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Mon Jul 26, 2021, 08:44 AM

Doctors, nurses & other health groups call for mandatory coronavirus vaccinations for health workers

Source: Washington Post

Medical groups representing millions of doctors, nurses, pharmacists and other health workers on Monday called for mandatory vaccinations of all U.S. health personnel against the coronavirus, framing the move as a moral imperative as new infections mount sharply. “We call for all health care and long-term care employers to require their employees to be vaccinated against covid-19,” the American Medical Association, the American Nurses Association and 55 other groups wrote in a joint statement shared with The Washington Post. “The health and safety of U.S. workers, families, communities, and the nation depends on it.”

The statement — issued by many groups calling for a mandate for the first time — represents an increasingly tough stance by the medical and public health establishment amid the sluggish pace of national vaccinations. It comes as new cases rip through the nation, driven by the hyper-transmissible delta variant. Confirmed coronavirus infections have nearly quadrupled during July, from about 13,000 cases per day at the start of the month to more than 50,000 now, according to The Post’s tracking. Hospital leaders in states such as Alabama, Florida and Missouri have implored holdouts to get vaccinated, citing data that the shots prevent hospitalizations and even death.

But many workers in the health field remain unvaccinated, despite having priority access to coronavirus vaccines, which first became available in December. More than 38 percent of nursing home staff were not fully vaccinated as of July 11, despite caring for patients at elevated risk from the coronavirus, according to data collected by the Centers for Medicare and Medicaid Services and analyzed by LeadingAge, which represents nonprofit nursing homes and other providers of elder care. An analysis by WebMD and Medscape Medical News estimated that about 25 percent of hospital workers who had contact with patients had not been vaccinated by the end of May.

Health leaders said that the slowed pace of vaccinations, coupled with the threat of the delta variant, compelled them to act. “We feel that it’s important to sign our name onto this,” said Rachel Villanueva, an OB/GYN and the president of the National Medical Association, which represents more than 50,000 Black physicians and is calling for a vaccination mandate for the first time. Villanueva added that new coronavirus cases could disproportionately affect front-line workers — many of whom are African American — and communities of color that continue to lag behind Whites on vaccination rates. “We want to continue to dispel myths, educate, increase confidence and increase vaccination rates in our communities,” she said.

Read more: https://www.washingtonpost.com/health/2021/07/26/mandatory-vaccinations-urged-health-workers/



Full headline: Doctors, nurses and other health groups call for mandatory coronavirus vaccinations for health workers

This is something I know I and some others have been posting about - you still have a significant number of those who work in the healthcare field as well as first responders (police, fire, EMS) who are NOT vaccinated - some claiming because the vaccine is only out there because of an "EUA" and is supposedly "not fully approved".

In reality and in a technical sense, the only significant difference between getting an EUA and "full" approval (outside of having additional data included on the record) is the fact that under a full approval, a vaccine maker can now "brand" their product and market/sell it to "the public" (i.e., hospitals and doctors).

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Reply Doctors, nurses & other health groups call for mandatory coronavirus vaccinations for health workers (Original post)
BumRushDaShow Jul 26 OP
bucolic_frolic Jul 26 #1
BumRushDaShow Jul 26 #3
LeftInTX Jul 26 #12
bucolic_frolic Jul 26 #13
LeftInTX Jul 26 #14
Claire Oh Nette Jul 26 #25
LeftInTX Jul 26 #36
Tomconroy Jul 26 #2
BumRushDaShow Jul 26 #9
MisterNiceKitty Jul 26 #16
Tomconroy Jul 26 #20
MisterNiceKitty Jul 26 #21
Tomconroy Jul 26 #23
MisterNiceKitty Jul 26 #26
Tomconroy Jul 26 #29
Tomconroy Jul 26 #33
Tomconroy Jul 26 #34
Tomconroy Jul 26 #35
MisterNiceKitty Jul 26 #37
Tomconroy Jul 26 #39
MisterNiceKitty Jul 26 #38
Tomconroy Jul 26 #40
riversedge Jul 26 #4
AllaN01Bear Jul 26 #5
IronLionZion Jul 26 #7
BumRushDaShow Jul 26 #11
IronLionZion Jul 26 #6
Quakerfriend Jul 26 #8
BlueWavePsych Jul 26 #10
lark Jul 26 #15
BumRushDaShow Jul 26 #17
catrose Jul 26 #18
lark Jul 26 #19
BumRushDaShow Jul 26 #22
Claire Oh Nette Jul 26 #27
BumRushDaShow Jul 26 #30
Claire Oh Nette Jul 26 #31
BumRushDaShow Jul 26 #32
Yo_Mama_Been_Loggin Jul 26 #24
Tomconroy Jul 26 #28

Response to BumRushDaShow (Original post)

Mon Jul 26, 2021, 09:00 AM

1. How did we get to the point where this wasn't a "NO BRAINER" at the earliest opportunity?

We are incredibly fractured. It's like personal opinions, beliefs, superstition, paranoia, feelings are way, way overblown. Thanks to the TV, the PC, the Smart Phone ... this is like eat all the potato chips you want - heck, eat ONLY potato chips - and be young, thin, healthy, with no problems, no carb overload, no diabetes ... just eat some more!

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Response to bucolic_frolic (Reply #1)

Mon Jul 26, 2021, 09:14 AM

3. It's because the bizarre, outlandish, and conspiratorial

have been given equal weight in the media, to common sense, reasoned thought, and science.

And the reporters throw up their hands and proclaim - "Well we're just reporting what they say". But their problem is "reporting" that nonsense AT ALL.

I know there are people who will say that "sunlight is the best disinfectant". But in this case, there is some crap that truly doesn't need to see the light of day because that is how the infection is spread. What was once anaerobic and controlled, becomes aerobic and explodes when given that oxygen.

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Response to bucolic_frolic (Reply #1)

Mon Jul 26, 2021, 10:37 AM

12. Because the Covid vaccine is still under "Experimental Use"

The word "experimental" conjures up "incomplete testing"....

That said...........It gives nut jobs a louder mouthpiece......


The health food industry, such as Mercola is one of the biggest spreaders of fake news regarding Covid....

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Response to LeftInTX (Reply #12)

Mon Jul 26, 2021, 10:41 AM

13. That collection

of bearded slobs listens to the health food industry?

I can understand health care workers understand "experimental use" of course, but what harm has that done over the years.

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Response to bucolic_frolic (Reply #13)

Mon Jul 26, 2021, 10:46 AM

14. I have read some strange responses to news articles on Facebook...

Or even our mayor's Covid update....

Some of these people are like the UFO believers......

They have this all "thought out"...

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Response to LeftInTX (Reply #12)

Mon Jul 26, 2021, 12:33 PM

25. Emergency Use Authorization.

The E stands for Emergency, not Experimental.

The experiments were clearly identified as such, during phase I, II, and III trials. The Emergency Use means the BENEFITS FAR OUTWEIGH THE RISKS. The vaccines are very safe--most Adverse events are within 20-30 minutes of the injection, and are predominantly injection site pain and inflammation. Headaches, body aches, all the other "symptoms" are reported as AEs. The dangerous blood clotting and heart problems occur with less frequency than they do in the general population.

ANyone saying "they did their research" and weren't satisfied with the safety, or were concerned about "all the side effects" are whining about headaches and arm pain. Less that 1% of vaccine recipients has "severe" side effects.

The anti-science know-nothings do not correspond one to one with the Autism Anti-vaxx crowd, but the idea vaccines were a problem comes from that single widely discredited study. We used to have truth in advertising laws--we need them for any program or podcast that purports to be news or information. Spin and propaganda do not make for news. Our media allows stupid the same respect and same platform as knowledge. This is the monster we created.

Bring on the vaccine passports. Huzzah to the hospital systems and schools and other businesses who are requiring vaccines. I sheltered in place, masked up, socially distanced myself, restricted my activities, and still managed to contract COVID in December from the one person I saw outside my home, a teacher who lives with her 88 year old mother. The kids were back in school half the time. The virus spread. Covid was an ass kicker, and not even close to the flu. I survived, and got my self vaccinated as soon as I was eligible. People like me have earned the right to return to "normal life." The unvaccinated at this point are choosing obstinance and ignorance and trying to pray the virus away. They should be restricted, not those vaccine compliant. The unvaxxed are a danger to public health, and they forfeit their entry into society. The coddling of adult toddlers must end.

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Response to Claire Oh Nette (Reply #25)

Mon Jul 26, 2021, 03:29 PM

36. Then they can make it mandatory for doctors, nurses, other healthcare officials

and teachers k-6

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Response to BumRushDaShow (Original post)

Mon Jul 26, 2021, 09:08 AM

2. I've looked into the vaccine mandate issue a little.

There is a US Supreme Court case from 1903 that says states can mandate vaccinations. That EUA thing has been floated about. Apparently it comes from a post 9/11 law. There seems to be a growing consensus among colleges, hospitals and some employers that it doesn't prevent an organization from imposing a vaccine mandate.
There is a federal case in Florida involving the CDC and the cruise industry which will probably tell us something about the CDC's power to do things like mandates

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Response to Tomconroy (Reply #2)

Mon Jul 26, 2021, 09:50 AM

9. "Apparently it comes from a post 9/11 law."

Probably from this - Public Health Security and Bioterrorism Preparedness and Response Act (P.L. 107-188). I forgot all about that one although I know it was originally prompted by the anthrax attacks but when it was finally passed, a whole pile of other things were loaded into it.

I suppose someone could try to shoe-horn something in that references that law.

Anyone working in the federal government (like myself) during and after 9/11, watched our worlds turn upside down.

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Response to Tomconroy (Reply #2)

Mon Jul 26, 2021, 11:14 AM

16. There's an article about this here:

https://www.statnews.com/2021/02/23/federal-law-prohibits-employers-and-others-from-requiring-vaccination-with-a-covid-19-vaccine-distributed-under-an-eua/

"EUAs are clear: Getting these vaccines is voluntary

The same section of the Federal Food, Drug, and Cosmetic Act that authorizes the FDA to grant emergency use authorization also requires the secretary of Health and Human Services to “ensure that individuals to whom the product is administered are informed … of the option to accept or refuse administration of the product.”

Likewise, the FDA’s guidance on emergency use authorization of medical products requires the FDA to “ensure that recipients are informed to the extent practicable given the applicable circumstances … That they have the option to accept or refuse the EUA product …”

Also a link to the FDA statute:

https://www.law.cornell.edu/uscode/text/21/360bbb-3

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Response to MisterNiceKitty (Reply #16)

Mon Jul 26, 2021, 11:30 AM

20. Some people have that opinion. Others do not.

No court has ruled.

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Response to Tomconroy (Reply #20)

Mon Jul 26, 2021, 11:43 AM

21. True, you know I meant to point that out

We're in untested territory right now. I think this piece provides the other side of the argument that you mention:

https://www.usatoday.com/story/news/factcheck/2021/05/25/fact-check-federal-law-doesnt-prohibit-covid-19-vaccine-mandates/5062104001/

An excerpt:

“The FDA does not mandate vaccinations,” said FDA press officer Alison Hunt in an email to USA TODAY. “Whether a state, local government, or employer, for example, may require or mandate COVID-19 vaccination is a matter of state or other applicable law.”

In guidance published Dec. 16, the U.S. Equal Employment Opportunity Commission said employers can set “a requirement that an individual shall not pose a direct threat to the health or safety of individuals in the workplace.” This can include vaccine requirements.

"This is a legal gray area, but there are few to no legal barriers to employers or schools requiring vaccines being distributed under EUAs," Yang said.

The Americans with Disabilities Act and the Civil Rights Act of 1964 offer some exemptions for employees with disabilities and “sincerely held” religious beliefs, respectively. In those instances, an employer must “show that an unvaccinated employee would pose a direct threat due to a ‘significant risk of substantial harm to the health or safety of the individual or others that cannot be eliminated or reduced by reasonable accommodation,” according to the EEOC. Employees that don’t receive a required vaccine eventually can be fired."

Note: that a mask and social distancing (or a permanent work from home policy) are reasonable accommodations to consider under the current situation.

A bit more from the article:

"Legal gray area for EUA vaccines

Social media users say one provision of 21 U.S. Code § 360bbb–3 limits the ability of states, employers and businesses to require vaccines that were approved for emergency use. Legal experts say it's a gray area, but there's nothing on the books that would specifically prohibit those mandates.

