The year 2020 has proven to be a defining year for the medical and biopharmaceutical fields across the world. Since the first half of the year, many countries across the world have been plagued with the COVID-19 pandemic. With countries now facing second and third waves of COVID-19 outbreaks and the total number of cases across the world reaching close to 60 million at the point of writing this article, biopharmaceutical companies race against time to search for a safe and efficacious vaccine that could help combat against the COVID-19 disease.
The last few months of 2020 has seen much promise in the area of vaccine clinical trials against COVID-19. A number of bio pharmaceuticals companies have announced success in their Phase 3 clinical trials. These results bring hope to the potential of a vaccine against COVID-19 in the near future. At the time of writing, there are 60 COVID-19 vaccines in the clinical development stage and 172 in the pre-clinical development stage. This article will provide a summary of the notable biopharmaceutical companies that have released results from its Phase 3 clinical trial for the COVID-19 vaccine and national regulatory approval across the world. The information in this article is based on clinical trial results released as of December 2020 and companies mentioned here are not ranked in any order.
Moderna. Inc.
Vaccine Candidate: mRNA-1273, LNP-encapsulated mRNA
Vaccine Platform: RNA
Dosage: 2 doses, one at 0 and 28 days
Since the reveal of the genetic sequence of the novel coronavirus by the Chinese authorities on 11 January 2020, Moderna quickly kick-started its quest towards development of a vaccine against COVID-19. Within days, on 13 January 2020, Moderna finalised the sequence for mRNA-1273 with the intention of the National Institute of Allergy and Infectious Disease (NIAID) to begin Phase I studies for mRNA-1273 against SARS-CoV-2. Following the success of Phase I and Phase II, Phase III clinical trial study of mRNA-1273 began promptly on 27 July 2020, in collaboration with NIH (National Institutes of Health) and BARDA (Biomedical Advanced Research and Development Authority).
The Phase III study completed an enrollment of 30,000 participants on 22 October 2020. On 16 November 2020, Moderna released an announcement that its Phase III study has met primary efficacy endpoints based on first interim analysis. Together with this, the first interim analysis that included 95 participants with confirmed cases of COVID-19 found to show statistically significant vaccine efficacy of 94.5 percent. Having scaled up its manufacturing for preparation of the COVID-19 vaccine, Moderna mentioned in a media release that by the end of 2020, it expects almost 20 million doses of the vaccine ready to ship to the U.S.
The Moderna COVID-19 vaccine was approved by the US Food and Drug Administration on 18 December 2020 for emergency use authorization which allows the distribution in the US for use in individuals 18 years of age and older.
AstraZeneca and Oxford University
Vaccine Candidate: AZD1222, ChAdOx1 nCoV-19
Vaccine Platform: Non-Replicating Viral Vector
Dosage: 2 doses, one at 0 and 28 days
On 30 April 2020, AstraZeneca and Oxford University announced an agreement for the collaboration to develop and distribute the recombinant adenovirus vaccine aimed at preventing COVID-19 infections.
The vaccine candidate, AZD1222/ ChAdOx1 nCoV-19 was developed by Oxford University’s Jenner Institute, together with the Oxford Vaccine Group. It is a replication-deficient chimpanzee viral vector based on a weakened version of the adenovirus that causes infections in chimpanzees and contains the genetic material of SARS-CoV-2 spike protein. Following a vaccination, the viral vector will produce surface spike protein, allowing the immune system to produce antibodies to fight against COVID-19 should it infect the body later.
Interim data from its Phase I/II trial demonstrated strong immune responses in all participants. These results were announced on 20 July 2020. This Phase I/II COV001 trial, led by Oxford University, found that AZD1222 was well tolerated coupled with robust immune ...
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