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Hot Topics in Medical Affairs – Check out the latest news in Medical Affairs in Medicines Development. IFAPP Academy provides an online, continuing professional development course, Medical Affairs in Medicines Development, resulting in the Professional Certification, Certified Medicines Development (CMD).

Addressing the myriad ethical dilemmas with vaccine trials, policies, and access

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A sophisticated global audience, including IFAPP Academy students, alumni, Global Fellows in Medicines Development, and members of the IFAPP National Member Associations, recently challenged the faculty during a fascinating discourse (Conversations with the Academy, March 30, 2021) on several ethical, policy, and access facets that have emerged as various COVID-19 vaccines are being made available in different nations.

Sandor Kerpel-Fronius, Professor, Semmelweis Medical University, Budapest, one of our eminent panel members, opines….

  1. US, UK, EU, AUS, Japan blocked an IP waiver for “generic” COVID vaccines to be mass-produced… this is an enormous ethical dilemma; how did Medical Affairs in Pharma play into this landmark decision?The technique producing mRNA vaccines might be very difficult and probably not easily manageable. Personally, I think the best approach would be to build production sites by the companies in less-developed regions.
  2. What about covid mRNA vaccines in pregnant women?Yes, they can be used; antibodies were even detected in newborn babies.
  3. What do you think about the recent prolongation of interval between first and second doses? Do you expect, with time, this time period can become even longer? Or, do you think this can lead to the situation that only one dose of vaccine will be sufficient for application?The prolongation is feasible since already after the first dose, marked antibody titers can be measured. Although this will provide some decrease in the protection against infection but will decrease the severity of the infection. However, the booster injection will be needed after the extended interval. Ethically, the advantage of more extensive vaccination of the population over slightly diminished individual protection can be justified.
  4. Given the lethal nature of COVID-19 and the importance of vaccines, what do you think about a degree of flexibility on the part of the regulators for approval of the vaccines, in the first instance, and then follow-up with real-world data?The follow-up of accelerated approval of orphan drugs is increasingly based on RWD. This approach might be possibly used also for vaccines to decrease the time until EUA is approved. However, the successful collection of RWD must be very carefully planned together with the communities receiving these vaccines.
  5. What type of social contract would the panel propose for worldwide distribution of the COVID-19 vaccines?An approach similar to COVAX but it should deal together with WHO to introduce an internationally acceptable unified approach for EUA procedure before donating or marketing vaccines internationally.
  6. Is it ethical that some parts of the world have not as yet received any vaccine due to their geographical location and economic situation and yet 60% of the adults have already been vaccinated in the UK? However, the enormous political pressure of the local citizens for first satisfying local needs will overrule internationally more correct ethical decisions. It might be argued in favor of such approach that rich nations can support international vaccination programs if their economic basis remain functional to support altruistic programs.
  7. Access, I believe, is the most hot-potato ethical issue. Do you offer any solution for equitable access?It would be necessary to improve local vaccine production also in underdeveloped regions making these regions capable for rapidly producing locally vaccines. The technical assistance of advanced producers will be needed. 
  8. What is your view regarding informed consent for Human Challenge Trials of vaccines?The fact that the natural history of the disease is not well understood, together with frequent fatal outcomes and lack of treatment, makes challenge studies ethically highly questionable. One should consider that Ethics Committees have to defend physically the subject and psychologically both the subject as well as the performer of such studies. In addition, also the society must be protected from the disastrous consequences of possible tragedies.
  9. I can see the practicality of asking for vaccine passports, but is it ethical? And is it in line with social liberty?Very difficult question. The introduction of such passports would be entirely ethical only after all people requesting vaccination would receive the treatment all over the world.
  10. What happens to those who are generally against vaccines because of religion and personal reasons?Personally, I think that it is not ethical if religion(s) interferes with medical treatments. Those people who refuse vaccination should ethically and administratively accept the possible negative consequences of their decision from the side of the community.

Sandor Kerpel-Fronius, MD, DSc, GFMD

IFAPP Academy Director and Module Chair, Sandor Kerpel-Fronius

 

How can learnings from the pandemic facilitate future access to innovative medicines?

