Vaccine Clinical Trials 101: How do we develop and test new vaccines?

[@cameronspalding9792]

Anyone watching during Covid season

[@anotherranger2924]

no, stfu

[@singerchandankumar9019]

Yes

[@theshadowlands14]

No I'm watching this 6 months from now

[@koushiktirupathi9265]

S me

[@azverndias913]

No dumbass, u ppl crave for attention so badly. Stfu noone cares

[@danielharte1906]

With this information I would say we are in phase 1 of testing, yall be safe though

[@chicagoopportunity2963]

Damn....

[@josefg8017]

It took less than a year for COVID 19 Vaccine

[@geloujadrochizamaki253]

Just means, anyone who had their vaccines are part of clinical trials. Anything can happen to them.

[@MindfulMaverick29]

6 years down to less than a year? How effective will the new coronavirus vaccine be?

[@matthewlee4834]

Most regulations are honestly just pointless red tape anyway. Don't get me wrong, I'm glad we have FDA and some regulation, but trust me: most pharmaceutical companies would be able to release safe products in half the time if they didn't have to jump through so many hoops

[@maxmuller6730]

@@matthewlee4834 maybe but you cant skip the needed time. if something takes 2 years, you cant speed it up I guess, otherwise you are not testing for possible long term effects if you are not taking "long time"

[@theQandA]

Yeah, plus the COVID-19 vaccines are not a traditional type of “vaccine.” They’re actually a gene therapy- a newer technology. Kind of makes the big rush even worse. www.swfinstitute.org/news/83947/covid-mrna-vaccines-are-a-form-of-gene-therapy

[@willejones1918]

@@matthewlee4834 Yea... the same FDA where 1/3 of the drugs passed by them since 2000 have had serious side effects, most taken off the shelf. So, yea, 10 years may seem like a long time, but it is how it should be done.

[@daMacadamBlob]

more scientists and resources have been allocated than usual, and they cut out bureaucratic red tape. also, mRNA had been in development for years prior to this, and they did the 3 phases simultaneously

[@carlosbolivar5935]

Now explain to us humans if it will be safe to get a vaccine made and tested in 1 year for COVID19......

[@sqrt-1646]

By doing stuff faster... Duh.

[@maxmuller6730]

@@sqrt-1646 like doing 2 years long term studys in 6months?? you cant speed up time, if its about long term it takes "long time" thats the thing. but I am sure they can speed up many other things but just not the time.

[@sqrt-1646]

@@maxmuller6730 You are forgetting that this is an RNA vaccine. en.wikipedia.org/wiki/RNA_vaccine#General “The mRNA vaccine platform technology [which the Pfizer/BioNTech vaccine uses] has been in development for over two decades,” said Dr Zoltán Kis, of Imperial College London. www.theguardian.com/society/2020/dec/08/how-has-a-covid-vaccine-been-developed-so-quickly That is one point. Another point is that the process of making a vaccine has 3 stages, each of which take months to complete. The way to speed up the process isn’t to cut corners, it’s to simply do all those three stages, at almost the same time.

[@sqrt-1646]

@@maxmuller6730 Citation for the last claim: www.nature.com/articles/d41586-020-03626-1 Another argument (not as strong as the first two) is that several companies had plenty of funding, so there was no delay in getting supplies and getting the salary for the scientists.

[@kasirojkt9245]

By adding more sample maybe. Some of time needed are sometime administrative and regulation time. In pandemic, those time needed can be bypassed

[@lapurdy71]

Nice general overview, but 1 part is Not accurate: Placebo (saline) controlled trials are the exception to the rule, rather than the standard process.

[@greischwitz]

They do not use placebos they never have

[@Nomadic813]

@@greischwitz Really? is this a quirk of vaccine methodology? Placebos are standard operating procedure in medical trials I thought.

[@greischwitz]

Nomadic813 yea they don’t use inert placebos they use other vaccines. That’s a fact. They never ever have been through a proper safety study

[@Nomadic813]

@@greischwitz Where are you finding this information? This paper from the National Library of Medicine, a panel for the WHO actually argues for restricting use of placebos in vaccine trials, implying then that Placebos are used. "In these trials, participants are randomized to receive either the vaccine under investigation or a placebo (i.e. an inert substance, such as a saline injection)" www.ncbi.nlm.nih.gov/pmc/articles/PMC4157320/

[@Nomadic813]

This article from the McGill university school of medicine, acknowledges that in some trials not true placebos are used... but provides a compelling reason why www.mcgill.ca/oss/article/covid-19-health/placebos-used-vaccine-trials-do-not-please-everyone

[@anthonyca]

Is ET writing on that board?

