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FDA advisers unanimously sign off on Johnson & Johnson's single-shot Covid-19 vaccine: Here's what happens next
ABC News via MSN ^ | 02/26/2021

Posted on 02/26/2021 9:18:48 PM PST by SeekAndFind

An independent advisory panel of infectious disease experts, doctors and scientists voted unanimously to recommend the COVID-19 vaccine from Johnson & Johnson for emergency use authorization from the Food and Drug Administration, a step closer to making a third COVID-19 vaccine available to Americans.

The recommendation paves the way for official emergency authorization by the FDA, allowing the vaccine to be provided to Americans while the company continues to study it. If that happens Friday night or over the weekend, some 4 million doses would be expected to start shipping as early as Monday.

"If the FDA [authorizes] the use of this new vaccine, we would plan to roll out as quickly as Johnson & Johnson can make the vaccine," President Joe Biden said Thursday.

The federal government will still determine how many doses are delivered to each state and states will determine which populations are eligible to be vaccinated based on available supply.

Anthony Fauci, one of the top infectious disease doctors in the country and a senior advisor to the White House on COVID-19 response, said he’s looking forward to the FDA review of the J&J vaccine but suggested its authorization is a foregone conclusion.

“We now have three highly effective vaccines. Importantly, each of them are very effective against severe disease and virtually all have them say that you look at the data and it's clear that you get essentially no hospitalizations, or deaths. And this is very good news,” he said in a briefing with reporters on Friday.

Here's what to know:

The vaccine requires only one shot, with 20 million doses due before April.

Unlike Pfizer and Moderna, the vaccine developed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, only requires one shot for the recipient to be considered fully immunized.

(Excerpt) Read more at msn.com ...


TOPICS: Culture/Society; Government; News/Current Events
KEYWORDS: covid19; fda; johnsonjohnson; vaccine
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1 posted on 02/26/2021 9:18:48 PM PST by SeekAndFind
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To: SeekAndFind

HEE’s THE PLAN ( and we know that things don’t always go according to plan, but anyway... ):

While 4 million doses would ship out initially, the company says it’s on track to produce 20 million doses by the end of March. Along with Pfizer and Moderna doses, that means the U.S. would have enough vaccine doses for 130 million adults — about half the adult population — to be vaccinated.

By the end of June, J&J is expected to have produced 100 million vaccine doses. That would put the U.S. in a position of having a surplus by mid-summer, when Pfizer and Moderna are expected to have delivered enough vaccine to immunize 300 million people.

Officials caution, though, that it will take time to get shots in arms.


2 posted on 02/26/2021 9:19:53 PM PST by SeekAndFind
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To: SeekAndFind

MORE DETAILS HERE:

https://abcnews.go.com/Health/latest-johnson-johnson-covid-vaccine-data-means/story?id=76092851

What the latest Johnson & Johnson COVID vaccine data really means: Earlier trials by Pfizer and Moderna didn’t include virus variants, J&J’s does.

_________________________________

Some have raised concerns that one of Johnson & Johnson’s previously reported vaccine data points — a 66% global efficacy in preventing moderately symptomatic disease — doesn’t seem as impressive as figures reported by Pfizer and Moderna, which exceeded 90% efficacy at preventing symptomatic COVID-19. But experts are quick to note that it may not be the best comparison: The Pfizer and Moderna clinical trials didn’t take into account new variants and still had 100% effectiveness against hospitalizations and deaths.

“This is a very different trial than the trials that were done last fall,” said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and a lead researcher for the Johnson & Johnson vaccine. “We live in a much more complicated pandemic today.”

While Pfizer and Moderna are conducting further research on their vaccines’ efficacy against variants — or if a booster will be required — Barouch emphasized that the Johnson & Johnson vaccine has a leg-up in terms of its data, because it’s the only one so far that’s been tested against variant strains.

“Overall, the vaccine provides very robust protection throughout the world, including against the worrisome viral variants that we’ve been hearing so much about,” Barouch added.

For many clinicians, the Johnson & Johnson vaccine performs best in what are the most important cases: severe illness that otherwise could lead to hospitalization — or even death. So while protection from moderate cases may be less robust, a newly reported 100% protection against deaths and hospitalizations is “huge,” said Dr. Darien Sutton, an emergency medicine physician and ABC News contributor.

“Knowing that this will help decrease the stress on hospital health care systems is, really, really great,” he added.

Dr. Paul Goepfert, director of the Alabama Vaccine Research Clinic, also emphasized the nuances in dissecting the data, underscoring the reduction in severe cases as key.

“Severe COVID and death are the main things you want to protect against,” he said, “because that’s most important in terms of helping people and keeping hospitalization rates down — and getting us back to normal.”

In addition to limiting severe cases of COVID-19, Johnson & Johnson’s vaccine is showing, according to the preliminary analysis, 74% protection against asymptomatic disease, which could help mitigate transmission. More research in this area is needed, but the data so far, according to Barouch, is “very promising.”

Beyond the numbers, experts say the Johnson & Johnson vaccine has some significant advantages over the Pfizer and Moderna vaccines — and not only because it requires a single dose, boosting convenience. Another advantage is its storage, as the vaccine can be kept for at least three months in normal refrigerators.

“That gives us the opportunity to put it in our primary care offices, pharmacies and community health centers, which translates into getting more people vaccinated,” said Dr. Simone Wildes, an infectious diseases specialist at South Shore Health outside of Boston.


3 posted on 02/26/2021 9:23:32 PM PST by SeekAndFind
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To: SeekAndFind

So will Independence Day be the unmasking of America?