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Conversations with the Academy series webinar, April 30, 2021

Conversations with the Academy

The COVID-19 pandemic has taken a grievous and burdensome toll on life, healthcare systems, and the global economy.

On the other hand, the favorable outcome with the accelerated development of vaccines, and the pragmatic utilization of the Emergency Use Authorization (EUA) instrument, has triggered an increasingly empowered patient and advocacy voice for pre-approval access to investigational treatments and biopharmaceutical innovation. This has also drawn attention to revisiting traditional tenets with future approvals of new drugs for very sick patients and the likely longer-term implications for medicines development paradigms and clinical trial design considerations.

As the healthcare and regulatory landscape evolves to tackle the emerging challenges and leverage learnings, fundamental issues are being highlighted around medical, regulatory, and ethical decision-making, increasingly sophisticated systems and data-sharing, and global collaboration and transparency.

What is the purview of the regulatory authorities today? How could the regulatory sciences systems and processes be refurbished to meet future needs? What are the demands on the biopharmaceuticals industry and regulators to remain relevant, offering substantial solutions for the clinical development and technical review of innovative medicines?

Expounding on the imperative for regulatory oversight models to evolve in response to changing healthcare and medicines development needs, David Jefferys, Senior Vice President, Eisai, Lawrence Liberti, Adjunct Assistant Professor, Temple University School of Pharmacy, and Leonard Sacks, Associate Director, US Food and Drug Administration, deliberated on key practices that have arisen, adapted, or accelerated by the pandemic. Which ought to continue in future endeavors, and what policy and scientific initiatives need to be instituted for a meaningful and sustainable change in direction?

The panel emphasized that the COVID-19 pandemic has displayed how researchers, manufacturers, and regulators have been able to expeditiously apply the components of the development toolbox in novel ways to deliver safe and effective vaccines, therapeutics, and devices, in record time.

While several stakeholders may view these events as portending a seismic transition with traditional medicines development and access, the emphasis is now on how and which elements of these experiences might be more broadly extrapolated to the overall cycle of evaluation, manufacturing, regulating, and monitoring innovative medicines.

The challenges notwithstanding, the pandemic has also created alternate avenues for developing and evaluating new medicines, as in the arenas of clinical trials design and conduct, application of digital technologies, remote monitoring and oversight, patient engagement, collaborative working, and knowledge and data sharing. The panel explored learnings from the past year and proposed opportunities to apply these to refining the development and access pathways for next-generation pharmaceuticals.

The discussants elaborated on identifying processes that could contribute to improving discovery, manufacturing, regulatory reviews, and post-authorization assessments. They expanded on the earlier deployment of Real-World Evidence (RWE) and its integration throughout the evaluation lifespan, considering aspects of new trial designs and approaches, including pragmatic trial concepts and the use of RWE and post-approval data.

Appreciating the role of heightened awareness and of collaboration – enhanced partnering between several sponsors and streamlined coordination among agencies – it is evident that promoting competency-based education would be essential to leverage the lessons learned and to bring better medicines to our societies.

The global community has witnessed unprecedented stakeholder engagement and dialogue to identify and enable potential flexibilities and efficiencies within acceptable social and legal frameworks. These have encompassed diverse domains such as supply chain processes, conduct, and reporting of clinical trials, manufacturing, rolling authorization reviews, and integrating post-authorization real-world leanings.

It will be critical to translate these learnings to future clinical assessment and regulatory sciences pathways with non-COVID trials and settings. Importantly, resource prioritization and optimizing development and regulatory models could continue to foster innovation and drive healthcare systems to address unmet medical and social needs.

Even as humanity anticipates the next health challenge….

A recording of this engaging session is available on IFAPP Academy’s YouTube page.

As always, we express our sincere appreciation for the keen insights from our expert faculty and hosts. And, we are motivated by your active participation at these events.

