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Researchers Publish Encouraging Early Data on COVID-19 Vaccine

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Diagram of how mRNA vaccine works
Credit: NIH

People all around the globe are anxiously awaiting development of a safe, effective vaccine to protect against the deadly threat of coronavirus disease 2019 (COVID-19). Evidence is growing that biomedical research is on track to provide such help, and to do so in record time.

Just two days ago, in a paper in the New England Journal of Medicine [1], researchers presented encouraging results from the vaccine that’s furthest along in U.S. human testing: an innovative approach from NIH’s Vaccine Research Center (VRC), in partnership with Moderna Inc., Cambridge, MA [1]. The centerpiece of this vaccine is a small, non-infectious snippet of messenger RNA (mRNA). Injecting this mRNA into muscle will spur a person’s own body to make a key viral protein, which, in turn, will encourage the production of protective antibodies against SARS-CoV-2—the novel coronavirus that causes COVID-19.

While it generally takes five to 10 years to develop a vaccine against a new infectious agent, we simply don’t have that time with a pandemic as devastating as COVID-19. Upon learning of the COVID-19 outbreak in China early this year, and seeing the genome sequence of SARS-CoV-2 appear on the internet, researchers with NIH’s National Institute of Allergy and Infectious Diseases (NIAID) carefully studied the viral instructions, focusing on the portion that codes for a spike protein that the virus uses to bind to and infect human cells.

Because of their experience with the original SARS virus back in the 2000s, they thought a similar approach to vaccine development would work and modified an existing design to reflect the different sequence of the SARS-CoV-2 spike protein. Literally within days, they had created a vaccine in the lab. They then went on to work with Moderna, a biotech firm that’s produced personalized cancer vaccines. All told, it took just 66 days from the time the genome sequence was made available in January to the start of the first-in-human study described in the new peer-reviewed paper.

In the NIH-supported phase 1 human clinical trial, researchers found the vaccine, called mRNA-1273, to be safe and generally well tolerated. Importantly, human volunteers also developed significant quantities of neutralizing antibodies that target the virus in the right place to block it from infecting their cells.

Conducted at Kaiser Permanente Washington Health Research Institute, Seattle; and Emory University School of Medicine, Atlanta, the trial led by Kaiser Permanente’s Lisa Jackson involved healthy adult volunteers. Each volunteer received two vaccinations in the upper arm at one of three doses, given approximately one month apart.

The volunteers will be tracked for a full year, allowing researchers to monitor their health and antibody production. However, the recently published paper provides interim data on the phase 1 trial’s first 45 participants, ages 18 to 55, for the first 57 days after their second vaccination. The data revealed:

• No volunteers suffered serious adverse events.

• Optimal dose to elicit high levels of neutralizing antibody activity, while also protecting patient safety, appears to be 100 micrograms. Doses administered in the phase 1 trial were either 25, 100, or 250 micrograms.

• More than half of the volunteers reported fatigue, headache, chills, muscle aches, or pain at the injection site. Those symptoms were most common after the second vaccination and in volunteers who received the highest vaccine dose. That dose will not be used in larger trials.

• Two doses of 100 micrograms of the vaccine prompted a robust immune response, which was last measured 43 days after the second dose. These responses were actually above the average levels seen in blood samples from people who had recovered from COVID-19.

These encouraging results are being used to inform the next rounds of human testing of the mRNA-1273 vaccine. A phase 2 clinical trial is already well on its way to recruiting 600 healthy adults.This study will continue to profile the vaccine’s safety, as well as its ability to trigger an immune response.

Meanwhile, later this month, a phase 3 clinical trial will begin enrolling 30,000 volunteers, with particular focus on recruitment in regions and populations that have been particularly hard hit by the virus.

The design of that trial, referred to as a “master protocol,” had major contributions from the Accelerating COVID-19 Therapeutic Interventions and Vaccine (ACTIV) initiative, a remarkable public-private partnership involving 20 biopharmaceutical companies, academic experts, and multiple federal agencies. Now, a coordinated effort across the U.S. government, called Operation Warp Speed, is supporting rapid conduct of these clinical trials and making sure that millions of doses of any successful vaccine will be ready if the vaccine proves save and effective.

Results of this first phase 3 trial are expected in a few months. If you are interested in volunteering for these or other prevention trials, please check out NIH’s new COVID-19 clinical trials network.

There’s still a lot of work that remains to be done, and anything can happen en route to the finish line. But by pulling together, and leaning on the very best science, I am confident that we will be able rise to the challenge of ending this pandemic that has devastated so many lives.