[@ShabLee]

Question with say the COVID vaccine, did they introduce COVID to both groups?

[@_zafir.2454]

this vid was used for our class

[@ekbalhussainkabir5054]

Nice

[@honesty_and_beyond]

im still waiting for the celiac disease vaccine , now it entering the 2nd phase , according to this video it means stil had another 4/8 years to be fully release :( . hopefully it really works

[@aymankouchammoussamir5151]

For Covid-19 it's just some months

[@honesty_and_beyond]

maybe the urgency its different , celiac rarely caused life threatening

[@TheHeavyassaulter]

@@honesty_and_beyond maybe you can keep fooling yourself.

[@honesty_and_beyond]

@@TheHeavyassaulter well, it was 2 year ago tho when i commented, before the study was failed so yeah why should i keep fooling myself?

[@oanmn2]

Well, should we let our covid scientists know this information ?

[@mayamaya-kn8mk]

No, we must rush the vaccine

[@sqrt-1646]

They already know this 🤣

[@bunnyluv1445]

i mean. theyre more knowledgeable than you, so i think its fine.

[@oanmn2]

Sarcasm ppl.......

[@adeelzafar3299]

Thank you for creating this video. It was very helpful!

[@zaphiel1]

Is there anyone monitoring this video and comments? Could someone tell me which trials used Double-blind, salt water placebo studies? And which ones have been done over a 6-10 year period? There seems to be some information(or misinformation) about some studies where phase 3 lasted in some cases as short a period as 5-10 days. Is there anyone willing to share real information, not just propaganda?

[@florie8723]

Thank you for your question. Here are some examples of vaccine clinical trials that were double-blind, placebo controlled: www.bmj.com/content/340/bmj.c1004 ; www.ncbi.nlm.nih.gov/pubmed/25018116/ ; www.ncbi.nlm.nih.gov/pmc/articles/PMC4162066/. The duration of these studies differs. I have never heard of a Ph3 study for vaccines of only 5-10 days... I believe shorter Ph1 clinical trials may have been done for Ebola vaccines, but the outcomes were based on safety as well as laboratory assessments of efficacy (rather than whether or not participants contracted the disease). Hope this helps!

[@zaphiel1]

Thank you for your response. I guess I should have been more specific. I was talking more about the childhood vaccines that are used in this country. While you did provide examples, and I thank you for that, the examples given are for vaccines that are 1. for elderly, and for 2 and 3 for use in other countries that, for diseases that I don't hear about much in this country. But as for my saying that some cases are as short as 5-10 days, you might be right, but just looking at a few examples, I don't think that I am that far off. According to the insert for Tetanus, Diptheria, and Pertussis, this one was compared to an older version of a tetanus and diptherua vaccine across aprox 35 days. And in the case of the Hep A vaccine it was compared to a placebo which contained amorphous aluminum hydroxyphosphate sulfate adjuvant, which from my understanding is controversial, across 28 weeks. what concerns me is that even though there are some vaccines that are done with Double-blind placebo studies, many of the ones that are give to our children in this country are done compared to some other vaccine, and are not studied long term across many years. What's more is that there is little information about studies that have been done studying the effects of multiple vaccines given across the first 5 years of life. I am sure that many parents looking for answers find a video like this, which lacks in detail and specifics. Anyway, as I said, thank you for your response.

[@lapurdy71]

You are correct in that placebo-controlled trials are rare in vaccine research. Also, ZERO schedule-level trials are done to justify the large schedule increases (3x the number of vaccines now as in the 70s/80s). Of interest would be large studies done in kids at the age they'd normally receive the vaccine which systematically collect all safety data vs. just a few select things like fevers, seizures, injection site AEs. We follow this process for new drugs and require drug-drug interaction trials for other indications, yet vaccines seem exempt despite being given to millions of kids each year.

[@greischwitz]

It’s true they never did a placebo double blind study. Not one time! And yes some trials were only 3 days

[@Chh_Nour]

@@greischwitz Can someone explain why placebo studies are useful when both the staff and the volunteers don't know who got which injection?

[@donthate.create]

Its a shame that no one is answering some very valid questions in the comments....

[@karanarora8304]

I'll return to this video in 2026 to tell how the covid 19 vaccine worked

[@johnglennmercury7]

I'm here because of the number of retards who insist we'll have a vaccine in 2021 for sure. I'm sure their great granddads promised they'd be home from WWI by Christmas 1914.

