Your Top Resources for Covid-19 Vaccines
Moderna on Thursday asked the FDA to approve the Covid-19 vaccine for children under 6 years of age. Based on clinical trial data, the company vaccine for children, which consists of two doses of 25 micrograms, was 51% effective against symptomatic infection in children between 6 months and 2 years and 37% effective for children aged 2 to 6 years. . In addition to the vaccine for children under 6 years of age, Moderna also asked the FDA to approve the vaccine for children aged 6 to 11 years and adolescents aged 12 to 17, with a spokesperson saying the company would complete the data submission for these groups over the next two weeks. During a Senate oversight hearing, Peter Marks, who oversees the regulation of vaccines for the FDA, suggested that the agency may consider Moderna applications for children under 18 as a whole rather than individually. Separately, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the FDA could review vaccine data from Moderna and Pfizer-BioNTech at the same time to directly compare the two vaccines and not confuse people. ». According to the New York Times, federal regulators are unlikely to consider Moderna’s application before June, when the FDA’s external advisory committee is scheduled to meet for vaccines for young children. (LaFraniere, New York Times, 4/28, Doherty, Axios, 4/28, AP / Modern Healthcare, 4/28, LaFraniere, New York Times, 4/26)
The FDA on Monday extended its approval for IV antiviral Veklury, also known as remdesivir, to children under 12, making it the first Covid-19 treatment approved for this age group. According to MedPage Today, Veklury is now approved for use in 28-day-olds weighing at least three pounds. The drug can be used either for hospitalized patients or for those at risk of serious outcomes. “As COVID-19 can cause serious illness in children, some of whom currently do not have a vaccination option, there is still a need for safe and effective COVID-19 treatment options for this population,” said Patrizia. Cavazzoni, director of the FDA Drug Assessment and Research Center. “Today ‘s approval of the first COVID-19 treatment for this population demonstrates the body’ s commitment to this need.” (Chen, Axios, 4/25, Reuters, 4/25, Walker, MedPage Today, 25/4)
Covid-19 boost protection after three months, according to a new study by Kaiser Permanente published in The Lancet Respiratory Medicine. For the study, the researchers analyzed Kaiser Permanente patient records between December 2021 and February 6, 2022. In total, there were 11,123 hospital admissions or ED visits and all patients included in the assay had received at least three doses of Pfizer-BioNTech vaccine. Overall, the researchers found that a booster dose was 80% to 90% protective against hospital admissions and ED visits caused by both delta and micron variants during the first three months of administration. However, after three months, protection against micron hospitalization was reduced to 55%, while protection against ED visits was reduced to 53%. “Pfizer BioNTech COVID-19 booster doses significantly improve protection against the micron, although this protection seems to decrease after three months of emergency visits, even for hospitalization,” said Sara Tartof, epidemiologist at the Department of Research and evaluation of the Kaiser Permanente. lead author of the study. “The downward trends in delta-related outcomes were generally similar to omicron but more effective at each point in time than those observed for omicron.” (Carbajal, Becker’s Hospital Review, 4/25)
The shortest known time between individual coronavirus infections is 20 days, according to a case report presented at the European Conference on Clinical Microbiology and Infectious Diseases (ECCMID). According to researchers, a 31-year-old health worker in Spain tested positive for Covid-19 on a PCR test on December 20, 2021. She was fully vaccinated and received a booster dose 12 days earlier. After this positive test, the patient, who was asymptomatic, was isolated for 10 days before returning to work. Then, on January 10, 2022, just 20 days after the initial positive test, the patient began to feel unwell and tested positive on another PCR test. According to the sequence of the whole genome, there were two different variants of the coronavirus, with the first being delta in December and the second being micron in January. “This case underscores the ability of the micron variant to avoid previous immunity acquired either from a natural infection with other variants or from vaccines,” said Gemma Recio, one of the study’s authors. “In other words, people who have had COVID-19 cannot assume that they are protected from re-infection, even if they have been fully vaccinated.” (Gleeson, Becker’s Hospital Review, 21/4, ECCMID Press Release, 20/4)
Pfizer and BioNTech on Tuesday asked the FDA to approve a booster dose of their Covid-19 vaccine for children ages 5 to 11. In a statement, Pfizer said data from a Phase 2/3 test showed that children in this group saw a “strong immune response”. after receiving a booster dose six months after their initial vaccine series. If approved, the dose will be the first souvenir available to children under 12 years of age. However, some health experts have suggested that a third dose may not be necessary for children at this point. “Over time, these two doses may not protect against serious diseases, so it could reasonably be [receive] a third dose, “said Paul Offit, who heads the Vaccine Training Center at Children’s Hospital Philadelphia.” But for now, protection against serious illness seems to persist. According to NPR, CDC data show that only 28.4% of children aged 5 to 11 years are fully vaccinated and only about 35% have received an initial dose. (Chen, Axios, 4/26; Stein, “Shots”, NPR, 4/26; Choi, The Hill, 4/26)
According to the CDC, the prevalence of sub-variable BA.2 is declining in the United States as a new sub-variable continues to spread. For the week ended April 23, BA.2 accounted for 68.1% of all new Covid-19 cases, up from 74.9% in the week ending April 9. In comparison, the sub-variable BA.2.12.1 accounted for 28.7% of new cases 19 cases in the week ending April 23, from 13.7% in the week ending April 9. The researchers estimate that BA.2.12.1 has a 27% growth advantage over BA.2, which is already more contagious than the original omicron variant of BA.1. BA.2.12.1, as well as a related BA.2.12 sub-variable, are currently leading to an increase in Covid-19 cases in New York. According to HHS data, Covid-19 cases nationwide have increased by 53% in the last two weeks since April 25. (Bean, Becker’s Hospital Review, 4/26)
