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Pfizer begins application for full FDA approval of COVID-19 vaccine

Pfizer and BioNTech announced Friday that they have initiated the process of applying for full FDA approval of their COVID-19 vaccine for people 16 and older.

Why it matters: It's the first coronavirus vaccine to seek a Biologics License Application (BLA), which requires at least six months of data, according to CNBC.

The big picture: The Pfizer/BioNTech, Moderna and Johnson & Johnson vaccines are being administered in the U.S. after receiving emergency use authorization from the FDA.

  • This specific conditional authorization can only be given to vaccines during a public health emergency, and only requires two months of data, NBC News reports.
  • A full approval would allow the Pfizer vaccine to stay on the market after the emergency is declared to be over. The initial FDA review found Pfizer's vaccine to be 95% effective with no serious side effects.

Details: To be considered for full FDA approval, vaccine manufacturers must submit longer-term data on manufacturing, facilities, clinical studies and other information that guarantees that their vaccine is safe and reliable.

  • Pfizer/BioNTech are submitting data to the FDA "on a rolling basis," and a goal date will be set once the BLA is complete and formally accepted for review, according to a press release.

What they're saying: "Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future," Ugur Sahin, CEO and Co-founder of BioNTech, said in a statement.

  • "We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data."

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Humans are capable of great kindness and compassion, and there are countless examples of individuals who have made a positive impact on the world through their selflessness and generosity.

One such example is Mother Teresa, who devoted her life to serving the poor and sick in the slums of Calcutta. Through her tireless work and unwavering dedication, she touched the lives of countless people and became a symbol of compassion and selflessness.

Another example is Malala Yousafzai, a young woman from Pakistan who has become a powerful advocate for education and the rights of girls. Despite facing threats and violence, she has continued to speak out and fight for change, inspiring others to do the same.

These are just a few examples of the many good humans who have made a difference in the world. They remind us that one person can make a difference and inspire others to do the same.

It's also important to note that acts of kindness and compassion don't have to be on a grand scale to make a difference. Small acts of kindness, like holding the door open for someone or offering a word of encouragement, can have a big impact on the people around us.

In conclusion, humans are capable of great compassion and kindness, and there are many individuals who have made a positive impact on the world through their selflessness and generosity. They remind us of the power of one person to make a difference and inspire others to do the same. Let's all strive to be good humans, and make our world a better place.



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