JAKARTA - The COVID-19 vaccine developed by the biotechnology company Moderna in partnership with the National Institutes of Health received positive results. In one study, it was explained that the vaccine could induce an immune response in all the volunteers who received it in a phase 1 study.
Launching CNN, Wednesday, July 15, these preliminary results published in the New England Journal of Medicine show that the vaccine works to trigger an immune response with mild side effects such as fatigue, chills, headache, muscle aches, or pain at the injection site. This vaccine is the first candidate in the US for a medical journal to review the vaccine which will later be published.
In particular, all the volunteers developed neutralizing antibodies to the virus at levels similar to those seen in people who naturally recovered from COVID-19, according to the study. Neutralizing antibodies bind to the virus and immobilize it from invading human cells.
The next phase is expected to start at the end of July in the large Phase 3 trial, the final pilot stage before regulators consider whether to provide a vaccine in large quantities. Moderna ensures that everything will go well in the next trial.
"The company remains on track to be able to deliver about 500 million doses per year, and possibly up to 1 billion doses per year, starting in 2021."
The Phase 1 study aims to look at safety and then to look at the immune response, said Dr. Lisa Jackson, a senior researcher at the Kaiser Permanente Washington Health Research Institute in Seattle who was involved in the study. Preliminary data from the previous study were released in May.
"We think the immune response looks promising, but we don't know if the levels we're looking at will actually protect against infection. It's very difficult to know that until you do actual efficacy trials," he said.
Moderna hopes to start further studies on July 27. Moderna's vaccine is also expected to be the first vaccine in the United States (US) to begin Phase 3 trials.
For now, new studies provide quick information with which to determine what doses to use for Phase 2 and Phase 3 trials. Phase 1 studies typically study small numbers of people and focus on whether the vaccine is safe and elicits an immune response.
In Phase 2, clinical studies are expanded and vaccines are given to people who have characteristics such as age and physical health, similar to people who are targeted for the new vaccine. In Phase 3, the vaccine is given to thousands of people and tested again for efficacy and safety.
"What do we really want to know? We want to know if a vaccine is safe and effective, that's what we want to know," said Dr. Paul Offit, a member of the panel that established the framework for vaccine studies in the US, was not involved in the study.
"Then we don't know anything about efficacy, which we really want to know. Is this vaccine going to work? The only way to find out is to do what's called a Phase 3 trial," he concluded.
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