COVID-19 Vaccine Development

Russia’s COVID-19 Vaccine Data Shows 91.4% Efficacy Rate

On 14th December 2020, Russian coronavirus vaccine developers published fresh results from their trial of the Sputnik V vaccine based on new data stating the vaccine had again been found to be 91.4% effective in protecting COVID-19. More than 100,000 people have already been vaccinated as part of Russia’s mass inoculation programme, which began in September alongside a Moscow-based human trial of the vaccine. The new results are based on data from 22,714 participants in the trial and were published after 78 confirmed coronavirus cases were reported among the group.

The data will be published by the Gamaleya Institute in an international peer-reviewed medical journal. The results were identical to interim results published on 24th Nov 2020, based on 39 cases of coronavirus among trial participants, that also found the shot to be 91.4% effective. The results will be used to submit the vaccine for emergency use authorisation in other countries. Trials of Sputnik V are ongoing in Belarus, the United Arab Emirates, Venezuela, and India.

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Pfizer and BionNTech Achieve Authorisation for COVID-19 Vaccine

On 2nd December 2020, Pfizer and BioNTech announced that the Medicines & Healthcare Products Regulatory Agency (MHRA) had granted a temporary authorisation for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19 in the United Kingdom (UK). This constituted the first Emergency Use Authorization (EUA) following data from Phase III trial which demonstrated a vaccine efficacy rate of 95% in participants without prior Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

On 11th December 2020, the US Food and Drug Administration (FDA) authorised the emergency use of the vaccine against COVID-19 in individuals 16 years of age or older. The vaccine is now authorised under a EUA while Pfizer and BioNTech gather additional data and prepare to file a planned Biologics License Application (BLA) with the FDA for a possible full regulatory approval in 2021.

Pfizer Chairman and CEO Albert Bourla stated: “More than 70 million cases of COVID-19 have been recorded globally, and that number is rising at an alarming rate. With the pandemic still raging, our vaccine will be in high demand and, upon authorization or approval, rapidly utilized to help beat back the virus. Recognizing this urgency, we have been planning for distribution for months and are continuing to work around the clock, so we can bring the vaccine to the world as quickly, efficiently and equitably as possible.”

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First Participants Dosed in Moderna’s Study of COVID-19 Vaccine Candidate in Adolescents

On 10th December 2020, Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the first adolescent participants had been dosed in Phase II/III study of mRNA-1273, Moderna’s COVID-19 vaccine candidate, in adolescents ages 12 to less than 18. The study is being conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA). This trial will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.

Stéphane Bancel, Chief Executive Officer of Moderna stated: “We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy adolescents in the U.S. Our goal is to generate data in the spring of 2021 that will support the use of mRNA-1273 in adolescents in advance of the 2021 school year. We are encouraged by the interim and primary analyses of the Phase 3 COVE study in adults ages 18 and above and this adolescent study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population. We hope we will be able to provide a safe vaccine to protect adolescents so they can return to school in a normal setting.”

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AstraZeneca’s COVID-19 Vaccine Phase III Trial Results Show Efficacy of the Vaccine

On 8th December 2020, AstraZeneca announced that results of an interim analysis of the Phase III trial conducted by Oxford University with AZD1222 were published in The Lancet, demonstrating that the vaccine is safe and effective at preventing symptomatic COVID-19 and that it protects against severe disease and hospitalisation. The study was based on 11636 participants accruing 131 symptomatic infections from the Phase III UK and Brazil trials conducted by Oxford University.

The primary efficacy endpoint of the programme based on the pooling of two dosing regimens showed that the vaccine is 70.4% effective at preventing symptomatic COVID-19 occurring more than 14 days after receiving two doses of the vaccine. A secondary efficacy endpoint of prevention of severe disease demonstrated no cases of severe infections or hospitalisations in the vaccine group. Further analysis of the efficacy regimens showed that when the vaccine was given as two full doses, vaccine efficacy was 62.1% and 90.0% in participants who received a half dose followed by a full dose.

Professor Andrew Pollard, Director of the Oxford Vaccine Group and Chief Investigator of the Oxford Vaccine Trial, stated: “Today, we have published the interim analysis of the Phase III trial and show that this new vaccine has a good safety record and efficacy against the coronavirus. We are hugely grateful to our trial volunteers for working with us over the past eight months to bring us to this milestone.”

Pascal Soriot, AstraZeneca’s Chief Executive Officer, said: “Today’s peer-reviewed publication enables a full disclosure of the Oxford programme interim analysis. The results show that the vaccine is effective against COVID-19, with in particular no severe infections and no hospitalisations in the vaccine group, as well as safe and well tolerated. We have begun submitting data to regulatory authorities around the world for early approval and our global supply chains are up and running, ready to quickly begin delivering hundreds of millions of doses on a global scale at no profit.”