[@johnglennmercury7]

So, we rush this through? Right? Cos rushing & skipping safety stages is just what we need in crucial medical research.

[@karanarora8304]

@@johnglennmercury7 haha yes exactly ppl think they'll a get a vaccine by 2021 that's y I said 2026 assuming just like Ebola virus vaccine this Corona vaccine would be made in atleast 6 years

[@aidenpierce2]

@@karanarora8304 no need wait until 2026. A vaccine is already almost approved (BionTech/Pfizer), in fact there are two more (ModeRNA & ChAdOx1 nCoV-19) about to come into market in few months.

[@joeygordon7265]

@@johnglennmercury7 🤣🤣🤣U there still? Have you taken the vax or are you skeptical?

[@Yosoy1an]

so how we gonna have a cover vaccine so fast?

[@sl4983]

Bill Gates (wink wink)

[@cool1eh1gh79]

How about an old vaccine like all the vaccines on the childhood schedule. Did they do randomized double blind trials?

[@DrJimWagnerAnnapolis]

If you can find one let us know ;)

[@kasirojkt9245]

I get confuse. If both participant and researcher dont know which group are placebo and which are real. Then how will they conclude the result ?

[@cristiannedelcu86]

Probably they get sample A, Sample B, Sample C, etc. Only the lead researcher knows which is which.

[@sl4983]

.

[@flyinghorse1878]

This is where Statistics comes in. What they rely upon is the massive number of participants on BOTH sides. With that they compared the actual outcome if Vaccine is N times favourable outcome compared to Placebo. This trial is again repeated in another setup by another group. With tens and hundreds of such trial repeated all over again and again all over the world, there is a common trend appear on the two CRITICAL measures - Safety and Efficacy.

[@urbanwrestling]

since vaccines are grouped together (i.e. MMR or DTAP) are the vaccines tested as a group or individually? Are infant/toddlers tested? Are multiple doses tested since many children receive several at one time? Are people vaccinated then exposed to the disease to determine if they are immune? How is efficacy measured?

[@DrJimWagnerAnnapolis]

@@japonicaren there has NEVER been a study testing the accumulated effect of groups of vaccines have on a human. WE have been the experiment

[@greischwitz]

They do not use placebos

[@Vynem1]

Thank you for this video! It was very informative. I have a few questions though. Are there studies done and results for those that were given the placebo as well? Where might I find this info? Thanks again for all of your help on this subject!

[@brianho6625]

I just wonder during double blind test phase 1. Will patient receiving real vaccine be exposed to the real virus environment in order to verify the effectiveness of the immunity? 2. Will patient receiving the placebo dose also be exposed to the real virus environment in order to verify the effectiveness of the immunity? 3. If it is necessary for the pacablo group exposed to virus environment without protection, then any moral ethnic valuation for increased risks for infection by purposely letting the pacablo group exposing to the harzard environment? The patient in the pacablo group may think they will be immused from specific virus/disease, which indeed doesn't protected by the vaccine.

[@zohan20001]

Not an expert but don't think they will expose them to the virus. They simply let them out to live their normal lives.

[@MK-ih6wp]

@@zohan20001 correct. They don't expose people to corona virus to see if the vaccine works. They just send them about their everyday lives, and the participants report back if they happen to get sick.

[@zohan20001]

@@MK-ih6wp so technically when they say efficacy is 95% , it's not really 95% efficacy in the layman's understanding . The layman would think that if u put a vaccinated person amongst the infected, he will be 95% protected which in fact is not the case.

[@MK-ih6wp]

@@zohan20001 100% correct. Use DuckDuckGo to figure out how they come up w their efficacy numbers (Google won't tell you). It is completely misleading the masses. The 94% is "Relative Risk". Which begs the question, relative to *what*?

[@zohan20001]

@@MK-ih6wp Apparently China's sinovac trial in Brazil showed 50% efficacy because their test subjects were mainly from the medical sector which had higher risk profiles. That would seem to be a more accurate picture of efficacy. So I think Pfizer's relative risk is not exactly that high absolutely too but then again that fact will not sell many vaccines would it?

[@marovahauhulh7054]

The people who needs to watch this are the ones who will never watch this. And even if they do, it's still lies to them. kinda funny and also sad

[@TheHeavyassaulter]

Good luck sending this to covidiots and them actually understanding that the covid vax came out within a year and they all are just lab rats... 😂🔬😅 They will probably just say I just listen to the experts...