"The law is "definitely untested," partially because it's only been around since 2004, said Margaret Foster Riley, a law professor at the University of Virginia, in an email. The FDA also issued relatively few EUAs prior to the coronavirus pandemic.

“The reality is that, because we have never had a mandate for a vaccine under an EUA, we are waiting for a court to weigh in on the debate about whether there is something about EUAs that should change the way we have been applying the law,” Rutschman said. “But there is nothing in the law itself to limit the ability of the government and employers to mandate vaccination."

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Response to MisterNiceKitty (Reply #21)

Mon Jul 26, 2021, 11:59 AM

23. Some big name colleges are mandating vaccines

For students. I'm sure they got some expensive legal advice before doing it. I guess it will all be 'academic' once the vaccines are fully approved

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Response to Tomconroy (Reply #23)

Mon Jul 26, 2021, 12:39 PM

26. I do believe those "mandates" are in anticipation of full FDA approval by the Fall

& not in force now. I could be wrong though. We shouldn't count chickens before their hatched.

Full FDA approval could hit an snag

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Response to Tomconroy (Reply #29)

Mon Jul 26, 2021, 03:43 PM

37. Yes & thanks

It says:

Universities that have created Covid-19 vaccine requirements like Indiana University and Rutgers University have faced steep opposition. Both universities have had groups of protestors enter university grounds calling for a change to the requirements. To get ahead of this, eight states have passed laws to ensure colleges are unable to set a Covid-19 vaccine requirement: Florida, Tennessee, Alabama, Arkansas, Oklahoma, Montana, Arizona and Utah. Ohio is the latest to do this, passing a law that will ban universities in the state from requiring Covid-19 vaccines until they are given full approval by the U.S. Food and Drug Administration.

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Response to MisterNiceKitty (Reply #37)

Mon Jul 26, 2021, 03:50 PM

39. Ithink the number of those states is now up to 20.

I'll think about coming out of retirement to take on those laws. Just doesn't sound too constitutional.
UConn and Umass are requiring them. I'd be surprised if there will be a college in the northeast that doesn't make vaccines mandatory.

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Response to Tomconroy (Reply #29)

Mon Jul 26, 2021, 03:48 PM

38. Also per CNN

"As of June 22, at least 34 states had introduced bills that would limit requiring someone to demonstrate their vaccination status or immunity against Covid-19, according to the National Conference of State Legislatures, which has been tracking legislation related to coronavirus vaccines. At least 13 states – Alabama, Arkansas, Florida, Indiana, Iowa, Kansas, Missouri, Montana, North Dakota, Oklahoma, Tennessee, Texas and Utah – have passed them into law, according to the document, and at least six of those include language pertaining specifically to schools or education."

https://www.cnn.com/2021/07/13/health/covid-19-vaccine-requirements-schools-analysis-wellness/index.html

A major legal fight is brewing.

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Response to MisterNiceKitty (Reply #38)

Mon Jul 26, 2021, 04:42 PM

40. NYC had a nice little wrinkle today:

Not absolutely required for employees, but if no card, it's masks and weekly testing for you.
Leave it to those sharp New York lawyers to figure out an angle.

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Response to BumRushDaShow (Original post)

Mon Jul 26, 2021, 09:26 AM

4. as it should be in a sane USA!!

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Response to BumRushDaShow (Original post)

Mon Jul 26, 2021, 09:32 AM

5. i thought that ALL health people were to get vaxxed first when the vaxx

first came out.

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Response to AllaN01Bear (Reply #5)

Mon Jul 26, 2021, 09:42 AM

7. Some of them chose not to get it

there are many conservative/libertarian healthcare workers. There was even that asshole who deliberately destroyed hundreds of doses right when it first became available.

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Response to AllaN01Bear (Reply #5)

Mon Jul 26, 2021, 10:24 AM

11. They were literally at the top of the list and front of the line

because they were the most exposed and many, to this day, have refused.

There have been many articles about the RW loons and POC having "hesitancy", but the media rarely will focus on the very people - those on the "frontline" - the healthcare workers, the police, fire, and EMS personnel, who ALSO refuse to get the vaccine.

