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New Novavax COVID-19 Vaccine Found To Be Safe and Effective in Trial – “Highly Efficacious and Very Safe” After Clinical Trials
SciTech Daily ^ | 12/18/2021 | UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE

Posted on 12/18/2021 10:36:41 PM PST by SeekAndFind

An investigational COVID-19 vaccine made by Novavax was found to be 90 percent effective at preventing COVID-19 illness, according to results from a Phase 3 clinical trial published on December 15, 2021, in the New England Journal of Medicine. The University of Maryland School of Medicine’s (UMSOM) Center for Vaccine Development and Global Health served as one of the trial sites, and Karen Kotloff, MD, Professor of Pediatrics at UMSOM, served as Co-Chair for the trial protocol.

In the study, researchers recruited nearly 30,000 adult volunteers at 113 clinical sites in the United States and six sites in Mexico. Approximately 20,000 participants received two doses of the vaccine spaced three weeks apart and 10,000 received placebo. In addition to being highly effective in preventing COVID illness of any severity, the vaccine was 100 percent effective in preventing moderate and severe disease that required hospitalization.

During the first few months of 2021 when the study was conducted in the U.S. and Mexico, the predominant circulating strain was Alpha. The assessment did not include Delta or Omicron, the newest variant of concern, which had not begun to circulate.

Most side effects were mild to moderate and transient. Fever was very rare. The most common side effects in the vaccine recipients included pain and tenderness at the injection site, headache, muscle aches, and fatigue that lasted a day on average. None of the recipients developed serious reactions like heart inflammation (myocarditis) or blood clots.

“Our study results indicate that this vaccine is highly efficacious and very safe. In addition, this vaccine has many attractive features. It is made from a small piece of protein, like many currently licensed vaccines in the U.S. and has convenient refrigerator storage requirements, so it will be an important addition to the COVID-19 vaccine portfolio, in the U.S. and in countries where supply is lacking,” said Dr. Kotloff.

The UMSOM site enrolled nearly 500 participants over 18 of age. The participants were demographically diverse to reflect those in the general population at highest risk for infection and illness, including under-represented minority groups who were disproportionately affected by the pandemic. About 12 percent of the study participants were in the high-risk group of those over age 65 years. About 27 percent of the study participants at UMSOM identified as Black, 19 percent Hispanic, 16 percent Asian, and 7 percent American Indian or Alaska Native.

REFERENCES:

“Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico” by Lisa M. Dunkle, M.D., Karen L. Kotloff, M.D., Cynthia L. Gay, M.D., M.P.H., Germán Áñez, M.D., Jeffrey M. Adelglass, M.D., Alejandro Q. Barrat Hernández, M.D., Wayne L. Harper, M.D., Daniel M. Duncanson, M.D., Monica A. McArthur, M.D., Ph.D., Diana F. Florescu, M.D., R. Scott McClelland, M.D., M.P.H., Veronica Garcia-Fragoso, M.D., Robert A. Riesenberg, M.D., David B. Musante, M.D., David L. Fried, M.D., Beth E. Safirstein, M.D., Mark McKenzie, M.D., Robert J. Jeanfreau, M.D., Jeffrey K. Kingsley, D.O., Jeffrey A. Henderson, M.D., M.P.H., Dakotah C. Lane, M.D., Guillermo M. Ruíz-Palacios, M.D., Lawrence Corey, M.D., Kathleen M. Neuzil, M.D., M.P.H., Robert W. Coombs, M.D., Ph.D., Alex L. Greninger, M.D., Ph.D., Julia Hutter, M.D., Julie A. Ake, M.D., Katherine Smith, M.D., Wayne Woo, M.S., Iksung Cho, M.S., Gregory M. Glenn, M.D., and Filip Dubovsky, M.D., M.P.H. for the 2019nCoV-301 Study Group, 15 December 2021, New England Journal of Medicine. DOI: 10.1056/NEJMoa2116185

Kathleen Neuzil, MD, MPH, FIDSA, the Myron M. Levine, MD, DTPH Professor of Vaccinology and Director, Center for Vaccine Development and Global Health (CVD) at UMSOM, and Monica McArthur, MD, Assistant Professor of Pediatrics, served as co-authors on this study.

The Novavax trial was part of Operation Warp Speed , a multi-agency collaboration led by the U.S. Department of Health and Human Services (HHS), which aims to accelerate the development, manufacturing and distribution of medical countermeasures for COVID-19. Novavax, based in Gaithersburg, MD, and the National Institute of Allergy and Infectious Disease also provided funding for the study.

“Throughout the pandemic, CVD has contributed to the advancement of several promising vaccine candidates. Our researchers worked meticulously and expeditiously to ensure that Americans and nations throughout the world had access to safe and effective vaccines to slow the pandemic and save lives,” said E. Albert Reece, MD, PhD, MBA, Executive Vice President for Medical Affairs, UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor and Dean, University of Maryland School of Medicine. “This latest study leads us a step closer to licensure of a new vaccine that will impact millions of people.”


TOPICS: Health/Medicine; Science; Society
KEYWORDS: covax; covid; novavax; vaccine
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To: rktman

This is a useful tool for those that are not vaxed and are being mistreated by their employer. Just insist on getting the Novavax and demand their employer to help them do it. It will never be here in America but they dont know that.


