Moderna coronavirus vaccine shows ‘promising’ safety and immune response results in published Phase 1 study


The Muslim Times has the best collection of articles for the war against Covid 19, especially the vaccines.

By Jacqueline Howard and John Bonifield, CNN

Updated 5:24 PM ET, Tue July 14, 2020

CNN — A Covid-19 vaccine developed by the biotechnology company Moderna in partnership with the National Institutes of Health has been found to induce immune responses in all of the volunteers who received it in a Phase 1 study.

These early results, published in the New England Journal of Medicine on Tuesday, showed that the vaccine worked to trigger an immune response with mild side effects — fatigue, chills, headache, muscle pain, pain at the injection site — becoming the first US vaccine candidate to publish results in a peer-reviewed medical journal
The vaccine is expected to begin later this month a large Phase 3 trial — the final trial stage before regulators consider whether to make the vaccine available.

Moderna noted in a press release on Tuesday that, if all goes well in future studies, “the Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021.”

Face masks have become our new normal, and with these masks, you can make sure you’re doing even more good than usual.

In the Phase 1 study, “the goal was to look at safety and then to look at immune responses,” said Dr. Lisa Jackson, a senior investigator at Kaiser Permanente Washington Health Research Institute in Seattle who was involved in the study. Early data from the study previously was released in May.

“We thought the immune responses look promising, but we don’t know whether the levels we’re seeing would actually protect against infection. It’s really hard to know that until you do the actual efficacy trial,” she said. “So we’re laying the groundwork for the trial that will provide those answers.”

Moderna expects to start the company’s largest study yet of its Covid-19 vaccine candidate mRNA-1237 on July 27, according to details released separately on Tuesday. It’s expected to be the first in the United States to begin Phase 3 trials.

For now, the new study “provided information rapidly that could be used to determine what dose to go forward with Phase 2 and Phase 3 trials. That’s a critically important decision to make and so having that information available so soon after the vaccine trial was initiated is pretty remarkable,” Jackson said.

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Categories: The Muslim Times, Vaccine

5 replies

  1. Moderna’s shares soared after the company said its potential vaccine to prevent Covid-19 produced a “robust” immune response in all 45 patients in its early stage human trial, according to newly released data published Tuesday evening in the peer-reviewed New England Journal of Medicine.

    Moderna’s stock rose more than 16% in after-hours trading on the news.

    All 45 patients produced neutralizing antibodies, which scientists believe is important for building immunity and provided more promising data that the vaccine may give some protection against the coronavirus. In the trial, each participant received a 25, 100 or 250 microgram dose, with 15 people in each dose group. Participants received two doses of the potential vaccine.

    After two vaccinations, the vaccine elicited a “robust” immune response in all participants in all dose cohorts, Moderna said. The company said the levels of neutralizing antibodies in patients in the high dose group were fourfold higher than in recovered Covid-19 patients.

  2. Earlier Tuesday, Moderna announced it would begin its late-stage trial for its vaccine on July 27. The trial will enroll 30,000 participants across 87 locations, according to Participants in the experimental arm will receive a 100 microgram dose of the potential vaccine on the first day and another 29 days later. Some patients will also receive a placebo.

  3. Moderna Inc. MRNA +6.34% said the pivotal study of its experimental coronavirus vaccine began Monday, with the first subjects receiving doses.

    Researchers plan to enroll 30,000 people across the U.S. in the last-stage, or phase 3, trial of the Moderna vaccine candidate. Results will determine whether two doses protects against symptomatic Covid-19, and should be cleared for widespread use.

    The company also received an additional commitment of up to $472 million from the federal government to support the large study, on top of the $483 million in funding earlier in the year for development, testing and preparations to manufacture at large-scale.

    Moderna, which codesigned the vaccine with the National Institute of Allergy and Infectious Diseases, previously reported promising results of the first study of the vaccine, showing it induced immune responses and was generally safe in a small number of people.

    The new phase 3 trial, titled Cove, is being conducted at nearly 90 sites in the U.S., including many in states where the virus has surged in recent weeks.

    No vaccine has proven to work safely against the coronavirus. Many vaccines developed to target other pathogens have failed in testing, including in phase 3 trials.

  4. The study, a Phase 3 clinical trial, is to enroll 30,000 healthy people at about 89 sites around the country. Half will receive two shots of the vaccine, 28 days apart, and half will receive two shots of a saltwater placebo. Neither the volunteers nor the medical staff giving the injections will know who is getting the real vaccine.

    The first shot was given to a person at 6:45 a.m., Dr. Anthony S. Fauci, the nation’s leading infections disease expert, said at a news briefing on Monday.

    Dr. Fauci estimated that the full enrollment of 30,000 people in the trial would be completed by the end of the summer, and that results might be available by November. Even earlier results might be possible, he said, but added that he doubted that would be the case.

    At the news briefing, Dr. Francis Collins, director of the National Institutes of Health, said that at least three more Phase 3 trials would be starting soon, each needing 30,000 patients. Those trials will involve vaccines made by Novavax, by a collaboration of the University of Oxford and AstraZeneca, and by Johnson & Johnson. All are part of the U.S. government’s Operation Warp Speed. A fourth vaccine, made by Pfizer and BioNTech, is also expected to start Phase 3 this month, but is not part of Warp Speed, Dr. Collins said.

  5. White House coronavirus advisor Dr. Anthony Fauci said Monday he is “not particularly concerned” about the safety risk of a potential coronavirus vaccine by Moderna, despite the fact that it uses new technology to fight the virus.

    The vaccine, which entered a large phase three human trial Monday, uses Messenger ribonucleuc acid, or mRNA molecules to provoke an immune response to fight the virus. Scientists hope mRNA, which relays genetic instructions from DNA, can be used to train the immune system to recognize and destroy the virus. While early studies show promise, mRNA technology has never been used to make a successful vaccine before.

    “It’s a novel technology. We are certainly aware of the fact that that there’s not as much experience with this type of platform as there are with other standards,” Fauci, director of the National Institute of Allergy and Infectious Diseases, told reporters on a conference call alongside National Institutes of Health Director Dr. Francis Collins. “I’m not particularly concerned. But I don’t want a lack of severe concern to get in the way that we are keeping an open mind to look for any possible deleterious effects as we get into and through the phase three trial.”

    Scientists could know whether a potential coronavirus vaccine by Moderna works as early as October, but will likely have the full results by November, Fauci said.

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