Off Topic And Now for Something Completely Different

Cityzen · Aug 23, 2022

DMD said: ↑

Part of the problem is that mistakes and misrepresentations that were clearly made, add fuel to the conspiracy theorists.

Simply denying that these things occurred is not liable to change many peoples minds, as they are liable to have seen it for themselves.

Click to expand...

Dr Cole has a somewhat chequered background.

DMD · Aug 23, 2022

Anal Frank Fingers said: ↑

Can this **** be moved to another thread. It's ****ing ruined one of the few threads that was entertaining without ****ery.
Click to expand...

Chazz Rheinhold said: ↑

I agree
We’ve got a covid thread and we had a conspiracy thread
Until
THEY
Shut it down
Click to expand...

Fair points, and my apologies for my involvement.

Idi Amin · Aug 23, 2022

Chazz Rheinhold said: ↑

I agree
We’ve got a covid thread and we had a conspiracy thread
Until
THEY
Shut it down
Click to expand...

Who are THEY?

balkan tiger · Aug 23, 2022

Sir Cheshire Ben said: ↑

Vaccine development is a long, complex process, often lasting 10-15 years, and involves a combination of public and private involvement.

The current system for developing, testing, and regulating vaccines developed during the 20th century, as the groups involved standardized their procedures and regulations.

Government Oversight
In the United States
At the end of the 19th century, several vaccines for humans were developed. They were smallpox, rabies, plague, cholera, and typhoid vaccines. However, no regulation of vaccine production existed.

On July 1, 1902, the U.S. Congress passed "An act to regulate the sale of viruses, serums, toxins, and analogous products," later referred to as the Biologics Control Act (even though "biologics" appears nowhere in the law). This was the first modern federal legislation to control the quality of drugs. This act emerged in part as a response to 1901 contamination events in St. Louis and Camden, which involved smallpox vaccine and diphtheria antitoxin.

The Act created the Hygienic Laboratory of the U.S. Public Health Service to oversee the manufacture of biological drugs. The Hygienic Laboratory eventually became the National Institutes of Health. The Act established the government’s right to control the establishments where vaccines were made.

The United States Public Service Act of 1944 mandated that the federal government issue licenses for biological products, including vaccines. After a poliovirus vaccine accident in 1954 (known as the Cutter incident), the Division of Biologics Standards was formed to oversee vaccine safety and regulation. Later, the DBS was renamed the Bureau of Biologics, and became part of the Food and Drug Administration. It is now known as the Center for Biologics Evaluation and Research.

Outside of the United States
In the European Union, the European Medicines Agency supervises regulation of vaccines and other drugs. A committee of the World Health Organization makes recommendations for biological products used internationally. Many countries have adopted the WHO standards.

Stages of Vaccine Development and Testing
In the United States, vaccine development and testing follow a standard set of steps. The first stages are exploratory in nature. Regulation and oversight increase as the candidate vaccine makes its way through the process.

First Steps: Laboratory and Animal Studies
Exploratory Stage

This stage involves basic laboratory research and often lasts 2-4 years. Federally funded academic and governmental scientists identify natural or synthetic antigens that could help prevent or treat a disease. These antigens could include virus-like particles, weakened viruses or bacteria, weakened bacterial toxins, or other substances derived from pathogens.

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. Animal subjects may include mice and monkeys. These studies give researchers an idea of the cellular responses they might expect in humans. They may also suggest a safe starting dose for the next phase of research, as well as a safe method of administering the vaccine.

Researchers may adapt the candidate vaccine during the pre-clinical state to try to make it more effective. They may also do challenge studies with the animals, meaning they vaccinate the animals and then try to infect them with the target pathogen.

Many candidate vaccines never progress beyond this stage, because they fail to produce the desired immune response. The pre-clinical stages often last 1-2 years and usually involve researchers in private industry.

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.

Once the IND application has been approved, the vaccine is subject to three phases of testing.

Next Steps: Clinical Studies with Human Subjects
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. If the vaccine is intended for children, researchers will first test adults, and then gradually step down the age of the test subjects until they reach their target. Phase I trials may be non-blinded (also known as open-label in that the researchers and perhaps subjects know whether a vaccine or placebo is used).

The goals of Phase 1 testing are to assess the safety of the candidate vaccine and determine the type and extent of immune response that the vaccine provokes. In a small minority of Phase 1 vaccine trials, researchers may use the challenge model, attempting to infect participants with the pathogen after the experimental group has been vaccinated. The participants in these studies are carefully monitored, and conditions are carefully controlled. In some cases, an attenuated, or modified, version of the pathogen is used for the challenge.

