The timing of the latest COVID-19 surge is not good for children. Millions have already started the school year, and the rest will start in the coming weeks. The COVID-19 vaccine is not yet available to 50 million Americans who have not reached their 12th birthday.
Vaccine availability does not stop this pediatric outbreak. However, it will help control the spread of the virus in everyone and will give many families a better sense of how to plan for the future. That’s why parents, teachers, and pediatricians want to know exactly when the youngest Americans will be shot as we rush towards the fall. The timeline is still uncertain, but the government and vaccine makers have provided tips to help us understand how the process evolves.
Vaccines for young children are most likely to be approved through the same emergency use mechanism that allowed adults to take shots from December last year. This process is a bit of a push-and-pull between the vaccine manufacturer and the government. Companies need to recruit participants, conduct clinical trials, collect data, and submit that information to the government. The FDA needs to inform you of the type, amount, and schedule of data your company is looking for. Once the FDA grants an emergency use authorization, the CDC should consider and provide recommendations to national physicians and public health agencies on when and how to use shots. (The latter step was completed in just one day after the FDA approved the Pfizer, Moderna, Johnson & Johnson vaccines for adults.)
Not everyone involved has complete control over how long it takes, but it does have some control. A Pfizer spokesperson told me that the company plans to submit EUA applications to groups aged 5 to 11 and groups aged 6 months to 5 “by the end of September.” Shortly thereafter. Then the FDA grabs the reins. After submitting the application in June, Moderna, aged 12 to 17 years old, still awaiting US approval for the vaccine, did not respond to a request for comment.But the company recently Told CNBC According to the document, “We need a package to support winter 2021 / early 2022 approval.”
The FDA says it expects the vaccine to be available to children under the age of 12 on the “Autumn or Winter Timeline” since May. But it doesn’t offer much in the way of updates. When asked the agency for the best estimate of when to issue an emergency license for Pfizer or Moderna shots for young children, the spokesperson shared comments made by the director of the agency’s Biologics Evaluation and Research Center. Did it. In early July, he showed that he was expecting results from clinical trials “late this year.”
As we approach that amorphous deadline, we can keep an eye out for signs of progress. The first milestone occurs when clinical trials of vaccines for children stop accepting new participants. When that happens, company researchers can devote themselves to assessing the exam itself. (By the way, Pfizer completed registration for 12-15 years old on January 22nd and submitted an application to the FDA on April 9th.) As of today, both Pfizer and Moderna exams are still “recruited.” Is listed as. National Library of Medicine clinical trial database.You can check their status here When here, Each. A more obvious milestone is reached when either vaccine manufacturer submits an EUA application. (Pfizer’s 12 to 15 year old application was approved on May 10, one month after the company submitted it.)
At the end of last month New York Times Pfizer and Modana Extend the recruitment phase of clinical trials At the FDA’s request, we are concerned that there is sufficient sample size among young children to detect rare side effects. Institutional critics, including the leadership of the American Academy of Pediatrics, Arguing This demand for more participants will prolong the approval process longer than necessary and prolong the harm caused to children. No I will give them a vaccine.
The exact time it takes for additional hires is not clear. Saad Omer, director of the Yale University Institute for Global Health, said some of his friends and colleagues working on clinical trials said their parents were eager to enroll their children, so the new directive is things. Told me that it might not be too late. He said the real limiting factor is the amount of follow-up the FDA wants from these new participants. Authorities have not published the exact time period required by pharmaceutical companies for pediatric trials.and Guideline document Studies of all age groups since June recommended at least 6 months of data on adverse events after each injection before a full license was granted. This is the interval to return the process to February. Of course, an emergency use authorization may be granted sooner. After all, authorities approved adult shots last year after just two months of safety data. However, there is no guarantee that it will be equally tolerant of adverse data for young children.
The current surge in pediatric cases also does not help the trial.Virus epidemic last fall Speeded up adult vaccine trialsThis is because pharmaceutical companies have more cases of COVID-19 in their datasets, which means there is more evidence to prove that the shots were effective. However, the same rigorous equation does not apply to the safety data most relevant to children, as the presence or absence of adverse effects does not depend on people’s illness.
Could these questions not be answered months ago just by starting clinical trials in children earlier? Delays are frustrating, but they are a common phenomenon in drug testing and tend to start with healthy adults and expand to include other populations. Nahid Badelia, director of the Center for Emerging Infectious Diseases Policy Research at Boston University, said that people with immunodeficiency, pregnancy, or under the age of 18 tend to be left out of the trial, both for difficulty in hiring and for reasons. There is. ” Recognizing that they are at higher risk from potential side effects.
Even if all children in the United States are vaccinated today, not all children in the United States can be vaccinated immediately. Two months ago, more than half of parents aged 3 to 11 were one Research Their children said they were unlikely to get a shot when it became available. And even if all American children received jabs today, their immunity did not ripen until the end of Workers’ Day. Vaccines under the age of 12 cannot eliminate anxiety in the new semester.
In the meantime, strategies learned to be used throughout the pandemic will keep children safer. masking, Quality ventilation, Frequent testing, and Vaccination many adults And as much as possible, all adolescents help reduce the case rate of children. It, in turn, helps keep many of them away from the hospital and avoid the as-yet-unknown long-term consequences of the virus.
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