"The vaccine was rushed."

[milestogo]

This is one of the more common arguments I've heard from those who are unvaccinated.

First of all, I am grateful that so many pharmaceutical companies stepped up and started working on vaccine development and came up with a vaccine as quickly as possible.

Second, I am glad that our technology was at a point where quick, safe vaccine development is possible.

Third, how many people are really in a position to evaluate how fast is too fast? How many people have the slightest idea how a vaccine is developed or how long it should take? Not that many.

Fourth, it is not the case that the vaccine was untested. Adverse events occur with any pharmaceutical, and some adverse effects to the vaccines have been reported. And these occur in a relatively small number of people.

Fifth, an expedited vaccine is not less safe and effective because it was expedited.

Finally, its a fucking pandemic. Why wouldn't you want to get a safe vaccine out that as quickly as possible. Would these idiots feel better if it was held back for 6 more months for no reason?

[Shermann]

1. Even if they were "rushed"

..and I'm not conceding that point, there have been over 9 million doses delivered to date. So, it would be the most comprehensive vaccine challenge trial in history. And we are at the tail end of that.

[maxsolomon]

9. 9 Billion.

worldwide.

500 million in the US

[Shermann]

16. Doh! Of course. nt

[Cairycat]

2. The University of Iowa

had been working on mRNA vaccines for nearly twenty years when this pandemic started. So mostly they needed to make it specific to COVID-19.

[pandr32]

11. +1

[Tickle]

60. That's exactly what

I explain to others when they talk about the vaccine being unknown to us.

[Ocelot II]

3. It wasn't rushed in the first place. The mRNA technology that made it possible

has been in development for at least a decade. The reason it took as long as it did to make the vaccines available (which wasn't very long at all, as such things go) is that there had to be field trials to be sure it worked and didn't cause side effects, and then large quantities had to be produced and distributed. It took only 10 days to sequence the virus itself back in January of 2020, and after that, because of the cut and paste process used in creating mRNA vaccines, the whole process took much less time than the creation of older vaccines. More here: https://www.sciencenews.org/article/covid-coronavirus-vaccine-development-speed

[Bernardo de La Paz]

20. Yes. The very point I was preparing to post. 10 years in development, including trials

And mRNA vaccines have been used before.

[ProfessorGAC]

25. The Only Reason A Mass Distribution Vax Hasn't Come Out...

...before now was strictly financial.
They could have made measles, DPT, TB, or rubella vaccine several years ago.
But, there were already plenty of existing options proven effective, with decades to streamline the process & cost. If something already works well, scaling up to full production makes no sense.
But, COVID came along and a true public health emergency was created with no alternative vaccines.
It made perfect sense to react as they did by going pedal to the medal on efficacy trials and full production.
If no vaccines for measles & smallpox existed, we'd have seen mRNA vaccines in mass use a quite a while back.

[Rebl2]

38. They should

have pushed that message-that mRNA vaccines have been used before. I never knew that.

[Rebl2]

46. What vaccines

have used mRNA before?

[Ocelot II]

48. A lot of research since the '90s; an Ebola vaccine was developed

but not used in the US; more info here: https://www.nature.com/articles/nrd.2017.243

[Rebl2]

50. Interesting!

[Bernardo de La Paz]

52. 2013, Rabies, influenza, Zika and more. 2001 first trial of mRNA. 2008 first mRNA vaccine

So simple to find. Search mrna vaccine wiki

The first human clinical trial using ex vivo dendritic cells transfected with mRNA encoding tumor antigens (therapeutic cancer mRNA vaccine) was started in 2001.[27][28] Four years later, the successful use of modified nucleosides as a method to transport mRNA inside cells without setting off the body's defense system was reported.[27][29] Clinical trial results of an mRNA vaccine directly injected into the body against cancer cells were reported in 2008.[30][31]

BioNTech in 2008 and Moderna in 2010 were founded to develop mRNA biotechnologies.[32][33] [...]

The first human clinical trials using an mRNA vaccine against an infectious agent (rabies) began in 2013.[37][38] Over the next few years, clinical trials of mRNA vaccines for a number of other viruses were started. mRNA vaccines for human use have been studied for infectious agents such as influenza,[39] Zika virus, cytomegalovirus, and Chikungunya virus.[40][41]

[Silver Gaia]

26. Yes! Thank you!

I already knew about this, so when I realized that the Pfizer and Moderna vaccines were using this same technology, I knew that it already had years of development behind it. I wish they had pushed that point from the beginning.

