The first phase 3 clinical trial of a vaccine against coronavirus in progression through the biotechnology company Moderna in collaboration with the National Institute of Allergy and Infectious Diseases (part of the National Institutes of Health) began on Monday.
Modern is one of the few corporations funded through the U.S. government. Through its Operation Warp Speed COVID-19 vaccine program. Three more vaccine trials will soon be launched, with 30,000 volunteers as a component of Operation Warp Speed.
Israel has just signed a contract with Moderna last month to buy a component of its vaccine if all goes well.
On Sunday, Moderna announced that it had earned another $472 million from the Advanced Biomedical Research and Development Authority to launch its Phase 3 and expand the COVID-19 vaccine. In the inventory market, the company’s percentage value increased by 11% in a matter of minutes.
To date, the vaccine in its Phase 1 and Phase 2 studies has been found to induce immune responses in all volunteers where it was injected and was safe. Side effects induced in some of the participants included fatigue, chills, headache, muscle aches and pain at the injection site.
The effects of the Phase 1 study were published in the prestigious New England Journal of Medicine, which concludes: “The mNR-1273 vaccine induced immune responses opposing SARS-CoV-2 in all participants, and no protection disorders restricting the trials have been identified. . These affect the additional progression of this vaccine. »
The trial, which is expected to be conducted with about 30,000 adult volunteers at 89 study sites in the United States, aims to determine whether the vaccine is (1) safe and (2) can prevent you from symptomatic COVID-19 after a series of two injections. . Dose.
The test is done with placebos and vaccines: volunteers will get two injections of one hundred mcg of the vaccine or two placebo injections, with an interval of approximately 4 weeks. Volunteers will not be notified if they have won a placebo or a vaccine. Neither do the investigators.
Phase 3 studies are conducted to determine efficacy and protection, after a drug or vaccine already has phase 1 and phase 2 legal trials for protection, immune responses (in the case of vaccines), dual protection control with a larger pattern, and specificity education with the target population.
Israel, already on the list, Prime Minister Benjamin Netanyahu told reporters last month that Israel had signed an agreement with Moderna Inc for the long-term acquisition of its possible COVID-19 vaccine.
“The company is advancing its development, they claim to be able to achieve it until the middle of next year,” Netanyahu said on June 17. “We hope they succeed.”
The Prime Minister added that Israel will also continue its own efforts to expand a COVID-19 vaccine at the Israeli Institute for Biological Research.
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