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News and Updates
An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
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<blockquote data-quote="imhotep" data-source="post: 25522543" data-attributes="member: 562115"><p>Moderna recently announced the preliminary results on their mRNA vaccine trial in the New England Journal of Medicine. Please find the summary below. FYI, the vaccine candidate is named “mRNA-1273” because it consists of an mRNA (messenger RNA) that encodes the full length, 1,273 amino acid SARS-CoV-2 spike protein. </p><p>The study itself has limitations due to the limited sample size and also older people (above 55) not being included. However, I should say that the results are promising. mRNA vaccines have never been used in humans till now. <img src="/styles/default/xenforo/smilies/default/yes.gif" class="smilie" loading="lazy" alt=":yes:" title="Yes :yes:" data-shortname=":yes:" /> </p><p></p><p></p><p><span style="font-size: 15px"><strong>BACKGROUND</strong></span></p><p>The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019 and spread globally, prompting an international effort to accelerate development of a vaccine. The candidate vaccine mRNA-1273 encodes the stabilized prefusion SARS-CoV-2 spike protein.</p><p></p><p><span style="font-size: 15px"><strong>METHODS</strong></span></p><p>We conducted a phase 1, dose-escalation, open-label trial including 45 healthy adults, 18 to 55 years of age, who received two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 μg, 100 μg, or 250 μg. There were 15 participants in each dose group.</p><p></p><p><span style="font-size: 15px"><strong>RESULTS</strong></span></p><p>After the first vaccination, antibody responses were higher with higher dose (day 29 enzyme-linked immunosorbent assay anti–S-2P antibody geometric mean titer [GMT], 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group). After the second vaccination, the titers increased (day 57 GMT, 299,751, 782,719, and 1,192,154, respectively). After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens. Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events.</p><p></p><p><span style="font-size: 15px"><strong>CONCLUSIONS</strong></span></p><p>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. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number).</p></blockquote><p></p>
[QUOTE="imhotep, post: 25522543, member: 562115"] Moderna recently announced the preliminary results on their mRNA vaccine trial in the New England Journal of Medicine. Please find the summary below. FYI, the vaccine candidate is named “mRNA-1273” because it consists of an mRNA (messenger RNA) that encodes the full length, 1,273 amino acid SARS-CoV-2 spike protein. The study itself has limitations due to the limited sample size and also older people (above 55) not being included. However, I should say that the results are promising. mRNA vaccines have never been used in humans till now. :yes: [SIZE=4][B]BACKGROUND[/B][/SIZE] The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019 and spread globally, prompting an international effort to accelerate development of a vaccine. The candidate vaccine mRNA-1273 encodes the stabilized prefusion SARS-CoV-2 spike protein. [SIZE=4][B]METHODS[/B][/SIZE] We conducted a phase 1, dose-escalation, open-label trial including 45 healthy adults, 18 to 55 years of age, who received two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 μg, 100 μg, or 250 μg. There were 15 participants in each dose group. [SIZE=4][B]RESULTS[/B][/SIZE] After the first vaccination, antibody responses were higher with higher dose (day 29 enzyme-linked immunosorbent assay anti–S-2P antibody geometric mean titer [GMT], 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group). After the second vaccination, the titers increased (day 57 GMT, 299,751, 782,719, and 1,192,154, respectively). After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens. Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events. [SIZE=4][B]CONCLUSIONS[/B][/SIZE] 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. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number). [/QUOTE]
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