Pravin Chopra, MD, GFMD

IFAPP Academy Faculty, Pravin Chopra, MD

 

The Ethics Behind Vaccine Trials, Policies, and Access

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Conversations with the Academy series webinar, March 30, 2021

ethics behind vaccine trials

 

2020 pummeled us with unforeseen and unfathomed circumstances, demanding sweeping changes with traditional mindsets, policies, and perspectives, even as the COVID-19 pandemic took a grievous and burdensome toll on life, healthcare systems, and the global economy.

From the early days, philosophy has expounded on the ethics in relationships between individual virtue, society, and the State. Fast forward to 2021, over a year into the medical and socio-economic upheaval ravaged by the pandemic. We confronted science being pitched versus politics. We witnessed unparalleled collaboration between biopharmaceutical rivals. We grappled with individual rights versus societal interests. We asked ourselves what is just, what is fair, what is legal, and what is right?

Guiding us through this minefield of emerging scenarios, Arthur Caplan, Professor, Division of Medical Ethics, New York University (NYU) School of Medicine, Sandor Kerpel-Fronius, Professor, Clinical Pharmacology, Semmelweis Medical University, Budapest, and Pravin Chopra, Chair, Scientific Advisory Committee, IFAPP Academy, reflected on the contentious bioethical issues in the year that has been….

The panel deliberations focused on the several important ethical, policy, and access issues that have become pressing and thrown into the limelight, contesting traditional thinking and concepts, even as various COVID-19 vaccines are being made available in different nations.

The accelerated development of these vaccines, some deploying novel platforms, receiving Emergency Use Authorization (EUA) in the backdrop of the pandemic, has triggered bioethical concerns around informed consent in emergency settings and for unapproved products. This has also drawn attention to revisiting traditional tenets with human challenge studies, clinical trial design elements, and regulatory oversight of the drug development paradigm. Moreover, patient engagement and advocacy groups are becoming increasingly empowered with seeking information about and pre-approval access to investigational treatments and biopharmaceutical innovation.

Who ought to receive vaccines first when they are still scarce and with usage restrictions? What are the overriding scientific, ethical, and political factors influencing national guidance on the use of vaccines, even without completed phase III evaluation of efficacy and safety, when vaccine supply is inadequate? Should a single-dose or even a delayed booster injection immunization strategy be deployed for compensating limited vaccine stores? How and when do nations decide whether to share vaccines with other nations? What is the optimal balance in the global dilemma of pursuing worldwide control of the pandemic by sharing vaccine rations with low-to-middle income countries internationally vis-à-vis prioritizing more complete vaccine coverage locally in wealthy nations? When, if ever, should vaccines be mandated, by whom, for whom, with what documentation — and with what penalties for non-compliance?

The benefits of vaccination are real and proven. Still, even with their perceived potential for effecting control of COVID-19 spread and damage, there remain multifarious difficult questions that must yet be addressed by individuals, society, and governments.

The engaging session elaborated on the multitude of bioethical considerations and issues arising with the COVID-19 vaccine development experience, the place of human challenge studies in assessing new vaccine candidates, and the impediments with patient informed consent vis-à-vis placebo-controlled trials under EUA settings. An audience poll on the value and legitimacy of challenge trials with COVID-19 vaccines provoked a dichotomous split reaction – reinforcing the contentious nature of either stance! The discussions generated awareness of regulatory learnings for future approvals of new drugs for very sick patients, and the likely longer-term implications for future medicines development processes and clinical trial design considerations

More critically, the discussants shared perspectives on the escalating debate surrounding vaccine policies and guidance with prioritization and allocations both within and between countries and the inevitable confrontations around equitable global vaccine access and administration logistical challenges, especially in emerging economies.

In parallel with the emphasis on strategies for addressing vaccine hesitancy and countering disinformation, a major patient advocacy and privacy issue that will necessitate urgent and thoughtful resolution hinges around vaccine mandates and immunity passports – especially with regard to data standardization and sharing across national borders, with increasing population mobility and interdependence of global economies. Notably, would be the moral and ethical connotations of excluding and depriving the social liberties of the large population groups not yet having access to vaccines?

Not unexpectedly, several of the themes addressed on this platform are already hitting the media waves globally! If you missed this fascinating discourse, a recording is offered here.