[Solly Mack]

29. Thank you

[uponit7771]

47. +1

[Roland99]

4. Check the videos at the bottom here

https://www.healthaction.org/vaccines101

[doc03]

5. One told me the other day it wasn't tested

enough. I said probably a billion people have taken it already how much testing you need. He said they don't know what the long term side effects will be. I wonder what their time frame would be? Like 5 years when we are all dead from COVID or what. It is no use talking to them.
They just throw all the bull shit on the wall and see what works.

[AnotherDreamWeaver]

6. We could ask them if the one developed in Cuba was rushed. nt

[mbromell69]

7. who needs science

when dumbasses can turn to DR ANUS CARLSON over at Pravda West to get recommendations on the best HORSE DEWORMING brand to combat COVID?

IGNORANCE IS BLISS in the land of MAGAts

[cadoman]

8. part of the reason the vaccine was released quickly is it performed so well in Pfizer's trial

Pfizer was seeing an effectiveness at such a high level that they were morally and legally obligated to break the observer blind after the first six months of their clinical trial.

In layman's terms, the science was so robust, thorough, and supportive of the safety and efficacy of the vaccine that the control group had to be vaccinated also (or at least given the opportunity to do so). The vaccine has since saved millions, if not billions, of lives, particularly from the rapidly spreading Delta and Omicron variants.

Sadly most gqp trash are not even aware of this fact and just how well the vaccines performed during their trial. MAGATS, get it through your neanderthal craniums: the vaccines are safe and effective!

[Random Boomer]

21. Saved millions, yes. Billions? No.

At even the most aggressive fatality rate of 3%, the highest possible figure for lost lives would have been 240 million. That's a horrific number as it is. No need to exaggerate.

The next virus pandemic that comes along, however, may well have a much higher fatality rate. The results of anti-vaxx sentiment could be catastrophic under those conditions.

[RockRaven]

10. The various Covid vaccines have been more thoroughly tested than Covid infection itself...

Just in term of sheer sample sizes (which isn't everything, but still). Over 9 billion vaccine doses have been given worldwide, all together.

We have more data about what happens to you after the vaccine(s) than we do what happens to you after an infection.

If fear of unknown future consequences is the deciding factor, the scales STILL tip in favor of getting vaccinated.

[Ocelot II]

18. Even assuming there are unforeseen side effects that won't kick in until years later,

isn't the risk of going blind or even dropping over dead five or ten years from now a reasonable risk, preferable over the much more immediate risk of catching a fatal case of covid? The vaccine gives you years you might not have had.

[pnwmom]

12. Tell them that researchers at MIT started work on the mRNA technology in the 70's.

Last edited Sat Jan 1, 2022, 05:42 PM - Edit history (1)

Over the decades since, many researchers had extensively tested the technology. They knew it was safe; the question was how effective the vaccines would be for Covid19.

But many people have the impression the science was rushed because their hero Trump, arriving at the tail end of decades of research, branded it as "Operation Warp Speed."

[Ocelot II]

19. And he tried to pressure the FDA into approving it before the election.

If the FDA had caved, many more people - including me - would have been justifiably skeptical. The fact that they didn't cave told me what I needed to know, and I was all over that vaccine as soon as I could get it.

[pnwmom]

39. Also, Pfizer refused to take US money to participate in Operation Warp Speed

because they didn't want any political deadline to taint their work.

Instead, Pfizer chose to partner with Germany.

[yardwork]

22. Scientists had also been working on coronavirus vaccines for years.

That's one reason it was possible to jumpstart the Covid-19 vaccine. It was expedited but not rushed.

[Richard D]

13. If you take into consideration how many people/hours . . .

. . . were put into it, there's not been any other vaccine that had more time and research put into it.

[NNadir]

14. These RNA vaccines are the culmination of more than 2 decades of work. The problem...

...idiots have with it is that it was available at exactly the right time that it was urgently needed.

[pnwmom]

40. More than 40 years, since it began at MIT in the 70's.

It was anything but an overnight success story.

[Wounded Bear]

15. Yeah, 3 years ago...

and now over 200 million in the US and several hundred million more around the world have gotten the shots.

How is it not safe?

[SCantiGOP]

17. Trumpers make two claims:

1 -- Vaccines are dangerous because they were rushed;

2 -- Trump saved billions of lives by rushing through the vaccine with Operation Warp Speed.

[Sogo]

23. They don't know what they're talking about.

They're just parroting something they heard on YouTube by someone with Dr. in front of his name (not necessarily an MD), or on Hannity, or Tucker, or on hate radio, or OAN.

