Moderna Therapeutics and the National Institute of Allergy and Infectious Diseases (NIAID) announced today that the researchers had injected the first volunteer into the first US coronavirus vaccine to reach the final stage of Phase 3 testing.
That person received the vaccine at 6:45 a.m. EST in Savannah, Geo., Said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIH) during a session informative. Because the trial will randomize participants to receive the vaccine or a placebo, and neither the researchers nor the volunteers will know what they received, that person will not know until the data is blinded if he or she was vaccinated against COVID- 19.
Finally, 30,000 healthy people will be immunized with the vaccine or a control to determine how effective the vaccine is at preventing COVID-19.
“The collaboration between NIH and Moderna, with much support from Operation Warp Speed, has reached a point where we have an opportunity to discover in the real world … what the status of the vaccine is in its ability to protect against disease and being safe, “said Dr. Francis Collins, NIH director. Moderna is one of the few companies to receive federal funding through the government’s Operation Warp Speed program to facilitate the development of a COVID-19 vaccine. .
Because this final phase of testing will focus on how well the vaccine works, compared to previous stages that focused on making sure the vaccine was safe, the researchers say they will make an effort to enroll volunteers who have more chances of being exposed to the virus. That includes people in high-risk occupations, such as healthcare workers, as well as people in areas of the US where the virus is spreading rapidly. The current network of 89 test sites matches the areas of the country where the virus is spreading, Fauci said. “I think we will get a good sample of virus activity, or transmission, currently in the country,” he said. That’s important because the more people volunteer in areas where the virus is actively circulating, the more likely those participants will be exposed to the virus. That would help researchers more quickly determine whether people who were vaccinated with the experimental injection had better protection against infection than those who received placebo.
Already, Collins said, a website created to invite people to express interest in enrolling in a trial has attracted 150,000 registered people. Not everyone will qualify for the test, but it is an indication of how much interest and willingness there is to participate, and how quickly the test will reach its volunteer goal.
If the virus continues to circulate widely, Fauci calculated that it might be possible to get a first pass of results as early as November. That schedule represents the few weeks it will take in July and August to reach the goal of enrolling 30,000 eligible volunteers, as well as the time for people in the study to receive the second dose of the vaccine, which arrives 28 days after the first and time to analyze the data. “It is certainly conceivable that if we have a real blast or a rash of infection in those places where we have active enrollment, then we might get a response before November. I doubt it but we leave open that it is a possibility,” he said.
The Moderna and NIAID scientists collaborated to develop the vaccine using a relatively new mRNA-based technology, which contains the genetic instructions for making proteins. The vaccine includes mRNA that encodes the spike protein for SARS-CoV-2, the virus that causes COVID-19. Once people are inoculated, their immune cells recognize the foreign viral mRNA and begin to build up immune responses against it. In theory, if you later expose yourself to the real virus, your immune system will be ready to fight it.
In previous studies, the vaccine triggered antibodies to the virus at levels similar to those found in people infected and recovering from the disease. Subsequent tests showed that the antibodies produced in response to the vaccine could neutralize laboratory versions of SARS-CoV-2. The phase 3 trial just started would be the real-world test of how the vaccine works when faced with the virus.
At the moment, that test will be considered successful if the vaccine is 60% effective in preventing vaccinated people from becoming infected with SARS-CoV-2. That is not as powerful as vaccines like measles, which is 97% effective, but “along with public health measures, [it] It would be a big important step to control this outbreak nationally and globally, “said Fauci.” I would like to see more of [60%] but we will take that amount. “
The researchers will track volunteers for a year to see if they develop any side effects, and scientists will also continue to follow them to track their immune responses for another year to learn more about how long the immunity provided by the vaccine lasts.
Stephan Bancel, CEO of Moderna, said the company has already begun manufacturing doses of the vaccine in anticipation of a positive trial result. “We are increasing manufacturing … and we are on track to deliver 500 million doses in fiscal year 2021,” he said. “The team is working hard to make close to a billion doses next year, and I think a billion doses will be feasible. It’s not yet in the bag, but I think the 500 million is in the bag for next year. “The company has received nearly $ 1 billion in federal funding from the Advanced Biomedical Research and Development Authority to develop its vaccine and complete your final test phase.
Collins said a group of public health experts is working on how to distribute those first doses if they are considered safe and effective. “There will be tens of millions of doses at the time the vaccine is determined to be safe and effective, [but] There will not be enough for everyone, “he said.” There will have to be decisions about who will have priority. “He said the Centers for Disease Control (CDC) Advisory Committee on Immunization Practices, along with a specially convened panel of experts from the National Academy of Medicine will provide guidance on how to prioritize the groups that need the vaccine. “We recognize that COVID-19 has highlighted health disparities that affect populations in the US, where hospitalizations, serious illnesses and deaths have fallen disproportionately on African Americans, Latinos, and Native Americans, and we know that this disease is also a particular danger to older people and people with chronic diseases, “said Collins. “Therefore, if we want to demonstrate the safety and efficacy of this vaccine, we particularly want to make sure that those groups are well represented in vaccine trial enrollment.”
The National Academy panel is expected to provide tentative distribution guidelines for Labor Day, which would then be open to public discussion, and would then form the basis of the recommendations the CDC advisory committee hopes to have ready by the end of September. .
