COVID-19 Vaccine Development
Oxford University and AstraZeneca’s AZD1222 Vaccine Meets Primary Efficacy Endpoint in Preventing COVID-19
On 23rd November 2020, AstraZeneca announced positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine. One dosing regimen showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen showed 62% efficacy when given as two full doses at least one month apart. The combined analysis from both dosing regimens resulted in an average efficacy of 70%.
Professor Andrew Pollard, Chief Investigator of the Oxford Vaccine Trial at Oxford, stated: “These findings show that we have an effective vaccine that will save many lives. Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply. Today’s announcement is only possible thanks to the many volunteers in our trial, and the hard working and talented team of researchers based around the world.”
AstraZeneca will prepare regulatory submission of the data to authorities around the world and seek an Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries.
Pfizer and Biontech Submitted Emergency Use Authorisation to FDA for COVID-19 Vaccine
On 20th November 2020, Pfizer and Biontech announced that the agency had submitted an application to the Food and Drug Administration to authorise its coronavirus vaccine for emergency use, setting in motion an accelerated regulatory process that could allow the first Americans to get a vaccine by the middle of December. The companies have already initiated rolling submissions with several regulatory agencies around the world, including the Medicines & Healthcare Products Regulatory Agency (MHRA), and intend to submit applications to other regulatory agencies worldwide.
The submission is based on a vaccine efficacy rate of 95% demonstrated in the companies’ Phase III clinical study in participants without prior SARS-CoV-2 infection and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. To date, the Data Monitoring Committee (DMC) for the study has not reported any serious safety concerns related to the vaccine.
Dr. Albert Bourla, Pfizer Chairman and CEO stated “Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential. We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”
European Medicines Agency (EMA) Initiates Rolling Review of Moderna’s mRNA Vaccine Candidate Against COVID-19
On 17th November 2020, Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced that the European Medicines Agency (EMA) human medicines committee (CHMP) has started a rolling review of mRNA-1273, the Company’s vaccine candidate against COVID-19.
U.S. NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase III study of mRNA-1273 had informed Moderna that the trial had met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This study, known as the COVE study, enrolled more than 30000 participants in the US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
Stéphane Bancel, Chief Executive Officer of Moderna stated: “The start of the rolling review process marks an important next step as we continue to advance mRNA-1273 in collaboration with European regulatory authorities. We will continue our ongoing dialogue with the EMA as we seek to develop a safe and effective vaccine. We are also scaling up global manufacturing with our strategic partners Lonza of Switzerland, and ROVI of Spain to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021.”
Covid-19 Vaccine Candidate Found to be 90% Effective
On 9th November 2020, Pfizer and BioNTech announced that their mRNA-based vaccine candidate, BNT162b2, has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8th 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase III clinical study.
The Phase III trial was initiated on 27th July 2020 and has enrolled 43538 participants to date, no serious adverse events have been observed while safety is still being collected. Analysis has evaluated 94 confirmed cases, BNT162b2 was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. Submission for Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November.
Dr. Albert Bourla, Pfizer Chairman and CEO stated: “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”
Johnson & Johnson’s Covid-19 Vaccine Trial Resumes in Brazil
On 3rd November 2020, the Brazilian Health Surveillance Agency (Anvisa) granted approval to Johnson & Johnson (J&J) for resuming a clinical trial of its Covid-19 vaccine candidate.
J&J’s trial in Brazil had been put on hold since 12th October 2020 to allow a safety panel to evaluate an unexplained illness of a participant in its planned 60000-person Phase III trial. According to Anvisa when the trial was interrupted, 12 volunteers in Brazil, all from Rio de Janeiro, had either received a dose of the vaccine or a placebo. The vaccine candidate is one of four being tested in Brazil, which has the world’s third worst outbreak behind the United States and India, and the second-highest COVID-19 death toll.
COVID-19 Research and Therapeutic Development
FDA Authorizes Regeneron Pharmaceuticals Monoclonal Antibodies for Treatment of COVID-19
On 21st November 2020, the FDA issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and paediatric patients (12 years of age or older weighing at least 40 kilograms) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions.
Data showed that when administered together it reduced COVID-19-related hospitalisation or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated.
FDA Commissioner Stephen M. Hahn stated: “The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic. Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system. As part of our Coronavirus Treatment Acceleration Program, the FDA uses every possible pathway to make new treatments available to patients as quickly as possible while continuing to study the safety and effectiveness of these treatments.”
FDA Authorises Eli Lilly’s Monoclonal Antibody Therapy Bamlanivimab
On 9th November 2020, the FDA announced that the agency had issued an emergency use authorization (EUA) for Eli Lily’s monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and paediatric patients. Bamlanivimab is authorised for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms , and who are at high risk for progressing to severe stage of the disease and/or hospitalization.
The safety and effectiveness of bamlanivimab continues to be evaluated, so far it has was shown in clinical trials to reduce COVID-19-related hospitalisation or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. It is not authorised for patients who are hospitalized or require oxygen therapy due to COVID-19. The data supporting the EUA was based on an interim analysis from a Phase II randomised, double-blind, placebo-controlled clinical trial in 465 non-hospitalised adults with mild to moderate COVID-19 symptoms.
FDA Commissioner Stephen M. Hahn stated :” As illustrated by today’s action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments and providing sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective. Through our Coronavirus Treatment Acceleration Program, the FDA continues to work around the clock and use every tool at our disposal toward these efforts.”
Issue Number: PN2011
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