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The U.S. will start giving COVID-19 pictures to 12- to 15-year-olds as Pfizer’s vaccine will get expanded authorization

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There is now an approved COVID-19 vaccine for younger teenagers, paving the way for vaccinations reaching a wider group of Americans at a time when the pace of vaccination is slowing.

The Food and Drug Administration extended emergency approval for BioNTech SE BNTX (-2.14%) and Pfizer Inc.’s PFE (-1.28% COVID-19 vaccine) to 12 to 15 year olds on Monday .

The vaccine was approved for people aged 16 and over in December. In the US, at least 55 million people have been vaccinated with the Pfizer vaccine since then, including about 2 million 16- to 18-year-olds data on disease control and prevention.

It’s also the only COVID-19 vaccine available for 16- and 17-year-olds.

See also: Four COVID-19 vaccines are being tested in children and adolescents. Here’s when to expect a shot for different age groups

The inclusion showed 100% effectiveness in an ongoing placebo-controlled study with 2,260 participants between the ages of 12 and 15 years. (Moderna Inc. MRNA, which also contains a two-dose mRNA-based vaccine, announced May 6 that initial data from its one-dose evaluation of the vaccine in 12-17 year olds showed an efficacy of 96 % showed.)

The FDA said Monday that nothing is different in terms of dosage or the spacing between doses for this new age group.

Last week, federal health officials almost predicted the EEA would be extended to younger teenagers.

“We know kids want to go to camp this summer,” Andy Slavitt, a senior advisor on the country’s COVID-19 response, said Wednesday during a briefing at the White House on Wednesday. “We know parents want them to be safe. We know parents prefer to let this be done – if they want to do this without a mask, vaccinations are the best answer. “

“Over 15,000 local pharmacies will be ready to vaccinate 12-15 year olds,” said Jeff Zients, White House COVID-19 response coordinator, two days later. “And we are working to ensure that more paediatricians and family doctors offer vaccinations in their offices so that young people can be vaccinated so easily and conveniently.”

Pediatricians say they are already answering questions from parents who they say are more concerned about the safety of vaccinations for their children than they are for themselves.

“Many parents are more cautious, asking more questions, and wanting to have all the information at hand and the security they need, even if they have previously accepted or taken the vaccine themselves,” said Dr. Hina Talib. a pediatrician at Montefiore Children’s Hospital, New York City, who specializes in adolescent medicine. “I think this is normal. I think that’s what defines parenting. “

For teenagers, many of the questions have centered on when they can get the shots – “vaccine envy is real,” joked a pediatrician and mother of a 15-year-old – and whether they need a parent to walk with them (they do).

For parents of teenagers, the questions are a little different. They want to know if the vaccine will affect teenagers if they are near or are going through puberty, including changes such as weight gain or starting their periods, or if future fertility could be affected.

See also: CVS is betting on future pediatric vaccine profits as reluctant adults fuel the recent decline in COVID vaccinations

“There’s also a reason we started with this age group,” said Talib. “That’s because their biology mirrors that of adults. When we enrolled children in studies, the strategy was called age de-escalation. “

This means that the vaccines are tested in order of seniority, so to speak. Vaccine manufacturers enroll adults first, then older teenagers, younger teenagers, and then much younger children. For example, Pfizer is expected to share the first batch of clinical trial data for 2-11 year olds in September. For babies and toddlers, these data are expected to arrive in November.

However, the current goal is to start immunizing 12-15 year olds as the number of cases of children continues to grow in the United States. The American Academy of Pediatrics announced that the number of COVID-19 cases in children rose 4% between April 15 and April 15 29.

“Now we are seeing that the disease is actually affecting our younger, adult population because it is still about to be vaccinated,” said Dr. Michelle Medina, pediatrician and one of the directors of the vaccine steering committee at Cleveland Clinic. “And in fact, we are also seeing a huge increase in COVID cases in children.”

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