Three doses of the Pfizer COVID-19 vaccine offer strong protection for children under 5 years of age, the company said Monday. Pfizer plans to release the data to U.S. regulators over the weekend to provide footage to children.
The news came after months of anxious waiting from parents desperately trying to vaccinate their babies, young children and preschoolers, especially as COVID-19 cases have risen again. 18 million children under 5 years of age are the only group in the United States who have not yet qualified for vaccination against COVID-19.
The Food and Drug Administration has already begun analyzing data from rival Moderna, which hopes to start offering two child-friendly doughs in the summer.
Pfizer has spent more time understanding its strategy. It aims to give children a lower dose – only a tenth of adults ’income – but during the trial, it was found that two shots didn’t seem enough for preschoolers. So the researchers gave a third blow to more than 1,600 young people – ages 6 months to 4 years – during the winter wave of the Omicron variant.
In a press release, Pfizer and its partner BioNTech said the additional injection meets levels of anti-virus antibodies to meet FDA standards for emergency vaccine use without safety concerns.
According to preliminary data, a three-dose series was 80% effective in preventing COVID-19 symptoms, the companies said, but warned the calculation was based on only 10 cases evaluated in study participants in late April. . The research rules state that at least 21 cases are needed to formally determine effectiveness, and Pfizer has promised an update as more data becomes available.
The companies have already sent data on the first two doses to the FDA and Drs. Ugur ინ ahin, CEO of BioNTech, said data on the latest third dose will be shown this week.
“Research suggests that a low 3 microgram dose of our vaccine, carefully selected based on tolerance data, gives children a high level of protection against the latest strains of COVID-19,” he said in a statement.
არის What is the next step? FDA vaccine leader Dr. Peter Marx promised the agency to “act quickly without sacrificing our standards” in evaluating the total dose of Pfizer and Moderna.
Agency Determines Estimated Dates Next month, its science consultants will publicly review each company’s data.
Moderna tries to be the first to vaccinate children. He Data sent According to the FDA, children develop high levels of anti-virus antibodies after two injections containing a quarter of the dose given to adults. The Moderna study showed that the symptomatic effectiveness of COVID-19 was between 40% and 50% with increasing mycone levels, as well as in adults who received only two doses of the vaccine. .
To aggravate the development of Moderna, the FDA only allows its vaccine to be used in adults.
The FDA is expected to review Moderna data in both the younger age group and studies of adolescents and young children. Other countries have expanded Moderna shooting for children under 6 years old.
Although COVID-19 is generally not as dangerous for adolescents as for adults, some children become severely or die. And in the omicron variant that was particularly severely affected in children, individuals less than 5 years of age were hospitalized at a higher rate than their previous Delta growth spike.
It is not clear what the need is for vaccination in younger children. Pfizer vaccines for children between the ages of 5 and 11 opened in November, but only 30% of this age group received the two recommended initial doses. Last week, U.S. health officials said elementary school children should take amp shots As everyone 12 and older should get, for the best protection from the latest coronavirus variants.
The Associated Press Department of Health and Science receives support from Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.
Source: Huffpost
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