As the world reels from deaths and illnesses due to COVID-19, the race is on for an effective, safe and long-lasting vaccine to help the human body block the novel coronavirus SARS-CoV-2. Several promising vaccines are already working their way through Phase 3, the final stage of clinical evaluation. The world remains optimistic that we will have one or more vaccines that will prove to be safe and effective by January 2021.
But, as encouraging as the early data has been, uncertainty has loomed over whether vaccines that appear effective and safe in developing antibodies in younger adults will work equally well for the geriatric population. It’s a critical issue given that older individuals are also at greater risk for a life-threatening illness if they do get affected from COVID-19.
Current Therapeutic Developments for COVID-19
Due to swift action taken by regulatory authorities, academic institutions, and pharmaceutical companies, various COVID-19 vaccines and therapeutic candidates have already emerged. These efforts continue to involve countless researchers, support staff, and others who are tirelessly working to understand the virus and develop ways to combat it. Current approaches include everything from traditional vaccines to cutting edge nucleic acid-based therapies and even repurposing certain existing drugs that might prove beneficial. While the development of COVID-19 vaccines and therapeutics is still in its infancy, here we highlight the efforts of some companies seeking innovative solutions to the current crisis;
Further, Moderna, Inc., is working closely with the U.S. National Institutes of Health, Moderna’s platform-based therapy (mRNA1273) has materialized to be a promising option, and the company has begun recruiting for a Phase I clinical trial. The company’s approach is distinctive in that manner, instead of using dead or weakened viruses like traditional vaccines, Moderna is using messenger RNAs (mRNAs). Once administered, these mRNAs will direct a vaccine recipient’s cells to produce proteins that mimic a spike protein that SARSCoV-2 uses to gain entry into host cells. The aim is that these proteins will elicit an immune response that will protect the recipient patient from future infection with the COVID-19 virus. The company has already produced clinical trial-ready batches of its product and at the same time is conducting necessary pre-clinical studies in animals and recruiting human volunteers for safety trials.
Moreover, on Wednesday, November 18, 2020 Pfizer Inc., announced after conducting the final potency analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficiency endpoints. Analysis of the data indicates a vaccine success rate of 95% in participants without prior SARS-CoV-2 infection and also in participants with and without prior SARS-CoV-2 infection in each case measured from 7 days after the second dose.
Moreover, the companies announced that the safety measures required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been attained. Pfizer and BioNTech propose to submit a request within days to the FDA for a EUA based on the totality of safety and potency data collected to date, as well as manufacturing data associating to the quality and consistency of the vaccine. This data will also be submitted to other regulatory agencies around the world.
This study will mark an important step in the Covid-19 journey to bring ahead a vaccine capable of helping the world fight Covid-19 pandemic. Further, based on projections, the companies anticipate to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021. Pfizer’s facilities that are a part of the manufacturing and supply chain are; St. Louis, MO; Andover, MA; and Kalamazoo, MI in the U.S.; and Puurs in Belgium. BioNTech’s German sites will support global supply.