Albuquerque, New Mexico 2021-09-20 10:10:34 –
“I think we really have reached the sweet spot,” said Gruber, who is also a pediatrician.
According to Gruber, the two companies aim to apply to the Food and Drug Administration by the end of the month for emergency use in this age group, and soon afterwards to regulatory agencies in Europe and the United Kingdom.
Earlier this month, FDA chief Dr. Peter Marks told AP that once Pfizer submitted the findings, his agency would evaluate the data “preferably within a few weeks” and the shots would be safe enough for young children. He said he would decide if it was effective.
External experts said scientists wanted to see more details, but said the report was encouraging.
“These top-line results are very good news,” said former FDA Vaccine Chief Dr. Jesse Goodman of Georgetown University. The level of immune response reported by Pfizer is reported to be “likely protective.”
So far, many Western countries have been vaccinated over the age of 12 and are waiting for evidence of what the appropriate dose is and that it works safely. Cuba began immunizing children up to the age of two with homemade vaccines last week, and Chinese regulators have cleared two brands up to the age of three.
Children are at lower risk of serious illness and death than older people, according to the American Academy of Pediatrics, but since the outbreak of the pandemic, more than 5 million children have been COVID-19-positive in the United States, at least 460. Is dead. As delta variants dominate the country, cases of children are increasing.
Gruber said he was “extremely urgent” to make the vaccine available to children under the age of 12. “There is a disgusting demand for parents to be able to bring their children back to normal life.”
In New Jersey, 10-year-old Maya Huber asked why she couldn’t be vaccinated as her parents and both teenage siblings had. Her mother, Dr. Nisha Gandhi, a critical care physician at Inglewood Hospital, enrolled Maya in the Pfizer study at Rutgers University. However, the family has not mitigated masking or other viral precautions until they know if Maya has received a genuine vaccine or dummy shot.
Knowing that she is protected, Maya’s first goal is “a large oversleep with all my friends.”
Maya said participating in the study was exciting, even though she was “very scared” about being jabed. But “after getting it, at least you were happy with it and relieved that it wasn’t hurt,” she told AP.
Pfizer said it studied low doses in 2,268 kindergarten and elementary school children. The FDA has called for so-called immune “bridged” research. It is evidence that young children have developed antibody levels that have already proven to be defensive in teens and adults. It was reported by Pfizer in a press release on Monday, not a scientific publication. Studies are still underway and there are not yet enough COVID-19 cases to compare rates between vaccinated and placebo-what may provide additional evidence. mosquito.
This study is not large enough to detect very rare side effects, such as heart inflammation that sometimes occur after the second dose, mainly in young men. The FDA’s mark said pediatric studies must be large enough to rule out higher risks to young children. Once the vaccine is approved for young children, Pfizer’s Gruber, like everyone else, will be carefully monitored for rare risks.
Moderna, the second US vaccine maker, is also studying the shots for elementary school children. Pfizer and Moderna are also studying younger children up to 6 months old. Results are expected later this year.
AP journalist Emma Tobin contributed to this report.
The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.
Pfizer says COVID-19 vaccine works in kids ages 5 to 11 Source link Pfizer says COVID-19 vaccine works in kids ages 5 to 11