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AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released so that vaccinations may begin early in the New Year.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided authorisation for emergency supply of COVID-19 Vaccine AstraZeneca, formerly AZD1222, for the active immunisation of individuals 18 years or older. The authorisation recommends  two doses administered with an interval of between four and 12 weeks. This regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose.

AstraZeneca is working with Public Health England and National Health Service England to support the deployment and roll out of the vaccine in the UK, in line with the MHRA and the UK’s Joint Committee on Vaccination and Immunisation dosing recommendation. The Company aims to supply millions of doses in the first quarter as part of an agreement with the government to supply up to 100 million doses in total.

Pascal Soriot, Chief Executive Officer, said: “Today is an important day for millions of people in the UK who will get access to this new vaccine. It has been shown to be effective, well-tolerated, simple to administer and is supplied by AstraZeneca at no profit. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government and the tens of thousands of clinical trial participants.”

Matt Hancock, UK Secretary of State for Health and Social Care, said: “This is a moment to celebrate British innovation - not only are we responsible for discovering the first treatment to reduce mortality for Covid-19, this vaccine will be made available to some of the poorest regions of the world at a low cost, helping protect countless people from this awful disease. It is a tribute to the incredible UK scientists at Oxford University and AstraZeneca whose breakthrough will help to save lives around the world. I want to thank every single person who has been part of this British success story. While it is a time to be hopeful, it is so vital everyone continues to play their part to drive down infections.”

Professor Andrew Pollard, Director of the Oxford Vaccine Group and Chief Investigator of the Oxford Vaccine Trial, said: “The regulator’s assessment that this is a safe and effective vaccine is a landmark moment, and an endorsement of the huge effort from a devoted international team of researchers and our dedicated trial participants. Though this is just the beginning, we will start to get ahead of the pandemic, protect health and economies when the vulnerable are vaccinated everywhere, as many as possible as soon possible.”

The decision to approve the vaccine was taken under Regulation 174 of the Human Medicine Regulations 2012, which enables rapid emergency regulatory approvals to address significant public health issues such as a pandemic. This is the first authorisation for this vaccine.

The MHRA’s decision was based on independent advice from its Commission on Human Medicines following a rolling review of trial data that included an interim analysis of the Phase III programme led by the University of Oxford. The data were also published in The Lancet on 8 December 2020.

Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials. AstraZeneca continues to work with regulatory authorities around the world to support their ongoing rolling reviews for emergency supply or conditional marketing authorisation during the health crisis. AstraZeneca is also seeking Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low- and middle-income countries.

AstraZeneca is working with its global partners to continue building manufacturing capacity of up to three billion doses of the vaccine globally in 2021 on a rolling basis, pending regulatory approvals. The vaccine can be stored, transported and handled at normal refrigerated conditions (two-eight degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.

AstraZeneca continues to engage with governments, multilateral organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.

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A report launched by pharmaceutical company Takeda UK reveals that, despite heightened public and media attention on the industry’s efforts to develop vaccines and treatments, the COVID-19 pandemic has had little positive impact on perceptions of pharmaceutical companies.

The Pharma: Repurposed report explores the importance of ‘purpose’ to the pharmaceutical industry and provides recommendations on how the sector can convey a stronger purpose to build trust and ultimately improve the lives of patients.

For the report, Takeda UK commissioned Ipsos MORI to conduct online interviews among adults ages 16-75 from the United Kingdom. A total of 1104 interviews were conducted in October 2020 and key findings include: Only 17% of respondents said their impression of pharmaceutical companies had improved, based on how the industry had reacted to the coronavirus pandemic over the previous six months. Over half (54%) said their impression had stayed the same and 16% said their impression had got worse.

The pandemic has had a positive impact on UK adults’ perceptions of healthcare professionals, with 44% of respondents saying their impression had improved. In contrast, UK adults’ impression of politicians has got markedly worse, with 51% of respondents saying their opinion of government ministers had worsened over the last six months.

When respondents were asked to express their opinion on a range of organisations and roles within the sector, just 38% had a total favourable opinion of pharmaceutical companies.

As per the survey, Over a third of respondents (36%) had neither a favourable nor unfavourable view of the pharmaceutical sector, suggesting that the industry has more work to do to engage the public with its role and activities. The survey revealed a high total favourable result for healthcare professionals (74%), and for healthcare charities (58%). Scientists within the pharmaceutical industry (53%) were also well regarded.

