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#COVIDVaccine

Today we welcome one of Sierra's very good friends, Alicia Mikolaycik Kurtz! An incredibly intelligent, kind, spunky human that also happens to be an Emergency Medicine Physician and Emergency Department Medical Director at Marian Regional Medical Center in Santa Maria, California! She is real, raw and has done her research. Now she is here to share all her knowledge with you to help you make the best decision for your family. Still have questions after reading this? Leave a comment on @momminlivinworkin on Facebook or Instagram!

 

Ok before we get started, it definitely needs to be said: I'm openly pro-vaccination in general. Why? Because I'm a doctor. And a scientist. And I have spent countless hours reviewing the data and evidence behind vaccines in general, data that I went to school to learn to interpret with a critical eye – very different than how the media and non-scientists interpret studies and data. And honestly? Vaccines are AMAZING. The data is clear over and over again: vaccines are effective, safe, and keep us from suffering unnecessarily. Everything you've likely heard about vaccines being unsafe for children or causing autism, etc., is very likely not true. If you are anti-vaccination for your children, I would encourage you to look up the actual data that supports vaccines from scientific journals or talk to your Pediatrician about it. I am all about keeping kids safe. 100%. And I can say with certainty – there is NOTHING more difficult for me as an ER doctor than telling a parent their beautiful, perfect child just died from an illness that is preventable by vaccines.


So, all of that said – I spent *lots* of time looking at the data and educating myself about the vaccines to be able to offer people fact-based advice, while being honest about what we still *don't* know. So let's get started!


Why should I get the vaccine?

For starters, because you don't want to die from COVID! While the vaccine is 90+ % effective at preventing COVID19, it has also been seen that for those people that do get the infection, it's a milder case and less likely to lead to death if you've been vaccinated. There is also some data from the Maderna vaccine that suggests the vaccine may help prevent asymptomatic transmission (COVID spreading between people with no symptoms who are unaware they have the infection). So, not only is getting the vaccine protective to you, it's protective to those around you and is ultimately what we need to be able to stop the spread of this thing and begin to imagine returning to life without wearing masks 24/7.


Is it safe? How do I know it is safe?

This is a really important question – and the quick answer is: YES. It's safe.


But the longer answer addresses what I think people actually want to ask – which is: How was the COVID vaccine developed so fast when previous vaccines have taken years to develop? How do I know it wasn't rushed or that it wasn't a political thing?


To answer this, let's first review a bit about how vaccines are developed. It happens in a few phases:


1. Map the virus. We have to study the virus itself. We look for parts of the virus that are stable, meaning not changing or evolving over time, but that are also unique enough that they are clearly this virus.

2. Develop the vaccine. Then we have to figure out how to make the actual vaccine. Will we use a tiny dose of the dead version of the virus itself? Will we use a tiny dose of a live virus but take away the part that lets it replicate or be dangerous? Or will we find a way to have our own bodies involved in the process (more on that later!)? And once we figure that out, there are all kinds of other questions -- like what temperature does it need to be stored at to make sure it doesn't spoil? How long is the shelf life? What does it need to be put in to keep it "fresh"?

3. Test the vaccine on animals. Does it even work? And was it safe?

4. Test the vaccine on people. And did it work then? And was it safe?

5. FDA authorization (and later, formal approval). The FDA must review all the data from the human studies and dive deep into the data to ensure it was truly safe and effective for those that got the vaccine. They also have to decide who it's safe for. Can kids get it? Pregnant women? What about breast-feeding moms? Immuno-compromised people? The elderly? Lots to think about in this analysis.

6. Make a bunch of vaccine doses! To be able to get it to everybody, you need to actually put together a bunch of doses in your vaccine making factory. This can mean creating new machines and manufacturing techniques. It all just depends on what that product ends up looking like in the end.

7. Distribute the vaccine. So now we have this product, but who's going to pay for it? The producers, like Pfizer & Moderna, need to secure buyers and actually sell doses to hospitals and other agencies. And how will they physically get the vaccine to those customers? Do they need special refrigerators or carrying cases? What about the people receiving the vaccine - what do they need to be ready to store it on site? How do they get that?



You can imagine that if you were a scientist trying to develop say, the chickenpox vaccine, and you were doing it alone with your team, constantly having to re-apply for funding every year or so, and working as a small group of 5-10 people, just phases 1-3 could take ages.


But now consider this pandemic - when hundreds if not thousands of scientists all over the world dropped what they were doing to work on THIS virus. To develop testing, try to find treatments, and yes -- to create a vaccine. With the whole world working on this and ample funding supplied in real time by the various governments of the world, Phases 1 & 2 were able to happen lickety split compared to previous vaccines. And all the while, prep for Phase 6 & 7 were underway too! Governments and the vaccine makers put together contracts and plans long before the vaccines were even done being tested. And these special refrigerators/freezers they need to be stored in were purchased by hospitals and others even before they knew when their vaccine shipment would come. Shortening all of these phases is what truly made the vaccine development happen at "warped speed."


What's important to note here, though, is that phases 3 and 4 – the actual testing of the vaccines, were NOT shortened at all. Vaccine trials are run by an agency separate of the government and were adamant that their process not be changed or shortened. There was definitely some political pressure on them to release preliminary results or to look at the data early, but they did not. They stood strong to protect the integrity of the science so they could stand by the quality of their work.


While the FDA was basically waiting and ready to review that data for emergency use authorization, they also did not speed their process. They deliberated over the data they way they would any item they are granting authorization for -- and spent an entire extra day talking about whether 16-18 year olds should be included in their recommendations to authorize use of the vaccine or not.


