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COVID-19 VACCINES ON THE HORIZON- CLINICAL TRIALS, EXCITEMENT & CHALLENGES

Updated: Nov 29, 2020


The latest report says, the first COVID-19 vaccine approval from Health Canada could come before Christmas with most Canadians expected to be vaccinated by September 2021. Eagerly and anxiously, we all have waited for this announcement with bated breath since long. But feds warn of logistical challenges. The Government of Canada is assertively pursuing the purchase and development of COVID-19 vaccines and related supplies to protect Canadians by engaging with international and domestic scientists and with businesses and manufacturers. Unfortunately, as Canada no longer has any domestic production capacity for vaccines, the Government is negotiating and signing agreements with a number of leading pharmaceutical companies to establish a guaranteed supply base of potential vaccine.


Canada has signed contracts for more doses per capita than any country in the world with expectation of their arrival in the next few months. That involves buying 126 freezers, including 26 ultracold ones, to hold millions of doses of vaccines. Two Covid-19 vaccines have been found to be highly effective in late-stage trials in recent days, boosting optimism at a time when health systems in Europe and the U.S. are once again in jeopardy. American pharmaceutical firm Pfizer and Biotechnology company Moderna are the first companies to release partial results from Phase 3 clinical trials in the race to develop a vaccine against the deadly SARS-CoV-3 virus that causes COVID-19.


PSPC (Public Services and Procurement Canada) is also procuring the equipment and supplies that will be needed to perform the final manufacturing and packaging stages of vaccine production in Canada, as well as the materials needed to support safe, efficient immunization such as syringes, needles, alcohol swabs and other supplies. There is an expected investment of up to $56 million to support clinical trials for a COVID-related vaccine which is funded from the Government’s $600 million to support COVID-19–related vaccine and therapy clinical trials led by the private sector and to support Canadian bio-manufacturing opportunities. Other projects are still under consideration.


Health Canada has started work on approving at least three vaccines. Investors have treated vaccine development as a race between companies, although there is likely to be global demand for as much vaccine as can be produced for the foreseeable future. Authorization of vaccines for children will take longer. Pfizer has started vaccinating volunteers under the age of 18 in trials, giving shots to children as young as 12. Moderna and Johnson & Johnson have said they hope to start testing the vaccine in younger patients soon. As per the reports, Moderna plans to ask the U.S. Food and Drug Administration for an emergency use authorization for its vaccine in the coming weeks.


Traditional vaccine versus mRNA vaccine


Traditional vaccines are made up of small or inactivated doses of the disease-causing organism, or the proteins that it produces, which are introduced into body to provoke the immune system into growing a response. mRNA vaccines, in contrast, trick the body into producing some of the viral proteins itself. Pfizer and Moderna vaccines contain messenger RNA and they are expected to have better effects than traditional vaccines. mRNA vaccines do not contain a live virus and do not carry a risk of causing disease in the vaccinated person. With the Pfizer and Moderna vaccines, messenger RNA is injected into the body, where it enters the cells and provides instructions to make antigens. When the cell presents the antigens to the body’s immune system, that triggers the production of T-cells and antibodies to fight the infection. Recent improvements in mRNA vaccines believed to increase protein translation, modulate innate and adaptive immunogenicity, and improve delivery.


Vaccines: Names, status, and updates


Pfizer/BioNtech: Status: Ends trial with 95% efficacy - approval pending. Phase 3 trials in the United States showed up to 95-per-cent effectiveness.


Moderna: Status: Interim Phase 3 results show greater than 90% efficacy – approval pending. Phase 3 trials in the United States showed up to 95-per-cent effectiveness.


AstraZeneca/Oxford: Status: Phase 3 in progress. Late-stage trials in Britain and Brazil showed 62- to 90-per-cent effectiveness based on the dosage and combination of doses.


Medicago/GSK: Status: Phase 2/3 trials in progress. Phase 2 / 3 trial launched Nov. 12 in U.S. and Canada.


NovaVax: Status: Phase 3 trials in progress


Janssen/Johnson & Johnson: Status: Phase 3 trials in progress