How Can We Be Sure COVID-19 Vaccines Are Safe?
In November, a Covid vaccine developed by Pfizer was approved by the Food & Drug Administration (FDA). Since then, a second vaccine made by Moderna has also been approved and distribution of both of these vaccines has begun. A third one, by AstaZeneca, is close to approval. At least 10 others are in various stages of development or trials. But, what actually does “approval” mean, and what does it tell us about the safety of these vaccines?
The Approval Process
Before a vaccine (or any medication, for that matter) gets its final approval for distribution, it goes through a pre-defined process:
Clinical Trials: Starting with only a few human subjects in Phase I, Phase II expands this to several dozen or hundreds until several thousands (about 30,000) are tested in Phase III. These trials are conducted in multiple locations (e.g., clinics, hospitals, universities) and monitored for compliance to a strict protocol and adverse side effects.. Vaccines approved by the FDA have all completed Phase III trials. This is not true for vaccines developed in China and Russia and experts have raised doubt about their safety (doubt does not mean they are unsafe: it only means their safety has not been demonstrated!)
Independent Expert Review: The Data and Safety Monitoring Board reviews safety and efficacy data from Phase III trials.
CDC Advisory Committee on Immunization Practices also reviews the data and makes recommendations about which populations should receive the vaccine first
FDA staff and their independent vaccine-advisory committee:
both do their own reviews
safety is one of the FDA’s top priorities when recommending that emergency use authorization be granted to a vaccine (as is the case with Covid-19 vaccines)
The western states (incl. WA, CA, OR, CO, AZ) Scientific Safety Review Workgroup gave input on vaccine safety and efficacy before the vaccines were released in WA and other states.
The Side Effects
So far, minimal side effects have been reported. The most serious side effects appear to be soreness in the vaccinated arm, general weakness and fatigue and headaches for about a day or so. This appears to be not substantially different from other vaccinations (flu, shingles, etc). Some people will have these side effects, many others won’t. People who have had serious reactions to other vaccinations should consult their physicians before getting vaccinated.
Are there populations who should not be vaccinated?
In general, in order to achieve “herd immunity”, researchers agree that we need to reach at least 70% vaccination coverage..However, the studies done so far (Phase III trials mentioned above) focused on the broader population. Some test subjects were excluded. For example, if you are under the age of 16, there is no data yet. The same is true for pregnant or lactating women. However, trials with these groups are underway. Also, people in this category may need to carefully evaluate the risk of not vaccinating against the risk of taking the vaccine.
Once vaccinated, can I stop wearing my mask?
The short answer is: probably not! While indications are that the vaccine is very successful at preventing you from contracting COVID-19, there is insufficient data about whether it prevents you from passing the virus on to someone else. Some of the vaccines currently not approved but in various stages of development appear to prevent transmission, but all that data needs to be confirmed and reviewed.
What other resources can I check if I have more questions?
Here are some links to sites that offer a lot more information and details about the vaccines.
The information for this article was obtained from various sources, including the websites listed in the “Resources” section above. Please keep in mind that the research about the coronavirus and Covid-19 is ongoing, and information and recommendations WILL change. The information shown here is valid as of January 2021. Please stay informed and consult with experts. As with all of the articles on the Solution Resources EAP website, we are offering this for informational and educational purposes only. If you need to make a specific decision about your health care, you should consult a qualified health care provider.