[milestogo]

31. Exactly.

They've heard it somewhere, and its easy to repeat. It makes them sound like they know something, but they don't. They have no knowledge of vaccines or vaccine development or the approval process. It just sounds like a good argument.

[onecaliberal]

24. The MRNA vaccines are a product of years and decades of research.

They don’t care to be informed about anything. They’re told what to say the bullshit line is towed. They aren’t interested in truth or reality.

[CBHagman]

27. Thank you.

In this time of shortened attention spans and what I suspect is a great deal of trauma-induced pessimism, people are not even using technology to learn about how things work. There would be no COVID-19 vaccines without decades of work that took place mostly out of the public eye.

[andym]

28. "Expedited", not rushed

but safety confirmed. That's how to put it.

[Collimator]

30. So was our trip to the moon.

There were a lot of lives ended as a direct result of our determination to "Beat the Russkies". We directed a massive amount of talent and treasure towards that goal and nearly everybody in the country beams with pride over that accomplishment.

When something is important enough, you usually find a way to make it happen. All the people whining about the vaccines and complaining about masks don't consider this pandemic important because it hasn't devastated their health or the health of someone important to them. What's important to them right now is the comfort of not wearing a piece of cloth over their face and being able to go out for meals and entertainment with no noticeable restrictions.

[CousinIT]

32. Testing steps normally done sequentially were done simultaneously but they were STILL done.

Every step completed, same protocols followed. It's not really a valid argument.

[Orrex]

33. Every single excuse used to deny or refuse the vaccine can be boiled down to this:

"I'm an ignorant, selfish asshole, and I refuse to change anything about my behavior or attitudes, even if doing so would save lives and improve public safety."

[Botany]

41. But what about that "it hasn't been tested meme?"

58.2% of the world population has received at least one dose of a COVID-19 vaccine.
9.18 billion doses have been administered globally, and 31.9 million are now administered each day.

https://ourworldindata.org/covid-vaccinations

[mnhtnbb]

42. I wish I could rec this post.

[liberal N proud]

34. The flue vaccine is a new vaccine each year

No two years vaccines are the same.
It took longer to develop and test the Covid vaccines than Flue

[Demovictory9]

57. excellent point

[DallasNE]

35. One Of The Really Big Differences This Time

Was the pool of people available for testing. It was basically everybody above 20 years of age. And the virus was everywhere. Normally the pool of eligible participants is far, far smaller so the body of evidence is tiny compared to the pandemic. Under these circumstances the normal time frame can and should be reduced because of the urgent need, which is what happened.

[PatrickforB]

36. I was paranoid as heck while they were 'rushing' through developing the vaccine.

And when it had finally been approved, I got mine as soon as I possibly could. Thank God they developed it as quickly as they did.

[bucolic_frolic]

37. You are trying to interfere with Operation Warped Mind

Foolish endeavor!

[Botany]

43. Now how were they able to make the vaccine so quickly?

Say hello to "The Big Dog" and his support for the Human Genome Project.
BTW I am sure that republicans were opposed to it too.



https://dnalc.cshl.edu/view/15071-The-Human-Genome-Project-Bill-Clinton.html

[DickKessler]

44. The development of the COVID vaccines was the culmination of many years of progress.

The notion that they were "rushed" is a fundamentally ignorant and inaccurate argument.

[former9thward]

45. I think people have forgotten that experts, including Fauci, said a vaccine would take a long time.

In April, 2020 Fauci said it would take at least 12 - 18 months to develop a vaccine. He also said vaccines sometimes take 10 years to be approved.

Fauci said it will take 12 to 18 months to get a coronavirus vaccine in the US. Experts say a quick approval could be risky.

After US Health Secretary Alex Azar said a coronavirus vaccine candidate had been developed in three days, with a clinical trial already in the works, Dr. Anthony Fauci, the top infectious diseases advisor to the White House, sought to temper his enthusiasm.

Fauci, director of the US National Institute of Allergy and Infectious Disease, said that the earliest the US could possibly get a vaccine would be in 12 or even 18 months — "at least."

Even a year-and-a-half would be staggeringly fast for vaccine development, and some experts have voiced concerns that a vaccine produced on that timeline could hurtle too quickly through safety trials.

https://www.businessinsider.com/coronavirus-vaccine-quest-18-months-fauci-experts-flag-dangers-testing-2020-4

Fortunately the experts were wrong but the statements were out there.

[BumRushDaShow]

51. Fauci was correct

The normal vaccine process - including the animal and human trials, takes that long and often up to 2 - 3 years or more on average.

