[ad_1]
Pfizer announced on Wednesday that its COVID-19 vaccine is safe and strongly protective in children as young as 12, a step towards starting vaccines in this age group before they return to school in autumn.
Most of the COVID-19 vaccines deployed around the world are intended for adults, who are more exposed to the coronavirus. Pfizer’s vaccine is licensed for ages 16 and over. But vaccinating children of all ages will be key to ending the pandemic – and helping schools, at least the upper classes, start looking a little more normal after months of disruption.
In the vaccine study of 2,260 U.S. volunteers aged 12 to 15, preliminary data showed that there were no cases of COVID-19 among fully vaccinated adolescents, compared to 18 among those who received dummy injections, Pfizer reported.
This is a small study, which has yet to be published, so another important piece of evidence is how well the injections boosted children’s immune systems. The researchers reported high levels of anti-virus antibodies, slightly higher than those seen in studies of young adults.
The children had side effects similar to those of young adults, the company said. The main side effects are pain, fever, chills and fatigue, especially after the second dose. The study will continue to follow participants for two years for more information on long-term protection and safety.
Boston College’s Dr Philip J. Landrigan said the results are encouraging.
“It’s hard to get kids to comply with masking and distancing, so something that gives them tough protection and pulls them out of the mix of spreading the virus is all for the good,” Landrigan said, who did not participate in the study.
It’s another positive development in the race against the virus even as cases in the United States, at 66,000 new infections per day, rise again and deaths average nearly 1,000 per day. The Director of the Centers for Disease Control and Prevention, Dr Rochelle Walensky, again warned Americans on Wednesday that “we cannot afford to let our guard down.”
Pfizer and its German partner BioNTech plan in the coming weeks to ask the US Food and Drug Administration and European regulators to authorize the emergency use of injections from the age of 12.
“We share the urgency to expand the use of our vaccine,” Pfizer CEO Albert Bourla said in a statement. He expressed “the hope of starting to vaccinate this age group before the next school year” in the United States.
Pfizer is not the only company seeking to lower the age limit for its vaccine. The results are also expected by the middle of this year from a US study of Moderna’s vaccine in young people aged 12 to 17.
But a sign that the results were promising, the FDA has already allowed the two companies to start US studies in children 11 years and under, who work until the age of 6 months.
“We aspire to a normal life. This is especially true for our children, ”BioNTech CEO Ugur Sahin said in a statement.
AstraZeneca started a study of its vaccine in children aged 6 to 17 in Britain last month. Johnson & Johnson are planning their own pediatric studies. And in China, Sinovac recently announced that it has submitted preliminary data to Chinese regulators showing that its vaccine is safe in children as young as 3 years old.
While most of the COVID-19 vaccines in use around the world were first tested on tens of thousands of adults, pediatric studies won’t need to be so large. Scientists have information about the safety of these studies and subsequent vaccinations in millions of additional adults.
A key question is dosage: Pfizer gave participants 12 years and older the same dose adults receive, while testing different doses in younger children.
It is not known how quickly the FDA would respond to Pfizer’s request to allow vaccination from the age of 12. The agency took about three weeks to review and license each of the vaccines currently available for adults. This process included holding a public meeting of outside experts to review and vote on the safety and effectiveness of each shot.
The process for reviewing data in children may be shorter, given the FDA’s familiarity with each vaccine. A spokeswoman for the agency said the FDA had no information to share on how the review worked, including whether additional public meetings would be needed.
Another question is when the country would have enough vaccines – and people to put them in the arms of teenagers – to allow children to start lining up.
Supplies are expected to increase steadily in the spring and summer, as states open up vaccinations to younger, healthier adults who so far have not had a turn.
Children make up about 13% of documented COVID-19 cases in the United States. to a tally from the American Academy of Pediatrics. That’s more than dying from the flu in an average year. In addition, a small number have developed severe inflammatory disease linked to the coronavirus.
Caleb Chung, who turns 13 later this week, agreed to volunteer after his father, a pediatrician at Duke University, presented the option. He does not know if he received the vaccine or a placebo.
“Usually I’m just home doing online classes and there’s not much I can do to combat the virus,” Caleb said in a recent interview. The study “was really a place where I could really help.”
His father, Dr Richard Chung, said he was proud of his son and all the other children who volunteered for the needle sticks, blood tests and other tasks that a study involves. .
“We need the children to do these tests so that the children can be protected. Adults can’t do this for them, ”Chung said.
___
PA video journalist Federica Narancio contributed to this report.
___
The Associated Press’s Department of Health and Science receives support from the Department of Science Education at the Howard Hughes Medical Institute. The AP is solely responsible for all content.
[ad_2]
Source link