Is the vaccine safe?

WIP said:

My point is this. We are in a state of emergency with the Covid virus. For this reason, certain processes were augmented in such a way to allow for faster development and processing of the vaccines. According to the College of Physicians of Philadelphia here are the steps to developing a vaccine under normal conditions.

1. Exploratory Stage. This stage involves basic laboratory research and often lasts 2-4 years. I suppose one could argue that the mRNA vaccines had undergone this stage since they were working on this concept for a few years already.
2. Pre-Clinical Stage. Pre-clinical studies use tissue-culture or cell-culture systems and animal testing to assess the safety of the candidate vaccine and its immunogenicity, or ability to provoke an immune response. The pre-clinical stages often lasts 1-2 years and usually involves researchers in private industry.
3. IND Application. A sponsor, usually a private company, submits an application for an Investigational New Drug (IND) to the U.S. Food and Drug Administration. The sponsor describes the manufacturing and testing processes, summarizes the laboratory reports, and describes the proposed study. An institutional review board, representing an institution where the clinical trial will be conducted, must approve the clinical protocol. The FDA has 30 days to approve the application.
4. Phase I Vaccine Trials. This first attempt to assess the candidate vaccine in humans involves a small group of adults, usually between 20-80 subjects. The goals of Phase 1 testing are to assess the safety of the candidate vaccine and to determine the type and extent of immune response that the vaccine provokes. The participants in these studies are carefully monitored and conditions are carefully controlled.
5. Phase II Vaccine Trials. A larger group of several hundred individuals participates in Phase II testing. Some of the individuals may belong to groups at risk of acquiring the disease. These trials are randomized and well controlled, and include a placebo group. The goals of Phase II testing are to study the candidate vaccine’s safety, immunogenicity, proposed doses, schedule of immunizations, and method of delivery.
6. Phase III Vaccine Trials. Successful Phase II candidate vaccines move on to larger trials, involving thousands to tens of thousands of people. These Phase III tests are randomized and double blind and involve the experimental vaccine being tested against a placebo. One Phase III goal is to assess vaccine safety in a large group of people. Vaccine efficacy is tested as well. These factors might include 1) Does the candidate vaccine prevent disease? 2) Does it prevent infection with the pathogen? 3) Does it lead to production of antibodies or other types of immune responses related to the pathogen?
7. Approval and Licensure. After a successful Phase III trial, the vaccine developer will submit a Biologics License Application to the FDA. Then the FDA will inspect the factory where the vaccine will be made and approve the labeling of the vaccine. After licensure, the FDA will continue to monitor the production of the vaccine, including inspecting facilities and reviewing the manufacturer’s tests of lots of vaccines for potency, safety and purity. The FDA has the right to conduct its own testing of manufacturers’ vaccines.

According to the FDA, Phase I trials typically take several months to complete. Phase II trials typically take several months to two years to complete. Phase III trials take typically take from one to four years to complete.

So, from R&D through approval a typical vaccine takes four years plus several months at minimum or up to 11 years plus several months worse case to achieve approval. With the Covid vaccines, time has not been allowed to thoroughly verify the vaccines according to normal processes. This is understood but....

It was decided that the risks from the virus outweighed the need for thorough testing so the vaccines were released for use under the emergency use authorization. This increases the risk potential from the vaccines themselves and for this reason, to force society to be vaccinated against their will is just plain wrong in my opinion.

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Rollo Tamasi said:

A quarantine works best but people got to live so that's out
My wife and I self-quarantine ourselves, most people don't have that option.

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jasonc said:

so antibody therapy for this isn't better that did not exist six months ago ..

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FDA authorizes REGEN-COV mAb for prevention for COVID-19

Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19

www.fda.gov

Sister said:

I did end up taking the first dose of Pfizer yesterday. Haven't had any side effects so far or anything, but please remember me in prayer. This wasn't the easiest decision... It just got fda approved... And really I didn't want to fear it. God can protect from a vaccine just as much as He can a virus. And I love Him with all my heart. It isn't mark of beast just yet. Despite origins, or whatever, I think it is more the division from it that has confused me. Confusion is not of God. And it hasn't pressed on my mind so much that I just went ahead and did this, so I have peace about it no matter what happens. I stand with anyone's decision not to take it too though. My husband is not.

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JLB said:

I hope all goes well for you.


God bless you.


Praying that all goes well for you, dear Sister.



JLB

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Sister said:

Thank you. I think it was more my mind being at peace then anything else. Not worried about the virus or the vaccine. Just wanted to stop thinking about it and it really has made a difference. Not bothering me having taken it now. No side effects this far.

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Rollo Tamasi said:

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