These are hard conversations around a somber reality that we must have – as the very essence and ethos of our society depends on it. Yet, there is hope that science, ethics, and above all, humanity shall prevail.

COVID-19 Vaccinology: Evidence Generation, Learnings, and Implications

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Conversations with the Academy series webinar, February 26, 2021

covid19 vaccinology

Tackling the plethora of emerging situations, Otfried Kistner, Independent Vaccine Expert and Consultant, Soneil Guptha, Pharmaceutical Physician-Scientist, and Kamlesh Thakker, Clinical Pharmacologist and Independent Consultant, delineated the urgent need for safe and effective vaccines, which, if deployed with timely distribution and extensive populations coverage, could potentially contribute to generating herd immunity and effective control of COVID-19, having afflicted tens of millions of people in a worldwide pandemic.

The panel warned that SARS-CoV-2 is a novel viral strain that is spreading rampantly and globally – even with evolving mutant strains — and consequently, traditional processes and timelines for vaccine development would fail to provide an immediate and comprehensive solution. In a pandemic situation, urgent clinical development and widespread rollout of new vaccines become paramount. While emphasizing adherence to the principles of relevance and limitations of immune response markers and systematic approaches to assessing safety and reactogenicity, a re-thinking around the efficient design of efficacy and safety studies, with clinically relevant case definitions, is warranted. More importantly, this knowledge needs to be continually supplemented and updated with real-world monitoring and evaluation of disease understanding and the comparative effectiveness of vaccines across diverse patient demographics and against new mutant forms.

To address this pressing challenge globally, several vaccines developed in such an accelerated manner have been authorized by nations across the world for emergency use in the pandemic and for large-scale deployment against the spread of COVID-19 and the rapid achievement of herd immunity. While some of these have even utilized novel mRNA platforms, it is critical to continually underscore that fundamental clinical development principles are not compromised. The panel cautioned that the utility of both traditional and newer approaches needs to be assessed in the context of transparent data and peer-reviewed results for the various Emergency Use Authorization (EUA) products.

Moreover, as has been the concerning experience with earlier vaccines, it is imperative to dispel COVID-19 vaccine hesitancy, even while advocating for equitable vaccine access across the world’s nations, if the desired herd immunity is to be successfully achieved. Judicious communication and intervention strategies to educate an often-circumspect public and dispel disinformation contributing to such vaccine hesitancy will need to be proactively considered and implemented, alongside fairness with access and vaccination outreach.

Additionally, the global audience was apprised on the spectrum across fundamentals and translational science considerations in vaccine development targeting SARS-CoV-2, encompassing accelerated clinical development of COVID-19 vaccines and the evolving regulatory considerations and guidance for their EUA and disbursement. Perspectives on the fast-tracked clinical assessment and development of COVID-19 vaccines during this pandemic were also shared. What could have been done differently to benefit and/or improve the outcomes and assessments? What elements could gainfully be extrapolated to overall medicines development? The potential implications of this paradigm shift on future drug development processes and access to innovative medicines, especially in critical care and rare diseases, are already the subject of intense public interest and scrutiny.

The panel also explored the typical profile of the vaccine refuser – stemming from a distrust of governments and staunch religious and political beliefs, among other personal experiential factors – and stressed the value and importance of medically factual disease and vaccine education in countering vaccine hesitancy and combating disinformation, while seeking to optimize access and vaccination rates amongst the world’s diverse populations.

A recording of this session can be viewed by clicking here.

Conversations with the Academy: Series prompts engaging dialogue around the global COVID-19 pandemic

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Conversations with the Academy series prompts engaging dialogue around the COVID19 pandemic

We stand today at the crossroads of a global challenge without precedent that demands researchers, policymakers, and governments address multiple dimensions which go far beyond the ramifications of the COVID-19 pandemic. And, while vaccines have transformed public health, particularly since national programs for immunization first became properly established and coordinated in the1960s, their traditional development typically requires years of research and efficacy and safety testing before reaching the clinic. But, 2020 saw a seismic shift in drug development paradigms as scientists embarked on a race to produce safe and effective coronavirus vaccines in record time.