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COVID-19 Research and Therapeutic Development

EUSA Pharma Announces First Patient Enrolled in a Randomised Phase III Clinical Trial Investigating Siltuximab in Hospitalised Patients with COVID-19

EUSA Pharma, a global biopharmaceutical company, announced today that the first patient has been enrolled in the SILVAR study at the Sparrow Hospital in Michigan. The SILVAR study is a multicentre, randomised, double-blind, placebo-controlled, parallel-arm, Phase III study designed to confirm the encouraging results of the observational, single-centre, control-cohort SISCO study.

The SILVAR study will evaluate the efficacy and safety of standard of care with or without intravenous siltuximab in selected hospitalised patients with COVID-19 previously treated with corticosteroids or another respiratory virus infection.

Lee Morley, Chief Executive Officer, EUSA Pharma stated: “We are delighted to have enrolled the first patient in the ‘SILVAR’ study of siltuximab, a monoclonal antibody that binds to and neutralises IL-6, an important mediator of the immune response to infection. This clinical trial represents an important step in finding a solution for hospitalised patients with serious respiratory complications due to an over reactive immune response to Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection that is not fully responsive to corticosteroid therapy, as well as those with any other respiratory virus infection associated with serious ARDS.”

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Eli Lilly and UnitedHealth Group partner on Study of Neutralizing Antibody for COVID-19

On 4th December 2020, Eli Lilly and Company and UnitedHealth Group announced a partnership to conduct a study of bamlanivimab (LY-CoV555) in high-risk, COVID-19 infected individuals. Bamlanivimab recently received a EUA by the FDA for the treatment of mild to moderate COVID-19 patients who are at high risk for progressing to severe COVID-19 and/or hospitalisation. The trial will evaluate the efficacy and safety of bamlanivimab versus a propensity-matched control in individuals that meet the EUA criteria.

The study will identify and treat a large, diverse population of high-risk individuals for COVID-19 with bamlanivimab under real-world conditions to reduce the severity of illness and hospitalisations. It will draw upon both UnitedHealth Group’s UnitedHealthcare health benefits business as well as its Optum health services business to detect and treat high-risk symptomatic patients who test positive for COVID-19, including daily symptom tracking, in-home SARS-CoV-2 testing and in-home infusion services.

Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories stated: “While bamlanivimab is authorized for emergency use based on the efficacy and safety data accumulated to date, larger pragmatic studies in diverse populations can help us further understand the efficacy and safety of SARS-CoV-2 neutralizing antibodies in real-world settings. Lilly is excited to partner with UnitedHealth Group to study our antibody therapy using a care delivery model that will allow rapid diagnosis and in-home treatment of patients at a high risk of complications.”

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FDA Authorises First COVID-19 and Flu Combination Test for Use with Home-Collected Samples

On 4th December 2020, the FDA announced the authorisation of the first diagnostic test for at-home collection of patient samples to detect both COVID-19 and influenza A and B. The FDA authorised Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when the home collection is determined to be appropriate by an individual’s healthcare provider. Patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collection kit.

FDA Commissioner Stephen M. Hahn stated: “Today’s authorization for a COVID-19 plus flu test using samples collected at home is a significant step toward FDA’s nationwide response to COVID-19. With the authorization of this test, the FDA is helping to address the ongoing fight against COVID-19 while in the middle of the flu season, which is important for many, including the most vulnerable of Americans. This is another example of the FDA working with test developers to bring important diagnostics to Americans. With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results.”

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Other Pharma Industry News

Gilead’s Tecartus™ Granted Conditional Marketing Authorisation for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma in Europe

On 16th December 2020, Kite, a Gilead Company, announced that the European Commission had granted conditional marketing authorization for Tecartus™. Tecartus is a chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. The conditional marketing authorisation covers patients who have already received two or more lines of systemic therapy, including BTK inhibitor. In the phase II ZUMA-2 trial, an overall response rate (including complete or partial) was observed in 93% of 60 patients treated with Tecartus™, with 67% of those patients achieving a complete response.

Ken Takeshita, Kite’s Global Head of Clinical Development stated: “We are proud our second cell therapy has been approved for use in Europe, and I extend my thanks to the patients who participated in the clinical trial and their families and caregivers, clinical researchers, regulators and dedicated colleagues at Kite who helped make this approval possible for patients living with relapsed or refractory mantle cell lymphoma.”

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Charles River Delivers Industry-First Deciphex Patholytix Digital Pathology Peer Review for GLP Studies

On 9th December 2020, Charles River Laboratories announced that it is the first company to offer clients Good Laboratory Practices (GLP) validated digital peer review using Deciphex Patholytix Preclinical for toxicologic pathology. Charles River, partnering with Deciphex, a leader in preclinical digital pathology software-as-a-service, will leverage Patholytix Preclinical software to enable this industry-leading, validated process for digital peer review to streamline and expedite the process of ensuring the quality and integrity of studies.

Kevin McDorman, Corporate Vice President of Pathology stated:” As part of Charles River’s continuing commitment to enable our clients to reach their development goals, we are excited to deliver a truly innovative GLP validated Digital Pathology Peer Review solution. By partnering closely with Deciphex, we have a transformational product, Patholytix Preclinical, that will drive greater efficiency and flexibility for study delivery across the globe.”

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Issue Number: PN2012

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