Over the past year, our attention has been focused on the pandemic which has caused so much havoc, disruption, anxiety and grief around the world. In December we saw a glimmer of light with the interim approval by Health Canada of a COVID-19 vaccine made by the German company BioNTech and its U.S. partner Pfizer Inc. Here is a summary of what we know about this vaccine.
Is the vaccine safe?
Some people have voiced concerns about its safety, citing its rapid development within one year. Previous vaccines have taken many years to develop before approval for widespread use. One of the reasons why the Pfizer clinical trials and regulatory approvals happened so quickly without sacrificing safety is because many of the stages of testing that usually occur one after the other were conducted at the same time. In addition, the companies that were working on this had a head start due to new technologies that were already in development long before COVID-19. Its successful development was really about the power of the entire pharmaceutical industry working together on a single problem.
The clinical testing for this vaccine involved over 43,000 people from the U.S., Germany, Turkey, South Africa, Brazil, and Argentina and included people who were Black, Hispanic and Asian. People with underlying conditions that are often associated with a higher risk of getting seriously ill from COVID-19 were included in the study. The results of the trials indicated that the vaccine will also benefit the elderly.
Have there been serious adverse effects?
Serious adverse events (unexpected and undesirable harmful effects) during the trial were low. In the U.K. two people experienced serious side effects after receiving the vaccine and the reasons for this are under investigation. It is thought that one person had a history of severe allergies. Both people have fully recovered.
Are there side effects from receiving the vaccine?
Mild to moderate reactions occur frequently. These may include injection site redness, pain and swelling, fatigue, headache, chills, joint pain and fever. These reactions are similar to what some people experience after receiving the flu shot. They are expected because this vaccine (like the flu shot) is supposed to trigger the body’s immune system.
How quickly does the vaccine work?
The Pfizer and recently approved Moderna vaccines require two doses. There is some protection after the first week of receiving the vaccine with much stronger protection after the second dose 21 days later. It is expected that other vaccines will become available that require only one dose.