What have we gleaned along this journey, when and where do we seek answers for the myriad of emerging ethical dilemmas? How do we leverage leanings for improving public health measures and outcomes? What are the implications for future drug development processes?

The Conversations with the Academy platform, under the aegis of the IFAPP Academy’s Value-Added Program offerings, explores this burgeoning medical, socio-economic, and ethical conundrum.

Our sincere appreciation for the perceptive opinions from our expert faculty and hosts. And, we remain encouraged by your continued patronage of the IFAPP Academy’s initiatives.

 

Click the below links to learn more about these webinars:

 

Pravin Chopra, MD, GFMD

IFAPP Academy Faculty, Pravin Chopra, MD

 

Strengthening IFAPP Academy Partnerships: Expanding Horizons

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Strengthening IFAPP Academy Partnerships

Last March 3rd, IFAPP Academy has co-organized jointly with Medical Affairs. Professional Society. (MAPS) and Australian Pharmaceutical medical and scientific Professionals Association (APPA), a dedicated webinar related to Professional Education, Capabilities, and Identity in Medical Affairs.

This virtual meeting of the medical affairs community investigated currently available educational opportunities with the view of developing a universally recognized base qualification that can be regionally adapted for medical affairs and medicines development professionals.

The main topics discussed were: Medicines Development Professional Identity; Core Competencies in Medical Affairs; Professional Education in Medical Affairs – the IFAPP Academy / King’s College experience; personal experience from University of New South Wales (UNSW) Alumni, and the experience of the University of Sydney with a Master of Medicine (Pharmaceutical and Medical Device Development) course.

The following quotes and summaries were retrieved from the panelists’ presentations:

Victoria Elegant, Amgen’s Vice President and Region Head of MAPS JAPAC, commented that the job requirements had changed substantially. “We’ve gone from needing to know about our therapeutic areas to actually needing to know about therapeutic areas plus needing to know about safety, about drug development, about regulatory, about access, and that’s why these courses are so critically important,” she said.

Matthew Britland, Vice President, APPA, explained to the audience: “We all know that medical affairs has exponentially grown over the last decade. It’s moved from very much a support function to a trusted strategic partner – and the skills set has also evolved significantly over the past few years. But there’s still a void in a globally recognized advanced scientific qualification or a capability framework across medical affairs, and there’s certainly no accreditation or certification that’s accepted across industry and peak bodies.”

Gustavo Kesselring, IFAPP Academy Vice President, stated: “At IFAPP Academy, our strong belief is that education and training for key professional development is the cornerstone for everything that we do in our professional life. Unfortunately, when we graduate as physicians or pharmacists or nurses, or in other areas of health science, we do not learn the science that is behind medicines development. We know the foundational knowledge of this science is unique and needed for the progression of our careers.”

“Our credo is we need a professional identity with a strong career pathway that needs to be developed (either as) medicines development or medical affairs professionals.”

Peter Stonier, Visiting Professor in Pharmaceutical Medicine, King´s College London, gave a detailed explanation about the IFAPP-King´s College London Professional Certification Program of Medical Affairs in Medicines, and its success in delivering an online competency knowledge-based course in the last 5 years to more than 400 students from 55 countries.

At the end, Lara Stallard-Taylor, Roche’s Senior Medical Manager, who completed a Masters of Pharmaceutical Medicines from UNSW, said ensuring consistent industry knowledge through education is the key. “We all find our way into medical affairs via our own path. It´s really important to have a rich pool of experience and diversity, but a foundation course like a Masters of Pharmaceutical Medicine for both aspiring and existing medical affairs professionals would provide a consistent industry knowledge base”.

steering committee

Gustavo Kesselring, MD, GFMD

 

National Medical Products Administration (NMPA) issues progressive guidance in China

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• National Medical Products Administration (NMPA) issues progressive guidance in China

Since joining the International Council for Harmonization (ICH) as a full regulatory member in June 2017, China has made great efforts to improve various laws, regulations, and guidelines.

The Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) usually issues multiple guidelines before the weekends and each holiday.  We call these a big “holiday tribute” for patients, policy-makers, and the pharmaceutical industry. Since January 1st, 2021, 23 guidelines have been issued by CDE, nine of which came before the Spring Festival, including:

  • Guidelines for Clinical Trials of Antimicrobial Drugs for Complex Abdominal Infections (No. 10 of 2021) [1];

Standardizes the clinical research and evaluation of antibacterial drugs for complicated intra-abdominal infections. Gives recommendations under the framework of Guidelines for Clinical Trials of Antibiotics (Apr.3, 2015) [2].

  1. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=8550f729714cebd6
  2. http://www.cde.org.cn/zdyz.do?method=largePage&id=1fbbf9c57018444e
  • Guidelines for the Research on Generic Drugs of Fulvestrant Injection (try-out) (No. 11 of 2021);

Alleviates the shortage of clinical supply of fulvestrant injection and accelerates the marketing of its generic drugs. Provides guidance on the technical requirements for pharmaceutical research and non-clinical research during the development of generic drugs, and clarifies the eligibility criteria for a waiver of bioequivalence studies in humans [3].

  1. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=6315483d03a55835
  • Guidelines for Clinical Trials of Intravenous Human Immunoglobulin for the Treatment of Primary Immune Thrombocytopenia (try-out) (No. 12 of 2021);

Guides and standardizes the clinical trials of immunoglobulin for intravenous administration (IVIg) for the treatment of primary immune thrombocytopenia (ITP). It mainly describes the key content in pre-marketing and post-marketing clinical trials of IVIg for ITP patients; outlines the required trials for post-approval changes (e.g., chemistry structure and activity). In the end, it gives advice on the risk management plan [4].

  1. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=501ac9ae9dd8c77f
  • Guidelines for the Design of Clinical Trials of Oncolytic Viruses (try-out) (No. 13 of 2021);

Guides and standardize the clinical trials of oncolytic viruses for the treatment of malignant tumors. It describes key points in the design of exploratory and confirmatory clinical trials. What’s more, it gives advice on the risk management plan [5].

  1. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=20b3679157e4d325
  • Guidelines for Clinical Trials of Immune Cell Therapy Products (try-out) (No. 14 of 2021) [6];

Specifies the clinical recommendations for immune cell therapy products in clinical trials under the framework of Guidelines for Research and Evaluation of Cell Therapy Products (December 22nd, 2017) [7]. Provides guidance on the clinical design for exploratory and confirmatory trials of Immune Cell Therapy Products. What’s more, it outlines the suggestions on long-term follow-up and post-marketing study or surveillance.

  1. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=9da2b313cd79f360
  2. http://www.cde.org.cn/zdyz.do?method=largePage&id=eae71557b900d210
  • Guidelines for the Study of Post-approval Pharmacy Changes to Chemical Drugs (try-out) (No. 15 of 2021);

Applicable to studies on changes of Chemical raw materials and chemical preparations to an approved chemical drug [8].

  1. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=b8480214871d6636
  • Guidelines for Post-approval Clinical Changes to Chemical Drugs and Biological Products (No. 16 of 2021);

Clarifies the clinical changes of an approved drug in China and applies to chemicals, preventive biological products, and therapeutic biological products [9].

  1. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=385e0e3036afcea5
  • Guidelines for Acceptance and Review of Changes to Chemical Drugs (try-out) (No. 17 of 2021);

Applies to the supplementary application items reviewed by the CDE (including the period of drug clinical trials) [10].

  1. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=72bbd9cbed6a1e39
  • Guidelines for Non-clinical Research and Evaluation of Gene Therapy Products (Draft, opening for Comments).

Provides recommendations for the non-clinical development of gene therapy products. It advises that non-clinical studies should follow the 3R principle of “Replacement, Reduction, Refinement, to avoid unnecessary use of animals and other resources [11].

  1. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=7c0c3775d594f3cd

For more information: http://www.cde.org.cn/news.do?method=news_index

 

Xiaojing Li, MMed
Senior Medical Manager, CSPC Pharma Ltd, China

Xiaojing Li, MMed

 

 

 

 

 

 

Disclaimers

  • The material in these reviews is from various public open access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred

Emergency Use Authorization (EUA) of COVID-19 vaccines in India

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COVID-19 vaccine

India’s regulatory authority granted a restricted emergency approval to two COVID-19 vaccines in India on January 3rd, 2021. The first of these was a recombinant chimpanzee adenovirus vector vaccine (ChAdOx1 nCoV-19). The second approved vaccine was an indigenously developed whole virion inactivated coronavirus vaccine (BBV152).

