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How Effective and Safe is the Pfizer/BioNTech Covid-19 Vaccine???



If you have been continuing to stay glued to the news about what has been up about the new vaccine that was approved on 12/12/2020 then you know that the Pfizer vaccine has been approved for ..with the Moderna one just approved for emergency use 20-0 by the FDA as I am writing this. Many people still question its effectiveness and safety based on how politicized it has become based on this past year's election as well as how quickly it has been pushed out compared to vaccines in the past. Despite these factors, there are still many anti-vaccinators out there as well who refuse to put even the most essential ones in their body due to fears of autism, cancer, etc. I am not saying there is anything wrong with this (everyone should have control of what goes into their body) but this only enhances the distrust of this vaccine. However, there have been studies by very reputable sources like the New England Journal of Medicine (2nd largest viewed medical journal). In this study, they reported not only the preliminary effectiveness of the vaccine but also talked about preliminary safety measures. The link to the article I have included below for your convenience:


https://www.nejm.org/doi/full/10.1056/NEJMoa2034577


As with all studies, they are never perfect and this is no different than the rest. Based on the study we do not have a full, drawn out data that we usually do as a result of the short term, emergency approval needed to quell the spread and deaths across the nation and the world. We have been in a race this entire year to find a cure so don't think that corners were cut, it is just that the timeline has been shortened to get approval for general population usage.


One major reason why this vaccine has been approved much faster than others lies within the vaccine itself. This vaccine is much different than any other vaccine created. A result of study and innovation over the past 30 years to create a vaccine that can not only help cure viruses but also assist in a cure for cancer (at least that is the hope for the future with the passing of this vaccine).


This vaccine uses an mRNA sequence of the Covid-19 virus itself instead of an actual weakened or dead virus as per usual in other vaccines such as for influenza, shingles, etc. Essentially, our cells are made of DNA but viruses only contain RNA in its core or nucleus. The RNA of a virus attaches to the appropriate sequence of our cells in order to infect and allow more virus to be produced, thus causing use to become ill. However, mRNA is just a MESSAGE. That's all it is. It cannot infect you. It cannot make you sick. It is just like you writing something on a label and sticking it to something to tell you what it is. Only a message. With this vaccine, if we just injected the mRNA our bodies would immediately destroy it. Therefore, in the laboratory, they needed to come up with a way for the message to get into our cells so that immunity can be produced. This comes in the form of a lipid nano-protein that covers the viruses mRNA so that it remains protected until it gets into our cells. Once the mRNA gets into our cells then the magic of the vaccine can take place. in contrast to other vaccines, the fact that this is mRNA instead of a weak or dead virus, it will go into our cells but NEVER into the nucleus or the core of the cell. Why is this important??? This is important because the mRNA will never impact or change the sequencing that makes our cell what it is. Our cell with the mRNA inside is still OUR cell...It is not the cell of our body CONTROLLED and INFECTED by the virus. Compared to other vaccines and even when we get the virus, we never have any manipulation of the cell itself and therefore no creation of a mutation.


When the mRNA enters our cell, it is brought to organelles or structures within the cell outside of the nucleus where OUR precious DNA is located where the spike protein of the mRNA of the virus is then replicated. When the spike protein is replicated then this is filtered out to our body where antibodies and an immunity to the virus itself can be created. By doing so, we DO NOT become infected by taking the vaccine and our body fights something dead or weaker. We just build an immunity.


Based off of what they found by performing the study, those who did take the vaccine had similar reactions as you would with any other vaccine (your body is still "fighting a foreign invader"). They found that within 1-2 days of vaccination and more after the second dose than the first dose that are 21 days apart, you may experience some mild to moderate pain and redness especially if you are younger. A smaller percentage of the ~37,500 people that completed the study also reported swelling of lymphatic structures (important in immunity and fighting infection) but only lasted for a few days longer than the pain and redness. Other people did note some more systemic reactions as well including fatigue, headache, and fever but again this is not too far out of the ordinary and can occur with other vaccines just like for influenza. Particularly interesting about the population studied is that they only studied a population that is > 16 years old, the middle age of the population (median) was 52 and 42% of the population of the study was > 55 years of age, 35% of the population was obese, and they even tested the effectiveness of the vaccine that included hypertension. There are benefits and drawbacks to using this type of population set. As of right now there is no safety data for those who are younger than 16 or those who are pregnant and therefore, people in these population groups will not be able to receive the vaccine until further testing and data is obtained. Additionally, it does show that it is safe and effective in those who do have stable, chronic conditions such as hypertension.


Once you receive the first dose of the vaccine, you will be able to have some level of immunity a few days after receiving the vaccine but only about 52% effective...therefore, you are still at risk of catching Covid-19. Within the first 7 days of receiving the second dose of the Pfizer vaccine, you will have 91% effectiveness at preventing contraction of the virus. Seven days later, you will have approximately 95% effectiveness at infection protection. What does this mean?


This means we will have excellent protection against the virus but still have at least 5% chance that we can still contract the virus. Therefore, until we have enough of the population vaccinated you will still need to wear a mask, social distance, limit the number of people you are doing activity with, and other similar measures people have been taking currently. This is all just another part of the battle to conquer. In this study, they did find that even those that did become infected after receiving the vaccination, there was preliminary evidence showing that the vaccine will protect you against severe infection.


The drawbacks of the study (just like with every study) is that there is no long term data. In order to fast track things, long term data of safety and how long the vaccine is effective had to be foregone. Therefore we are not sure about any changes and its impact on fertility, presence of carcinogens, and whether there is long term effectiveness which is what most people are concerned about. As has been reported on the news, there have been some people who had severe allergic reactions both in the UK and in Alaska. All cases occurred while still at the facility as you need to stay for 30 minutes after injection should anything like this occur. All persons were treated appropriately and will not be receiving the second dose to avoid another severe reaction. As of now, continued administration of the vaccine is going as originally planned. Hopefully there will not be many more severe reactions in people and everything else will go smoothly. In conclusion, we still have a ways to go before we are out and in the clear from the Covid-19 virus. There are still a lot of things that need to be ironed out in regards to treatment and vaccination as the long term data is not much longer than anyone receiving the vaccine since the 12th of December. I will continue to examine further research into this as well as examine how things with the Pfizer vaccine are different from the Moderna vaccine. As of writing this, as I am not an emergency medical provider but still an essential worker as a business owner of a Mobile Physical Therapy business I will not be eligible to receive the vaccine to receive it yet. If I had the choice I would wait a little until more safety data has been obtained but eventually will be getting the vaccine. Just like I am sure the rest of you want to get back to "normal", I do as well.



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Dr. Robert Berghorn, Jr.

rberghorn@ascentphysicaltherapyny.com

516-3TRINOW (516-387-4669)

Fax: 516-321-0721

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