How Safe and Effective is the Covid-19 Vaccine….and Does It Turn You Into a GMO ?

A very large study was published in the New England Journal of Medicine on December 10 that was looking at Covid vaccine efficacy and safety. Pfizer was responsible for the design and conduct of the trial, data collection, data analysis, data interpretation, and the writing of the manuscript. BioNTech was the sponsor of the trial, manufactured the clinical trial material, and contributed to the interpretation of the data and the writing of the manuscript. 43,448 participants in a double blind study received either active Covid vaccine or a placebo in a 1:1 ratio. A double blind study is one in which neither the patient or physician/healthcare worker have knowledge of which is being given. Two doses were given 3 weeks apart. The findings in general were as follows:

• The median age of participants was 52 and evenly male and female. The study was performed at 152 sites worldwide (United States, 130 sites; Argentina, 1; Brazil, 2; South Africa, 4; Germany, 6; and Turkey, 9.
• There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants who received actual vaccine and 162 cases among those assigned to placebo.
• The vaccine was 95% effective in preventing Covid.
• Efficacy was between 90-100% across varying age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions.
• The main side effects were short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.
•  Mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction and occurred in around 65% of those over 55 and around 80% of those under 55.
• Roughly 55% had fatigue and headache. Interestingly fatigue and headache were also reported by many placebo recipients, around 23% among younger vaccine recipients and 15% among older recipients !
• Fever was reported after the second dose by 16% of younger vaccine recipients and by 11% of older recipients. Most did not have fever after the first dose. Fever and chills resolved usually by the end of 2 days.
• More serious events during a drug trial are called adverse events (AE) and are unexpected medical problems that happen during treatment with a drug or other therapy. Adverse events may be mild, moderate, or severe. 27% getting vaccine reported an AE and 12% receiving placebo reported an AE. Some of the AE’s seen were lymphadenopathy (swollen glands) in 0.3%. Very few participants in either group had severe adverse events leading to withdrawal from the trial. Four serious adverse events were reported in vaccine recipients (shoulder injury related to vaccine administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia).
• Two vaccine recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the vaccine or placebo.

So there you have a summary of the data to date from this very large worldwide study. The study is planned to continue safety monitoring of participants for the next 2 years. Let’s talk about how this vaccine is completely different than any other previous human vaccine.

This vaccine is the first RNA based vaccine. Traditional vaccines, which expose the body to proteins made by a virus or bacteria, are often made by using weakened or inactive versions of that virus or bacteria. Measles, Mumps, Rubella vaccines are examples of this. DNA and RNA vaccines use part of the virus’ own genes to stimulate an immune response. They deliver the “message” to our cells to make a protein that our immune system recognizes as an “invader” and antibodies are then made that will be there the next time we are exposed to that virus or bacteria. But prior to the Covid vaccine there has never been ANY MASS PRODUCTION of either a DNA or RNA vaccine. DNA vaccines would “create” a step that involves mRNA or “messenger”RNA. The Covid vaccine skips that and directly delivers mRNA to our cells and “tells” them to make a protein……from Covid….so that our immune system can make antibodies. This vaccine does a very good job of that 95% of the time.

Now here’s where it gets REALLY interesting. Hold onto your hats! The development of the Covid Vaccine started on January 10, 2020, when the SARS-CoV-2 genetic sequence was released by the Chinese Center for Disease Control and Prevention and disseminated globally by the GISAID (Global Initiative on Sharing All Influenza Data) initiative. Literally within a WEEK……this vaccine had essentially been developed! Eleven months later we already have study results showing 95% effectiveness with generally acceptable side effects……so far. I don’t know about you, but something is pretty unusual about all of this but that’s a topic for another day.

Do scientists have any concerns about mRNA and DNA vaccines. YES.  Maria Gennaro, MD, a professor of medicine at the Rutgers New Jersey Medical School says that “With a DNA vaccine, there is always a risk it can cause a permanent change to the cell’s natural DNA sequence. Instead, if you inject mRNA, it cannot get integrated into the genetic material of a cell. It is also ready to be translated into protein.” Currently there are NO approved DNA vaccines. So it seems a mRNA vaccine may be safer.

Some other “good” information about mRNA vaccines?

• mRNA cancer vaccines have been employed in numerous cancer clinical trials, with some promising results showing antigen-specific T cell responses and prolonged disease-free survival in some cases.
• mRNA vaccines have elicited potent immunity against infectious disease targets in animal models of influenza virus, Zika virus, rabies virus and others.
• According to an article in Nature Reviews Drug Discovery in 2018, “mRNA is a non-infectious, non-integrating platform, there is no potential risk of infection or insertional mutagenesis.” In other words…..it “shouldn’t” mess up your genetic material.

So to answer my original question……Does getting the Covid vaccine make you a GMO (genetically modified organism)? NO IT DOESN’T. BUT, could we be genetically modified by something else in the future? Absolutely!…So keep questioning and doing your own homework before you inject something just because they TELL YOU to. It is miraculous that there is a vaccine this quickly for this scourge and it is our only current answer to the end of this horror. Will I get the Covid vaccine? In all honesty, I simply haven’t decided yet…….probably.