Both companies still had to finish their trials, but the announcements were exciting. A week earlier, Pfizer had released preliminary data showing that its vaccine was ninety per cent effective. Pfizer, working with the Germany-based immunotherapy company BioNTech, was performing similar trials on its own vaccine, with forty-two thousand volunteers. The vaccine was nearly ninety-five per cent effective. Eleven volunteers had developed severe cases all of them were in the placebo group. officials, telling them that, of ninety-five confirmed cases of COVID-19 among trial participants, ninety were in the placebo group. A few days later, the Data and Safety Monitoring Board held a call with Moderna’s management and N.I.H. On the morning of November 11th, Moderna announced that it had hit that threshold. Once a predetermined number of volunteers develop symptomatic cases, the board members take their first peek at the data. No one can see who got what except the members of the Data and Safety Monitoring Board, an independent group of experts appointed by the National Institutes of Health. Half the volunteers receive a placebo, and half receive the vaccine. A Phase III clinical trial for an experimental vaccine is simple, at least in concept. Honeycutt was one of thirty thousand volunteers nationwide, aged eighteen and older, in Moderna’s Phase III trial-the final test of safety and efficacy before a company applies to the U.S. Food and Drug Administration for authorization. Honeycutt hoped that she had got the real thing. After the injection, Honeycutt was kept under observation for thirty minutes, to be sure that it did not trigger an anaphylactic reaction during that time, the vaccine, if that’s what she’d been given, was crossing her cell membranes, into the cytoplasm, where the ribosomes would begin using its code to manufacture a defense against the virus. No vaccine made from mRNA has ever been licensed for commercial use. Developed by the Massachusetts-based biotech company Moderna, the vaccine contains a microscopic chain of messenger RNA, the atom-size instructions for building proteins. Neither of them knew whether the liquid was a placebo or an experimental vaccine known as mRNA-1273. “I believe in helping people.”Ī nurse gave Honeycutt an injection. She also knew that the study needed people from high-risk demographics: over sixty-five, with underlying health conditions. Honeycutt, who lives alone in a tranquil suburb of San Diego-“the kind of place where you know all your neighbors”-had seen friends fall gravely ill. In the seven months since the first cases of COVID-19 had been identified in the United States, 5.6 million people had been infected and a hundred and seventy-five thousand had died. This would be her sixth time volunteering in a clinical trial, and it had never felt more important. Honeycutt, who is sixty-nine years old, with short white hair and a matter-of-fact disposition, spent much of her career as a fund-raiser in the fields of education and science. After a brief screening, a research assistant led her into an exam room, where a doctor administered a nasal-swab test and performed a physical examination. She was volunteer number four hundred and ten out of four hundred and sixty-six that the clinic had recruited to test a potential coronavirus vaccine. On a hot afternoon in August, Debbie Honeycutt walked into the crowded waiting room of the Medical Center for Clinical Research, an experimental-treatment facility tucked inside a squat office building in San Diego.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |