File photo shows Pfizer vaccines. Each Pfizer vial contains six doses for vaccination against the COVID-19 virus. (U.S. AIR FORCE\/SENIOR AIRMAN REBECKAH MEDEIROS)<\/figcaption><\/figure>\nGruber said the companies aim to apply to the Food and Drug Administration by the end of the month for emergency use in this age group, followed shortly afterward with applications to European and British regulators.<\/p>\n
Earlier this month, FDA chief Dr. Peter Marks told the AP that once Pfizer turns over its study results, his agency would evaluate the data \u201chopefully in a matter of weeks\u201d to decide if the shots are safe and effective enough for younger kids.<\/p>\n
An outside expert said scientists want to see more details but called the report encouraging.<\/p>\n
\u201cThese topline results are very good news,\u201d said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. The level of immune response Pfizer reported \u201cappears likely to be protective.\u201d<\/p>\n
Many Western countries so far have vaccinated no younger than age 12, awaiting evidence of what\u2019s the right dose and that it works safely. Cuba last week began immunizing children as young as 2 with its homegrown vaccines and Chinese regulators have cleared two of its brands down to age 3.<\/p>\n
While kids are at lower risk of severe illness or death than older people, more than 5 million children in the U.S. have tested positive for COVID-19 since the pandemic began and at least 460 have died, according to the American Academy of Pediatrics. Cases in children have risen as the delta variant swept through the country.<\/p>\n
\u201cI feel a great sense of urgency\u201d in making the vaccine available to children under 12, Gruber said. \u201cThere\u2019s pent-up demand for parents to be able to have their children returned to a normal life.\u201d<\/p>\n
In New Jersey, 10-year-old Maya Huber asked why she couldn\u2019t get vaccinated like her parents and both teen brothers have. Her mother, Dr. Nisha Gandhi, a critical care physician at Englewood Hospital, enrolled Maya in the Pfizer study at Rutgers University. But the family hasn\u2019t eased up on their masking and other virus precautions until they learn if Maya received the real vaccine or a dummy shot.<\/p>\n
Once she knows she\u2019s protected, Maya\u2019s first goal: \u201ca huge sleepover with all my friends.\u201d<\/p>\n
Maya said it was exciting to be part of the study even though she was \u201csuper scared\u201d about getting jabbed. But \u201cafter you get it, at least you feel like happy that you did it and relieved that it didn\u2019t hurt,\u201d she told the AP.<\/p>\n
Pfizer said it studied the lower dose in 2,268 kindergartners and elementary school-aged kids. The FDA required what is called an immune \u201cbridging\u201d study: evidence that the younger children developed antibody levels already proven to be protective in teens and adults. That\u2019s what Pfizer reported Monday in a press release, not a scientific publication. The study still is ongoing, and there haven\u2019t yet been enough COVID-19 cases to compare rates between the vaccinated and those given a placebo\u2014something that might offer additional evidence.<\/p>\n
The study isn\u2019t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose, mostly in young men. The FDA\u2019s Marks said the pediatric studies should be large enough to rule out any higher risk to young children. Pfizer\u2019s Gruber said once the vaccine is authorized for younger children, they\u2019ll be carefully monitored for rare risks just like everyone else.<\/p>\n
A second U.S. vaccine maker, Moderna, also is studying its shots in elementary school-aged children. Pfizer and Moderna are studying even younger tots as well, down to 6-month-olds. Results are expected later in the year. (With Joshua Santos\/Saipan Tribune)<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"Pfizer said Monday its COVID-19 vaccine works for children ages 5 to 11 and that…<\/p>\n","protected":false},"author":11,"featured_media":352146,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[94],"tags":[666,140,3556,163],"class_list":["post-352143","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-headlines","tag-chcc","tag-commonwealth-healthcare-corp","tag-disease-control","tag-kids"],"_links":{"self":[{"href":"https:\/\/www.saipantribune.com\/index.php\/wp-json\/wp\/v2\/posts\/352143","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.saipantribune.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.saipantribune.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.saipantribune.com\/index.php\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/www.saipantribune.com\/index.php\/wp-json\/wp\/v2\/comments?post=352143"}],"version-history":[{"count":0,"href":"https:\/\/www.saipantribune.com\/index.php\/wp-json\/wp\/v2\/posts\/352143\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.saipantribune.com\/index.php\/wp-json\/wp\/v2\/media\/352146"}],"wp:attachment":[{"href":"https:\/\/www.saipantribune.com\/index.php\/wp-json\/wp\/v2\/media?parent=352143"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.saipantribune.com\/index.php\/wp-json\/wp\/v2\/categories?post=352143"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.saipantribune.com\/index.php\/wp-json\/wp\/v2\/tags?post=352143"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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