4 posted on 02/26/2021 9:24:02 PM PST by lightman (I am a binary Trinitarian. Deal with it!)
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To: lightman

Unfortunately no. The mask is here to stay with the masktards.


5 posted on 02/26/2021 9:30:30 PM PST by HighSierra5
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To: SeekAndFind

Government is the disease

You are the cure

99.997% of the time
Which makes you more effective than Moderna...


6 posted on 02/26/2021 9:31:46 PM PST by Vendome (I've Gotta Be Me https://youtu.be/wH-pk2vZG2M)
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To: All

Johnson & Johnson and AstraZenica are the 2 “Christian non-friendly” vaccines that were part of “Operation Warp Speed” (abortion cell lines used):

https://lozierinstitute.org/what-you-need-to-know-about-the-covid-19-vaccine/


7 posted on 02/26/2021 9:34:48 PM PST by Drago
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To: SeekAndFind

Those pharmaceutical companies are sure cranking out those new, multi-million dollar vaccine contracts all of a sudden.

Wonder how long before the Big Tech companies are competing over government-mandated, vaccine-branding of human limbs ?

You know, for the safety of the compliant proletariat.


8 posted on 02/26/2021 9:51:00 PM PST by BrexitBen
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To: SeekAndFind

Is this the one that doesn’t have the RNA (ribonucleic acid) in it?


9 posted on 02/26/2021 9:55:07 PM PST by deks (Vote with your wallet! Boycott domestic enemies of freedom! Buy no Chinese products!)
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To: deks

J&J is a real vaccine made the old fashioned way they took a coronavirus that causes a common cold and added the spike proteins from the Rona so that when you get exposure to the real Rona your body already knows how to make antibodies.

As too the abortion cell lines. It was not made with HK293 it was tested on the genetic clone of HK293 that is a clone of a clone of a clone of a clone for the last 40 years. At this point to get the world back to normal I would support the actual harvesting of live organ materials as opposed to just 40 year old cloned materials. It’s simpley the needs of the many out weigh the needs of the one or the few. The classic ethics example of the street car and the man on the tracks. I kill that man on the tracks every time.


10 posted on 02/26/2021 10:07:31 PM PST by JD_UTDallas ("Veni Vidi Vici" )
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To: deks

RE: Is this the one that doesn’t have the RNA (ribonucleic acid) in it?

Yes it is. JNJ uses the traditional inactivated adenovirus to trigger the human body’s immune response when exposed.


11 posted on 02/26/2021 10:12:43 PM PST by SeekAndFind
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To: SeekAndFind

Thank you! I may get this one. I refused one the other day at the VA Clinic I go to


12 posted on 02/26/2021 10:17:02 PM PST by The Mayor (I am outraged at your outrage toward the outrage!)
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To: JD_UTDallas; SeekAndFind

I may have had the flu once as a teenager...since then I never get the flu and never had a flu shot. Not sure if that means I have some immunity...

I wasn’t planning on getting a ‘rona vaccine, but will consider this one if people don’t start dropping dead from it.


13 posted on 02/26/2021 10:20:47 PM PST by deks (Vote with your wallet! Boycott domestic enemies of freedom! Buy no Chinese products!)
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To: deks

I have been offered Pfizer amd Moderna three times now I’m in group 1B and have turned them down the J&J is the version that is a real.vaccine not a experimental therapy. It also prevents the passing on of the illness like a real vaccine should do in this case 70% ish of the time. The current research shows that asymptomatic transmission is rare.


14 posted on 02/26/2021 10:33:30 PM PST by JD_UTDallas ("Veni Vidi Vici" )
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To: Drago

Moderna and Pfizer were tested on aborted fetal cell lines. Johnson and Johnson is not mRNA.


15 posted on 02/26/2021 10:52:56 PM PST by DesertRhino (Dog is man's best friend, and moslems hate dogs. Add that up. .... )
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To: Drago

Moderna and Pfizer were tested on aborted fetal cell lines. Johnson and Johnson is not mRNA.


16 posted on 02/26/2021 10:52:56 PM PST by DesertRhino (Dog is man's best friend, and moslems hate dogs. Add that up. .... )
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To: SeekAndFind
Anthony Fauci, not one of the top infectious disease doctors in the country…

There, fixed it.

17 posted on 02/26/2021 10:54:48 PM PST by immadashell (New Planned Parenthood slogan: Black Babies’ Lives Don't Matter!)
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To: JD_UTDallas

“It’s simpley the needs of the many out weigh the needs of the one or the few.”

That makes perfect sense...to Marx, Mao, Chavez, etc.


18 posted on 02/26/2021 10:55:41 PM PST by DesertRhino (Dog is man's best friend, and moslems hate dogs. Add that up. .... )
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To: lightman
So will Independence Day be the unmasking of America?

I was thinking much sooner in April.

19 posted on 02/26/2021 11:09:22 PM PST by FreeReign (Never forget The Steal)
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To: DesertRhino

You can add Abraham Lincoln, Johnson and Churchill to that list all of them sacrificed hundreds of thousands for the common good of millions. It’s not a commie thing to realise as a species there are times when people must die for the common good. That’s just cold reality. America incinerated over a million Japanese women ,children and civilian men with the fire bombings of Edo and the atomic bombs to save an estimated 6 million lives should America invade Japan.


20 posted on 02/26/2021 11:20:22 PM PST by JD_UTDallas ("Veni Vidi Vici" )
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