A promising Phase 1 trial will progress to the next stage.

Phase II Vaccine Trials

A larger group of several hundred individuals participates in Phase II testing. Some 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.

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 (the placebo may be a saline solution, a vaccine for another disease, or some other substance).

One Phase III goal is to assess vaccine safety in a large group of people. Certain rare side effects might not surface in the smaller groups of subjects tested in earlier phases. For example, suppose that an adverse event related to a candidate vaccine could occur in 1 of every 10,000 people. To detect a significant difference for a low-frequency event, the trial would have to include 60,000 subjects, half of them in the control, or no vaccine, group (Plotkin SA et al. Vaccines, 5th ed. Philadelphia: Saunders, 2008).

Vaccine efficacy is also tested. These factors might include 1) Does the candidate vaccine prevent disease? 2) Does it prevent infection with the pathogen? 3) Does it lead to the production of antibodies or other types of immune responses related to the pathogen?

Next Steps: Approval and Licensure
After a successful Phase III trial, the vaccine developer will submit a Biologics License Application to the FDA. The FDA will then 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.

Post-Licensure Monitoring of Vaccines

A variety of systems monitor vaccines after they have been approved. They include Phase IV trials, the Vaccine Adverse Event Reporting System, and the Vaccine Safety Datalink.

Phase IV Trials

Phase IV trial are optional studies that drug companies may conduct after a vaccine is released. The manufacturer may continue to test the vaccine for safety, efficacy, and other potential uses.

VAERS

The CDC and FDA established The Vaccine Adverse Event Reporting System in 1990. According to the CDC, VAERS' goal is “to detect possible signals of adverse events associated with vaccines.” (A signal in this case is evidence of a possible adverse event that emerges in the data collected.) About 30,000 events are reported each year to VAERS. Between 10% and 15% of these reports describe serious medical events that lead to hospitalization, life-threatening illness, disability, or death.

VAERS is a voluntary reporting system. Anyone, such as a parent, a health care provider, or friend of the patient, who suspects an association between a vaccination and an adverse event, may report that event and information about it to VAERS. The CDC then investigates the event and tries to find out whether the vaccination actually caused the adverse event.

The CDC states they monitor VAERS data to

Detect new, unusual, or rare vaccine adverse events

Monitor increases in known adverse events

Identify potential patient risk factors for particular types of adverse events

Identify vaccine lots with increased numbers or types of reported adverse events

Assess the safety of newly licensed vaccines

Not all adverse events reported to VAERS are actually caused by a vaccination. The two occurrences may be related only in time. And, it is probable that not all adverse events resulting from vaccination are reported to VAERS. The CDC states that many adverse events, such as swelling at the injection site, are underreported. Serious adverse events, according to the CDC, “are probably more likely to be reported than minor ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes.”

VAERS has successfully identified several rare adverse events related to vaccination. Among them are

An intestinal problem after the first vaccine for rotavirus was introduced in 1999

Neurologic and gastrointestinal diseases related to yellow fever vaccine

According to Plotkin et al., VAERS identified a need for further investigation of MMR association with a blood clotting disorder, encephalopathy after MMR, and syncope after immunization (Plotkin SA et al. Vaccines, 5th ed. Philadelphia: Saunders, 2008).

Vaccine Safety Datalink

The CDC established this system in 1990. The VSD is a collection of linked databases containing information from large medical groups. The linked databases allow officials to gather data about vaccination among the populations served by the medical groups. Researchers can access the data by proposing studies to the CDC and having them approved.

The VSD has some drawbacks. For example, few completely unvaccinated children are listed in the database. The medical groups providing information to VSD may have patient populations that are not representative of large populations in general. Additionally, the data come not from randomized, controlled, blinded trials, but from actual medical practice. Therefore, it may be difficult to control and evaluate the data.

Rapid Cycle Analysis is a program of the VSD, launched in 2005. It monitors real-time data to compare rates of adverse events in recently vaccinated people with rates among unvaccinated people. The system is used mainly to monitor new vaccines. Among the new vaccines monitored in Rapid Cycle Analysis are the conjugated meningococcal vaccine, rotavirus vaccine, MMRV vaccine, Tdap vaccine, and the HPV vaccine. Possible associations between adverse events and vaccination are then further studied.

https://historyofvaccines.org/vacci...de/vaccine-development-testing-and-regulation
Click to expand...

