Moderna Has Positive Phase 1 Vaccine Results and Hopes for July Phase 3 Start

Moderna (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

The Moderna vaccine is just phase 1 detection of immune response. Phase 3 starts in July if things go well, and then they have to scale up. This vaccine does not train your immune system to make antibodies. It gives you mRNA so your body can attack the virus. The mRNA is telling your immune system to how to target COVID. Your body does not know what to do. It is good for front line people and people who are very ill to do better but it will be easy for virus to mutate around it.

Based on the interim Phase 1 data, the Moderna-led Phase 2 study will be amended to study two dose levels, 50 µg and 100 µg, with the aim of selecting a dose for pivotal studies. The NIAID-led Phase 1 study is being amended to include a 50 µg dose level cohort across each of the three age groups. Moderna anticipates the dose for the Phase 3 study to be between 25 µg and 100 µg and expects Phase 3 trial initiation in July, subject to finalization of the clinical trial protocol.

“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. “When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”

SOURCES – Moderna Therapeutics, CNBC
Written by Brian Wang, Nextbigfuture.com

8 thoughts on “Moderna Has Positive Phase 1 Vaccine Results and Hopes for July Phase 3 Start”

  1. Don’t get your hopes up. They are still many months away from a generally available vaccine. And they don’t know if the vaccine will be effective.

  2. Yes, and in this period there is a very high proliferation of companies that promise to investors that they will deliver the new coronavirus vaccine. DEVELOPING VACCINES TAKES YEARS AND SOMETIMES DECADES, and it is not due to lack of financial interest. HIV vaccine has yet to be developed. Furthermore even if an effective vaccine could be developed IT WILL STILL TAKE YEARS TO DEMONSTRATE ITS SAFETY especially if it is developed with a new technology. No RNA vaccine has been approved for use in humans and there are indications of possible autoimmune responses. Despite the relevance we cannot and should not expect a CoVid vaccine in few months because we need to be able to asses its safety in the mid/long-term (at least few years).

  3. This vaccine does not train your immune system to make antibodies.

    That’s not ambiguous. It’s just wrong.
    I don’t blame Brian. It must be very difficult to wade through the different jargon used in so many technical fields.

  4. The writing is ambiguous , but I think he meant an uninitiated immune system won’t “see” the virus.

  5. What? Who wrote this? The mRNA expresses viral proteins in your cells that absolutely do “train your immune system” to attack those proteins if they show up on a real virus. It’s a proper vaccine, if it works.

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