r/WomensHealth – Regarding vaccine hesitancy…

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I get it. I truly cannot express to you how much I get it. I’m a forever recovering hypochondriac and getting this vaccine was really hard for me.

I get that it feels like it was rushed. I get that its difficult feeling like the government always has your best interest at heart (depending where you live.) Which is why I choose to listen to the doctors and the scientists and not politicians regarding the safety and efficacy of this vaccine. I’m mostly going to talk about the mRNA vaccines because I feel those are the ones people are most skeptical of.

And, a disclaimer here. I do not work in the medical field. I am simply trying to gather up the information we do have in one place and present it in a way that feels demystified. I feel confident the information here is accurate, but welcome any corrections because I’m only one lay person! And if you have any questions about what is presented here, or are still just curious or have doubts, I definitely encourage you to bring it up with your doctor!

tl;dr – The COVID vaccines have gone through the exact same rigorous safety and efficacy evaluations as any other FDA approved drug. It’s been able to move faster because it has been a priority to every government in the world, so massive amounts of resources and attention have been directed to their development, and have been moved to the top of the pile of drugs waiting for FDA evaluation and approval. Also, mRNA vaccines are a decades old technology and have been deployed in clinical trials for other viruses and some cancers years ago.

How these vaccines work

A small piece of the virus’s DNA sequence is essentially programed into a synthetic messenger RNA. mRNA works in our bodies to deliver instructions for what proteins to make. Our own mRNA and the synthetic stuff only lives in your body for a few days, and the proteins being produced are only produced for a few weeks.

So these vaccines deliver the instructions required for our own bodies to make the famous spike protein of the coronavirus. The vaccine itself is only in your body for a few days, and the spike proteins your body makes only last for a few weeks while your body figures out how to destroy the spike proteins. Then your body remembers this for next time it comes into contact with this, and similar, spike proteins. These are the antibodies (and T cells etc.)

Regarding Efficacy

The mRNA vaccines have been proven to be extremely effective at preventing COVID 19 and preventing severe disease. They are even being proven effective at preventing symptomatic disease with the variants, including Delta, though at a slightly less efficacy.

https://www.nejm.org/doi/full/10.1056/nejmoa2035389

Moderna’s phase III trials of their original formulation showed a 94.1% efficacy at preventing disease, and nearly 100% effective at preventing severe disease. They recently came out saying their original formulation is still 93% effective 6 months later.

Pfizer showed in their phase III trials that their original formulation was 95% effective at protecting against symptomatic disease, and nearly 100% effective at preventing severe disease. These rates have also fallen, to being about 83.7% effective 6 months later.

https://www.nejm.org/doi/full/10.1056/nejmoa2034577

I want to be clear though, these are still some of the most effective vaccines in history. For reference, the flu vaccine every year confers anywhere from 40-60% efficacy, but would be higher if more people got the flu vaccine.

I also want to address some people’s worries about breakthrough infections. Most vaccines are actually formulated to prevent disease, not infection. Creating a vaccine that prevents infection is called ‘sterilizing immunity’ which is really hard to do, and few vaccines actually do that. We expect breakthrough infections to happen to some degree, and these are still some of the most protective vaccines in history. And again, the efficacy rate improves as more people get vaccinated.

That all being said, The Mayo Clinic just a released a pre peer reviewed study on the effectiveness of both vaccines on the Delta variant. It appears Pfizer’s efficacy has dropped down to 42% and Moderna’s to 76% in July when the Delta variant became the dominant variant. These results suggest the FDA may soon recommend boosters.

https://www.medrxiv.org/content/10.1101/2021.08.06.21261707v1

Regarding Safety

So here’s where I think most people are finding issue. It feels like the vaccine was rushed, and I completely agree! It feels that way, but if we break down the whole process and everything leading up to this point, we can see all of these vaccines have gone through the exact same protocol as every other vaccine on the market.

  1. To start with, mRNA vaccines are not new. We’ve been developing this technology for decades and have even previously deployed mRNA vaccines in clinical trials for other viruses such as Zika and cytomegalovirus, as well as certain cancers. Why those vaccines have not been FDA approved ultimately comes down to funding and demand.

https://www.cidrap.umn.edu/news-perspective/2017/01/zika-mrna-vaccine-enters-clinical-trial-angola-reports-cases

2. My next point is funding. COVID vaccine developers have been absolutely flooded with funding from governments around the world as well as individual donors, because everyone has a vested interest in ending this pandemic. Typically when scientists want to conduct research or develop a new technology, they need to take the time to apply for grants and approach investors to prove that the advancement is both needed and that their approach is viable. That was obviously not needed for these vaccines; we all agree they’re needed and we’ve known mRNA vaccines are viable. Immediately having all the resources necessary is a huge boon for developers and pushes the timeline even faster.

3. And since everyone is interested in ending this pandemic, governments all over the world have temporarily relaxed typical protocols for sharing information across borders. (It would be cool if this were permanent but that’s probably unlikely). Thousands of scientists all over the world dropped what they were doing and worked around the clock to come together to work on these vaccines. Normally it may just be like a dozen people in one country working towards an end goal, but with this free flowing information and collaborative effort, the timeline was again pushed faster.