Oxford/AZ- ChAdOx1 nCoV-19, marketed as COVISHIELD, has been manufactured by Serum Institute of India (SII) under the expert foundation laid by Oxford University and Astra Zeneca. Even before its emergency approval, more than 40 million doses of the vaccine had already been manufactured by the SII under the at-risk manufacturing and stockpiling license from the DCGI. A pooled analysis of phase 2/3 trials conducted in over 20,000 participants from the UK, Brazil, and South Africa showed that the ChAdOx1 nCoV-19 vaccine had an acceptable safety and immunogenicity profile with efficacy against symptomatic COVID-19. To establish the safety, efficacy, and immunogenicity of COVISHIELD in India, SII together with the Indian Council of Medical Research (ICMR) came forth to conduct a phase II/III clinical trial at 15 different centers across India. Interim safety and immunogenicity data obtained from this trial were comparable to the data from an overseas clinical trial conducted with COVISHIELD. Considering the above data, the Subject Expert Committee of Central Drugs Standard Control Organization (CDSCO), India after due consideration and detailed contemplation, recommended that COVISHIELD be granted permission for restricted use in emergency situations subject to certain regulatory conditions. The final results of the trial are still awaited.

BBV152 (COVAXIN) has been developed indigenously by an Indian pharmaceutical company: Bharat Biotech. There is sufficient safety and immunogenicity data from pre-clinical studies. The phase I data recently published in the Lancet portrays that COVAXIN was seen to enhance immune responses and had acceptable safety outcomes. Phase II trial has also been completed, and phase III trial is ongoing in about 25,800 Indian volunteers. In India, the regulatory authority granted an emergency authorization to COVAXIN based on pre-clinical data, Phase I, Phase II data, and interim results generated from the phase III clinical trial.

The approval of COVID-19 vaccines in India is a very important milestone that will lay the foundation for India to supply the vaccines to many other countries in the world. World Health Organization has welcomed and encouraged the regulatory decision on the emergency use authorization of COVID-19 vaccines in India. Although a vast number of people in India have applauded the emergency authorization of COVID-19 vaccines, there are a good number of people who have been shadowed by a sense of doubt fueled by the lack of transparency about the clinical trial protocols and also in part by the non-availability of the detailed trial results in the public domain. In addition to this, Phase III trials in India with both the vaccines have not been completed yet. Even though the complete phase III trial results are not yet available, it is important to educate the public that sufficient data has been generated from the earlier phases of clinical trials and interim results of the phase III trial. This highlights the importance of educating recipients about the regulatory protocols and the essentiality of vaccination in health emergency situations, as posed by the pandemic. Keeping this in mind, the Ministry of Health and Family Welfare in India has created a web portal and helpline number to solve queries related to COVID-19 vaccination.

The COVID-19 vaccination drive in India began on January 16th, 2021, with the initial beneficiaries consisting of Healthcare workers. The drive has now been extended to frontline workers. To date, about 7 million people have already been inoculated with the first dose of the vaccine against COVID-19. India has emerged to be the fastest country to vaccinate a vast number of people within a short time. However, it seems like the journey has just begun. The challenge still seems far from completion considering the huge population of India, i.e., 1.38 billion.

References:

  1. Recommendations of the SEC meeting to examine COVID-19 related proposals under accelerated approval process made in its 134th meeting held on 01.01.2021. From:https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/134th%20COVID-19%20Recommendation%2001.01.2021.pdf
  2. Mohapatra PR, Mishra B. Regulatory approval of COVID-19 vaccine for restricted use in clinical trial mode. Lancet Infect Dis. 2021 Jan 25:S1473-3099(21)00045-1.
  3. Voysey M, Clemens SAC, Madhi SA, et al; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 January 9th;397(10269):99-111.
  4. Ella R, Vadrevu KM, Jogdand H, et al, Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial. Lancet Infect Dis. 2021 Jan 21:S1473-3099(20)30942-7.

