Editor's Desk 
COVID-19 Vaccine Development: Lens on Three Late-stage Candidates
Summary
- With the COVID-19 pandemic showing no signs of slowing down, the degree of hospitalisation required in COVID-19 disease yelps for both treatment and vaccine to treat patients and help control the spread of the virus.
- According to the World Health Organization (WHO), there are 34 candidate vaccines under clinical evaluation with a further 142 candidate vaccines in preclinical evaluation.
- Moderna, AstraZeneca-Oxford University and BioNTech-Pfizer are some of the frontrunners with their respective vaccine candidates under Phase III clinical trials. The developers are anticipating a filing before the end of 2020.
- If approved, vaccines may hit the market in early 2021, prompting healthcare companies to scale up manufacturing capabilities.
As on 8 September 2020 (at 10:39 AM CEST), there were 27.03 million COVID-19 cases in the world with 881,464 reported deaths according to WHO.
At present, the mortality rate is much lower than at the onset of the pandemic. The pandemic, which has witnessed a colossal number of deaths during the initial phase, is currently experiencing clinically milder COVID-19 cases. While one explanation may include that the virus is losing its malignancy, the healthcare systems have also come up with better treatment modalities.
DO READ: COVID-19 Vaccine Race Continuing at War Time Speed, Who will Pull Off?
However, with the pandemic showing no signs of slowing down, the degree of hospitalisation required in COVID-19 disease yelps for both treatment and vaccine to contain the spread of the virus and treat patients.
According to the World Health Organization, there are 34 candidate vaccines in clinical evaluation and 142 candidate vaccines in preclinical evaluation. There are nine candidate vaccines which are currently part of the COVAX initiative. This global initiative that aims to assist vaccine manufacturers in providing safe and effective vaccines to countries worldwide post the candidate vaccines are licensed and approved.
INTERESTING READ: Coronavirus Vaccine – ‘Silver bullet’ OR NOT as per WHO
Selected manufacturers with advanced stage (Phase III) candidate vaccines
On that backdrop, let us cast an eye on a few Phase III candidates.
mRNA-1273 by Moderna / NIAID
Moderna, Inc. (NASDAQ:MRNA) has collaborated with National Institute of Allergy and Infectious Diseases (NIAID) and Biomedical Advanced Research & Development Authority to study the safety and immunogenicity of the vaccine candidate, mRNA-1273 to prevent COVID-19 in adults aged 18 years and older. The candidate vaccine is currently in Phase III clinical trial.
The study evaluates the efficacy, safety, and immunogenicity of mRNA-1273 to thwart COVID-19 for up to 2 years post mRNA-1273’s second dose. The study started on 27 July 2020 and is expected to finish by 27 October 2022. As on 4 September 2020 at 5:00 PM ET, 21,411 participants were enrolled in the COVE Phase III Study.
DO READ: Up ~484% in a year, More Boost for Moderna with Late-stage Trial of COVID-19 Vaccine
Since March 2020, over 300 people have been administered with the vaccine with no serious side effects. More than 1,900 participants have been recruited in Moderna’s infectious disease vaccine clinical studies in the US, Europe, and Australia.
AZD1222 by AstraZeneca / University of Oxford
UK-based Biopharmaceutical Company, AstraZeneca PLC (LON:AZN) and the University of Oxford have collaborated for the development and supply of the Oxford University’s potential recombinant adenovirus vaccine, known as AZD1222, to prevent COVID-19 infection from SARS-CoV-2. The agreement allows AstraZeneca the rights of worldwide manufacturing and distribution of the vaccine. The candidate vaccine is currently at Phase III clinical trial in the US. Trial centres across the world will enrol almost 50,000 adults aged 18 years with 30,000 for US-based trial. Late-stage Phase II/III trials for the candidate is ongoing in the UK and Brazil and a Phase I/II trial in South Africa. There are trials planned in Japan and Russia.
AstraZeneca is looking at manufacturing partners to support the global rollout of its COVID-9 candidate vaccine dubbed AZD1222. The Company has signed agreements with New York-based Albany Molecular Research and UK’s Oxford Biomedica to support the production of the vaccine through 2021.
DO READ: Next move on Vaccine: Government’s agreement with AstraZeneca catering 25 million Australians
The Phase III trial is estimated to complete by November with mass production anticipated by 2021. The US phase III trial is a part of US’ “Operation Warp Speed” program that intends to supply 300 million doses of an effective vaccine by January 2021. The program is also supporting building medical countermeasures for COVID-19.
BNT162b2 by BioNTech / Pfizer
Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have collaborated to evaluate RNA-based COVID-19 pandemic candidate vaccines to select a single candidate vaccine and identify the dose level for a critical global safety and efficacy trial. The companies are focusing on two lipid nanoparticle–formulated, nucleoside-modified RNA candidate vaccine known as BNT162b1 that encodes the SARS-CoV-2 receptor-binding domain (RBD), and BNT162b2 that encodes the SARS-CoV-2 full-length spike protein to escalate its potential for stimulating virus-neutralising antibodies.
GOOD READ: Trump Goes COVID-19 Vaccine Shopping, Pumps ~US$2 Billion in Pfizer/BioNTech candidate
Across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants in a Phase I study in the US. These results led to the selection of the BNT162b2 candidate for the pivotal Phase II/III global study that started in July 2020. The study aims to enrol 30,000 participants, of which more than 11,000 participants have been enrolled.
If the clinical trials end up as per expectation, Pfizer and BioNTech may seek regulatory review of BNT162b2 in October 2020. Post-approval (if any is obtained), the companies intend to supply up to 100 million doses globally by 2020 end with ~1.3 billion doses by 2021 end.
INTERESTING READ: It’s all about the Vaccine Game: Gears that can put ASX 200 into a transition
News reported through various sources and compiled with AI. This is automatically generated news content from known, popular, and reliable sources available at the time of publication.
We do not take any responsibility for, nor make any representations regarding, the accuracy, completeness, credibility, or
reliability of the content.
In case of any discrepancy, error, or copyright claim, we will promptly review and remove the content in question where appropriate.
We do not claim ownership of third-party content and assume no responsibility or liability whatsoever for any information contained herein. The credit, links and images are kept intact as an honest gesture, are property of its respective owners.
