People around the world eagerly await the progression of an effective vaccine to protect against the fatal risk of coronavirus 2019 disease (COVID-19). It is increasingly transparent that biomedical studies are on track to provide such assistance in record time.
Just two days ago, in an article in the New England Journal of Medicine [1], researchers exhibited encouraging effects of the vaccine that is the ultimate complex in human testing in the United States: a cutting-edge technique for the NIH Vaccine Research Center (VRC), in partnership with Moderna Inc., Cambridge, MA [1]. The centerpiece of this vaccine is a small non-infectious extract of messenger RNA (MRNA). The injection of this mRNAT into the muscle will induce a person’s body to produce a key viral protein, which in turn will inspire the production of protective antibodies opposed to SARS-CoV-2, the new coronavirus that causes COVID-19.
While it regularly takes five to ten years to expand a vaccine rather than 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 earlier this year and watching the SARS-CoV-2 genome series appear on the Internet, researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) thoroughly studied viral instructions, focusing on the component that encodes a protein that the virus uses to bind and infect human cells.
Because they reveled in the original SARS virus in the 2000s, they believed that a technique similar to vaccine progression would paint and modify an existing design to reflect the other series of the complex SARS-CoV-2 protein. Literally, within a few days, they had created a vaccine in the lab. They then painted with Moderna, a biotechnology company that produces personalized vaccines against cancer. In total, it was only 66 days from the time the genome series was performed in January to the beginning of the first human examination described in the new peer-reviewed article.
In the NIH-supported human phase 1 clinical trial, researchers found that the vaccine, called mRN-1273, was sometimes well tolerated. More importantly, human volunteers have also developed significant amounts of neutralizing antibodies that target the virus in the right position to prevent it from infecting their cells.
Conducted at Kaiser Permanente Washington Health Research Institute, Seattle; and Emory University School of Medicine in Atlanta, the essay led by Kaiser Permanente’s Lisa Jackson concerned healthy adult volunteers. Each volunteer won two vaccines in the arm in one of the 3 doses, administered one month apart.
Volunteers will be monitored for a full year, allowing researchers to monitor their fitness and antibody production. However, the recently published document provides provisional knowledge on the first forty-five participants in the Phase 1 trial, aged 18 to 55, for the first 57 days after their time of vaccination. The knowledge revealed:
No volunteer has experienced adverse events.
The optimal dose for the higher degrees of neutralizing antibody activity, while protecting patient safety, appears to be one hundred micrograms. The doses administered in the phase 1 trial were 25, one hundred or 250 micrograms.
More from volunteers reported fatigue, headache, chills, muscle aches or pain at the injection site. These symptoms were maximum, not unusual after vaccination and in volunteers who won the vaccine dose. This dose will not be used in larger trials.
Two doses of one hundred micrograms of the vaccine caused a physically powerful immune response, which was last measured 43 days after the dose. These responses were higher than the average grades observed in blood samples from others who had recovered from COVID-19.
These encouraging effects are being used to count long-term rounds of human testing of the mNR-1273 vaccine. A Phase 2 clinical trial is already underway to recruit six hundred healthy adults. This test will continue to outline the protection of the vaccine, as well as your ability to cause an immune response.
Meanwhile, at the end of this month, a Phase 3 clinical trial will begin recruiting 30,000 volunteers, with specific recruitment in regions and populations that have been affected by the virus.
The design of this trial, called the “main protocol”, benefited from the primary contributions of the Accelerating Therapeutic Interventions and COVID-19 Vaccine (ACTIV) initiative, a remarkable public-private partnership involving 20 biopharmaceutical companies, education experts and various agencies. Now, a coordinated effort within the U.S. government, called Operation Warp Speed, supports the immediate conduct of these clinical trials and ensures that millions of doses of any successful vaccine will be in a position to make the vaccine effective and safe.
The effects of this first phase 3 trial are expected in a few months. If you are interested in volunteering for these or other prevention trials, contact the new NIH COVID-19 clinical trial network.
There are still many paintings to do and anything can take place in the direction of the final line. But through the combination and construction of the most productive clinical evidence, I am sure that we will face the challenge of ending this pandemic that has devastated so many lives.
