September 25, 2021

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COVID-19 vaccines for children aged 5-11 Approval before the end of 2021

COVID-19 vaccines for children aged 5-11 Approval before the end of 2021.

COVID-19 vaccines for children aged 5-11 Approval before the end of 2021



COVID-19 vaccines for children aged 5-11 Approval before the end of 2021.

Good news! U.S. FDA officials: Children aged 5-11 are expected to be vaccinated against children’s COVID-19 before the end of this year

Introduction:

According to U.S. Food and Drug Administration (FDA) officials, the COVID-19 vaccine for children aged 5-11 may be available before the end of the year.

Understanding that with the reopening of schools and the infectiousness of the Delta variant, the FDA stated: We assure the public that we are working hard to meet this critical public health need as quickly as possible, and we very much hope that a child’s COVID-19 vaccine will be available in the next few months. For use.

Vaccine test data for children aged 2-5 will also be submitted in November this year. In the next six months, the United States is expected to achieve universal vaccination! The United States’ goal is not to completely eliminate the virus, but to minimize the severe illness rate and fatality rate. It seems that this winter epidemic prevention may be a turning point.

The head of vaccines at the U.S. Food and Drug Administration (FDA) said on Friday that once the required data is obtained, the agency will quickly assess the situation of COVID-19 vaccination for young children and will not cut corners.

Dr. Peter Marks told the Associated Press that he is “very, very hopeful” to be able to vaccinate children aged 5-11 by the end of this year. Maybe earlier: Pfizer expects to submit its research results by the end of September, and Dr. Marks said the agency is expected to analyze the results within a few weeks.

COVID-19 vaccines for children aged 5-11 Approval before the end of 2021.

In the United States, anyone 12 years and older is eligible for the COVID-19 vaccine. But with the reopening of schools and the Delta virus variants causing more and more infections in children, many parents worry about when younger children can be vaccinated. Dr. Scott Gottlieb, former director of the U.S. Food and Drug Administration (FDA), also said: “If we continue to see the acceleration of these children’s infections, especially as the Delta variant moves to the northeast, I think There may be more pressure to try to approve the vaccine as soon as possible.”

Pfizer’s German partner BioNTech told Der Spiegel on Friday: “In the next few weeks, the company will seek to approve the COVID-19 vaccine for children aged 5-11.” The United States makes a second vaccine. The manufacturer Moderna told investors this week that it expects to release data for this age group before the end of the year. The two companies are also testing their vaccines, including 6 months old, but these results will be announced later.

Dr. Marks of the FDA spoke with the Associated Press (AP) on Friday about the steps involved in eliminating pediatric vaccines. For clarity and length, the dialogue has been edited:

Q: Many parents have long hoped to vaccinate children under 12 when the school reopens. Why does it take so long?

Answer: Before you approve a project for a certain age group, you must first research this age group. Children under 12 years old, they are not small adults, they are not. So we really need to study this, and may even change the dose administered-in fact, it is necessary to change the dose.

We must review the data when the FDA submits it to us. We will study it very quickly, and believe that when we use data to study these vaccines will be safe and effective, we can assure parents that the benefits of their children vaccinating one of these vaccines will definitely outweigh any risks.

Q: After the FDA requested the expansion of research on children, the American Academy of Pediatrics (AAP) cited the increasing threat of Delta to children as an example and urged that a decision be made as soon as possible. Why does the FDA need these additional data?

Answer: I am not sure how many different opinions there are. We obviously want to see children between the ages of 5 and 11 vaccinated as soon as possible. But in terms of time, the difference between the smaller data set and the larger data set is not very large, because there are enough voluntary participants here-their parents are very interested in letting their children between 5 and 11 years old Get vaccinated-so it doesn’t take that much time.

I think we will be able to make people better aware that these vaccines are indeed safe and effective for their children.

Q: Can children between the ages of 5 and 11 be vaccinated before the end of the year?

Answer: I am hopeful about this. Very, very promising in this regard.

Q: Once the company submits data, how quickly can the FDA take action?

A: Pfizer issued a public statement saying that they intend to provide us with their data before the end of September. . . We will do a thorough research on this as soon as possible, so that at the end of the day, in the hope that in a few weeks instead of months, we will be able to draw some conclusions again, unless there are discoveries that we do not expect.

Q: How will these trials prove to be effective for children?

A: In children aged 12 to 15, we have seen an immune response that is actually as good as, or even better than, Pfizer’s vaccine, and actually better than children aged 16 and above. So we hope to see similar results.

Q: Will these trials provide information on some very rare side effects, such as heart inflammation that sometimes occurs in adolescents and young adults?

Answer: We will at least know that this is not. . . The incidence is much higher in younger children. We can rule out this possibility. We will also make sure that there are no other side effects that are not seen in the elderly.

Q: The two top vaccine reviewers of the FDA recently announced that they will be leaving. The agency is also evaluating booster injections for adults. Does this make the decision to vaccinate children more difficult?

Answer: I am not worried that we will suffer any delays due to this. . . We will do parallel processing.

Q: There are reports that some parents are looking for adult vaccines for their children. Do you have any suggestions?

Answer: My strongest suggestion is, please don’t do that. Please let us conduct the necessary assessments to ensure that when you vaccinate your child, you are vaccinating your child in the correct dosage and in a safe manner.

If you want to do something for your child now, it is to make sure that you are vaccinated, your family is vaccinated, all people in contact with your child are vaccinated, and your child knows how to wear a mask.

Reference:

https://medicalxpress.com/news/2021-09-fda-younger-kids-shots-year.html

Note: This article aims to introduce the progress of medical research and cannot be used as a reference for treatment options. If you need health guidance, please go to a regular hospital for treatment.

(source:internet, reference only)


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