The first Phase 3 clinical trial of a coronavirus vaccine in development by biotech company Moderna together with the National Institute of Allergy and Infectious Diseases (part of the National Institutes of Health), began Monday.
Moderna is among a handful of companies that are funded by the US government under its Operation Warp Speed COVID-19 vaccine program. Three other vaccine trials will be launching Phase 3 trials soon as well – each with 30,000 volunteers as part of Operation Warp Speed.
Israel just signed a contract with Moderna last month to purchase some of its vaccine if all goes well.
This past Sunday, Moderna announced it had received an additional $472 million from the Biomedical Advanced Research and Development Authority to launch its Phase 3 study and develop the COVID-19 vaccine. On the stock market, the price of the company’s shares jumped 11 percent within minutes.
Thus far, the vaccine has been found in its Phase 1 and Phase 2 studies to induce immune responses in all the volunteers in whom it was injected and was generally safe. The side effects that were induced in some of the participants included fatigue, chills, headache, muscle pain and pain at the injection site.
The findings of the Phase 1 study were published in the prestigious New England Journal of Medicine, with the researchers concluding, “The mRNA-1273 vaccine induced anti-SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified. These findings support further development of this vaccine.”
The trial, expected to be carried out with some 30,000 adult volunteers at 89 research sites around the United States, is to determine whether the vaccine is (1) safe, and (2) can prevent symptomatic COVID-19 after a series of two injected doses.
The study is being carried out with placebos and vaccines: volunteers will receive either two 100 mcg injections of the vaccine or two injections of placebo, about four weeks apart. The volunteers will not be told whether they received placebo or vaccine. Neither will investigators.
Phase 3 studies are carried out to test for efficacy and safety, after a medication or vaccine has already cleared Phase 1 and Phase 2 trials for safety, immune responses (in the case of vaccines), double checked again for safety with a larger trial sample and tested for specificity with the target population.
Israel Already on the List
Prime Minister Benjamin Netanyahu told reporters last month that Israel has signed an agreement with Moderna Inc for the future purchase of its potential COVID-19 vaccine.
“The company is advancing its development, they claim they can achieve it by the middle of next year,” Netanyahu said in a statement on June 17. “We hope that they succeed.”
The prime minister added that Israel will also continue its own efforts to develop a COVID-19 vaccine through the Israel Institute for Biological Research as well.