Reference:
[1] An mNS SARS-CoV-2 vaccine – Preliminary Report. Jackson LA, Anderson EJ, Rouphael NG, Ledgerwood JE, Graham BS, Beigel JH, et al. Nejm. 2020 July 14 [Publication Print]
Links:
Coronavirus (COVID-19) (NIH)
Dale and Betty Bumpers Vaccine Research Center (National Institute of Allergy and Infectious Diseases / NIH)
Modern, Inc. (Cambridge, MA)
Safety and immunogenicity of the 2019-nCoV vaccine (mRA-1273) for the prophylaxis of SARS-CoV-2 infection (COVID-19) (ClinicalTrials.gov)
“The NIH is launching a network of clinical trials for COVID-19 vaccines and other prevention tools,” NIAID Press Release, NIH, 8 July 2020.
Acceleration of curative interventions and COVID-19 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
So interesting! This indicates years of paintings in various spaces of biology, which converge on a spectacular result and a new and easier approach to making vaccines. I wonder if these other people’s plasma would help COVID-19 patients, such as the plasma of cured patients, especially given what appears to be a high degree of antibodies. I suppose this may not be ethical, as it is a trial, but with the growing instances and desperate documents and patients … The NIH proves its value once again.
Current knowledge shows that the threat of dying from COVID-19 increases particularly with age (over 60-69 years). Antibody responses in older adults also tend to be less physically potent with age, and vaccines don’t look as good when given to people over age 60. Is it planned to check this vaccine and/or others in other people whose age increases? them on the greatest threat of death due to the disease? Are there cohorts of older people planned for healing trials?
… And is there one for the overall lack of CD8 response?
This is news Let’s hope this vaccine is for everyone very soon. I’ll review the clinical trials for more information. Thank you Carol Cady RN.
NIH, as expected, advanced the search for a Covid 19 vaccine! Glory!
HATS TO ALL LEADING SCIENTISTS FOR THEIR COLLABORATIVE PRACTICES. I HAVE TESTIFIED FOR YEARS AS INNI CLINICAL RESEARCH THANK YOU AT NIH CLINICAL CENTER (3NW)!
The response of CD8 T cells is zero: it does not question the RNA technique, because the explanation of why to go in that direction is to get just that. The merit of this high-risk experimental technique on the traditional technique for protein vaccine would be questionable
Will other people over the age of 60, with a pre-existing condition, receive an “approved” Covid 19 vaccine when available, or even a level 3 clinical trial?
Congratulations to NIAID and Dr. Collins on the advance with MRM! America is fortunate to have committed scientists who have put their noses on the millstone to find a solution… my prayers and the most productive desires for their continued success!
Perhaps the contagion of the newly disseminated (expired) virus can also be mitigated if positive patients inhaled n-acetylcictein … My speculation is that the integrity and orientation of the complex protein is based on at least one disulfide bond. Theoretically, if this disulfide is canceled, the complex protein will not bind gently to ACE2 and decrease its transmission (especially to physical care workers) and possibly also decrease the spread in the lungs.
I have a good physical condition, I am 68 years old, I have no physical condition problems, would it help? I live in az
Hello Teresa, thank you for your note. You may need the COVID-19 prevention network. Here’s the internet address: https://www.coronaviruspreventionnetwork.org/
Thank you Dr. Collins and Dr. Fauci. As someone who has worked hard for more than 8 years on NHLBI’s award-winning (and effective) Heart Truth for Women crusader under Bush 2, we hope this will also build on the wonderful physical fitness public communication functions that Dr. Fauci and the NIAID are so fluid and able to deliver. The country obviously wants it. Get on with the smart job. We help you.
I sense that minorities with fitness disorders are necessary for the study. How can I participate in the study?
Thank you so much for your interest, Gaynelle! You can learn more about vaccines and prevention trials here: https://www.coronaviruspreventionnetwork.org/
So interesting! This indicates years of paintings in various spaces of biology, which converge on a spectacular result and a new and easier approach to making vaccines. I wonder if these other people’s plasma would help COVID-19 patients, such as the plasma of cured patients, especially given what appears to be a high degree of antibodies. I suppose this may not be ethical, as it is a trial, but with the growing instances and desperate documents and patients … The NIH proves its value once again.
A2: Henrietta cells have played a leading role in thousands of discoveries. They were a tool for my own … https://t.co/ksC4If64Ys two days ago
American innovators answered our call! #RADx of the NIH awarded 7 contracts to millions of COVID19 tests plus … https://t.co/HF5KNx4tpq 3 days ago
In initial funding through NIH @UCSF School of Pharmacy, researchers found that some of the so-called “inert” ingredients … https://t.co/RUHFDeb72n 4 days ago
Kendall Morgan, Ph.D.
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