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FDA’s Approach for Children Under 5 Years COVID-19 Vaccine

FDA’s Approach for Children Under 5 Years COVID-19 Vaccine

 


Unvaccinated people are at greatest risk of acquiring SARS-CoV-2 and are dramatically more likely to suffer serious illness or death as the United States passes an unthinkable 1 million COVID 19 deaths. It’s getting higher.

About two-thirds of eligible Americans are fully vaccinated, with nearly 80% receiving at least one dose, but only about 30% of those eligible for a booster dose. I am. Moreover, the need for a safe and effective COVID-19 vaccine for children under the age of 5 continues.

It all says, “There is some work to be done here to educate the general public about the importance of getting the latest information on the COVID-19 vaccine.” Susan R. Bailey, MDThe former President of AMA said during AMA:COVID-19: What Doctors Should KnowWebinar on the latest information on the second booster and pediatric vaccines.

“In order for patients to be able to answer their questions, first, as a physician, we will deepen our understanding of the vaccine and booster development process, the relevant scientific rigor, and how their effectiveness will help in the fight against COVID-19. You need to make sure you understand, “said Dr. Bailey, the moderator of this webinar.

At the Webiner, Peter Marks, MD, and PhD, directors of the Food and Drug Administration’s (FDA) Center for Biopharmaceutical Evaluation and Research, discussed pediatric COVID-19 vaccines, the latest COVID-19 vaccine booster, and Johnson changes. .. & Use of Johnson vaccine.

Learn why Dr. Marks was in it Seven people commended by AMA for their work during the COVID-19 pandemic..

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“There are completed exams from two sponsors in the process of submission and review, and we are working as quickly as possible to review these. We are fully ready to review the data by June. I’m looking forward to it, “he added. “But I’ve heard so much from my parents how hungry these vaccines are, so I’m not going to withhold anything here.”

“We have to do it right, because we need to feel that our parents are confident in vaccination of their children,” said Dr. Marks. ..

this”AMACOVID-19 updateCOVID-19 vaccine for young children..

“Additional vaccination can improve immunity and prevent potentially serious complications such as hospitalization and death, emergency department and emergency care visits, and long-term COVID-19,” said Dr. Marks. increase. “Preventing long COVID-19 may be one of the important things that vaccination can help, as additional data will emerge regarding the neurological complications of COVID-19 and its potential effects on the brain. There is sex.

“We know that vaccinated people, even if they are infected with COVID-19, tend to have a lower incidence of subsequent long-term COVID,” he added.

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FDA recently revised Johnson & Johnson COVID-19 The vaccine “Emergency Use Authorization Based on the Continued Occurrence of Thrombosis with Thrombocytopenia Syndrome,” said Dr. Marks. “We have found that one million doses of vaccination cause about 3.5 times, which is extremely rare.

“Unfortunately, it is associated with about 1 death per 2 million doses, which are clearly due to vaccination,” he added. “This is the situation in the United States using mRNA vaccines, and there are currently hundreds of millions of doses in which similar risks cannot be identified.”

Therefore, “Vaccine this for individuals who could not take one of the mRNA vaccines because they were not clinically appropriate for either an allergic reaction or myocarditis, or because they did not want to take the mRNA vaccine. I felt it was appropriate to narrow down to, “Dr. Marks said.

Please visit to get the latest informationAMACOVID-19 Resource Center for PhysiciansIt features frequently updated information on clinical questions, advocacy, medical ethics, and more.

Sources

1/ https://Google.com/

2/ https://www.ama-assn.org/delivering-care/public-health/how-fda-s-approaching-covid-19-vaccines-kids-under-5

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