Some data was published and discussed here (back in January) - https://www.news-medical.net/news/20210106/Low-acceptance-of-COVID-19-vaccine-among-healthcare-workers-in-USA.aspx

Low acceptance of COVID-19 vaccine among healthcare workers in USA

Dr. Liji Thomas, MD Jan 6 2021

As the coronavirus disease 2019 (COVID-19) pandemic continues to progress, the first vaccines have been rolled out, and several countries are planning to complete the first round of universal immunization within the first quarter of this year. However, vaccine uptake is a concern that has taken center stage in the recent past, with a flood of misinformation and doubts about the safety and utility of the vaccine spreading far and wide.

A recent preprint research paper published on the medRxiv* server in January 2021 reports that vaccine acceptance is low even among healthcare workers (HCWs) in the USA. This is a significant issue as this segment of society is typically entrusted with the task of communicating reliable information about such preventive measures to their patients, which is associated with greater compliance with vaccination campaigns and schedules. Moreover, their participation in these programs models adherence to the community at large.

Study details

The current study used a cross-sectional design based on an online questionnaire. All participants were above 18 years of age and were working in a healthcare facility of some kind. HCWs were classified into four groups, namely, direct medical provider (DMP), Direct patient care provider (DPCP), Advanced practice providers, and administrative staff who have little direct patient contact.



HCWs were asked about their perception of personal risk of acquiring COVID-19 and whether they had taken care of COVID-19 patients. Moreover, they were asked if they were willing to take the COVID-19 vaccine once available. Possible reasons for not accepting the vaccine were explored as well. The researchers received approximately 3,500 responses, with over half being below the age of 40 years. Three in four were female, and over 80% were white. Again, 80% had taken a Bachelor’s or higher degree, 44% said they were Democrats, and about 60% denied any comorbidities.

(snip)


So based on the above, it didn't seem like they were "anti-vax", just "anti-COVID-19 vaccine" due to mistrust and what they perceived as a "rushed process".

I posted the below in another thread (something that pertained for here in the Philly metro area as of this past April) - https://philadelphia.cbslocal.com/2021/04/19/covid-in-pennsylvania-nearly-half-of-nursing-home-workers-in-pennsylvania-have-declined-covid-19-vaccine-report-shows/

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Response to BumRushDaShow (Original post)

Mon Jul 26, 2021, 09:40 AM

6. Anti-vax healthcare workers are the worst

it's a major liability where they can infect vulnerable patients who are weakened during treatment

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Response to BumRushDaShow (Original post)

Mon Jul 26, 2021, 09:48 AM

8. There is no mandate for covid

vaccine in my hospital and yet, they have had a mandate for flu vaccine for years.
I believe the are waiting until the vaccines are no longer considered ‘experimental’ by the FDA.

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Response to BumRushDaShow (Original post)

Mon Jul 26, 2021, 10:20 AM

10. Good idea!

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Response to BumRushDaShow (Original post)

Mon Jul 26, 2021, 10:55 AM

15. When it's fully approved, it has the effect of having law behind it and it can then be required.

Hospitals here can't require it under the Governors new law, but I was told by a friend that the local hospital's attorney said as soon as the vaccines received regular approval they will be covered under current FL law and will be required of hospital ee. Of course, there will be a lawsuit about this, and Scott stacked FL courts with rw'ers, so even that may not be enough. I thought we had defeated them, but they are showing a resilience to facts, truth and showing any care for any living human.

I'm feeling very pessimistic stuck here in the middle of a major Covid spike in my city/county. I will now be returning to wearing a mask when going inside any business.

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Response to lark (Reply #15)

Mon Jul 26, 2021, 11:16 AM

17. Interestingly enough, the same goes for the military

who normally mandate vaccines and line 'em up to get them. But because the COVID-19 vaccines are still under an EUA, then they can't mandate them.

I think it is a foregone conclusion that they will get the final sign-off, which in actuality, doesn't change much other than paperwork. But it will then allow the companies to actually "officially" market and sell their products to the public (obviously in this case, "public" meaning doctors and hospitals/medical facilities).

I.e., it'll eventually be just like what I hear on my local news radio station every day - an ad for Prevnar13 (pneumonia vaccine).

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Response to BumRushDaShow (Original post)

Mon Jul 26, 2021, 11:18 AM

18. How long before it's fully approved? And what's standing in the way of that?

I'll be interested to see whether that stamp of approval actually changes any of these people's minds.

