Moderna's COVID-19 vaccine gets key panel's endorsement, is set to become the second cleared by FDA for use in US. A key expert panel recommended Thursday the Food and Drug Administration authorize the COVID-19 vaccine developed by Moderna, which in trials was shown to be safe and 94.5% effective. The FDA is expected to act quickly, with doses potentially reaching states next week. Ref. USAToday.
Moderna says its COVID vaccine found to be 100% effective in children 12 to 15 after the second dose. According to a study released by the company Tuesday, the Moderna vaccine was 93% effective against COVID-19 in children aged 12 to 17 after the first dose and 100% effective two weeks after the second dose, with no cases of COVID-19 reported among vaccinated participants. Moderna said the trial involved more than 3,700 adolescents, two-thirds of whom received the vaccine and one-third of whom were given a placebo. Ref. USAToday.
FDA panel supports Moderna COVID-19 booster shots for older Americans, other adults at higher risk because of their health or profession. The FDA committee voted 19-0 in favor of the recommendation. The Moderna booster shot will be a half-dose of the same vaccine already given. Data showed the lower dose was just as effective with potentially fewer side effects. Ref. USAToday.
Moderna requests FDA emergency use authorization for 4th dose of its COVID-19 vaccine as booster for all adults. Moderna said its request for approval for all adults was made “to provide flexibility” to the Centers for Disease Control and Prevention and medical providers to determine the “appropriate use” of a second booster dose. Source 2k.
Moderna requests FDA emergency use authorization for 4th dose of its COVID-19 vaccine as booster for all adults. Moderna said its request for approval for all adults was made “to provide flexibility” to the Centers for Disease Control and Prevention and medical providers to determine the “appropriate use” of a second booster dose. Source 7u.
FDA panel recommends Moderna's COVID vaccine for youngest kids in US, paving way for vaccinations as early as next week. An FDA advisory committee found Moderna's COVID vaccine safe and effective for children ages 6 months to 6 years old. The vaccine from Pfizer-BioNTech is expected to be recommended for the youngest kids later this afternoon. Vaccinations are planned to begin Tuesday. Source 6g.
Moderna is suing Pfizer and its German partner BioNTech for patent infringement over the companies’ COVID-19 vaccine. Moderna claims Pfizer and BioNTech infringed on patents it filed between 2010 and 2016 related to its “foundational mRNA technology.” A Pfizer spokesman said the company cannot comment as it has not yet been served with the lawsuit. Source 4e.