Children between the ages of 12 and 15 are now eligible to receive Covid-19 booster injections. This is a decision made by the FDA based on the results of a study that was not conducted in the United States, and there was even no study to strengthen the impact on children. This change is based on an analysis in Israel where the vaccine was studied in adults 50 years and older.
According to Monday expansion In the emergency authorization of Pfizer and BioNTech vaccines, children between 12 and 15 years of age can receive booster immunizations five months after receiving the second shot of the primary vaccine series. The five-month interval comes from an analysis of the efficacy of Pfizer’s vaccine in Israel, where the increase in cases last summer prompted officials there to approve a third dose in response to the delta variant. The study included people aged 50 and over who had received two injections at least five months ago.
Of the 843,208 people in the study, 758,118 received the booster immunization with Pfizer vaccine.According to the result Publish In the New England Journal of Medicine at the end of last month, 65 people died in the intensive group, while 137 people died in the non-reinforced group. The results showed that people who received booster vaccination at least five months after the second dose of Pfizer vaccine had a 90% reduction in the death rate due to Covid-19 compared with people who did not boost vaccination. The vast majority of participants in this study are 65 years and older. The death toll reported in the study, whether in the enhanced or unenhanced version, mainly occurred in the elderly group. The authors of the published study pointed out that the limitations of the study included its relatively short 54-day duration and lack of adverse event data.
Other regulatory agencies are implementing Covid-19 booster injections, and the time interval between the main series of injections and booster injections varies from country to country. The United Kingdom allows boosters to be administered three months or later after the second dose of the two-injection vaccination regimen.According to the National Health Service Guidelines, The booster will be Pfizer or Moderna; for those who cannot receive any kind of mRNA vaccine, the booster may be an AstraZeneca vaccine injection.
FDA Acting Commissioner Janet Woodcock said in a conference call with reporters on Monday that the agency made its decision based on data provided by the vaccine manufacturer.
“We have five months of data, and we can reliably predict what will happen in a larger population,” she said. “Hope we can get real-world data from the UK, we can see what this shows. As [Peter Marks, director of the Center for Biologics Evaluation and Research] As I just said, some profit/risk considerations may mitigate the impact on the earlier boost. We don’t know until we get the data. Now, the actions we are taking are based on the information we have. “
The risk/benefit mentioned by Woodcock is myocarditis, which is an inflammation of the heart, a rare side effect observed in some patients (mainly men) with Pfizer and BioNTech vaccines. Max said the risk of myocarditis seems to peak in 16- and 17-year-olds, and 98% of reported cases are mild, leading to one-day hospitalizations that can be treated with non-steroidal anti-inflammatory drugs or acetaminophen. .
“We didn’t see a lasting impact,” Max said. “This is not to say that we don’t care about this and it is not important, but that in this country with a large number of omicron and delta cases, the potential benefits of vaccination in this case are beyond this risk.”
This Pfizer and BioNTech vaccines are the only vaccines fully approved by the FDA So far. This approval applies to people 16 years and older. In May of last year, children aged 12 to 15 received emergency authorization; In October, the agency extended the authorization to children 5 to 11 years oldThe decision on Monday to extend the authorization for enhanced injections to people in the 12 to 15 age group was made about six weeks after the agency’s widespread release Authorization booster For anyone 18 years and older, at least six months after the second injection of the messenger RNA vaccine.
The five-month interval of booster immunization for children aged 12-15 only covers those who receive Pfizer vaccine as the primary vaccine. For those who have received other authorized vaccine injections, the enhancement plan remains unchanged: two months after a single injection of Johnson & Johnson, and six months after two injections of Moderna vaccine. But the November decision on boosters allows mixing and matching, so those who receive Moderna or J&J injections for primary vaccination can receive Pfizer vaccine as boosters.
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