Pfizer says the Covid vaccine stimulates a strong immune response in young children

The Pfizer-BioNTech coronavirus vaccine has been shown to be safe and highly effective in infants aged 5-11, the two companies announced early Monday morning. This news should help relieve months of anxiety between parents and teachers about the potential protection of children and their close contact from the coronavirus.

The need is urgent: kids now explain 1 or more in 5 new cases, And a highly contagious delta variant sent More children enter the hospital The intensive care unit for the past few weeks is better than any other time in the pandemic.

Pfizer and BioNTech will apply to the Food and Drug Administration by the end of the month for permission to use the vaccine for these children. If the regulatory review goes as smoothly as for older children and adults, millions of elementary school children can be vaccinated before Halloween.

According to Dr. Bill Gruber, senior vice president and pediatrician at Pfizer, test results for children under the age of five are not expected until the fourth quarter of this year at the earliest.

Pfizer and BioNTech published their results in a statement that did not include detailed test data. The findings have not yet been peer-reviewed or published in scientific journals.

However, experts said the new results are consistent with those seen in older children and adults.

Dr. Christine Oliver, a pediatrician and vaccine expert at Mount Sinai Hospital in New York, said: “We were waiting for these children to be protected.”

Children are at a much lower risk of Covid-19 than adults, even when exposed to the delta mutation. Still, some infected children Life-threatening condition It is called pediatric multisystem inflammatory syndrome, or MIS-C.Yet others may have Prolonged symptoms For several months.

About 30,000 children Hospitalized for Covid In August; the states with the least vaccinations reported the highest rates. At Seattle Children’s Hospital, about half of the children admitted to Covid are 12 years of age or older, said Dr. Danielzer, a pediatric infectious disease expert at the hospital.

“I was disappointed by the fact that the most ill children infected with acute Covid-19 or MIS-C in our hospital are those who may have been vaccinated,” Zerr said. The doctor said.

School reopening is fueling a surge as the ideological battle over masking and vaccine obligations takes place in the community. In Mississippi, nearly 6,000 students were virus-positive in a week in a state without mask mandates, requiring more than 30,000 students, teachers, and staff to be quarantined.

In a county in South Carolina where mask obligations were banned, more than 2,000 students had to be quarantined daily. Distance learning is not an option in many districts, so the safety of medically vulnerable children is subject to the actions of others in many parts of the country.

Unvaccinated children can spread the virus to their families, teachers, and other people with whom they interact regularly, especially grandparents and those vulnerable to serious illness or death, even if they do not get sick themselves. I can do it.

Wearing a mask and good air circulation can significantly reduce viral infections.But children are as likely as adults Infect the virus According to a recent review of evidence by the Centers for Disease Control and Prevention, it is more likely to do so to others and than adults over the age of 60.

The Pfizer trial included 2,268 children between the ages of 5 and 11, two-thirds of whom were vaccinated twice every three weeks. The rest were injected with two saline placebos.

Given that children rarely get seriously ill, this trial was not large enough to draw meaningful conclusions about the ability of Covid or the vaccine to prevent hospitalization. Instead, researchers relied on measuring the immune response of adolescents, assuming that the level of antibody protection found in older people is equally protective in young children.

Vaccinated children produced a strong immune response comparable to the antibody levels seen in previous trials of participants aged 16 to 25 years. However, children in the 5-11 year group achieved this response with a 10 microgram vaccine. This is one-third of the dose given to older children and adults.

Researchers have seen many side effects in young children, including fever, headaches, and malaise, at high doses, but none were serious, Dr. Gruber said. At a dose of 10 micrograms, “actually, after the second dose, there is less fever and less chills than seen at ages 16-25.”

Immune defense weakens with age and side effects become less severe. Dr. Yvonne Maldonado, who leads the study at Stanford University and chairs the American Academy of Pediatrics for Infectious Diseases, said this reduced efficacy is the reason most vaccines are filled in childhood and much lower doses for children. Is often sufficient. Committee.

“You want to reach a sweet spot that is high enough not only to give you the lowest dose that can elicit a reaction, but also to get a good and sustainable antibody response.” She said.

In children under the age of five, only 3 micrograms (one-tenth that of adults) have been tested in the trial and are likely to prove sufficient, she said.

NS Pfizer-Full FDA approval of BioNTech vaccine In August, children aged 12 to 15 years who were still vaccinated under an emergency use authorization were not included. As with adolescents, businesses seek urgent permits from children aged 5-11.

Next, FDA scientists need to weigh the benefits of vaccines against the risk of side effects. In rare cases, the vaccine may cause myocarditis, an inflammation of the heart in adolescents.

However, in a large Israeli study based on electronic health records of 2 million people over the age of 16, Covid Much more likely To cause these heart problems.

FDA to Pfizer-BioNtech and Moderna in July to detect side effects in young children Expand their exam Includes 3,000 children. However, based on the company’s conversation with the FDA, Dr. Gruber said he believed the FDA would turn the vaccine into a green light with the data available so far.

The debate about the risks of vaccines for children aged 6 months to 5 years can be even more noisy than the fierce disagreement about immunity in healthy adults and teens.

“Some people don’t really feel that there is compelling data that people under the age of five need to be vaccinated,” said Dr. Maldonado.

Most children are spared serious post-infection illnesses, but children’s hospitals and ICU units are flooded, but “Why don’t you want to prevent infections that could put your child in the ICU?” She added.