine shortages and ongoing guideline changes, some reported by the media before we are informed. Waiting lists can total thousands, with many patients registering with multiple locations, necessitating significant time confirming appointments to ensure every dose is used. For every vaccination, there is associated equipment, infectioncontrol, counselling, monitoring, paperwork, EU Digital COVID Certificate generation; all while ensuring the dayto-day pharmacy operations continue. Despite the challenges, it has been a privilege to help expedite the roll-out of COVID-19 vaccination.

Untapped potential

he unique position of community pharmacists offers many benefits to vaccination campaigns. By September 2021, over 250,000 COVID-19 vaccinations were administered in community pharmacies. As the healthcare provider who patients see the most, opportunities for education, reassurance, and support are obvious. People know and trust us; the familiar faces of the pharmacy team provided comfort to many vaccine-hesitant patients. Pharmacies also improve vaccine access, with diverse geographical reach and attractive opening hours, and an alternative to long queues and large crowds in vaccination centres. It did not take a global pandemic to invent pharmacy vaccination; we have carried out flu, shingles, and pneumonia vaccinations for many years. What the pandemic did advance was our reach. New regulations introduced included the ability to vaccinate off-site, email prescriptions and remote consultations. The expansion of our capabilities cannot end here. Pharmacists could greatly increase access and uptake of many other vaccines, including childhood immunisations. With diverse clinical expertise, we also have the potential to free up our colleagues in general practice by supporting medication adherence, contraception provision, minor ailments treatment, and much more. We are ready, willing, and more than able to participate in a more integrated healthcare system, prioritising patient-centred care, education, and preventative health.

Róisín Curley MPSI Pharmacist, Curley’s totalhealth Pharmacy, Ballyhaunis, Co. Mayo

Haven Pharmacy and totalhealth Pharmacy have joined forces. Same great Pharmacies, same trusted Teams, more choice for our Patients and Customers. totalhealth.ie havenpharmacy.ie

As many people will have already experienced, pharmacies offer a highly convenient vaccination service. They are available in local communities, without the need to travel or join long queues. ~Dermot Twomey, President, Irish Pharmacy Union

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The processes to validate, approve and recognise new manufacturing facilities, an essential step in scaling up vaccine production, are still not agile enough.

How to accelerate the supply of vaccines to all populations worldwide Over the past few decades, the global regulatory environment has become more stringent and demanding to consistently guarantee the quality, safety and efficacy of medicines and vaccines.

Paula Barbosa Associate Director, Vaccines Policy, IFPMA

he increase in requirements by regulatory authorities has not been implemented equally across the world. Nowadays, we have a high heterogeneity in terms of dossier review, approval processes and timelines, with each country having specific data requirements and processes which often differ between countries. As such, it is virtually impossible for every country in the world to have access to medicines and vaccines at the same time.

The emergence of variants has led to the need to react quickly by developing, manufacturing, and approving new vaccines against those variants, for whom most of the above challenges will also apply. Regulatory requirements under COVID-19 Unfortunately, while vaccines are widely recognised as the most important tool to exit the COVID-19 pandemic, regulatory requirements have not been harmonised and simplified across the world to expedite access. It has highlighted some weaknesses in the system, more precisely in the regulatory management for manufacturing and controls. For instance, the processes to validate, approve and recognise new manufacturing facilities, an essential step in scaling up vaccine production, are still not agile enough. There are multiple changes in process that can happen after a vaccine is first approved, such as

