COVID-19 Vaccine Development
EC Signs COVID-19 Vaccine Contract with AstraZeneca
On 27th Aug 2020, the European Commission (EC) announced that it had signed its first contract with AstraZeneca for the supply of a COVID-19 vaccine candidate to the European Union (EU) Member States. The agreement in place will allow purchase of a vaccine for all the Member States of the EU as well as donation to lower and middle income countries or the re-direction to other European countries.
All EU Member States can buy 300 million doses of the vaccine, with an option for an additional 100 million doses, with distribution carried out on a population-based pro-rata basis. Licensed from the University of Oxford, AstraZeneca’s recombinant adenovirus vaccine candidate is currently undergoing large-scale Phase II / III clinical trials. The contract with AstraZeneca builds on the Advanced Purchase Agreement approved on 14th Aug 2020.
Ursula von der Leyen, President of the European Commission, stated: “The Commission is working non-stop to provide EU citizens with a safe and effective vaccine against COVID-19 as quickly as possible. The entry into force of the contract with AstraZeneca is an important step forward in this respect. I am looking forward to enriching our portfolio of potential vaccines thanks to contracts with other pharmaceutical companies and engaging with international partners for universal and equitable access to vaccination.”
J&J Announces Agreement with US Government for 100 Million Doses of Investigational COVID-19 Vaccine
On 5th Aug 2020, Johnson & Johnson (J&J) announced that its Janssen Pharmaceutical Companies entered into agreement with the US government for large scale domestic manufacturing and delivery of 100 million doses of Janssen’s SARS-CoV-2 investigational vaccine called Ad26.COV2.S, following Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA).
The company is developing the vaccine candidate as part of an ongoing research and development collaboration with US Biomedical Advanced Research and Development Authority (BARDA). It is currently undergoing Phase I / IIa clinical trials in the US and Belgium.
Paul Stoffels,Vice Chairman of the Executive Committee and Chief Scientific Officer, J&J stated: “Johnson & Johnson’s global team of experts has worked tirelessly alongside BARDA and scientific partners to pursue a SARS-CoV-2 vaccine that can help to stop the spread of COVID-19. We greatly appreciate the U.S. government’s confidence in, and support for, our R&D platform and efforts and the scalability of our vaccine technology. We are scaling up production in the US and worldwide to deliver a SARS-CoV-2 vaccine for emergency use”.
Oxford University’s Vaccine Approved for Phase II and III Trials in India
On 3rd Aug 2020, it was announced that India’s drug regulatory agency has granted approvals to Serum Institute of India (SII) to conduct phase II and III human trials for the COVID-19 vaccine COVISHIELD developed by the University of Oxford, based on the recommendations of the Subject Expert Committee on COVID-19.
SII partnered with AstraZeneca, which developed the vaccine along with The University of Oxford, to manufacture this vaccine for low- and middle-income countries. Around 1600 volunteers will participate in the phase II / III trials.
India’s Health Minister stated: “Drugs Controller General of India has given approval to Serum Institute of India to conduct Phase II / III clinical trials of Oxford University-Astra Zeneca COVID19 vaccine (COVISHIELD) in India.”
COVID-19 Research and Therapeutic Development
FDA Grants EUA for Gilead’s Remdesivir to Treat All COVID-19 Hospitalised Patients
On 28th Aug 2020, the FDA announced that it had extended the scope of the EUA for Gilead Sciences’ Veklury (remdesivir) to treat all hospitalised patients with COVID-19. The agency granted the latest EUA for remdesivir after review of data from the Phase III SIMPLE trial in hospitalised patients with moderate COVID-19 pneumonia. The primary endpoint assessed patients at day 11 on a seven-point ordinal scale. The approval is also based on results from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 study in hospitalised patients across a variety of disease severity groups.
The drug is an experimental nucleotide analogue with broad-spectrum antiviral activity in-vitro and also in-vivo in animal models against different emerging viral pathogens. It is being studied in Phase III clinical trials globally in various COVID-19 patient populations, formulations and as a combination with other therapies. FDA Commissioner Stephen M. Hahn, stated: “The FDA continues to make safe and potentially helpful treatments for COVID-19 available as quickly as possible in order to help patients. The data to support today’s action are encouraging. The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus. We are working with drug developers to conduct randomized clinical trials to further study the safety and effectiveness of a number of potential therapies for COVID-19.”
Celltrion’s Antiviral Antibody Treatment for COVID-19 Receives Green Light to Phase I Trials
On 4th Aug 2020, Celltrion announced development of CT-P59, its antiviral antibody treatment for COVID-19, after receiving authorisation to begin phase I trials. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) gave the treatment its approval to begin phase I trials following Korea’s Ministry of Food and Drug Safety (MFDS) approving the company’s investigational new drug application on the back of positive preclinical results in July.
Sang Joon Lee, Senior Executive Vice President of Celltrion stated: “We were able to secure MHRA approval after close discussions with British regulators. We are currently aiming to recruit around 50 COVID-19 patients in total for both trials in the U.K. and Korea, although this number is subject to change. Both trials will test the treatment’s safety, tolerability and virology, pharmacokinetics and immunogenicity.”
