Portland, Oregon 2022-05-23 07:36:40 –
The company announced on Monday that three doses of Pfizer’s COVID-19 vaccine could provide strong protection for children under the age of five. Pfizer plans to provide data to US regulatory agencies later this week as a step towards getting young children to take shots.
The news comes after months of waiting for parents to vaccinate their babies, toddlers and preschoolers, especially as the number of cases of COVID-19 is increasing again. 18 million tonnes under the age of 5 is the only group in the United States that is not eligible for COVID-19 vaccination.
The Food and Drug Administration has begun evaluating data from rival Moderna. It hopes to start offering two kid-sized shots by the summer.
Pfizer had a hard time understanding that approach. It aims to give Tot an even lower dose (only one tenth of what adults receive), but during the exam, the two shots do not seem to be strong enough for preschoolers. I found out that As a result, researchers gave a third shot to more than 1,600 adolescents aged 6 months to 4 years during the winter surge of Omicron variants.
In a press release, Pfizer and its partner BioNTech said the additional shots were successful, with sufficient levels of virus-fighting antibodies to meet the FDA’s standards for emergency use of vaccines without safety issues. raised.
Preliminary data suggested that the triple-dose series was 80% effective in preventing symptomatic COVID-19, but they were only calculated by the end of April among study participants. Warned that it is based on 10 cases. The rules of investigation state that at least 21 cases are required to formally determine validity, and Pfizer has promised to update as more data becomes available.
The two companies have already submitted data to the FDA on the first two doses, and BioNTech CEO Dr. Ugur Sahin said the final third-shot data will be submitted this week.
“This study suggests that a carefully selected low-dose 3 microgram vaccine based on tolerability data provides infants with a high level of protection against recent COVID-19 strains.” He said in a statement.
What’s next? Dr. Peter Markes, FDA’s Vaccine Officer, has promised authorities to “act quickly without sacrificing standards” when assessing total doses from both Pfizer and Moderna.
Authorities set a tentative date next month for scientific advisors to publicly discuss each company’s data.
Modena aims to vaccinate small children first. It submitted data to the FDA, saying that Tot will develop antibodies that fight high levels of the virus after two injections, including one-quarter of the dose given to adults. A Moderna study found that efficacy against symptomatic COVID-19 was 40% to 50% during omicon surge, as in adults who received only two vaccines.
Complicating Moderna’s progress is that the FDA has so far only allowed the vaccine to be used by adults.
The FDA is expected to review Moderna’s data on both the youngest age group and studies on teenage and elementary school children. Other countries have already extended Moderna’s shots to children up to the age of six.
COVID-19 is generally not as dangerous to young people as adults, but some children can become seriously ill or even die. And the Omicron variant was particularly devastating to children, with children under the age of five being hospitalized at a higher rate than at the peak of previous delta surges.
It is not clear how much demand is needed to vaccinate the youngest children. Pfizer shots aged 5 to 11 years began in November, but only about 30% of that age group received the first two doses recommended. Last week, US health officials said that for best protection against the latest coronavirus variants, elementary school students need to get booster shots that everyone over the age of 12 should receive.
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