COVID-19 manufacturers, Pfizer-BioNTech, announced a change in its application to the US Food and Drug Administration (FDA) for the use of the vaccine under 5 years old. In the statements made, it was stated that the application for emergency use approval was frozen until the results of the three-dose trial were released.
emerged in the past few months Omicron The rapid spread of its variant in Turkey and in the world has increased the devastating effects of COVID-19, which has been in our lives for almost two years, to high levels again. As we all know, scientists emphasize in every statement they make that vaccines are still our biggest weapon in the fight against the disease.
Of course, considering the contagiousness of the disease, experts underline that every age group should be vaccinated. One of the most used vaccines in the world in recent months. Pfizer/BioNTech We mentioned that the COVID-19 vaccine has been approved by the US Food and Drug Administration (FDA) for the ages 5-11. Pfizer and BioNTech, which developed the vaccine earlier this month, under 5 years old had applied for emergency use approval. However, the new news showed that there was a change in this application.
Emergency use approval application for under 5 years old has been postponed
Pfizer and BioNTech, which applied for the emergency use approval of the vaccine at the beginning of February after 1.6 million children under the age of 4 caught COVID in the USA, stated that the FDA had made such a request for public health under the age of 5. However, the new statements came from the companies based in the USA and Germany that developed the vaccine. postponing your applications. showed.
In a news broadcast by CNBC, the application was made for the under-5 group. It will be frozen until the first results of the 3-dose vaccine trials are available to the FDA. was recorded. Both companies stated in their statement that they expect the results to be positive and the level of protection to be high.
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FDA official Peter Marks also spoke about Omicron in teenagers and children. youth and children the increase in the rates of cases and hospitalizations increased the importance of the vaccine; therefore, he emphasized that 3 doses of vaccination data should be transmitted to them. It was also included in Marks’ statements that it would be evaluated whether two doses of vaccine would be sufficient for the under-five group.
Source :
https://www.aa.com.tr/tr/dunya/pfizer-biontech-5-yas-alti-cocuklara-kovid-19-asisi-acil-egitimim-basvurusuna-erteledi/2500737