Pfizer And BioNTech Seeking Emergency Use Authorization From FDA

The pharmaceutical companies, Pfizer and BioNTech have requested an Emergency Use Authorization for their Covid-19 vaccine that is specifically made for children between 6 months to 4 years of age.

Pfizer And BioNTech Seeking Emergency Use Authorization From FDA

During this pandemic, many children have been infected by this virus. Did you know in the U.S more than 10.6 million children under 4 years of age have tested positive for COVID-19? During the Omicron variant surge hospitalization cases for children have increased tremendously.

Pfizer And BioNTech Seeking Emergency Use Authorization From FDA

This number is frightening not only for the parents but also for the government. To decrease this number the US Food and Drug Administration (FDA) has asked Pfizer and BioNTech to initiate a rolling submission of data. 

The pharmaceutical companies said that they will complete the EUA submission data in a few days. They will also submit clinical trial data to the European Medicines Agency and other prominent health agencies around the world.

To discuss the submission, FDA will conduct a vaccine advisory committee on 15th February.

The FDA needs to ensure that the vaccines are safe and effective. Apart from the safety, building trust around this vaccine is also important. Parents will only give vaccines to their little ones if they know it will not harm their children.

The data will help the committee understand if the ingredients are safe for the children or not. FDA wants a transparent and data-driven process to analyze the safety and effectiveness of the vaccine.

The vaccine will be given to children in three doses. Currently, the pharmaceutical companies have asked FDA to authorize their first two doses of vaccine.

If the two doses are authorized, then it will become the first vaccine for children between 6 months to 4 years of age. The companies can also start giving vaccines to the children while awaiting potential authorization of a third dose.

Children will get the vaccine as an injection into the muscle. The vaccine will help children fight the current version of omicron and also the potential future variants of the virus 

The company says that its vaccines have demonstrated favorable safety, tolerability, and efficacy profile in multiple clinical trials. Numerous real-world studies are also conducted for all age groups starting from 5 years old.

Since the hospitalizations of children under 5 years have increased during the COVID-19 pandemic the main aim of Pfizer and BioNTech is to provide parents with an option for protecting their children.

The two doses will make a baseline immunity in the children and prevent severe consequences of the virus. 

In December, Pfizer made changes in its clinical trials to test a three-dose version of the vaccine since the lower dose didn’t generate the desired immunity power. It was inferior to the response measured in those aged 16 to 25. Although for the babies up to age 2 the results were great.

Pfizer/BioNTech vaccine dose for people 12 and older is 30 micrograms of the vaccine. While for children between 5 to 11 years of age the vaccine dose is 10 micrograms. The youngest children get 3 micrograms of the vaccine.

John Grabenstein, who is the former executive director of medical affairs for vaccines at Merck, has a different opinion on the vaccine. 

According to him, the FDA should consider this vaccine as a two-dose regimen rather than considering it as a three-dose regimen where they approve the first two doses now.

John Grabenstein believes that the FDA shouldn’t approve the vaccine because they don’t have the trial data of the third dose. Since the authorities don’t know how safe and effective the third dose will be on the children, they shouldn’t authorize this vaccine.

If this vaccine gets approved then the parents would be very relieved and happy since now they have an option to protect their children. It might also help reduce the hospitalization cases of the children. 

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