You could develop and approve a vaccine in the time it takes to read all that these days

DMD · Aug 23, 2022

Idi Amin said: ↑

Who are THEY?
Click to expand...

Sir Cheshire Ben · Aug 23, 2022

balkan tiger said: ↑

You could develop and approve a vaccine in the time it takes to read all that these days
Click to expand...

If people read things in their entirety rather than selected bits thrown onto the internet to mislead fools then the world would be better.

Opening the link shows how easy it is to just copy & paste selected parts of an article.

The B&S Fanclub · Aug 23, 2022

DMD said: ↑

Click to expand...

I'M guessing that's Luton.

DMD · Aug 23, 2022

The B&S Fanclub said: ↑

I'M guessing that's Luton.
Click to expand...

I had no idea until I opened it on youtube in response to your post.

21.10.2006 Luton Town v Leeds United 5-1

Stockholm Tiger · Aug 23, 2022

EDIT I changed my mind it'll just result in more **** posts spoiling a fun thread.

rovertiger · Aug 23, 2022

Phinius T Bookbinder · Aug 23, 2022

Idi Amin said: ↑

Who are THEY?
Click to expand...

You shouldn’t even ask that question. THEY know everything. I shouldn’t even be on here with this message. I’m compromised now. **** man I can hear them now.

yours
Anon

rovertiger · Aug 23, 2022

SW3 Chelsea Tiger · Aug 23, 2022

rovertiger said: ↑

Click to expand...

No joke! The rents in London are ridiculous….always been higher down south, but the gap has widen significantly

DMD · Aug 23, 2022

Landed a new job as a conductor on a ghost train.

All going ticketty-boo so far.

DMD · Aug 23, 2022

A genie granted me a single wish, so I said I just wanted to be happy. I'm now living with 6 dwarves and working in a mine.

Plum · Aug 23, 2022

Paddy was granted 2 wishes by his genie. Genie: what's your first wish? Paddy: An everlasting pint of guinness please. Genie: And your second? Paddy: Oh, I'll be having the same again.

rovertiger · Aug 23, 2022

Ipswich blackout 3rd kit.
Not as good as ours.

TwoWrights · Aug 23, 2022

tigerscanada said: ↑

Well I never !
Click to expand...

Oh come on, you must have done.

Ron Burguvdy · Aug 23, 2022

TwoWrights · Aug 23, 2022

Ron Burguvdy said: ↑

View attachment 241460
Click to expand...

Fake, no mention of the smell of fresh paint.

Off Topic And Now for Something Completely Different

Cityzen Well-Known Member

DMD Eh?
Forum Moderator

Idi Amin Well-Known Member

balkan tiger Well-Known Member

DMD Eh?
Forum Moderator

Sir Cheshire Ben Well-Known Member

The B&S Fanclub Well-Known Member

DMD Eh?
Forum Moderator

Stockholm Tiger Well-Known Member

rovertiger Well-Known Member

Phinius T Bookbinder Well-Known Member

rovertiger Well-Known Member

SW3 Chelsea Tiger Well-Known Member

DMD Eh?
Forum Moderator

DMD Eh?
Forum Moderator

Plum Well-Known Member

rovertiger Well-Known Member

TwoWrights Well-Known Member

Ron Burguvdy Well-Known Member

TwoWrights Well-Known Member

Share This Page

About Us

Quick Navigation

Like us on Facebook

Buy us a beer!

Useful Searches

Off Topic And Now for Something Completely Different

Cityzen Well-Known Member

DMD Eh? Forum Moderator

Idi Amin Well-Known Member

balkan tiger Well-Known Member

DMD Eh? Forum Moderator

Sir Cheshire Ben Well-Known Member

The B&S Fanclub Well-Known Member

DMD Eh? Forum Moderator

Stockholm Tiger Well-Known Member

rovertiger Well-Known Member

Phinius T Bookbinder Well-Known Member

rovertiger Well-Known Member

SW3 Chelsea Tiger Well-Known Member

DMD Eh? Forum Moderator

DMD Eh? Forum Moderator

Plum Well-Known Member

rovertiger Well-Known Member

TwoWrights Well-Known Member

Ron Burguvdy Well-Known Member

TwoWrights Well-Known Member

Share This Page

DMD Eh?
Forum Moderator

DMD Eh?
Forum Moderator

DMD Eh?
Forum Moderator

DMD Eh?
Forum Moderator

DMD Eh?
Forum Moderator