Last week, Health Canada announced approval of the first vaccine against COVID-19 infection for use in Canada. The development of highly effective vaccines against a virus that we couldn’t name a year ago will surely go down in history as an unequalled biomedical triumph.
The vaccine development process normally takes decades, not months, to accomplish. However, unprecedented levels of collaboration between international governments, researchers and pharmaceutical companies led to the production of COVID-19 vaccines at astonishing speed.
It is perfectly justifiable to wonder if this is too good to be true. Is the approved vaccine safe and effective? Have corners been cut in the vaccine development process? Are approval processes for COVID-19 vaccines rigorous enough?
We know that the recently approved Pfizer-BioNTech vaccine cannot cause disease. It does not contain SARS-CoV-2, the virus responsible for COVID-19 infection. The messenger RNA vaccine works by instructing our own cells to make spike proteins found on the outside of the disease-causing virus. These proteins in turn stimulate our bodies to make protective antibodies.
The design and size of the study proving the vaccine’s safety and efficacy meet the rigorous standards of testing required for vaccine approval. The vaccine was studied in a randomized controlled trial enrolling over 43,000 people from United States, Germany, Turkey, South Africa, Brazil and Argentina. Data show that the vaccine is 95% effective and the effect is consistent across gender, race, ethnicity and age. We can have confidence that the vaccine will work in different populations, under various conditions and in places with higher and lower rates of COVID-19 infection.
The swiftness of approval for the Pfizer-BioNTech vaccine is also unprecedented. The United Kingdom, first to approve the vaccine, had several teams conducting assessment of the vaccine simultaneously, to ensure speed and rigor in the process. In our country, Health Canada was able to review safety and efficacy data expediently because they received data from vaccine manufacturers as it was collected. The regulator concluded that the evidence met strict standards for quality, safety and efficacy.
However, there is still work to be done. Trials are needed on vaccine safety and efficacy in pregnant women and children before approval in these populations. It is also too early to know how long immunity will last after vaccination or what long-term side effects, if any, there might be. A Health Canada vaccine registry to monitor and collect data on those being immunized will help answer these and other questions.
Implementing vaccine roll-out will be challenging but there are promising signs that we can do this successfully. The federal government is coordinating and paying for vaccine administration and will ensure that Canadians across the country will have access to the vaccine. Provinces have agreed that those who need the vaccine most will get it first and will follow national guidelines on how to prioritize populations.
Governments, community organizations and health care professionals will work to make sure that people have accurate information that they can trust about the safety and the effectiveness of the COVID-19 vaccine. Everyone deserves the best information to ensure they can protect themselves and their loved ones.
For some of us, getting the COVID-19 vaccine will be the best Christmas present we receive this year. For the rest, the gift is the promise the vaccine brings for better things to come in the new year. In the meantime, we need to continue taking care of ourselves and others by following all public health restrictions in place and knowing that it is up to every one of us to keep each other safe.
By Vamini Selvanandan© 2020. This work is licensed under a Creative Commons CC BY 4.0 license. This article was originally published in the Rocky Mountain Outlook on December 17, 2020. Photo credit: Thirdman on Pexels.com
- Pfizer News Release. Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints
- CBC News. Health Canada approves Pfizer-BioNTech COVID-19 vaccine
- Health Canada. COVID-19 Vaccines