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new types of fridges used or tests performed. We can see dozens of changes each year, which you need to multiply by the number of countries where the vaccines are approved, resulting in thousands of variation dossiers. This will become even more significant for COVID-19 vaccines as data will change at a faster pace than for regular vaccines. Several countries perform testing on vaccine batches which is redundant and time-consuming, and not always using the same test method and applying the same specifications. Initial COVID-19 vaccine batches have limited expiration dates. Therefore, redundant local testing reduces the remaining shelf life for a vaccine, potentially resulting in discarding expired doses. The emergence of variants has led to the need to react quickly by developing, manufacturing, and approving new vaccines against those variants, for whom most of the above challenges will also apply. The way forward There are four areas which provide solutions for the regulatory concerns, which are: 1. Science and risk based approaches 2. Global regulatory harmonisation 3. Use of reliance, work-sharing, and recognition processes 4. Digitalisation These solutions are not new and, whilst this pandemic has witnessed some progress at authority level, a lot needs to be done. Ultimately, quick and widespread access to medicines and vaccines is most important.

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Vulnerable groups can be protected by chickenpox vaccine Chickenpox, for most of us, is remembered as a nasty childhood itch lasting a few days and it’s gone. For a minority it’s more serious, even life-threatening, but a vaccine is available to protect this population.

hickenpox is a common, preventable infection caused by the varicellazoster (VZV) which, in the vast majority of cases, causes nothing more severe than an unpleasant itchy blistering rash. In certain vulnerable populations, however, it can cause more serious illness, even death. But this can be prevented by adoption of the vaccine against the varicella-zoster (VZV).

recovery, but for certain vulnerable populations it can be a big problem. The groups at most risk include children and adults who need to take immunosuppressive medications for medical conditions such as arthritis or inflammatory bowel disease. If these patients contract the chickenpox virus, it can cause more severe disease that can damage the lungs, liver, or brain. Pregnant women are also at risk of severe disease, and the virus has the potential to damage the developing baby if infected in the womb.

Dr Ronan Leahy MB Consultant in Paediatric Immunology and Infectious Diseases, Senior Clinical Lecturer in Paediatric Immunology, Chair, Drugs and Therapeutics Committee, Children’s Health Ireland (CHI) at Crumlin WRITTEN BY Sean Duke

The vast majority of people who get chickenpox will make a full recovery, but for certain vulnerable populations it can be a big problem.

The feasibility of Ireland adding the VZV vaccine to its national vaccine programme is undergoing evaluation.

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Signs and symptoms Some 90% of adults in temperate climates have had chickenpox by the time they reach adulthood. Once a person is infected, and has recovered from chickenpox, the virus lies dormant in a person’s body, only to wake up when they experience sickness or stress as adults and cause painful shingles. It is transmitted from person to person either by direct contact with skin blisters or by inhaling tiny viral particles suspended in the air. It is one of the most contagious diseases that is known to medicine. The chickenpox rash appears 10-21 days after exposure. The pox evolves from flat pink spots that blister with clear, then cloudy, fluid which then dry and crust. The rash is invariably very itchy. Other symptoms include fever, loss of appetite, headache and malaise. The vast majority of people who get chickenpox will make a full

Vaccine in Ireland The VZV vaccine is licensed and marketed for use in Ireland. It is not yet part of the National Primary Immunisation Programme for all children in Ireland, but has been part of the vaccination schedule for all children in many countries such as Canada and the US. Parents can request it from their GP, however the cost for the vaccine and its administration is borne by the parent. The feasibility of Ireland adding the VZV vaccine to its national vaccine programme is undergoing evaluation. The availability of a vaccine against the virus that causes chickenpox is great news for these vulnerable groups. Vaccinating all children early in life has the potential to protect the children themselves from both chickenpox and shingles. It also protects the children from severe disease if they subsequently need to take immunosuppressive medications. Furthermore, it prevents children from infecting vulnerable family members. The VZV vaccine is a live attenuated vaccine – or weakened form of the virus – and was first licensed for use in 1984. The usage data has proven VZV vaccines to be highly immunogenic, efficacious and safe. Chickenpox vaccination protects approximately 86-98% of children and 75% of adolescents and adults.

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EVERY VACCINATION IS A LITTLE VICTORY In the ongoing battle against serious childhood diseases.

PP-VAC-IRL-0153 Preparation Date: September 2021

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