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The Pfizer-BioNTech coronavirus vaccine has been shown to be safe and highly effective in young children ages 5 to 11, the companies announced early Monday morning. The news should help alleviate months of anxiety among parents and teachers about when children and their close contacts may be safe from coronavirus.
The need is urgent: Children are now more than one in five new cases, and sent a highly contagious Delta variant more children to hospitals and in intensive care units more in the past few weeks than at any other time in the pandemic.
Pfizer and BioNTech plan to apply to the Food and Drug Administration by the end of the month for authorization to use the vaccine in these children. If regulatory review goes as smoothly as it does for older kids and adults, millions of elementary school students could be vaccinated before Halloween.
Pfizer senior vice president and pediatrician, Dr. According to Bill Gruber, trial results for children younger than 5 are not expected until the fourth quarter of this year at the earliest.
Pfizer and BioNTech announced the results in a statement that did not include detailed data from the trial. The findings have not yet undergone peer-reviewed or published in a scientific journal.
But experts said the new results match those seen in older children and adults.
D., a pediatrician and vaccine specialist at Mount Sinai Hospital in New York. “There will be a lot of parents who will breathe a sigh of relief when they hear this,” Kristin Oliver said. “We expected the protection of these children.”
Children have a much lower risk of Covid-19 than adults, even when exposed to the Delta variant. Nevertheless, a small number of infected children condition involving risk of death It is called multisystem inflammatory syndrome or MIS-C in children. However, there may be others persistent symptoms For months.
Approximately 30,000 children hospitalized for covid in August; the least vaccinated states reported the highest rates. As a pediatric infectious diseases specialist at the hospital, Dr. According to Danielle Zerr, about half of children admitted to Seattle Children’s hospital for Covid are older than 12.
Dr. “I was appalled by the fact that the sickest children in our hospital with acute Covid-19 or MIS-C are those who can be vaccinated,” Zerr said.
The reopening of schools fueled this increase as ideological battles raged over masking and vaccination imperatives in communities. In Mississippi, among non-mask-mandated states, nearly 6,000 students tested positive for the virus in a week, and more than 30,000 students, teachers, and staff had to be quarantined.
A county in South Carolina where the mask requirement is prohibited has had to quarantine more than 2,000 students in one day. Distance education is not an option in many counties, so the safety of some medically vulnerable children in many parts of the country has been the subject of actions by others.
Unvaccinated children can transmit the virus to family members, teachers, and others with whom they interact regularly—grandparents or those who are vulnerable to serious illness or death—even if they don’t get sick themselves.
Wearing a mask and good air circulation can significantly reduce virus transmission. But children are just as likely as adults. transmit the virus According to a recent review from the Centers for Disease Control and Prevention, adults over 60 are more likely to do it than adults.
The Pfizer study included 2,268 children ages 5 to 11, of whom two-thirds received two doses of the vaccine three weeks apart; the remainder were injected with two doses of saline placebo.
Given how rarely children get seriously ill, the trial was not large enough to draw meaningful conclusions about the vaccine’s ability to prevent Covid or hospitalization. Instead, the researchers relied on measurements of young people’s immune response, assuming that the protective antibody levels seen in older people would also be protective in younger children.
Children who received the vaccine produced a robust immune response, comparable to antibody levels seen in previous trials of participants aged 16 to 25 years. But children ages 5 to 11 achieved this response with 10 micrograms of the vaccine, which is one-third of the dose given to older children and adults.
Dr. At higher doses, researchers observed more side effects such as fever, headache and fatigue in younger children, but none were severe, Gruber said. With the 10 microgram dose, “in fact, after the second dose, we see less fever, less chills than we see in 16- to 25-year-olds.”
The immune defense weakens with age and the side effects also become milder. D., who led the research at Stanford University and chair of infectious disease at the American Academy of Pediatrics. This drop in potency is why most vaccines are met in childhood, and why a much lower dose is usually sufficient for children, says Yvonne Maldonado. Board.
“You want to reach the sweet spot where you give the lowest dose that can cause reactions, but also high enough to give you a good, sustained antibody response,” he said.
In children younger than 5 years old, just three micrograms — one-tenth of the adult dose — is being tested in trials and seems likely enough, he said.
Understand the Vaccine and Mask Instructions in the US
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- vaccination rules. On August 23, the Food and Drug Administration Pfizer-BioNTech’s coronavirus vaccine granted full approval It paves the way for people aged 16 and over to increase their tenure in both the public and private sectors. became private companies increasingly mandatory vaccines for employees. Such powers legally allowed and upheld in court appeals.
- Mask rules. Centers for Disease Control and Prevention in July suggested The fact that all Americans, regardless of vaccination status, wear masks in public in areas with outbreaks was a reversal of the guidance it presented in May. See where the CDC guidance applies, and where states created their own mask policies. The battle over masks has become contentious in some states. local leaders defying state bans.
- Colleges and universities. More than 400 colleges and universities require their students to be vaccinated against Covid-19. Nearly all in states that voted for President Biden.
- Schools. Both of them California and New York City imposes vaccination requirements for education personnel. A survey published in August found that many American parents with school-aged children are against compulsory vaccinations for students, but More support for mask missions for unvaccinated students, teachers and staff.
- Hospitals and medical centers. Many hospitals and major healthcare systems require their employees to be vaccinated against Covid-19. By citing increased caseloads fueled by the delta variant and stubbornly low vaccination rates in their communities, even within the workforce.
- New York City. Proof of vaccination is required for workers and customers. indoor dining, gyms, performances and other indoor situations, but the app doesn’t start until September 13. Teachers and other education workers The city’s large school system will need at least one dose of the vaccine by September 27, with no weekly testing option. City hospital staff they should also be vaccinated or undergo weekly tests. Similar rules apply to New York State employees.
- at the federal level. The Pentagon has announced that it will try to make coronavirus vaccines mandatory for the country. 1.3 million active-duty soldiers No later than mid-September. President Biden announced all civilian federal employees would have to get vaccinated against coronavirus or subject to regular testing, social distancing, mask requirements and restrictions on most trips.
NS FDA full approval of Pfizer-BioNTech vaccine Figures for August did not include children aged 12 to 15 who are currently vaccinated under emergency use authorization. As they do for adolescents, companies will seek emergency leave for children ages 5 to 11.
Scientists at the FDA must then weigh the benefits of the vaccine against the risk of side effects. In rare cases, the vaccine has caused myocarditis, an inflammation of the heart, in young people.
But a large Israeli study based on the electronic health records of two million people aged 16 and over has found that Covid’s much more likely to cause these heart problems.
To detect side effects in young children, the FDA announced in July from Pfizer-BioNtech and Moderna. expand your experiments It will cover 3,000 children. But based on the company’s discussions with the FDA, Dr. Gruber said he believes the agency will give the vaccine the green light with the data available so far.
The debate about the risks of vaccination for children aged 6 months to 5 years will be even more intense than the fierce disagreements about vaccination of healthy adults or teenagers.
Dr. “There are some people who don’t really feel there are convincing data that children under five should be vaccinated,” Maldonado said.
While most children have recovered from serious illness after infection, and children’s hospitals and intensive care units are overflowing, “Why don’t you want to prevent an infection that could potentially put your child in the intensive care unit?” she added.
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