Total unfavourable views of Government ministers stood at 55% and other politicians at 54%. Less than half (48%) of respondents trust the pharmaceutical industry to act in the best interest of society. In contrast, 82% of respondents trust healthcare professionals to act in society’s best interests and over 70% trust healthcare charities to do so.

Jon Neal, MD UK and Ireland at Takeda, said: “The pharmaceutical industry has faced several reputational challenges over the years. However, perhaps now more than ever, the development of new treatments relies on cross-sector collaborations and public trust and willingness to engage with the sector. Therefore, we need to address perceptions of the industry to improve the future of healthcare and ultimately save lives.

“We hope this report will lead to further discussion about how the industry can convey a stronger purpose to build trust with both patients and other healthcare organisations. Employees in pharma companies such as Takeda are completely committed to improving the lives of patients and yet this research shows our commitment to patients and our purpose is not widely understood or accepted. We need to do more and I hope this report will lead to further discussion and opportunities to work with others from across the industry to increase understanding of our role in society and how we operate.”

Ben Page, Chief Executive of Ipsos MORI, commented: “Our research with Takeda suggests that the public have a higher opinion of roles or organisations that articulate a strong purpose around their role in and value to society. The pharmaceutical industry has historically struggled to clearly articulate what it does and what it stands for. If the sector wants to better connect with the public, it needs to start talking much more openly about its activities and values.

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US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 12 to 1 that the data presented support the use of Entresto® (sacubitril/valsartan) in treatment of patients with heart failure with preserved ejection fraction (HFpEF). This was based on data supporting the benefit of Entresto in reducing worsening heart failure (total heart failure [HF] hospitalizations and urgent HF visits) in patients studied in PARAGON-HF. If approved by the FDA, Entresto could become the first therapy indicated for use in treatment of patients with HFpEF, as well as the first medication approved for both major types of chronic heart failure, HFpEF and heart failure with reduced ejection fraction (HFrEF), both based on trials that included active comparators (valsartan and enalapril, respectively).

With no approved therapies for HFpEF to address the prevention of HF hospitalizations and urgent visits, a significant unmet medical need exists for a treatment to reduce the burden associated with this debilitating condition. The FDA is expected to make a decision on the supplemental New Drug Application (sNDA) in the first quarter of 2021.

“Managing HFpEF has historically been a clinical and scientific challenge due to the heterogeneity of the condition,” said Scott Solomon, MD, Professor of Medicine at Harvard Medical School and Brigham and Women's Hospital, and PARAGON-HF Executive Committee Co-Chair. “Today’s vote represents much needed progress in this area of unmet need and is a positive step toward bringing a potential therapy to millions of patients suffering from this type of heart failure.”

The Committee’s positive decision is based on the totality of evidence from efficacy and safety analyses, including findings presented from a pre-specified subgroup analysis of PARAGON-HF, the largest and only Phase III active-controlled study to date in patients with HFpEF and additional evidence from PARAMOUNT (a Phase II trial in HFpEF), as well as PARADIGM-HF (a Phase III trial in HFrEF). Data from PARAGON-HF demonstrated a favorable safety profile for Entresto in patients with HFpEF, which is in line with the vast clinical and post-marketing experience in HFrEF, and showed clinical benefit of Entresto in HFpEF patients.

“Our commitment to reimagine medicine through our extensive clinical trials program on heart failure has been unwavering, and we are encouraged by the Committee’s response today,” said David Soergel, MD, Global Head of Cardiovascular, Renal and Metabolic Drug Development, Novartis. “We appreciate the valuable insights shared by the patient and advocacy community about this devastating disease, and we look forward to FDA’s decision on the potential approval of this new indication.”

HFpEF affects more than 3 million Americans, and is increasing in prevalence as the population ages. It is a complex disease for which it is difficult to develop treatments due to its heterogeneous pathophysiology and the varied impact of symptoms among patients, despite decades of research. HFpEF can change the structure of the heart and occurs when the muscle tissue of the heart thickens and stiffens so that it cannot expand to fill with enough blood to meet the body’s needs. HFpEF is associated with high rates of recurring heart failure hospitalizations, emergency room visits and urgent doctor’s office appointments. Each hospitalization event is associated with worsening long-term prognosis, and approximately one in four patients are re-admitted for heart failure within one year of discharge.

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