DOCTOR IS IN by Dr. Adil Manzoor OP/ED
The Do you know how many times over the last few months I have heard, “how can we know it’s safe if it doesn’t have full approval?” or something more in the light of, “the vaccines cannot be safe because they are only approved for emergency use.” If you spend quite some time on social media, you’ll have heard these before too.
It was always a huge bother explaining what emergency approval truly meant to this set of people. Well, that’s no more – thank you, FDA! Before I move into what full approval is, I should say this – the emergency approval does not in any way whatsoever mean the vaccine was and is unsafe for use.
There are due protocols to be followed before the FDA can approve a drug for use. When it comes to vaccines, the regulations are even more stringent because of how delicate vaccines are.
Full approval is definitely the goal of every drug and vaccine because it shows that the FDA has absolute and total trust in the drug, backed by studies and valid clinical tests to show the drug is, indeed, safe.
To get a drug fully approved by the FDA, at least six months of safety data is needed. I’m sure you already see why we couldn’t afford to wait for full approval of the COVID vaccine. I mean, it would have been suicidal to our healthcare system.
If you remember quite well, there were times before the vaccine came around where hospitals were literally overflowing with sick patients. I’m talking of times where hospitals had to start turning back patients because all beds were filled. The vaccine was our only saving grace, and it came through.
Naturally, vaccines take several years to make and get authorized. Several years in this context may be as much as 15 years. This makes it understandable that the public had reasonable doubt when the vaccines became available after barely nine months. It sounds like the whole process was rushed and, hence, the vaccines could not be trusted.
The fear of many was further reinforced when the vaccines “only” had a EUA (Emergency Use Authorization). But, the reality is that the FDA will never approve a dangerous drug, no matter the context or conditions. If the vaccines were not safe to use, best believe that the FDA will not approve them at all. However, this was not the case with the COVID vaccines. The FDA considered two months of safety data and then decided to give a EUA.
This was one hundred percent the right move as that reassured a lot of people on taking the vaccine, which is unsurprising considering the high level of trust the public places on the FDA. There was still the clan that believed the vaccine was not safe for use, though, because of the lack of full FDA approval.
This is why it is big news that the FDA has given the Pfizer vaccine full approval. Now, many people who were truly worried about the vaccine’s safety will be encouraged to take them.
I have been saying and will keep on saying, at least until the situation changes, that the vaccine is still our best bet of beating the virus. We need to get people to take them, and full approval is one of these ways.
The Pfizer vaccine still doesn’t have full approval for children between ages 12 and 15. The reason for this is that the studies and data submitted to the FDA for inspection were for people over the age of 16. This makes sense as people in this category were given priority at the early stages of vaccine development.
Experts have suggested that there may be full approval later this year for people in this category. But, again, this doesn’t at all mean that the vaccine is not safe for children between this age class. This is just the FDA following protocols. Stay safe.
This article was written by Dr. Adil Manzoor DO, a Board Certified Internist & Board Eligible Pediatrician, who works as a Hospitalist, and Emergency Room Physician. He is also the current President of Garden State Street Medicine, a non-profit organization whose sole purpose is to provide free preventive and acute urgent care services for the homeless. He is also the co-founder of his own unique medical practice Mobile Medicine NJ.
References
· https://www.google.com/amp/s/amp.cnn.com/cnn/2021/08/25/health/fda-approval-pfizer-vaccine-wen-wellness/index.html
· https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
· https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/full-fda-approval-of-a-covid-19-vaccine-what-you-should-know?amp=true
