
This is going to be an uncomfortable post. But I’ve been doing a lot of soul searching and I want to talk about two of the most common {and what I feel are truly legitimate} concerns that keep surfacing when people discuss their fears and concerns surrounding the COVID vaccine.
A lot of people are not traditional antivaxxers. They have had all of their immunizations, immunize(d) their children, and even get annual flu shots. They have never had any doubts about the necessity or safety of any vaccine — until now. But why? What makes the COVID vaccine any different?
One of the most prominent concerns is that there’s not enough research. I truly mean no disrespect, so I hope no one takes offense. But I must ask, how much research would be satisfactory?
A common misconception is that, in the shadows, some government figures surreptitiously and hastily threw something together and called it a vaccine. Which honestly sounds just horrifying. I wholeheartedly agree. Who would willing volunteer to get in line for that mess?
Fortunately, that’s not how this works… that’s not how any of this works.
Now, you might be wondering, if it wasn’t just thrown together, how was a vaccine for a brand new virus manufactured so quickly? It’s a valid question.
The answer isn’t the huge secret conspiracy that some have suggested.
For one thing, while SARS-CoV-2 {the virus that causes Covid-19} may be new, Coronaviruses, as a whole, are not.
Virologists and immunologists have learned a tremendous amount from more than twenty years of research on earlier coronaviruses, like the severe acute respiratory syndrome (SARS) virus and the virus that causes Middle East respiratory syndrome (MERS), as well as the seasonal coronaviruses. They know considerably more about their transmission and their vulnerabilities, crucial information that is key to a successful vaccine.
Moreover, think about technology. Not just medical technology, but technology, in general. From manufacturing electronics, cars, and airplanes, to constructing homes, skyscrapers, and bridges, things that once took years or even decades can now be completed in a matter of months, weeks, or days. Because the foundational knowledge that has been gained and the processes that have been developed, over time, have made things much more efficient.
Thanks to trial and error, the blood, sweat, and tears of those who worked so tirelessly before us, and advancements in science and technology, we haven’t had to start from scratch with a lot of things in a very long time.
This is what happened with the Covid-19 vaccines. They did not just appear from nowhere. They weren’t the products of a few guys in a grimy basement somewhere, throwing ingredients together, hoping no one would notice that they had no idea what they were doing.
Decades of research by tens of thousands of well-educated, highly respected scientists from all over the world is what put in place the essential knowledge and methods responsible for the rapid development of these lifesaving vaccines.
Still, research is just one concern. The other issue many are grappling with is the lack of FDA approval.
I feel compelled to take a moment to mention that I find it interesting that none of us has really seemed all that bothered about vitamins, herbals, and dietary supplements, or the variety of mixes, powders, potions, pills, and oils, etc. that our friends, family members, and/or celebs are trying to pedal to us that are ALSO not approved or even regulated by the FDA, which also may have unknown long term effects. But that’s just my opinion, so I’ll try to keep my whataboutisms to a minimum.
Back to the facts…
If the main thing that makes you pause about getting the vaccine for yourself or supporting that decision from people you care about is its lack of FDA approval, there’s good news on the way.
Pfizer and Moderna are working on their status.
According to the FDA, for a drug to be approved it needs to have at least 6 months of data proving that the benefits outweigh the known and potential risks. 6 months worth of data obviously wasn’t available until recently.
Pfizer and Moderna both received their emergency use authorization in December 2020.
Pfizer moved quickly, submitting its application for full approval on May 7. Which they talk about in this press release.
Moderna wasn’t as quick, but submitted theirs on June 1st. Which you can read about in their own press release.
J&J, on the other hand, got the green light in late February, but has yet to file for full approval, although they reportedly have pLaNs to do so “lAtEr” in 2021, whatever that means. 🤨
There was originally discussion about expediting full approval. But after things were so heavily politicized, they had concerns that moving too quickly would erode more trust in vaccines just when we need them most.
Still, it takes so long to grant full approval that a lot of people seem to be under the impression that the FDA has reservations about doing so at all. A lot of the unvaccinated individuals I’ve spoken with have cited concerns about the length of time it’s taking. They feel like there must be problems no one wants to tell us about.
Although there are cases of vaccine injuries and adverse reactions, they are published for all the world to see. The real problem is we just aren’t used to watching and waiting {like watching paint dry} as they go through their entire approval process. It’s usually happening in the background. Under normal circumstances, most of us may not even hear about a drug or vaccine until it’s been fully approved. So we aren’t familiar with things.
But it is a lengthy ordeal. Like I mentioned earlier, manufacturers can’t submit their application until they have at least 6 months of data. Once they satisfy that threshold, they can complete and submit their application. Then it can take another six months to a year for the FDA to scrutinize all the required supporting documentation, before they can reach a decision. That review process includes comprehensive reviews of clinical trial data and expert reports; inspection of equipment and manufacturing facilities; and multiple meetings with company executives.
This long and arduous process is why they opted for the emergency use authorization in the interim. They are currently deep in the process, so hopefully full approval will happen soon to put more people at ease.
Whether or not you choose to get the vaccine, I respect your decision. I hope this information can help provide some perspective and ease some of the concerns so many of us are having. Please stay safe and take care yourselves. 💗