New Novavax COVID-19 Vaccine Found To Be Safe and Effective in Trial – “Highly Efficacious and Very Safe”

COVID-19 Vaccine Success

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.

“Our study results indicate that this vaccine is highly efficacious and very safe.” — Karen Kotloff, MD, Professor of Pediatrics at UMSOM

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.

Reference: “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.”

 

8 Comments on "New Novavax COVID-19 Vaccine Found To Be Safe and Effective in Trial – “Highly Efficacious and Very Safe”"

  1. Reuters reporting Japan is at 1% of its COVID peak cases and falling. India is at 3% of its peak and falling. What did these countries do? Ditch vaccine mandates for ivermectin. Since April 28, India medical officials started providing Hydroxychloroquine and ivermectin to its massive population. As India is the major pharmaceutical manufacture in the world, they were ready for this massive drug distribution. MIRACULOUSLY!, COVID cases have plummeted quickly since then. Meanwhile, all “first world” countries in Europe are reporting a rise in cases. Get your ivermectin before it is too late https://medicalfeedom.wiki/

  2. I have not yet been “vaccinated” against Covid-19. Not because I am “anti-vax” or opposed to vaccines in any way, but because I am very much against the current treatments for the virus. the current treatments are not vaccines by any medical definition; they are gene therapy treatments that are HIGHLY experimental.

    Just because we have a very confused President who goes on national television and claims the “vaccines” are safe and effective, does not make it true. Not only are the current treatments the first of their kind in human history (they literally interact with a person’s DNA), they are also the least tested vaccines in medical history. Think about that for one minute… a first-of-its-kind vaccine treatment is also the least tested treatment ever. And you wonder why people like me refuse it?

    Just look at the extreme and unprecedented levels of protection against civil lawsuits and criminal charges that the pharmaceutical companies have demanded regarding these treatments. The creators of the treatment know full well that they are highly experimental and completely unproven to be safe or effective.

    However, the Novavax vaccine is different and I intend to take it when it is approved. The Novavax treatment is a legitimate vaccine created the way that all other successful vaccines have been created since 1795. Finally, people will have the option of a real vaccine versus the experimental gene therapy treatment that has been pushed and mandated by ignorant and corrupt politicians.

  3. Nice try Clair!

  4. I understand not wanting a different type of Vaccine that is new. But we are speaking RNA not DNA.

    “FACT: COVID-19 vaccines do not change or interact with your DNA in any way.”

    This is from the CDC.

    That said, I’m glad Novavax shows promise for those uncomfortable with RNA vaccines. Hopefully it will also be easier to produce for so many countries that can not obtain Vaccines currently.

    Also, nice try Claire.

  5. Here is the CDC link for those interested. To say it is not effective is patently false. If you don’t want the vaccine bcz of RNA & untested, fine. Don’t spread misinformation or make sweeping statements that aren’t true. This is a medical issue, not political.

    https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html

  6. It’s not effective Mel. If it was you wouldn’t have leagues like the NFL, NBA and NHL shutting down because of exploding cases. What do all these entities have in common? They all have a <95% vaccinated group. This is a political issue at its very core. The government should in no way, shape or form have any authority to have a say in what people choose to put in their bodies.

  7. @K, No vaccine is 100%. None. This vaccine has prevented CoVid becoming severe & leading to death. We are fortunate to be living in a time where mRNA has been studied for decades & was ready to be used.

    This was made a political issue. It was a medical one but it has been leveraged and exploited for people’s political agendas, and/or hidden agendas. We also live in the age of social media where misinformation is rife & exploits people’s fears. Fears are being projected onto this vaccine that have much deeper psychological and sociological roots.

    I’m familiar with arguments against the vaccine. I’m not gonna try & change your mind…doubt I could. You do you…just hope you don’t infect someone who can’t be vaccinated (a child) or someone immune suppressed with something like cancer. Of course, based on your belief system, you think it is political & so that’s not even possible.

    Also, in your post I think u meant >95%. If you meant <95%, you disproved your own hypothesis.

Leave a Reply to Mel Cancel reply

Email address is optional. If provided, your email will not be published or shared.