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.
“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.”
There’s a world of difference between enslaved chicom intellectualism and highly motivated Indian patriotism. India is a formidable competitor despite the cultural constraints/conflicts between its various regions. They will easily surpass many of the European welfare states in progress and quality of life in short order. As far as the chicoms, when India decides they are hungry enough, they will have them for lunch, and be hungry a half hour later. A free Chinese people will be the result.
I’m with you. I had (have) high hopes for this vax but we’ve been lied to so much by big Gov’t, I’m not sure I can trust this vax either.
Interesting points of note:
-out of the appx 14,000 shot and placebo people (split evenly), 10 shot and 96 placebo folks came down with virologically confirmed, symptomatic mild, moderate, or severe Covid-19 with an onset at least 7 days after the second dose, for a VE of 90%.
-these trials ran for about three months only. In contrast, 59% of industry-sponsored vaccine clinical trials fail to make it through clinical trials, which on median take 9 years for the ones that make it to approval.
-Solicited systemic adverse events were reportedly more frequently in the vaccine group than in the placebo group after both the first dose (45.7% vs. 36.3%) and the second dose (64.0% vs. 30.0%). While not stated explicitly, these adverse events effectively remove people from society for days, reducing their possible exposure to COVID19.
-The shots don't guard against fatality: Two deaths related to Covid-19 were reported, one in the vaccine group and one in the placebo group. (The death in the vaccine group occurred in a 53-year-old man in whom Covid-19 symptoms developed 7 days after the first dose; he was subsequently admitted to the ICU for treatment of respiratory failure from Covid-19 pneumonia and died 15 days after vaccine administration. The death in the placebo group occurred in a 61-year-old man who was hospitalized 24 days after the first dose; the participant died 4 weeks later after complications from Covid-19 pneumonia and sepsis.)
So, net-net-net, these shots lower your chance of contracting COVID19 for up to three months after the second injection. However, it doesn't lower your risk of dying from this bug, you likely need boosters forever, they make you sicker initially than the placebo group, and we have zero long-term clinical trial data to see if maybe these shots are non-efficacious in the long-run...parenthetically such trials accompany all legitimately-tested vaccines but statistically there is a 59% chance that these shots would fail a kosher long-term clinical trial that should take about nine years if we really put safety first.
I'll say it again: if people are in a high morbidity cohort and feel like they need to get these shots, I will never criticize them. Heck, even if they AREN'T in such a cluster I won't say a thing-Personal health is a personal matter.
But the decision to avoid shots, when put in this light. doesn't seem crazy.
Looks like the UK's Deep State may be blinking. Look what made it into print. If you get the chance, read the entire article and the comments, too. Whoa...
PROFESSOR CARL HENEGHAN: I'm a GP on the frontline, and I don't think we're overwhelmed with Covid
Come see me after five years of successful use. Till then, I will not comply
Hi.
A vaccine made from the deactivated Rona virus.
Brilliant.
5.56mm
Gotta understand that their “90% efficacy” equates to about an actual 1% potential reduction...
Yup, cause they are trying to pressure the holdouts into giving in since “everyone else has had it”.
Problem is, that line of reasoning doesn’t work on me. I don’t care if “everyone else” anything. I’m not “everyone else”.
Deep State underestimated us.
Unfortunately, I don’t think they will make that mistake again.
I wondered where Novavax went. It just seemed to drop off of the radar a few weeks ago almost like an intentional media blackout.
Did they at least try to define an adequate primary series?
This has been a strawman argument from the pro-vaxxers since the beginning. “Get the vaccine and you won’t get as sick and/or die”. The dirty little secret is that most people — by far — who got COVID didn’t get that sick or die. Many had to even been told that they had COVID unknowingly…
This vaccine will never be approved. Your guess will be as good as mine as to what excuse will be given for denial.
It has been almost a year since the trial of this vaccine.
If I could know more I might be inclined to consider it. That is quite a difference in agreeing to take it.
This write-up seems more credible than others I have seen. Short and to the point without a lot of wiggle words and intent to baffle with BS.
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