The FDA approves its use in kids ages 12 to 15

A group of teenagers who acted as “Covid-19 Student Ambassadors” joined Governor Gretchen Whitmer to receive a dose of Pfizer Covid vaccine at Ford Field to encourage Michigan residents to get their vaccines on Jan. Detroit, Michigan.

Matthew Hatcher | Getty Images

The Food and Drug Administration on Monday approved Pfizer and BioNTech’s motion to allow their Covid-19 vaccine to be given to children ages 12-15 in an emergency so states can vaccinate middle school students before the fall.

The U.S. agency, which grants the use of the shot in teenagers, will also accelerate the country’s efforts to fight infection, say public health officials and infectious disease experts.

The two-dose vaccine is already approved for use in people aged 16 and over. The Centers for Disease Control and Prevention’s Vaccine Advisory Board scheduled a meeting on Wednesday to review the recordings for children. If approved by the CDC as expected, it could be distributed to teens as early as this week.

Acting FDA Commissioner Dr. Janet Woodcock said the decision “moves us closer to a return to a sense of normalcy and an end to the pandemic”. She assured parents that the agency “did a rigorous and thorough review of all available data” before approving it for teenage use.

The companies announced in late March that the vaccine was 100% effective in a clinical study involving more than 2,000 adolescents. They also said the vaccine produced a “robust” antibody response in the children that outperformed that in a previous study in older teenagers and young adults. The side effects were generally consistent with those seen in adults, they added.

Vaccinating children is seen as critical to ending the pandemic. The nation is unlikely to achieve herd immunity – if enough people in a given community have antibodies to a given disease – until children can be vaccinated, health officials and experts say.

According to the government, children make up around 20% of the total US population. According to experts, between 70% and 85% of the US population must be vaccinated against Covid to achieve herd immunity and some adults may refuse to get the shots. Although now more experts say herd immunity becomes less likely as variants spread.

The Chief Medical Officer of the White House, Dr. Anthony Fauci, said in April that the US could start vaccinating older children against Covid-19 from the fall, while elementary school-age children may get their shots early next year.

The vaccine is given in two doses three weeks apart, according to the FDA, with the same regimen according to the FDA for people aged 16 and over.

FDA approval for children under the age of 12 could come in the second half of this year. In a presentation to coincide with the company’s earnings release on May 4th, Pfizer expects to file for approval of its toddler vaccine in September and toddler vaccine in November. The filing process for full FDA approval for people aged 16 and over has already begun, the company announced on Friday.

In late March, Pfizer and BioNTech started a clinical trial testing their vaccine in healthy 6-month-old to 11-year-old children. Moderna and Johnson & Johnson, whose vaccines are approved for people aged 18 and over, are also testing their recordings in younger age groups.

The FDA’s announcement also comes in the context of President Joe Biden’s push to reopen schools for personal learning. Biden’s government has already announced that it will invest $ 10 billion in Covid testing for schools to accelerate returns to face-to-face courses across the country.

Vaccinating children can also give the green light to after-school activities such as sports, arts, and other personal activities.

While parents feel relieved that their children can be vaccinated, some health experts have questioned whether doses should be kept for children who are considered less at risk for serious illness while leaving vulnerable people around the world unprotected.

Dr. Craig Spencer, director of global health and emergency medicine at Columbia University Medical Center, said there need be no either-or choice between vaccinating children and distributing shots to the rest of the world. The US can do both, he said. But he’s frustrated that the US has stopped focusing on getting the rest of the world vaccinated.

“If I were to ask you whether a 12 year old with no medical problems or a 57 year old healthcare worker who cares for Covid patients every day should be vaccinated, the answer is very clear, right?” he said. “Why does this calculation change when it comes to a health worker from another country?”

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