4. We also have to remember technological advancement continues to accelerate. The technology we have now even compared to 10 years ago is immeasurable, and sequencing the entire genome of any organism takes no time at all. And since we already had the mRNA technology ready to go, it took almost no time to just plug in that chosen DNA sequence and get started on clinical trials. Truly, we had this vaccine basically ready to go, we just needed to sequence theDNA of SARS-CoV2 and choose an appropriate protein.

5. We also have been studying coronaviruses for over 50 years. Though SARS-CoV2 itself is a novel virus, its very similar to SARS-CoV1, which we have been studying since its outbreak in 2002, and could even use information from the MERS outbreak in 2012. Basically, we already understood this virus’s structure, genome and lifecycle. It’s not like we were starting from scratch.

Clinical Trials and FDA approval

So this brings me to clinical trials. Every single COVID vaccine (in the US) has to go through the exact same protocols as every other vaccine on the market today. No steps were skipped or rushed. The guidelines are as follows;

  1. Pre Clinical Trials, where the vaccine is first tested on animals

  2. A lab submits an Investigational New Drug (IND) application to the FDA, where the FDA reviews the results from the Pre Clinical Trials

  3. Upon approval, a lab inspection is then scheduled and conducted to make sure the lab is in accordance to Good Laboratory Practices, a set of practices that has been established since the FDA’s inception

  4. The FDA also inspects the vaccines materials and the manufacturing technology for quality and safety

  5. Phase 1 Clinical Trials: the vaccine is tested on 20-100 healthy adults for 2 months

  6. Phase 2 Clinical Trials: based on the safety and efficacy shown in Stage 1, the vaccine is tested one hundreds more adults of varying health statuses and demographics for 2 months

  7. Phase 3 Clinical Trials, where the vaccine is used on thousands of people where we can get an even better idea of common and rare side effects in the general population. this section is also 2 months long

  8. The manufacturing process is again assessed to determine quality and safety of large scale production of the vaccine

  9. Seeking Approval to distribute and market in the US. The benefits and risks of the vaccine are weighed, and the decision is reviewed by a team of experts including doctors, chemists, statisticians, manufacturing and facility experts, pharmacologists, toxicologists, microbiologists, experts in postmarketing safety, clinical study site inspectors, and labeling and communications experts. This is where we are now in waiting to get the Pfizer and Moderna vaccines FDA approved. Though this process needs to be reviewed by a lot of people, and that takes a lot of time, it is being prioritized right now

  10. The FDA and respective labs continue to follow up with trial participants for years and the FDA regularly inspects and regulates the labs making the vaccine for quality, efficacy and safety

https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101

The vaccine was not rushed, it was prioritized

Much of the time historically spent getting vaccines developed and approved is more or less waiting time. There’s all kinds of bureaucratic hoops to jump through, there’s normally more obstacles by way of funding, information sharing, limited man power, and limited interest. Massive amounts of resources were simply funneled into this endeavor and developers aren’t having to submit their applications to a long pile of other applications waiting to be approved. COVID vaccine development has been prioritized by everyone, so its just been moving through the technical and legal slog more quickly.

What we know about vaccines

So why is each phase of clinical trials 2 months long? Because we know it is extremely rare to experience vaccine side effects beyond 6-8 weeks. That is accepted as the rule, and any exceptions to that rule are so rare they are simply case studies. We have deployed mRNA vaccines years ago in trials for other viruses, and long term side effects have not been reported

https://www.nature.com/articles/nrd.2017.243

It is also literally impossible for a vaccine to cause a side effect that the disease itself cannot cause, besides of course, allergy to a vaccine ingredient. COVID itself made me skip my period and then I had awful awful PMS symptoms for months after, and so far the COVID vaccine has made my period a bit irregular, but it is not forever. I have friends who are healthcare workers and got the vaccine in November, and their cycles have all returned to normal within 6 months. Any strong immune response or trauma can effect your menstrual cycle. Your reproductive system is meant to be adaptable, because you’re body doesn’t want you to get pregnant under stressful conditions. This isn’t proven but if I had to guess, part of the reason our bodies are reacting in SUCH an inflammatory manner to COVID and the vaccines is because its a completely foreign invader. We haven’t had regular exposures to this virus for our entire lifetime, so it has to deploy all weapons in its arsenal to figure out what works best. Most other pathogens, we’ve had some practice

We know the vaccine doesn’t cause infertility because then we would be seeing COVID itself causing infertility. Which has not been the case.

Blood clots, Guillan Barre and heart inflammation are all rare side effects of the vaccine, but you’re more likely to get them if you get COVID. Heck, you’re more likely to get blood clots from your birth control than the vaccine.

Conclusion

I know that this likely isn’t going to change anyone’s minds who are vehemently anti-vax or anti-COVID vax. But I know some people are just nervous about the whole thing but want some more information and reassurance, so I hope this feels reassuring in some way. It’s also unfortunate many of our governments havent been very communicative during this whole process and are now just expecting people to willingly put something that feels so foreign and unstudied in our bodies. Thankfully, we do actually know a lot about these vaccines and how theyre working in our bodies. And hopefully it is reassuring to know that these vaccines have gone through the exact same rigorous testing and evaluation as all other drugs on the (US) market.

Please, if you have any further questions or concerns about this vaccine or any other I am happy to talk with you.

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