21 posted on 12/19/2021 1:48:56 AM PST by reviled downesdad (Some of the lost will never believe the Truth.)
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To: 13foxtrot
It is based on the spike protein grown from moth-based proteins rather than mRNA

The difference is with Novavax there is a finite amount of spike protein injected whereas with mRNA vaccines the gene gives a signal to your body to create the spike proteins, which can go haywire and start over-replicating and attacking organs to a dangerous level.

22 posted on 12/19/2021 2:12:31 AM PST by Mozzafiato
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To: SeekAndFind

I’m sure Novavax, an injection of pure, toxic spike proteins, will prefer the Pfizer option wherein they don’t have to release their data for 75 years.

I believe when people started to walk away from the ‘vaccines’, merchandise sat on the shelves and companies like Moderna and Pfizer complained they hadn’t taken their haul yet. So hold off maybe on Novavax until the others get their take, for this round.


23 posted on 12/19/2021 2:39:32 AM PST by ransomnote (IN GOD WE TRUST)
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To: SeekAndFind

Still. No.


24 posted on 12/19/2021 2:41:09 AM PST by Viking2002 (Whatever.)
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To: kiryandil

LOLOL


25 posted on 12/19/2021 2:46:40 AM PST by Salamander ("Salamander has barbaric tendencies" /Gundog)
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To: 13foxtrot
spike protein grown from moth-based proteins

Lämp?


26 posted on 12/19/2021 2:54:13 AM PST by Salamander ("Salamander has barbaric tendencies" /Gundog)
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To: metmom
My dog found this under the sofa


27 posted on 12/19/2021 2:56:34 AM PST by Salamander ("Salamander has barbaric tendencies" /Gundog)
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To: SeekAndFind

India developed Covaxin has some promising results and is a traditional vaccine. Therefore Fascist Fauci and his Pfizer handlers will never let it get approved for USA use. Over 100 million Indians have been vaccinated with it.

Covaxin, which uses traditional, inactivated-virus technology, induced a robust antibody response two weeks after the second dose was given, the investigators concluded. No severe adverse events or vaccine-related deaths occurred during the randomized trial involving 24,419 adults.


28 posted on 12/19/2021 3:14:45 AM PST by DAC21
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To: SeekAndFind

More vaccines tested on fetal cell lines. No thanks.


29 posted on 12/19/2021 3:30:17 AM PST by frogjerk (I will not do business with fascists)
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To: MinorityRepublican
They still works against severe disease and ultimately death

No. No they don't.

30 posted on 12/19/2021 3:32:29 AM PST by frogjerk (I will not do business with fascists)
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To: alexander_busek; Singermom

Trial results to be publicly released 75 from now.


31 posted on 12/19/2021 3:38:48 AM PST by A strike (Public Health 21st century murder by government. DoktorFauxiMengeleGates to a TerreHaute gurney now)
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To: MinorityRepublican

Still flackin’ and shillin’


32 posted on 12/19/2021 3:41:40 AM PST by A strike (Public Health 21st century murder by government. DoktorFauxiMengeleGates to a TerreHaute gurney now)
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To: DAC21

RE: Covaxin, which uses traditional, inactivated-virus technology, induced a robust antibody response two weeks after the second dose was given, the investigators concluded.

But then, so are China’s two known vaccines, Sinovac and Sinopharm, both based on the traditional inactivated virus technology.

They weren’t very good. Chile for instance, which used the Chinese vaccines heavily, still experienced another outbreak.


33 posted on 12/19/2021 3:44:11 AM PST by SeekAndFind
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To: SeekAndFind

“Chile for instance, which used the Chinese vaccines heavily, still experienced another outbreak”

That is true for all vaccines.


34 posted on 12/19/2021 3:49:32 AM PST by DAC21
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To: Salamander

That looks like the Omigawd variant!
I hope you quarantined...


35 posted on 12/19/2021 3:56:13 AM PST by Adder (Proud member of the FJB/LGB community. /s is implied where applicable..)
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To: DAC21

Covaxin was not developed or tested using fetal cells. Traditional, most effective and moral for use. Neither the U.S. or Australia will get it :(


36 posted on 12/19/2021 4:10:32 AM PST by JosephW (Lost women seek a new daddy by voting for left wing candidates, instead of having strong husbands.)
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To: Adder

I haven’t seen him with it in several days.

I suspect it’s made its way back under the sofa, where it waits in darkness, formulating its evil plan for world domination.

It may have had babies under there, too.

;)


37 posted on 12/19/2021 4:13:39 AM PST by Salamander ("Salamander has barbaric tendencies" /Gundog)
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To: frogjerk

But if you don’t take the jab, you could die even worse!


38 posted on 12/19/2021 4:15:01 AM PST by Salamander ("Salamander has barbaric tendencies" /Gundog)
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To: SeekAndFind
Meanwhile...

Report: CDC overcounts millions of vaccinations

The stats are crap.

All of them.

BTW, I'm betting that this is a modified limited hangout, and that the real overcount is way higher.

39 posted on 12/19/2021 4:20:54 AM PST by mewzilla (Those aren't masks. They're muzzles. )
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To: kiryandil

Perfect…


40 posted on 12/19/2021 4:39:37 AM PST by Caipirabob (Communists...Socialists...Fascists & AntiFa...Democrats...Traitors... Who can tell the difference?)
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