The approval process in this case was dependent on the candidate meeting the criteria for efficacy (per W.H.O. meaning at least 50%, which was echoed by FDA) with minimal/typical adverse reactions.

And also note that "approval" is actually referring to obtaining approval of the "BLA" (Biologics License Application) which is generally known as the "full approval" versus what WAS "initially approved" for the ones in the U.S. last December through to February (the last to date being Janssen (J&J)), which was an EUA ("Emergency Use Authorization" ), and was not the same as approval of a BLA.

Pfizer only got approval for its BLA this past August 23rd, 2021 - https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine after formally begining an overlapping Phase 1/2 trial in May 2020.

From your link -

Vaccines can take 15 to 20 years to get from inception to approval, Mark Feinberg, CEO of the International AIDS Vaccine Initiative, told STAT News. They have to be tested in the lab, then in animals, before being tested for safety in a small group of people. After that, they're tested in more people to see if they can prevent a disease.

For example, vaccines for other kinds of coronaviruses that caused two recent deadly epidemics — MERS and SARS — took longer than 18 months to develop, and neither have made it all the way through the approval process.

After severe acute respiratory syndrome (SARS) broke out in 2003, it took 20 months for a vaccine to be trialed on humans. The outbreak had subsided by that time, and a vaccine was under development until 2016, and was ultimately put on hold.

Middle East respiratory syndrome (MERS) broke out in the Arabian Peninsula in 2012, and spread to South Korea in 2015. There is still no approved vaccine, as the outbreak died down before serious testing.

The highlighted 3rd paragraph above is actually what they were able to use as a starting point to pivot to use for SARS-COV-2 vaccine development and trials since they had a "working copy" of something that had been developed for SARS-COV-1.

Fauci's Center (NIAID) under NIH was involved in the Moderna vaccine development, which actually started their trial before Pfizer in March 2020. Moderna has not received BLA approval yet.

In general, pharmaceutical companies don't like doing vaccines because they are essentially "loss leaders" and don't net them the types of profits they are accustomed to when compared to solid dosage forms, particularly if they use albumin-based manufacturing processes. The associated public health agencies have basically had to beg them to make vaccines. However COVID-19 flipped that whole script.

[former9thward]

54. He was not correct.

He said a vaccine would take a year or two to develop. It was developed a few months after he said that.

[BumRushDaShow]

58. If you had actually followed what has going on the past couple years

you would have noticed that a number of companies other than the ones we are familiar with who eventually got EUAs, were "developing" COVID-19 vaccines and had to delay or withdraw them, so they are NOT finished "development" nor are approved.

Development for the currently approved (either EUA or BLA) vaccines were not just started "a few months after he said that".

E.g., one of the "Operation Warp Speed" companies that received research money - GSK/Sanofi partnership - attempted to "develop" one and found with early trials that it FAILED for targeted efficacy and/or elicited insufficient immune response . Similarly other U.S. government-funded companies also opted to delay and/or start over -

Sanofi
Merck
Novavax
AstraZeneca-BARDA (due to manufacturing issues with Emergent BioSolutions)

Why the three biggest vaccine makers failed on Covid-19
GlaxoSmithKline, Merck and Sanofi are left playing catch-up to upstarts with new technology

Hannah Kuchler in New York and Leila Abboud in Paris February 16 2021

As pharmaceutical companies raced to develop Covid-19 vaccines, crossing the finishing line in record time, the world’s three biggest vaccine makers were also-rans. GlaxoSmithKline, Merck and Sanofi are now left playing catch-up, after upstarts including Moderna and BioNTech demonstrated their mastery of new technologies that will shape the industry for years to come.

New Jersey-based Merck recently dropped its vaccine development programme completely, while Paris-based Sanofi and the UK’s GSK are having to redo an early-stage trial of the jab they are jointly developing, after a dosing mistake. According to Zain Rizvi, a medicine access researcher at advocacy group Public Citizen, the “immense scarcity” of vaccines around the world is directly connected to these big pharma groups being “missing in action”.

The vaccine market already looks completely different this year — and depending on variants in the virus that causes Covid-19 and the need for boosters, some of the changes could stick. In 2020, GSK, Sanofi, Merck and Pfizer dominated the market with best-selling vaccines for flu, pneumonia, HPV and shingles.