I react to basically the whole encyclopedia of drugs--it's called paradoxical reactions--so I'm really careful about what medicines I take, even though they're approved. That said, I've never had a wildly out-of-line reaction to a vaccine, though my child reacted to the DTP.

I'm surrounded by fragile people--cancer patients, diabetes, aged. There was no way I wasn't going to get the vaccine, though I admit to lying awake shaking in fear the night before my appointment.

I told the clinic people about my history, and they made me wait longer and checked me every 2 minutes. I signed up for the CDC service where they check on you every day (until you tell them not to) and never had anything to report after the first few days of fluish symptoms that many people had. I still receive check-in texts every month or so.

So as a person who legitimately looks at every pill and procedure and says, "I don't know what this is going to do me," I really want to know what these hesitant people think is likely or possible to happen to them that (1) outweighs the possible damage and (2) couldn't be fixed with current medical knowledge.

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Response to catrose (Reply #18)

Mon Jul 26, 2021, 11:22 AM

19. I read yesterday that it will take 2 more months for full approval.

Damn, wish it could be sooner. We need that NOW so hospitals and the military can require vaccinations and we will be so much further ahead when that happens. If our RW courts will let that happen?

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Response to catrose (Reply #18)

Mon Jul 26, 2021, 11:56 AM

22. "How long before it's fully approved? And what's standing in the way of that?"

THEY (the pharmaceutical companies) have to submit their final data with their application for full approval, and then the final review by the various Vaccine Committees will commence, with their yay or nay recommendation coming shortly thereafter.

Pfizer literally just submitted their application about 10 days ago and it was accepted - https://www.sciencemag.org/news/2021/07/when-will-covid-19-vaccines-be-fully-approved-and-does-it-matter-if-they-are

Some excerpts from the above link -

What’s the difference between full approval and an EUA?

It’s one of scale. FDA will review much more data, covering a longer period of time, before granting full approval. “It’s not a huge difference, but it is a real difference,” Goodman says. The agency will analyze additional clinical trial data and consider real-world data on effectiveness and safety. It will inspect manufacturing facilities and make sure quality control is very strict. “It’s an exhaustive review,” Goodman says.

FDA is already familiar with much of the data, however, for instance on the very rare side effects caused by the J&J and Pfizer vaccines that didn’t show up in clinical trials.

When might the vaccines be approved?

On 16 July, FDA accepted Pfizer’s application “under priority review”—meaning it will move faster than during standard reviews, which typically take at least 10 months; the agency now has until January 2022 to review the materials. That seems like a long time, but last week an FDA official told CNN that the decision is likely to come within 2 months. “The review … has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the [January] Date,” an FDA press officer confirmed to Science in a statement.

FDA has not formally accepted Moderna’s application, possibly because the company has not yet submitted all the required materials.


A typical vaccine approval process, which is generally not reported about in the mass media because much of the public doesn't really care about the "sausage making" and it's too technical anyway, can take several years, including the patient trials, dosage studies, manufacturing processes/cGMPs, assay/testing criteria, sterility/stability studies, etc. So what is going on here is unprecedented due to the severity of the pandemic.

I think these companies want to present as much data as they can and as I understand it, wanted to also simultaneously submit an application for an EUA for their boosters (which might end up being a slightly altered entity from their current vaccines, so would need to start from scratch for review). That way they can get a 2-fer as a way to expedite.

This was expected to happen this fall - for what would be just short of 1 year post-original EUA approval, but well over a year from the first trials that started some time April/May 2020.

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Response to BumRushDaShow (Reply #22)

Mon Jul 26, 2021, 12:46 PM

27. Mumps, 1967, took four years to develop

Four years was, at the time, incredibly fast.

The mRNA vaccines have been in development since the first SARS. That virus was more lethal and extinguished itself by not spreading fast enough and killing its hosts. These vaccines really weren't made in a year. Once scientists sequenced the genome, it was a matter of applying the delivery system to the right RNA sequence. Neither Moderna nor Pfizer took money from TFG's Warp Speed.

It's my hope the FDA hearings and Statistical analysis and data review will be complete by the end of August, so that states & schools can require vaccines, like they do with polio, mumps, measles, tetanus, RSV, and other childhood immunizations.

