https://www.nytimes.com/2021/09/20/health/covid-children-vaccine-pfizer.html
https://www.statnews.com/2021/09/20/pfizer-covid-19-vaccine-children/?utm_content=buffer45f59&utm_medium=social&utm_source=twitter&utm_campaign=twitter_organic
this seems rather underwhelming ngl
Quote:
Given how rarely children become severely ill, the trial was not big enough to draw meaningful conclusions about the vaccine's ability to prevent Covid or hospitalization. Instead, the researchers relied on measurements of the youngsters' immune response, on the assumption that the protective levels of antibodies seen in older people would be as protective in younger children.
The children who got the vaccine produced a strong immune response, comparable to the levels of antibodies seen in the earlier trials of participants aged 16 to 25 years. But children in the 5- to 11-year-old group achieved this response with 10 micrograms of the vaccine, a third of the dose given to older children and adults.
At higher doses, the researchers observed more side effects in younger children, including fever, headache and fatigue, although none were severe, Dr. Gruber said. With the 10-microgram dose, "we're actually seeing after the second dose, less fever, less chills than we see in the 16- to 25-year-olds."
https://www.statnews.com/2021/09/20/pfizer-covid-19-vaccine-children/?utm_content=buffer45f59&utm_medium=social&utm_source=twitter&utm_campaign=twitter_organic
Quote:
Outside experts viewed the data as positive, but limited.
"It's not a lot to go on, but what we do have to go on looks great," said Kathleen Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine. "A lower dose of this vaccine in children appears as good as the higher dose in older children and adults."
Pfizer's press release did not include any data on the extent to which the vaccine reduced the chances that children would become sick. Gruber said that there were not enough cases of illness to tell. But outside experts said it was reasonable to assume that similar levels of antibodies would mean similar protection from disease.
John Moore, a professor of microbiology and immunology at Weill Cornell Medical College, emphasized that the FDA will be able to analyze both safety and efficacy data from the vaccine. "The bigger dimension is what they're going to have available for safety assessments because of course that's going to matter," Moore said.
One worry could be cases of myocarditis, an inflammation of the heart, that have been seen, albeit rarely, in adults. These have occurred only once in every tens or hundreds of thousands of vaccine administrations. But no clinical trial is going to be big enough to give an accurate study of such a rare risk.
"It appears that children in the five to 11 year old age group are the least likely to have severe outcomes of Covid," said Neuzil, citing recent data from the Centers for Disease Control and Prevention. "So not that it's not important and not that it's not a disease worth preventing, but if your severe outcomes are lower, then you're going to have a higher bar for the vaccine performance. You're going to want to be very careful about safety issues."
But that has to be balanced against the risk of Covid-19, experts said. Recent data show more infected children are being hospitalized, and more are ending up in intensive care units. It is no longer just children who have other ailments that are becoming sick, they said.
Neuzel said that she believed that risks could best be dealt with by making sure that parents understand them, and are making an informed choice for their children.
"If this misperception that children do not get affected persists, some people could think it's not necessary to vaccinate children or this smaller risk of side effects could be enough to not vaccinate children," said Flor M. Munoz, an associate professor of pediatrics at Baylor College of Medicine and an investigator in the trial. "We have a different pandemic now than the pandemic we had in 2020."
That means a decision has to be made on more limited data than regulators might like.
"We're stuck between an urgent need for a vaccine and the uncertainty that comes about with making decisions on modest studies," said Andrew T. Pavia, the chief of the division of pediatric infectious disease at the University of Utah. Assuming that the safety and efficacy data hold up when closely examined, Pavia said he thinks the best option is to go ahead and to continue to track rare side effects among people who choose to receive the vaccine.
Gruber, the Pfizer executive, emphasized that public health authorities will have to be the ones to judge whether Pfizer's data are enough to authorize its lower dose vaccine for children.
But Gruber argued that it is important to think of the benefits of the vaccine beyond just preventing severe illness.
"Until we actually get control of the pandemic and children are felt to be protected, there are still going to be significant restrictions in terms of masking, after-school activities, all the things that allow children to be children," said Gruber. "You know, I'm a pediatrician. I see the vaccine as liberating. To allow people to get back to their normal lives, that particular aspect can't be lost in all of this."
this seems rather underwhelming ngl