Reference:

[1] A SARS-CoV-2 mRNA Vaccine—Preliminary Report. Jackson LA, Anderson EJ, Rouphael NG, Ledgerwood JE, Graham BS, Beigel JH, et al. NEJM. 2020 July 14. [Publication ahead of print]

Links:

Coronavirus (COVID-19) (NIH)

Dale and Betty Bumpers Vaccine Research Center (National Institute of Allergy and Infectious Diseases/NIH)

Moderna, Inc. (Cambridge, MA)

Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19) (ClinicalTrials.gov)

NIH Launches Clinical Trials Network to Test COVID-19 Vaccines and Other Prevention Tools,” NIAID News Release, NIH, July 8, 2020.

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) (NIH)

Explaining Operation Warp Speed (U.S. Department of Health and Human Services, Washington, DC)

NIH Support: National Institute of Allergy and Infectious Diseases

17 Comments

  • Becky B says:

    So interesting! This indicates years of work from multiple fields of biology, converging to a hopefully spectacular outcome and new simpler method for making vaccines. I wonder if the plasma from those individuals would help patients with COVID-19, like the plasma from recovered patients, especially given what looks like higher levels of antibodies. I suppose that might be unethical since it is a trial but with the skyrocketing cases and desperate docs and patients…… NIH proves its worth again.

  • immunodiva says:

    Current data show that the risk of dying from COVID-19 increases dramatically with age (over 60-69). Antibody responses in older folks tend to become less robust with age also, and vaccines don’t work as well when given to those over 60. Are there plans to test this vaccine, and/or others, in people whose age puts them at higher risk of death from the disease? Are there elderly cohorts planned for trials of therapeutics?

  • carol cady says:

    This is fantastic news. Hopefully and very soon this vaccine will be available for everyone. I will be checking out the clinical trials for more information. Thanks, Carol Cady RN

  • Patricia Chieffo says:

    NIH, as expected, ahead of the research for a Covid 19 vaccine! Kudos!

  • Joan Maher says:

    HATS OFF TO ALL THE FRONT LINE SCIENTISTS FOR YOUR COLLABORATIVE PRACTICES. I WITNESSED THIS FOR 16 YEARS AS A GRATEFUL CLINICAL RESEARCH RN AT THE NIH CLINICAL CENTER (3NW)!

  • Nelson says:

    CD8 T-cell response is zero: does this not question the RNA approach – because the reason to go that way is to get exactly that. The advantage of this experimental high-risk-approach over the classical protein vaccine approach would become questionable

    • Patricia Chieffo says:

      Will those over 60 yrs and older, with a pre-existing condition, be considered for an “approved“ Covid 19 Vaccine when available, or even a stage 3 clinical trial?

  • Roseanne M Woo-Haltresht says:

    Congratulations to the staff of NIAID and Dr. Collins on the breakthrough with m-RNA! America is blessed with dedicated scientists who put their nose to the grindstone to work out a solution … My prayers and best wishes on your continued success!

  • Leo S says:

    Parhaps the contagiousness of newly shed (exhaled) virus could be dampened if positive patients were to inhale n-acetyl cysteine … My hypothesis is that the spike protein’s integrity and orientation is dependent on at least one disulfide bond. Theoretically, if this disulfide is undone, the spike protein will not easily bind to ACE2 and reduce its transmission (especially to healthcare workers) and perhaps reduce spread within the lungs as well.

  • Teresa G. says:

    I’m 68 healthy no health concerns would I be able to help ? I live in AZ

  • Robert Wuhrman says:

    Thank you Dr. Collins and Dr. Fauci. As someone who worked closely for over 8 years on NHLBI’s award winning (and effective) Heart Truth for Women campaign under Bush 2, this hopefully likewise takes advantage of the great public health communications capabilities that Dr. Fauci and NIAID are so readily and often able to deliver on. The country clearly needs it. Keep up the good work. We’re rooting for you.

  • DR. SAUMYA PANDEY, PH.D. says:

    A clinical research-oriented spectacular insight in the ever-expanding SARS-Covid-19 pathogenesis in susceptible population-subsets; the recent vaccine research study targeting mRNA and spike proteins with antibody production in Covid-positive cohorts deserves an applause with elegant depiction of mRNA-1273 vaccine data.
    Multicentric clinical trials with pooled samples would yield reproducible outcomes with higher sensitivity and specificity endpoints.

  • Gaynelle G. says:

    I understand minorities with some health issues are needed for the study. How can I be a part of the study?

  • BBN says:

    So interesting! This indicates years of work from multiple fields of biology, converging to a hopefully spectacular outcome and new simpler method for making vaccines. I wonder if the plasma from those individuals would help patients with COVID-19, like the plasma from recovered patients, especially given what looks like higher levels of antibodies. I suppose that might be unethical since it is a trial but with the skyrocketing cases and desperate docs and patients…… NIH proves its worth again.

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