Covid US: Pfizer asks FDA to expand emergency use of vaccine to include children aged 12 to 15


Pfizer asks FDA to expand emergency use of its COVID-19 vaccine to include kids ages 12 to 15

  • Pfizer Inc has asked the FDA to expand emergency use of its COVID-19 vaccine to Americans between ages 12 and 15  
  • Recent clinical trial data found that the vaccine was 100 percent safe and effective in younger teens
  • If approved by the FDA, 12-to-15 year olds could be immunized before the start of the 2021 school year 
  • Pfizer and its partner BioNTech are also studying how well their vaccine works in children aged six months to 11 years old and expect approval in early 2022

Pfizer Inc has asked the U.S. Food and Drug Administration (FDA) to expand emergency use of its COVID-19 vaccine to Americans between ages 12 and 15. 

When the vaccine was originally authorized for use by the FDA in December 2020, it was only for those aged 16 and older. 

But recently, Phase III clinical trial data showed that the vaccine was 100 percent safe and effective in younger teenagers.

If approved by the FDA, 12-to-15 year olds could be immunized against coronavirus before the start of the 2021 school year. 

In a statement on Twitter, the New York-based drugmaker said it plans to request similar rulings in other countries that are using the vaccine. 

If approved by the FDA, Pfizer said 12-to-15 year olds could be immunized before the start of the 2021 school year

If approved by the FDA, Pfizer said 12-to-15 year olds could be immunized before the start of the 2021 school year

In the trial, about 2,200 teenagers were enrolled in the U.S. compared to 40,000 for the aged 16 and older trial. 

Half of the group received two doses of the vaccine three weeks apart and the other half were given two placebo injections. 

A total of 18 cases of COVID-19 were reported in the placebo group while no cases were reported in the vaccine group. 

What’s more, side effects were similar to those seen in the larger trial among 16-to-25-year-olds, including pain at the injection site, tiredness, fever and headaches. 

At the time, Pfizer CEO Albert Bourla said the hope was ‘starting to vaccinate this age group before the start of the next school year.

Researchers plan to track participants for two years to collect information long-term protection, effects and safety. 

Pfizer and its partner BioNTech are also studying how well their vaccine works in children aged six months to 11 years old and expect approval in early 2022 (file image)

Pfizer and its partner BioNTech are also studying how well their vaccine works in children aged six months to 11 years old and expect approval in early 2022 (file image)

It is unclear how long the FDA will take to review data, but director for the Centers for Disease Control and Prevention Rochelle Walensky told ABC News on Wednesday she expects Pfizer’s vaccine to be authorized for 12-to-15 year olds by mid-May.

It is unclear if the FDA’s advisory committee will need to meet first to recommend use of the vaccine in younger kids as they did in December 2020. 

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Pfizer and its German partner BioNTech are also studying how well their vaccine works in children between ages six months and 11 years old. 

The first volunteers in the early-stage trial were given their first injections in March and the companies hope to expand eligibility to that age group by early 2022. 

Although children are less likely to develop severe COVID-19 or develop complications, health experts say inoculating kids and teenagers is a critical step in the U.S. reaching ‘herd immunity.’ 

According to Market Watch, shares of Pfizer were up one percent in trading on Friday upon the news.  

Children are often the last group to be tested during clinical trials because they are not merely little adults. 

Their bodies and immune systems behave differently, meaning they might have different treatment needs.

What’s more, children may need different doses or needle sizes depending on their height, weight and age – which is why most children are only vaccinated after safety has been well-documented in the adult population.

So far, 112 million Americans – 33.7 percent of the population – have received at least one dose and 66.2 million – 19.9 percent – are fully immunized. 

About an average of three million people are being vaccinated every day and President Joe Biden has set a goal of 200 million vaccinations in his first 100 days in office.   



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