The Phase I trial partners the company with Chungnam National University Hospital to test safety in 32 healthy volunteers who have not been diagnosed with the virus, and completion is targeted by the third quarter of 2020. Celltrion aims to have interim results from both phase I trials by the end of 2020, but the length of the trial will depend on the patient recruitment process. An additional trial involving close contacts of COVID-19 patients is scheduled to start within the year, with results expected by the first quarter of 2021.
Interleukin-6 Inhibitors Improves Outcomes for COVID-19 Patients
On 5th Aug 2020, new research from Boston Medical Center found that patients experiencing severe COVID-19 symptoms had improved outcomes when administered with Interleukin-6 inhibitor, sarilumab or tocilizumab, given to mediate severe systemic inflammatory responses. Data showed that the treatment was most effective when administered earlier in the disease course and reduced mortality rates and the need for intubation and appeared to be more effective compared to other options, including remdesivir and dexamethasone.
Patients were treated with Interleukin-6 inhibitor, based on internal reviewed guidelines. The findings were published in the International Journal of Infectious Diseases.
Dr Manish Sagar, a researcher at Boston Medical Center and associate professor of medicine and microbiology at Boston University School of Medicine stated: “At a time where treatments are being tested with urgency throughout the COVID-19 pandemic, our study results offer some hope towards finding solutions to better treat patients throughout this disease.”
UK to Roll Out COVID-19 Diagnostic Providing Results in Under Two Hours
On 3rd Aug 2020, Oxford Nanopore announced an agreement with the UK’s Department of Health and Social Care, to roll out its novel LamPORE test. This will support the UK’s efforts to manage the continued reduction of COVID-19 and containment of new cases. An initial 450,000 of Oxford Nanopore’s LamPORE test will be used by the UK government as COVID-19 diagnostics, which yield results in under two hours.
Under the agreement, LamPORE SARS-CoV-2 tests will be made available for use by a number of UK National Health Service (NHS) testing laboratories. According to Oxford Nanopore, as well as providing a large number of tests for existing labs, the programme will help the UK to understand the different use cases for the technology, for example the potential asymptomatic screening of frontline staff. Due to its scalability, it has the potential to provide both large-scale screening to detect the virus in broader populations and rapid, focused and localised analysis.
UK Health Secretary Matt Hancock stated: “Oxford Nanopore’s new rapid LamPORE tests will benefit thousands of people with fast and accurate test results, removing uncertainty and breaking chains of transmission quickly and safely. I am hugely grateful for the fantastic work Oxford Nanopore have done to push forward this important innovation in coronavirus testing.”
Other Pharma Industry News
BioLife Plasma Opening First Plasma Collection Centre in US
On 6th Aug 2020, BioLife Plasma Services, part of Takeda Pharmaceutical Company Limited, announced the opening of a new plasma collection centre to collect standard plasma from healthy donors.
Screened plasma collected from healthy individuals is processed into a wide variety of therapeutics for people around the world with rare, life-threatening diseases. Following COVID-19, the company implemented additional screening and safety measures in line with public health guidance for the safety and health of donors and employees, as well as that of collected plasma. All donors are required to wear a mask or other cloth face covering inside the facility.
Jason Kilpatrick, Manager of the BioLife Plasma Services in Baton Rouge stated: “Now, more than ever, donors in the Baton Rouge area have a unique opportunity to make a difference in the community through plasma donation, and we are deeply committed to making treatment options available for patients who rely on plasma-derived medications. Plasma is a lifeline for thousands of people with rare, chronic and complex diseases, and we are excited to open the first BioLife plasma collection center in Louisiana.”
Sanofi Under Formal Investigation Over Epilepsy Drug Depakine
On 3rd Aug 2020, Sanofi announced that the company is under investigation regarding charges of manslaughter over epilepsy drug Depakine (valproate). The drug is said to cause birth defects and slow neurological development when taken during pregnancy. Estimates show that approximately 15,000 – 30,000 children had congenital birth defects or were stillborn after exposure to Depakine.
Data showed that the drug increases the risk of congenital malformations, autism and learning difficulties by 10 – 40% in children whose mothers took it during pregnancy. The company denied the charges and is challenging the merits of the investigation, they do not intend to compensate or be part of a state-backed compensation mechanism for the drug.
Separately, Sanofi is facing charges on aggravated fraud and unintentionally causing injury in 42 cases filed by families. Sanofi says that it had already warned health authorities of the drug’s risks in the 1980s.
PPD Partners with Pfizer in New Service Agreement
On 3rd Aug 2020, PPD a leading global contract research organization (CRO) announced signature of a new three-year agreement with Pfizer for provision of drug development services to advance Pfizer’s drug portfolio. The company will provide wide-ranging expertise in global clinical development and laboratory services to support Pfizer’s drug development initiatives across multiple therapeutic areas.
David Simmons, PPD’s Chairman and CEO stated: “United in purpose, we are committed to building on our long-standing relationship with Pfizer with innovative solutions, quality execution and the dedication of our talented teams to help Pfizer deliver exciting new therapies. PPD is strategically positioned to continue supporting Pfizer in its pursuit of breakthroughs that change patients’ lives. We are privileged to take the next steps together and contribute to Pfizer’s initiatives to achieve a healthier world.”
Issue Number: PN2008
Would you like a personal copy directly to your mailbox each month? Just send an email to firstname.lastname@example.org with the subject “Pharma News Please”