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Response to Claire Oh Nette (Reply #27)

Mon Jul 26, 2021, 01:54 PM

30. Yes - they started working on them back in 2003

Pfizer and Moderna were both part of Operation Warp Speed. But because Pfizer has deep pockets, they didn't request any grants for research but still got an almost $2 billion government contract and Moderna did get seed money from the government since they were working with NIH personnel on the research and development of the vaccine candidates to be evaluated -

Trump Administration Selects Five Coronavirus Vaccine Candidates as Finalists

By Noah Weiland and David E. Sanger
Published June 3, 2020Updated July 27, 2020

WASHINGTON — The Trump administration has selected five companies as the most likely candidates to produce a vaccine for the coronavirus, senior officials said, a critical step in the White House’s effort to deliver on its promise of being able to start widespread inoculation of Americans by the end of the year.

By winnowing the field in a matter of weeks from a pool of around a dozen companies, the federal government is betting that it can identify the most promising vaccine projects at an early stage, speed along the process of determining which will work and ensure that the winner or winners can be quickly manufactured in huge quantities and distributed across the country.

The announcement of the decision will be made at the White House in the next few weeks, government officials said. Dr. Anthony S. Fauci, the federal government’s top epidemiologist and director of the National Institute of Allergy and Infectious Diseases, hinted at the coming action on Tuesday when he told a medical seminar that “by the beginning of 2021 we hope to have a couple of hundred million doses.”

The five companies are Moderna, a Massachusetts-based biotechnology firm, which Dr. Fauci said he expected would enter into the final phase of clinical trials next month; the combination of Oxford University and AstraZeneca, on a similar schedule; and three large pharmaceutical companies: Johnson & Johnson, Merck and Pfizer. Each is taking a somewhat different approach.

(snip)

https://www.nytimes.com/2020/06/03/us/politics/coronavirus-vaccine-trump-moderna.html


Merck's initial attempt failed so they pulled out and had planned to partner with another vaccine maker since they have some new facilities designed to manufacture vaccines, but has now mainly shifted to work on supplying an anti-viral product.

Sanofi-GSK, who was not part of Operation Warp Speed also had issues with their first attempts and were to supposedly be planning to submit for EUA by the end of the year, and have their product currently under review in the EU.

You also have NovaVax who plans to submit data by the fall.

But note that doing the approvals is not just a review of the clinical data by ACIP (CDC) or VRBPAC (FDA). There is a review of the actual manufacturing and quality control processes that need to happen through inspections of the plants, and looking at sterility and other conditions.

And regarding that latter process, that is how they found out about the problems with Emergent BioSolutions - https://www.usatoday.com/story/news/nation/2021/04/21/covid-19-fda-issues-withering-report-us-factory-making-j-j-vaccine/7319674002/

Emergent had been contracted to produce Janssen's (J&J's) vaccine here in the U.S. that was actually being manufactured in Belgium and shipped from overseas, and AstraZeneca's vaccine, that was being manufactured in the UK and Sweden.

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Response to BumRushDaShow (Reply #30)

Mon Jul 26, 2021, 02:02 PM

31. Thanks for the detail.

I used to work in clinical trials, at the old Syntex, then Roche, and another cardiovascular start up. Syntex educated the crap out of us on Clinical Trials, including the inspection of manufacturing facilities.
I hammered out consent form language and investigator contracts, and then ran point for resupplying our docs with appropriate supplies.

Nothing meets higher scrutiny standards than vaccines, and nothing makes less profit. That I remember well.

I don't care who funded the immediate research; Warp Speed was a no brainer. It allowed a reprioritization, and everyone focused.

Thanks for the links!

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Response to Claire Oh Nette (Reply #31)

Mon Jul 26, 2021, 02:07 PM

32. You are welcome

and I worked for the feds (now retired) so...

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Response to BumRushDaShow (Original post)

Mon Jul 26, 2021, 12:30 PM

24. Only makes sense.

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Response to BumRushDaShow (Original post)

Mon Jul 26, 2021, 12:52 PM

28. For those with an interest, here is a link

To the statute that authorized the CDC to regulate activity and possibly impose a nationwide vaccine mandate:

https://www.law.cornell.edu/uscode/text/42/264

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