[@tramarthomas6105]

@@TheHeavyassaulter the comment was directed towards guys like you. You watched this entire video, that simplified a lot of the information so that people can understand, and that's what you came away with? Bizarre

[@МладенСтанковић-о3р]

@@tramarthomas6105 how can you simply a period in wich the vaccine is credited they said 6-10 YEARS not months as covid vaccine was created

[@mukundmurali3018]

That hand is extremely thin!

[@theuniversal6282]

No Its the lighting

[@reallyoriginalusername9086]

@@nelser1160 aka lighting

[@WelshyAutomotive]

that’s what you took away from this video eh

[@flyinghorse1878]

Lets start of with the "Healthy Volunteers" definition. By this can one inferred all those who had known chronic diseases such as heart problems, diabetics, those under long-term medications etc. Also pregnant women is excluded because the risk of harming the baby. So all vaccine clinical trial results is derived based on this restricted Group. And therefore all argument validity is also contingent that the argument is ONLY referring to this group of people. Not those outside this group, Right ?

[@riccardoleone4265]

The hell the trials should last at least 6 years in normal conditions

[@simonhorler5795]

There is no placebo, that was stoped in 1984.

[@zlatan379]

In 6-10 year everyone will caught corona atleast once.

[@arasseo_wakarimashita3904]

Herd immunity will come in...that is what happened on spanish flu...vaccine was developed 30 years after

[@lobsangphuntsok3205]

I am really confused now. How people vacine/placebo gets infected? I have watched bunch of videos and no where they have explained. What happen after they get the shot. Will they carry on their daily life or some special instructions to carry out daily life. From where they contract virus????

[@kasirojkt9245]

Definetely not from placebo. But from contamination during test procedure or from poeple, during or soon after test.

[@sinuendo]

They carry on daily life and fill out a symptom check diary app twice a week. If they get infected with the virus, the study group has to know within 24 hours. The participant will keep an id card on hand to let doctors know they are in a trial if they require intensive medical care. You cannot get the virus from the vaccine, but the vaccine doesn't stop you from getting the virus. However, the illness should be less severe if antibodies are present from the vaccine. They want people to carry on their daily lives because that's how the study group determines efficacy.

[@lobsangphuntsok3205]

@@sinuendo Cheers. Your explanation clear the cloud of doubt. That's what I was thinking.

[@sinuendo]

@@lobsangphuntsok3205 awesome, glad to hear! I just got my first shot in the J&J Ensemble2 trail, and have no side effects so far in 48 hours other than a sore arm

[@lobsangphuntsok3205]

@@sinuendo Wishing you a luck.

[@MikeM-pr7po]

Lol, 2021 is a hilarious time.

[@fernandohuerta8207]

I believe it covid 19 vaccine will be available by the end of the year because it’s very related to the flu that is also a coronavirus

[@walter7005]

I'm watching this because School wants me

[@joeygordon7265]

You're principal is an anti-vaxxer🤣🤣, Just kidding

[@guillermofrancisco6010]

thx for the information

[@Whatamanpig]

No saline solution in the test. I call bullshit sent me a study someone.😀😝

[@manutdfan348]

I'm here because of Covid-19.

[@larry9187]

Same

[@Lee-qw7uz]

Man imagine if they sent placebo vaccines to certain states..

[@aryanpandey2929]

Covid vaccine banne mein 10 saal lagenege?

[@dallinnguyen8025]

Anyone watching this after Russia released Corona Vaccine?

[@sl4983]

How is it going there?

[@zamh1376]

awesome

[@AbdoRyudamon]

Yeah we can’t wait 10 years on COVID

[@ahnafishrak9947]

the asmr is so much man

[@_zafir.2454]

wassup

[@ridaaman1608]

what okok

[@searchalice]

How shark’s me…due to the nowadays pandemic

[@apope06]

Clinical trials = humans are lab rats😂

[@jeanchernandezrodriguez9890]

I feel sorry for the people who get salt water 🙂

[@kasirojkt9245]

The actual sometime are not salt water. But other vaccine or other ingredient have similar effect as vaccine. Bcs salt water placebo are easily perceived as placebo by participants

[@sl4983]

@@kasirojkt9245 how are they easily perceived as placebo?

[@kasirojkt9245]

@@sl4983 the feel afer the shot.

[@kevinsoo633]

Donald trump process - just inject anything

[@flexfootball6462]

What a fucking comedian

[@sl4983]

@@flexfootball6462 I know right? 🙄

[@Paul-ob6vm]

Whos here because of Putin ?