FDA clears for use in children 12 to 15 years old – fr

FDA clears for use in children 12 to 15 years old – fr

The Food and Drug Administration on Monday approved Pfizer and BioNTech’s request to allow their Covid-19 vaccine to be given to children ages 12 to 15 in emergencies, allowing states to vaccinate middle school students before fall.
The U.S. agency that clears the vaccine for use in adolescents will also speed up the nation’s efforts to reduce infections, according to public health officials and infectious disease experts.

The two-dose vaccine is already approved for people 16 years of age and older. The Centers for Disease Control and Prevention’s vaccine advisory committee has scheduled a meeting for Wednesday to review vaccines for children. If approved by the CDC as planned, it could be distributed to teens as early as this week.

Acting FDA Commissioner Dr Janet Woodcock said the move brings us one step closer to a return to a sense of normalcy and the end of the pandemic. She assured parents that the agency “undertook a rigorous and thorough review of all available data” before allowing it to be used in adolescents.

The companies said at the end of March that the vaccine had been shown to be 100% effective in a clinical trial involving more than 2,000 adolescents. They also said the vaccine elicited a “robust” antibody response in children, surpassing those in a previous trial in older teens and young adults. The side effects were generally consistent with those seen in adults, they added.

Immunizing children is considered essential to end the pandemic. The country is unlikely to achieve herd immunity – when a sufficient number of people in a given community have antibodies to a specific disease – until children can get vaccinated, officials say. health and experts.

Children make up about 20% of the total United States population, according to government data. Between 70% and 85% of the U.S. population must be vaccinated against Covid to gain herd immunity, experts say, and some adults may refuse to be vaccinated. Although more and more experts are now saying herd immunity looks increasingly unlikely as the variants spread.

White House chief medical adviser Dr Anthony Fauci said in April that the United States could start vaccinating older children against Covid-19 by fall, while children of age elementary school children could start getting vaccinated early next year.

The vaccine will be given in a series of two doses, three weeks apart, the same regimen for ages 16 and older, according to the FDA.

FDA approval for children under 12 could come in the second half of this year. In a slide presentation accompanying the company’s publication of the May 4 results, Pfizer said it plans to seek approval of its vaccine for use in toddlers and young children in September and infants in September. November. The submission process has already started to gain full FDA approval for use in people aged 16 and older, the company said on Friday.

At the end of March, Pfizer and BioNTech launched a clinical trial testing their vaccine in healthy children aged 6 months to 11 years. Moderna and Johnson & Johnson, whose vaccines are licensed for people 18 and older, are also testing their vaccines in younger age groups.

The FDA’s announcement also comes amid President Joe Biden’s efforts to reopen schools for in-person learning. The Biden administration has already said it will spend $ 10 billion on Covid testing for schools to speed the return to in-person learning across the country.

Immunized children can also give the green light to extracurricular extracurricular activities such as sports, art, and other in-person activities.

While parents may feel relieved that their children can get the vaccine, some health experts have questioned whether doses should be reserved for children, who are considered to be at less risk of serious illness, while more people need to be vaccinated. risk in the world are not protected.

Dr Craig Spencer, director of global health and emergency medicine at Columbia University Medical Center, said there was no need to choose between immunizing children and distributing vaccines to the rest of the world. The United States can do both, he said. But he added that he was frustrated that the United States had not focused more on vaccinating the rest of the world.

“If I were to ask you if a 12 year old child with no medical problem or a 57 year old health worker who cares for Covid patients every day should get vaccinated, the answer is very clear, right? “Why does this calculation change when it comes to a health worker from another country? “


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