It's important to realize that despite all of the political turmoil we've experienced in general in 2020, we can trust that the scientific community protected their work in this investigation and truly kept politics out of the part that matters most in deciding if this is safe or not: the science.


How does the COVID19 vaccine work?

The COVID19 vaccines from Pfizer and Maderna are called mRNA vaccines. Reaching back into your high school biology archives, the "programming" for our bodies comes from our DNA which is long, long strips of messages that get translated into shorter strips of messaging – strips of RNA. RNA is then "read" by the body to create proteins, which come together to form all kinds of good stuff in your cells, and basically... make you!


An mRNA vaccine inserts a strip of mRNA that your body then reads to build a protein from the Coronavirus. In this case, the "spike protein." This spike protein is not the part of the Coronavirus that infects or hurts you, but rather is a piece of the Coronavirus that is consistently recognizable. It's like the face of the virus, but without any bite! Your body makes the Coronavirus spike proteins which then float around your body, unable to do anything except that -- just float around. Your immune system recognizes that this is not part of your body! Your RNA did not make this! It's an intruder! Therefore, you mount an immune response and build antibodies that can fight and kill this protein.


For right now, the fact that you can kill this thing with your immune system is irrelevant -- because there's not actually anything to kill. BUT! If you were to be exposed to the real Coronavirus, your body would be ready to go with this pre-organized army of antibodies that recognize that stupid COVID face (the spike protein!) and are ready to fight it off before it can hurt you or make you sick.


Pretty cool, right?!?! Science and your body are amazing.


Can I just get one dose? If I do what happens?

You can, but it would not lead to the same levels of immunity/protection that getting the two doses would.


The Pfizer vaccine appears to be 52% effective at 10 days after the primer (first) dose, and 95% effective at 1 week after the booster (second) dose.


The Maderna vaccine appears to be 80% effective at preventing COVID 28 days after the primer, and 94% effective 14 days after the booster.


To put this in context, flu vaccines save thousands of lives and are worthwhile even when they are <50% effective. An effectiveness of 95% is impressive!


What about long term effects?

So far, we have not seen any negative long term side effects related to the COVID vaccinations. (In contrast, there are many long term horrible outcomes from getting sick with COVID19!) With most vaccines, if something "bad" is going to happen to you because of the vaccine, it would happen within the first 3 months. This is how the length of the vaccine studies is determined; they go on long enough to observe for those worrisome, long-term effects. After that period of time, it is very unlikely that any injury or illness experienced by a person would be related to the vaccine they received.


Like most vaccines, we do see some short term minor side effects from the COVID19 vaccine – things like soreness at the injection site, fever, or body aches that can last for a few days. These are common, but generally not a big deal.


Note: In contrast to expected minor side effects, serious adverse outcomes were rare and included some Bell's Palsy (which was seen in both the vaccine and placebo group suggesting it may have just been normal rates in that population and not related to the vaccine and one person had severe nausea and vomiting after the Maderna vaccine. Two people in the UK did have allergic reactions to the vaccine during the initial rollout there, but notably both had a history of severe allergic reactions and already had their own Epi pens. No other allergic, anaphylactic type reactions have been seen or reported so far.


Should I get the vaccine if I am pregnant or breastfeeding?

This question is a little tougher, because even though the group that was studied in these vaccine trials was huge, there were not that many pregnant or breastfeeding people – or at least not enough to run separate data that would mean anything. The sample size just isn't big enough for that.


However, with that said, generally speaking vaccines are very safe for pregnant and breastfeeding women.


(And just to put this one to rest now: There is no evidence that this or any other vaccine will lead to infertility in women. This was a widely circulated conspiracy theory posted on social media with no scientific credibility that has been repeatedly debunked.)


The CDC states that the option to vaccinate should be available to women who are pregnant and breastfeeding. And the American College of OB/GYNs (ACOG) states that “pregnant health care workers... should be prioritized for vaccination alongside their non- pregnant peers.”

In the Moderna trials specifically, animal data in pregnant and lactating rats showed no adverse events with this mRNA vaccination protein.


So bottom line? So far, the data points to yes, it's safe. And odds are, it is. More data will certainly be available in the future, but for now, you'll have to make your own choice.


If I was pregnant or breast-feeding would I get vaccinated? Absolutely without a doubt. As have all of my doctor mom friends who are pregnant or breastfeeding now. Because one thing's for sure: the risk of getting the vaccine is far outweighed by the risk of getting sick with COVID19.


What about children? Why are they not getting vaccinated?

They will be! But like everything else in science, we test stuff on adults first. It's an ethical principle we follow that I think is a good one: test it on the adults, work out the kinks, find any issues... then move on to studying it on children.


Given the very safe profile of these vaccines so far, trials in kids will likely start in the very near future.


In the end, we're all trying to make the decisions we think are safest for our families. As a doctor, I have seen how terrifying COVID19 infection can be - what it does to kids, and parents, and young people – and the countless lives it has stolen from our world. I see this vaccination as a celebration of our human resilience, our ability to work together in the scientific community to come up with solutions to problems and continue to fight to keep our families safe. I received my first dose of the vaccine on Dec 21st, and am already counting the days to my second dose!


Whatever you decide to do – keep wearing those masks, keep your physical distance from those outside your "COVID bubble," and wash those hands a bajillion times!


Stay safe out there!


-Alicia Mikolaycik Gonzalez, Md, FACEP


*Interested in hearing more from Alicia?? Check her out on, Real Talk Podcast. Real Talk is a podcast based on an in-person experience where doctors, APs, nurses, and other healthcare professionals share stories about their real, human experiences working in medicine. It's vulnerability and joy in medicine at its best. Find them on facebook @realtalkwithalicia, Insta @real.talk.podcast or twitter @aliciakurtz_md!

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