The Food and Drug Administration said on Sunday that three doses of the Pfizer-BioNTech coronavirus vaccine would be effective in preventing Covid’s disease in children under the age of five, judging by the level of shot-induced virus-blocking antibodies. Said it seems.
Agency evaluation Posted online prior to Wednesday’s External Vaccination Experts Meeting, summoned to recommend how the FDA should decide to apply for vaccination of the youngest child in the country from both Pfizer and Modana. rice field.
Some public health experts expect the FDA to approve both Moderna and Pfizer vaccines, providing parents with two vaccine options. The Centers for Disease Control and Prevention also needs to review its recommendations after the FDA has acted. The only Americans who are not yet eligible for shots are about 18 million children under the age of five.
In a staff analysis, the FDA said data submitted by Pfizer and its German partner BioNTech suggest that three doses are more effective than two doses. However, officials said it was difficult to reach a definitive conclusion because the number of cases of Covid was so small among the 1,415 children who were vaccinated three times during the clinical trial.
Pfizer said only eight children in the placebo group and two children in the vaccination group became ill. The trial protocol stated that 21 cases are needed to make a validity judgment.
So far, the FDA seems to be positive about the demand for both Pfizer and Modana pediatric vaccines. Parents are so eager to get the youngest child a coronavirus vaccine, and some say they will accept it at a low efficacy rate as long as the vaccine is safe.
In an analysis of Pfizer’s data, the agency said that children under the age of 5 were hospitalized and had higher Covid mortality rates than children aged 5 to 17 years, “of an effective Covid-19 vaccine in this age group. It emphasizes the benefits. “
Authorities also said that among children over the age of five who already qualify for Pfizer’s vaccine, Shot helped prevent hospitalization and other serious consequences. The form of the virus.
“Given the uncertainty of the Covid-19 pandemic and the potential for SARS-CoV-2 infection to continue for the next few months, the deployment of vaccines for children aged 6 months to 4 years is Covid-. It may have beneficial effects on 19. Related morbidity and mortality in this age group, “said the FDA. The agency has identified minimal side effects.
On Friday, the FDA said Moderna’s coronavirus vaccine for children under the age of 6 was also effective in preventing symptomatic infections without causing annoying side effects. The two vaccines are based on the same type of technique, but with different dosages and regimens. Moderna proposes two doses with one-fourth the intensity of the adult dose. Pfizer proposes three doses at one-tenth the intensity of adult shots.
