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Following a year marked by over 1.7 million deaths and numerous lockdowns, people are now relieved to learn that COVID-19 vaccines are now being distributed to the general public. Widespread vaccination may allow life to return to pre-pandemic levels, but this scenario is contingent on people's willingness to receive the vaccine. Some people are worried about vaccine safety in general, while others are wary of COVID vaccines in particular because of their novelty and fast turnaround time.
How does a vaccine get approved?
Vaccines, like all other drugs, must be approved by a government before they can be used. An independent body oversees the approval process in - country or group of countries.
All medications, including vaccines, must go through three phases of clinical testing:
- Step I : testing the vaccine on a small group of volunteers (20-80) to ensure that it is safe and to assess the maximum dose.
- Stage II : finding out if the vaccine is effective by splitting 100-300 volunteers into two groups and administering the vaccine to one group and a placebo to the other.
- Step III : randomly assigning thousands of volunteers to either a vaccine or a placebo community. Don't tell the volunteers or physicians which group they're in (this is known as a 'double-blind' trial), to see how the vaccine works and if there are any side effects.
If a trial is unsuccessful, for example, if the findings show that the vaccine is not effective in preventing disease or is causing adverse side effects, the trial is discontinued, and the vaccine is not approved.
Even after the vaccine has been approved, it is transferred to Phase IV, where it is closely monitored and data on side effects is gathered. This is crucial to assess if there are any particularly unusual results, such as those with a 1 in 100,000,000 chance of occurring.
When a vaccine has been widely distributed, it is continuously monitored. Since scientists and researchers around the world are sharing their findings, a single issue with the vaccine anywhere in the world would prompt immediate investigation and, if necessary, improvements.