Among the top vaccine makers, only Pfizer has a successful Covid-19 vaccine, developed with German company BioNTech. This year, life sciences data platform Airfinity forecasts Pfizer will triple its vaccine revenue thanks to its Covid-19 vaccine, while vaccine sales at Novavax and Moderna will overtake those at Merck, GSK and Sanofi.

https://www.ft.com/content/657b123a-78ba-4fba-b18e-23c07e313331

So Fauci was correct that typically it takes time to develop these vaccines to spec and desired outcomes (efficacy and safety) and this ALSO must include getting the manufacturing details right.

I.e., "development" from start to finish is not just creating the active biologic itself and making it through the trials, but also requires nailing manufacturing scale-up that complies with required cGMPs and produces consistent QA results, which is what can bog the whole thing down, but is included in that reference for the "time normally required".

The fiasco with manufacturing Janssen (J&J) locally, since currently, pending Merck's partnership to scale up manufacturing, all the doses are imported from Belgium (and this issue includes the similarly platformed AstraZeneca, which was originally part of Operation Warp Speed having received funding here in the U.S. and was to be co-manufactured at that same plant) is exactly the type of example of the lengthy processes that can and do happen with getting vaccines (or any type of drug or medical device) approved. The ones that got done the fastest were the ones who knew the drill and had actually started earlier with related vaccine R&D (including trials) for SARS COV-1 vaccines before actually switching to focusing on the later-related SARS COV-2 vaccine effort.

Since you are a lawyer (and not a scientist as I am) - see 21CFR 600 and 610 specifically for part of what is required from the regulatory perspective.

[former9thward]

61. Fauci was (and is) the senior PR person for public health.

You are treating his comments like he was an obscure scientist making comments on a journal article. Someone in his position has to make his position crystal clear in 10 second sound bites. That is his job. When he said the vaccine would take one or two years to develop the horse was out of the barn. And if you remember, members of Congress (no, not Republicans) used his comments to question the vaccine when it was announced.

[BumRushDaShow]

62. You apparently have mistaken and elevated Fauci's role

in NIAID above all the other senior public health officials who are agency heads with equal say, since you are not a federal employee who has worked for one of those agencies like I have before retiring.

And as a non-scientist, you are seeing first hand the difficulty with trying to force scientific personnel to "sound bite science".

It's exactly what is shown in this film -

[former9thward]

63. Before I became a lawyer I received a M.S. in Public Health Sciences.

So I do know a little about science. It is not I who elevated Fauci. It was Trump and Biden. He is on TV shows more than anyone else in the federal government health system. Enjoy your movie...

[BumRushDaShow]

64. You still miss the fact that we are talking about the federal government

There are multiple people involved in "Public Health" - normally coordinated by the head of the US Public Health Service (PHS) - the Surgeon General (currently Vice Admiral Vivek H. Murthy), who would usually be the "point person".

At present, you have one agency - FDA - who is STILL lacking a Commissioner (a nominee was only recently submitted this past November), so the staffing is still incomplete.

Murthy has been doing the rounds (and is expected to continue to do so) as well -

Senate confirms Dr. Vivek Murthy as US surgeon general
CNN Digital Expansion 2018, Caroline Kelly

By Caroline Kelly, CNN

Updated 8:27 PM ET, Tue March 23, 2021

(snip)

Murthy was a top health adviser to the Biden campaign. He was part of Biden's public health advisory committee as the pandemic first took hold in the US and served as a co-chair of the President-elect's Covid-19 advisory board during the transition.

Two sources familiar with the matter told CNN in December that Murthy is expected to have an expanded portfolio in the Biden administration. As surgeon general under President Barack Obama, a position he held from 2014 to 2017, Murthy helped lead the national response to the Ebola and Zika viruses and the opioid crisis, among other health challenges.

(snip)

https://www.cnn.com/2021/03/23/politics/senate-confirms-vivek-murthy-surgeon-general/index.html

But Fauci is actually the only one who is a CAREER (not appointed) official, having been so for the past 50+ years and has been involved with the federal government's role in the research (and patents) related to the Moderna vaccine, so he has special insight (but limited for public disclosure due to the usual NDAs).

Biden hasn't even been in office a year so all of the pieces and parts of the federal public health apparatus are still being assembled.

And perhaps you need to watch the movie, but I expect you prefer "sound bite science".

[DenaliDemocrat]

49. Thank God it was rushed

It’s also been given in billions of doses. There has never been a better clinical trial than what we just experienced. They are safe.

[ZonkerHarris]

53. If they say that blame Trump and Pence for it.

[DemocraticPatriot]

59. The research that enabled the fast development of the COVID vaccines

was accomplished under President OBAMA...




THANK YOU, President Obama!!!!!