For Jacqueline Almeida, next week will not be coming soon.
She has seen her roll her eyes when a friend asks to meet them outdoors. She failed in trying to convince her sister to vaccinate her son. She was told by a stranger on Twitter that putting her daughter in a mask was equivalent to child abuse.
Still, the vaccine for the youngest Americans faced a delay. Almeida, 33, from Franklin, Tennessee, said:
But now there is some good news. The vaccine should be available to a 6-month-old son and a 2-year-old daughter in a few days. A scientific advisor to the Food and Drug Administration on Wednesday recommended the Pfizer-BioNTech vaccine for children aged 6 months to 4 years and the Moderna vaccine for children aged 6 months to 5 years.
The authorities themselves approve the vaccine on Friday, and the Centers for Disease Control and Prevention may follow Saturday. If all goes according to plan, about 18 million children in this age group will be the first to be immune to the coronavirus, the last part of the country’s vaccine strategy.
However, after a series of regulatory delays, only one in five parents plans to immunize their young children immediately. Recent research..
In a letter to FDA authorities in April, nearly 70 scientists provided their own assessments. The delay was preventable. Their argument is technical, but it has broad implications.
According to scientists, authorities and manufacturers have opted to evaluate vaccines by tracking blood levels of antibodies. However, if regulators also consider other parts of the immune system, it may have been clear early on that vaccines can prevent serious illnesses, if not infections in infants.
In particular, scientists argued that vaccine manufacturers should have measured so-called T cells, which can kill infected cells and remove the body of the virus. “We could probably have made another decision about advancing the vaccine early,” said John Welly, director of the Institute of Immunology at the University of Pennsylvania and one of the signatories of the letter. rice field.
“If you don’t measure T cells, you lose most of what’s happening,” he added. “Well, we’re in the next 18 months. At this point, we can put some energy into something like that.”
The FDA declined to comment on the letter, but Dr. Wheely said agency officials called scientists about a month ago to discuss their ideas.
Vaccine manufacturers have conducted extensive trials to measure the effectiveness of vaccines in the prevention of symptomatic infections in adults. However, in a child study, researchers examined blood levels of antibodies after vaccination and compared them to those found in young adults.
The FDA has approved the Pfizer-BioNTech vaccine for children aged 5 to 11 and adolescents aged 12 to 15 using this method, called immunocrosslinking. Children 2-4 years old.
The two companies decided to evaluate whether the third dose improved the performance of the vaccine. Then, during the winter, some infants in clinical trials were infected with the Omicron mutant.
Based on preliminary data on these infections, the FDA said the company would consider approving two doses of the vaccine while continuing the third test. This is the decision that caused the mixed reaction from parents and experts.
However, the number of infections among children increased, the accumulated data did not support the FDA’s decision, and the FDA was urged to cancel the planned review. Omicron variants rampaged across the country, confusing the front and back left parents and leaving the children vulnerable.
The CDC reported in April that about 75% of children could have been infected with the coronavirus by March. Many of them occurred during the Omicron surge. A record number of children have been hospitalized, but still far fewer than adults.
Experts said in an interview that more information about vaccine-generated T-cell immunity could have delivered shots to desperate parents faster and prevented at least some of their hospitalizations.
Antibodies are essential to neutralize the virus during invasion and prevent infection, and can be easily measured with just one or two drops of blood. but, Dozens of quick tests For antibody levels, it takes at least a few milliliters of blood to evaluate T cells and at least one day to test just a few samples.
The inclusion of T cells in vaccine analysis “significantly increases the complexity and cost of research,” said Dr. Camille Cotton, an infectious disease specialist at Massachusetts General Hospital and a scientific advisor to the CDC.
“It’s not as easy as an antibody, but it definitely helps,” she said.
And not everyone is convinced that T cells are an important indicator of immunity. Dr. Miles Davenport, an immunologist at the University of New South Wales in Sydney, said low levels of antibodies alone may be sufficient to prevent serious illness.
“There are no studies demonstrating that levels of vaccine-induced T cells predict either the risk of infection or the risk of serious illness,” said Dr. Davenport.
Nevertheless, epidemiological data show that hospitalizations and deaths in vaccinated people remained relatively low, even as antibody levels declined and infections increased sharply. This suggests that something other than antibody levels protected people from serious illness, Dr. Wheely said.
“The mortality rate was increased only in the very old population, or in people with immunodeficiency, and the T cell response was deficient or inadequate,” he added. “There’s a lot of good situation data out there, but we’re really losing a smoke-breathing gun.”
The University of Pennsylvania’s new initiative may provide several answers.Called Immune Health ProjectThis study simultaneously evaluates the response of T cells to antibodies in immunocompromised patients after vaccination.
Unanswered questions about child immunity may explain why about 40% of infant parents are on the fence about immunity: less than 30% of children aged 5-11 years receive two doses The demand for the youngest child may be even lower.
Monica Lo, 35, the vice-rector of a Seattle school, is hesitant. “The corona vaccination is so quick and quick that I wanted to spend a little more time,” she said.
Both Rho and her husband are fully vaccinated, but her seven-year-old son, Jean, was only vaccinated once in January before the trip to Hawaii was planned. They decided to delay his second dose because of data suggesting that doing so might produce better immunity, Mr. Law said.
The couple also has a two-year-old daughter, and Lo is pregnant with her third child in July. But they have no plans to vaccinate her daughter yet, Mr. Law said: “We will not be in line.”