Nishtha Khatri, MD
Assistant Professor, Seth GS Medical College and KEM Hospital, India

IFAPP Academy - Nishtha Khatri,MD

 

 

 

 

 

 

Disclaimers

  • The material in these reviews is from various public open access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred

Conversations with the Academy Series continues to garner promising participation by the global learning community

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Conversations with IFAPP Academy DecemberConversations with the Academy Series continues to garner promising participation by the global learning community

The December event in the series featured an eminent panel exploring evolving Health Economics Outcomes Research (HEOR) concepts, driven by the changing healthcare landscape and increasing expectations to demonstrate value. Dr. Laurent Pacheco, Managing Director, Syneos Health Consulting; Dr. Seema Haider, International HEOR Advisor; and Dr. Jennifer Stephens, Partner, and Clinical Director, Pharmerit, addressed the challenges and trends in the healthcare market across the globe, with the HEOR audience expanding beyond payers and Health Technology Assessment (HTA) bodies, to a variety of stakeholders, including patients and regulators.

Physicians need HEOR data to inform their treatment decisions to meet the healthcare needs of patients best. Importantly, HEOR brings a real-world perspective. As countries adopt universal healthcare systems and develop HTA frameworks, they need transparent, understandable, and effectively communicated HEOR data to help inform healthcare decision making.

The panel highlighted perspectives to better deliver and communicate HEOR information and real-world data. They emphasize cross-functional collaboration in biopharmaceuticals, patient centricity, and leveraging digital transformation. If you missed this, a recorded session is offered at https://youtu.be/kYmr7IrDtk8

The most recent discussion, Real World Evidence and Real-World Data: from Disease Management to Evaluating Drug Safety and Effectiveness, on January 28th, seeks to analyze the rapidly increasing interest and relevance of real-world evidence to answer clinical, regulatory, and policy-pertinent questions, which cannot be wholly or directly addressed by traditional randomized controlled trials. The recording will be made available soon on IFAPP Academy’s YouTube page.

As always, we express our sincere appreciation for the keen insights from our expert faculty and hosts. Furthermore, we are motivated by your active participation at these events.

Pravin Chopra, MD, GFMD

IFAPP Academy Faculty, Pravin Chopra, MD

Conversations with the Academy series engenders considerable interest with learning community

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Conversations with the Academy

Under the umbrella of the IFAPP Academy’s Value Added Programs and Services, offering continuing professional development initiatives and avenues for networking for our expanding learning community, the Conversations with the Academy webinar programs have garnered enthusiastic engagement.

In the third event in the series Dr. Mark Lightowler, CEO, Phorix Limited, highlighted The Role of Digital Tools in Changing Health Behavior, exploring the evidence for behavioral change parameters – e.g., physical activity, medication adherence, smoking cessation — to be considered in health outcome programs, in tandem with patient engagement tools. While evaluating how innovative digital tools are unlocking our understanding of behavior and our ability to change, Dr. Lightowler shared insights and resources to promote behavioral change in the workplace.

Following on, Dr. Birka Lehmann, Senior Expert Drug Regulatory Affairs, reviewed the New European Regulation for Clinical Trials, stressing the need for further legislative changes to drive a more harmonized approach by regulatory agencies granting clinical trials and Ethics Committees agreements. Dr. Lehmann outlined the transition with the regulations, which underscore the harmonization of conditions, emphasizing the new challenging interactions needed by regulatory agencies, Ethics Committees, and applicants. New timelines have to be respected by all involved partners. That e-handling of applications and approvals is imperative. Don’t miss the recording.

The panel discussion on Health Economics Outcomes Research, on December 17th,  explored the evolving healthcare landscape and increasing expectations to demonstrate value.  Subscribe to the Academy’s YouTube page to be notified once this recording has been posted.

We express our sincere appreciation for the invaluable inputs and contributions from our expert faculty and hosts. We are encouraged by your active participation at these events and look forward to your continued support and engagement.