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Pfizer Emergency Authorization Application [Aged 5 to 11] – FDA Response

Pfizer Emergency Authorization – COVID-19 and vaccine for COVID-19 has become a hot topic in the United States and all around the world. We are seeing major development regularly with the virus treatment and prevention vaccine for the same.

Pfizer, one of the biggest manufacturers of vaccines for COVID-19, recently filed an application to the United States Food and Drug Administration for the approval of a COVID-19 booster dose for children ages 5 to 11.

The company published the news on the 26th of April 2022. in a statement, they made it very clear that they are looking for approval for the booster dose of their vaccine for all the people above age 5. 

Pfizer Emergency Authorization Application

On the 26th of April 2022, Pfizer made it public that they are looking for approval for the booster dose of the COVID-19 vaccine for children above the age of 5.

It is going to be approved for emergency use, and they have also mentioned data points from a study involving 4500 children in the United States, Poland, Spain, and Finland. The results of the study were promising, and now the company is looking for approval under the emergency use authorization.

Further in the study, the company found that everyone involved in the study demonstrated a strong immune response to the following booster dose. At the same time, there were no new safety signals which is the best news for the company. 

Apart from that, the company is also conducting a study on three different age groups. Pfizer has also included children from age six months to two years and two years to five years in separate studies. The company is going to release the data points later in the year 2022.

Surely the booster dose is going to help every child above the age of 15 to ensure the safety against the COVID-19. As per several studies, the next wave of COVID-19 is surely going to hit children more than anyone else.

Recently, the Centers for Disease Control and Prevention of the United States released their data point where they mentioned that around 75% of children in the United States had coronavirus infections.

Response of FDA Pfizer Emergency Authorization

Till now, the United States Food and Drug Administration has not announced anything on the request of Pfizer emergency authorization.

As per the reports, the Food and Drug Administration of the United States has selected three possible dates on which they are going to review the requests made by several pharmaceutical companies, including Pfizer emergency authorization.

As per the sources, the Food and Drug Administration of the United States has selected three possible dates, June 8th, June 21st, and June 22nd, on which they are going to discuss the requests.

Currently, three different requests are pending for the vaccine for novel coronavirus in front of the Food and Drug Administration of the United States.

Just like Pfizer’s emergency authorization, their competitor Novavax and Moderna are also looking for similar authorizations. Novavax is looking for Authorization from adults ages 18 and over. 

One of the biggest competitors of Pfizer, Moderna, is also looking for the authorization of primary vaccine doses for children below the age of 5 to six months. Till now, there is no rule or regulation which will allow any vaccine manufacturers to vaccinate children below the age of 5.

Pfizer Emergency Authorization
Pfizer Emergency Authorization

Current rules of Vaccine

Before we wrap this session, let’s take a look at the current rules of vaccines in the United States. All of these rules and guidelines are released by the Centers for Disease Control and Prevention of the United States.

As per the current guidelines issued by the Centers for Disease Control and prevention, no one below the age of 5 is eligible to get any vaccine for COVID-19. Neither modern nor Pfizer has been approved to vaccinate children below the age of 5 even with the consent of parents unless it is for studies.

The Pfizer vaccine is the only vaccine that is approved for children below the age of 18 to age 5 In the United States of America by the Food and Drug Administration.

Apart from Pfizer, two other major vaccine joints are working in the United States of America, but they both have not been approved by the Food and Drug Administration of the United States to vaccinate children below the age of 18.

Booster Dose Rules

As per the current regulations of the Centers for Disease Control and prevention, everyone above the age of 12 can get one booster dose of COVID-19 after completing their initial series of vaccines.

Everyone must wait at least five months after taking the final days off the primary series and taking the booster dose. 

At the same time, everyone above the age of 18 is eligible to get the booster dose of either Pfizer or Moderna. While everyone below the age of 18 to 12 is only eligible to get the booster dose of Pfizer only.

Booster doses of Moderna below the age of 18 have not been approved by the Food and Drug Administration of the United States. 

Apart from the first booster dose, everyone above the age of 50 is also eligible to get the second booster dose of novel coronavirus. Pfizer and Moderna both have been recommended by the Centers for Disease Control and prevention for the second booster dose.

You must wait at least four months after taking the first booster dose before getting the second booster dose. Apart from that, moderately and severely immunocompromised people above the age of 12 are also eligible to get the second booster dose, but you should wait at least three months before taking the second booster dose.

Parents and Health Experts on Pfizer Emergency Authorization

Soon after the announcement of Pfizer’s emergency authorization application, several parents and health experts reacted to the news

A lot of parents are happy that the Food and Drug Administration of the United States is considering the request made by Pfizer and other vaccine manufacturers to vaccinate children below the age of 5.

Now, the summers are coming, and parents can have Peace of Mind knowing that their little ones are extra protected with the vaccination. 

Doctor Chirag Patel is an assistant chief medical officer at UF Health Jacksonville who says that parents should be motivated to get the COVID vaccine for their children.

Just like everyone else on the earth, children can also get infected with the virus and spread it to others. They can also become one of the biggest carriers of coronavirus to people who are at higher risk.

In the requests submitted by Pfizer and Moderna, doctor Chirag Patel did not see any cases of severe illness requiring hospitalization in the kid who received the vaccine.

No matter what, the basic side effects of taking the vaccine are also going to be the same as the kid’s vaccine for COVID-19. Fever and pain on the site of vaccination are going to be the biggest side effects of the vaccine for COVID-19. 

Takeaways

Soon after, the data published by the Centers for Disease Control and Prevention stated that around 75% of children in the United States had been infected with the COVID-19 in recent waves.

The situation is not going to come down in the coming months as a lot of countries are seeing fresh cases of novel coronavirus. 

Kids need protection from the virus, and recently Pfizer asked for emergency use approval of their vaccine in the children below the age of 5 to six months. It is going to be the biggest step in the country as no other country has approved vaccines for children below the age of 5.

As always, the United States of America is going to lead the world in vaccination also. The United States Food and Drug administration representatives are going to sit on three different dates in June to determine the application sought by different vaccine manufacturers.

Pfizer emergency authorization application is just one out of three which are going to be discussed during those dates. A lot of people are happy that vaccine manufacturers, along with the Food and Drug Administration of the United States, are thinking about children below the age of 5.

As per the current regulations of the Centers for Disease Control and prevention, everyone above the age of 5 is eligible to get the primary dosage of or with the vaccine. Children between the age of five and 18 can get only the Pfizer vaccine, while Moderna is still looking for approval from the FDA.

Will Pfizer’s emergency authorization application get approved?

Nobody can say anything till the Food and Drug Administration of the United States announces the status of the application. But, as per the trend, we can expect that Pfizer is going to get the approval as they are the only vaccine approved for children below the age of 18 to five in the United States. Other vaccine manufacturers, such as Moderna, are looking for approvals for initial doses.

When can we expect the vaccine of Pfizer for children below the age of 5?

Till now, the company has been looking for emergency use of approval under the Pfizer emergency authorization application from the Food and Drug Administration of the United States. If everything goes right then, we can expect the vaccine to hit the market by the fall of the third quarter of 2022.

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