What was the mortality rate for people who took part in the covid vaccine trials?

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Fruli
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How did they determine that vaccines are a success? I’m searching for published studies before I can make a decision.

Where can I find those?

Also, how do they know the vaccines have no long term effects? For example, the last thing I want to do is start on this course and find out that now that I’ve started, I’m going to need a booster every two years (hypothetical example). If that was the case I’d prefer to let nature take its course than get started on a lifetime dependency of a vaccine.
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OscarF
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There's a lot to pick out in your questions - so I'll just get started. Firstly - just from all of my extensive research - take the vaccine, it's safe.

Firstly, as you know, all of the vaccines were clinically trialed for an extensive period of time. The way that the covid vaccines were trialed is basically: you take a two groups of people, you give one the vaccine and one you just... leave and then from each group see how many get covid. To some people, that sounds a bit "iffy", but trust me it's not - centuries of research prove this to be a very effective way to test drugs and vaccines. Now, on to the more scientific and in-depth version of how the covid vaccines in particular were actually tested: (sources: https://www.jnj.com, CDC, NHS, GOV.uk, the NHI and the full publciations for the Pfizer/BioNTech vaccin, Moderna Vaccine and the Oxford/AstraZeneca Vaccine).

It is split into 5 stages.

Stage 1 - the preclinical stage:

This research-intensive stage is designed to find natural or synthetic antigens—foreign substances that induce an immune reaction in your body—that trigger the same reaction an actual virus or bacteria would. Identifying the right antigen or antigens can often take up to four years.

Stage 2 - Phases 1/2a and 2b:

Phase 1 testing marks the first time the vaccine is tested in a small group of adults, usually between 20 to 80 people, to evaluate its safety and measure the immune response it generates. Phase 2a studies aim to determine the most effective dose, and expand the safety experience with the vaccine.

Researchers look for expected reactions to the vaccine—which could include anticipated adverse events, like headache, muscle pain, redness and swelling at the injection site or low-grade fevers—as well as serious adverse events, which are expected to be rare, over the entire duration of the study.


Phase 1 and 2a clinical trials normally last several months to even a year before proceeding to Phase 2b or Phase 3 trials, in which the pool of people receiving the vaccine increases.

However, in the case of the covid vaccines, they combined Phase 1 and Phase 2 trials for its investigational SARS-CoV-2 vaccine into one phase, known as Phase 1/2a—a step it often takes with its vaccine platform in order to answer many questions in one study, at one time.


Stage 3 - Efficacy trials:

In this stage of the clinical trial, even more volunteers receive the vaccine to study whether it's effective.

In September, as an example, Janssen scientists plan to administer the investigational SARS-CoV-2 vaccine to tens of thousands of healthy people, as well as those particularly vulnerable to COVID-19 in areas where the highest rates of viral transmission are.

In preparation for this phase of the study, Janssen worked with leading epidemiologists and modelers around the world to predict these hot spots.

Before volunteers are vaccinated, they will be tested to make sure they currently do not have the SARS-CoV-2 virus. Half of the group will be assigned to receive the vaccine; the other half will receive a placebo. Then they will all be followed closely for up to two years to see if they do develop COVID-19-related symptoms, such as fever, headache, shortness of breath, dry cough or gastrointestinal distress.

"It may be that some people do go on to develop COVID-19, even after having been vaccinated, but they may have substantially milder symptoms than those who develop COVID-19 in a control group,” Dr. Douoguih says.

As in previous phases, adverse events can potentially occur and are not uncommon, particularly in large studies like this. If an unexpected serious adverse event (SAE) occurs, recruitment or medication dosing may be paused so all pertinent medical information can be reviewed before deciding whether to restart the clinical trial. A clinical study might also be required to go on a regulatory hold by a regulatory health authority, such as the U.S. Food and Drug Administration (FDA).

In the case of the covid vaccine, there was a scare with the Oxford/Astrazeneca vaccine - but it was concluded that the vaccine ahd absolutely nothing to do with the death of a vaccine recipient.

Stage 4 - Regulatory approval and licensure

After a successful Phase 3 trial, vaccine manufacturers submit an application to regulatory bodies such as the European Commission or the U.S. Food and Drug Administration (FDA). At this stage, clinical trial data is reviewed to make sure the vaccine is safe and effective.

For FDA approval, “among the things we have to show is that the manufacturing process is consistent, and that we can produce consecutive batches of vaccine that induce the same immunity in people," Dr. Douoguih says.

Once the vaccine is approved, enough of the product needs to be manufactured to immunize those who need it. And in this case, Janssen will need to demonstrate that it can provide a supply of doses worldwide to the public, including underserved populations, on a not-for-profit basis for emergency pandemic use—a commitment it made in March as part of a landmark partnership with the Biomedical Advanced Research and Development Association (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services.

Stage 5 - continuous monitoring.

Even after the vaccine is approved and licensed, regulatory agencies stay involved, continuing to monitor production; inspecting manufacturing facilities; and testing vaccines for potency, safety and purity.

Chairman and CEO Alex Gorsky Discusses Johnson & Johnson's Response to COVID-19 at the Fortune Brainstorm Health Conference
The FDA also monitors adverse events that may occur related to receiving the vaccine, including through its Vaccine Adverse Event Reporting System and Phase 4 clinical trials—optional studies pharmaceutical companies may be required to perform after a vaccine is licensed to continue to monitor safety and effectiveness.

The end result: A potentially life-saving vaccine for COVID-19 that’s “been developed in months, which is something that, up until now, has been virtually unheard of,” Dr. Redlich says. “But there is an urgent medical need for us to do this, and do it safely.”

Well that was quite extensive- now just on to your last few points:

a booster shot every two years is not a bad thing. Think about it EVERY TWO years. That's a fairly long time, if you'd rather die instead well then - that's not a very popular ideology.

And as per the death rates... 0. No-one died as a result of any of the major covid vaccines - some scares, but all were ruled - conclusively - to be in no way, shape or form to do with the vaccine or clinical trials. (And I think that all of the scares came from recipients of the placebo anyway)...

If you want to find the research - which you might find a bit cumbersome to read as it's all in medical jargon - you can find it here:

https://www.thelancet.com/journals/l...661-1/fulltext
https://www.nejm.org/doi/full/10.1056/NEJMoa2035389
https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
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