• Sun. Nov 28th, 2021

Vaccine 5-11 years Pfizer and Moderna: how it works, ‘leaflet’, symptoms

Byeditorial

Oct 26, 2021

Pfizer and Moderna covid vaccine in the 5-11 year range. Is it effective? What is the ‘leaflet’? How does the first and second dose vaccine work? To define the picture, also for effects and symptoms, are above all news from Moderna and Pfizer. “There is no doubt as to how pediatric vaccination will be the indispensable completion of the vaccination campaign” against Covid-19. “It will directly protect adults and children”, says Guido Rasi, former executive director of the European Medicines Agency Ema, scientific director of Consulcesi and consultant to Commissioner Figliuolo on vaccines, trying to clarify whether or not to immunize children. “There are no fears about the vaccine for children between 5 and 12 years old,” explained Franco Locatelli, president of the Higher Health Council and coordinator of the Technical Scientific Committee. Pfizer Pfizer / BioNTech’s anti-Covid vaccine had a efficacy rate of 90.7% in the prevention of symptomatic infection among children aged 5 to 11, according to the data of a clinical study that the American Pfizer presented to the FDA drug agency whose response is awaited. The news bounces on the US media. Children under 12 involved in the trial received a dose of 10 micrograms, one third lower than that given to older populations (30 micrograms). According to the results submitted by the manufacturers to the FDA, the dosage was shown to be safe and the reported side effects were mild. Of the 2,268 children recruited, double the proportion of the placebo group received the vaccine. In the control group, 16 children contracted Covid, while among the vaccinated, 3 became ill: an efficacy of more than 90%. Pfizer submitted the first data in view of a meeting scheduled for next week, in which the advisory committee of the Fda will decide whether to recommend to the agency to grant authorization to Comirnaty in the under 12 bracket. If the FDA says yes, the ball will go to the Centers for Disease Control and Prevention (Cdc) who next month will provide operational indications for the campaign in In children aged 6 to 11, Moderna’s Covid vaccine “shows a robust immune response” and a “favorable safety profile”. Side effects were “mild or moderate in severity”, the most common symptoms being “fatigue, headache, fever and pain at the injection site”. This was announced by the US company, presenting the first data from a phase 2/3 study conducted in this age group. “Positive” data, explains the company in a note. Two 50 microgram doses of the mRna-1273 vaccine were evaluated in the trial. These were “generally well tolerated and showed robust neutralizing antibody titers.” Modern explains that the primary endpoints, immunogenicity targets, have been met and plans to submit “soon, in the short term,” the results to the US FDA. to the European Medicines Agency Ema and other regulatory agencies around the world. The interim analysis shows the results of the KidCove study in children aged 6 to less than 12 years after the two doses of 50 µg. 4,753 participants of this age group were enrolled in this cohort. In the study, the ratio of geometric means (Gmr) of neutralizing antibody titers to Sars-CoV-2, which compared the response in children to the response in young adults from the Phase 3 Cove study, was 1.5, with a rate of seroresponse of 99.3%. These results, argues Moderna, “demonstrate a strong immune response in this cohort of children one month after the second dose.” “We are encouraged by the immunogenicity and safety profile of mRna-1273 in children aged 6 and under. 12 years “, says the CEO of Moderna, Stéphane Bancel. “We look forward to applying for” approval “to regulatory authorities globally and remain committed to doing our part to help end the Covid pandemic with a vaccine for adults and children of all ages.” KidCove is a randomized, observer-blind, placebo-controlled expansion study aimed at evaluating the safety, tolerability, reactogenicity and efficacy of two 50 µg doses of mRna-1273 administered to remote healthy children than 28 days. The study population is divided into three age groups (6 to less than 12 years, 2 to less than 6 years, and 6 months to 2 years). The vaccine was “generally well tolerated, with a safety and tolerability generally consistent with the Cove Phase 3 study in adolescents and adults. Most adverse events were mild or moderate in severity. The most common solicited adverse events were fatigue, headache, fever and pain at the site of injection, “the note reads. Safety data continues to accumulate and the study continues to be monitored by an independent safety monitoring committee. All trial participants will be monitored for 12 months after the second injection to assess long-term protection and safety. Data collection continues. And the company plans to submit the material for peer review and publication in a magazine. The phase 2/3 study continues to enroll children aged 6 months to less than 6 years.