FDA Gives Full Approval for Pfizer COVID-19 Vaccine

The United States Food and Drug Administration (FDA) on Monday gave full approval for the Pfizer-BioNTech COVID-19 vaccine. Action can help build public confidence in vaccine as country and world tackle the rapidly spreading delta variant of the coronavirus.

Acting FDA Commissioner Janet Woodcock said in a statement: “… as the first COVID-19 vaccine approved by the FDA, the public can be very confident that this vaccine meets the high standards of safety, efficacy and manufacturing quality that the FDA requires of an approved product.

The vaccine, manufactured by Pfizer and its German partner BioNTech, was the first vaccine to be approved for emergency use by the FDA last December. The FDA has also approved Moderna and Johnson & Johnson’s vaccines for emergency use.

The FDA based its latest decision on a study of 40,000 volunteers aged 16 and over. He said: “The vaccine was 91% effective in preventing COVID-19 disease.” The agency also noted that the shot “is effective in preventing COVID-19 and potentially serious results including hospitalization and death.

Approval could lead to vaccine requirements

The full approval came as governments, schools and businesses across the United States consider requiring vaccinations for employees, students and others.

Last month, US President Joe Biden announced that federal employees and those working with the federal government are required to show proof of vaccination or have ordinary trial.

Members of the US military will need to be vaccinated against COVID-19 starting next month.

Also on Monday, New York City announced that it is requiring all teachers and public school workers in the nation’s largest school system to be vaccinated.

Dr Carlos del Rio works at Emory University in the State of Georgia. He told The Associated Press, “I think a lot of companies were waiting” for full FDA approval. He noted that requiring people to have their picture taken “becomes much easier when you have full approval.”

A study by the AP-NORC Center for Public Affairs Research released this week found that a majority of Americans, up to 59%, support a vaccine requirement for teachers and students.

In the United States, Democrats and Republicans hold differing views on vaccine requirements in schools. Only 38% of those who identified as Republicans support a vaccine mandate for teachers. By comparison, 81% of self-identified Democrats support such a demand.

The Kaiser Family Foundation reported earlier this month that most unvaccinated adults in the country don’t think vaccines are working. Some even see the injections as a greater health risk than the disease itself.

FDA Chief Woodcock said, “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, FDA approval of a vaccine may now breathe extra confidence to get vaccinated.

Recall shots

The FDA said the vaccine continues to be available in emergencies for young people between the ages of 12 and 15.

The agency also advised a third shot, known as a booster, for those with debuff. immune system. But the Biden administration announced last week that it plans to deliver the third blow to all Americans.

Israel has one of the highest vaccination rates in the world thanks to Pfizer-BioNTech injections. In early July, it became the first country to give coronavirus boosters to people with weakened immune systems. Israeli Prime Minister Naftali Bennett then announced that the country would offer the recall to anyone over the age of 60.

Israel’s health ministry reported on Sunday that the third injection of Pfizer had dramatically improved protection against serious illness and infection among Israelis aged 60 and over.

However, health officials at the World Health Organization (WHO) have called on richer and more vaccinated countries to delay the offer of boosters. They said it would be better to give more vaccines to unvaccinated people in developing countries.

WHO Chief Dr Tedros Adhanom Gebreyesus said: “We cannot accept countries that have already used most of the global vaccine supply using even more vaccines, while more vulnerable people remain unprotected.

I am Jill Robbins.

Hai Do wrote this story for VOA Learning English with additional reporting from The Associated Press. Ashley Thompson was the editor.

______________________________________________________________

Words in this story

variant – nm something that is different in some way from others of the same kind

confident – adj. sure something is true

results – nm something that happens as a result of an activity

ordinary – adj. happens again and again

mandate – n an official order to do something.

breathe – v. gradually bring someone to have (a feeling, etc.)

immune system – the system that protects your body against disease and infection

global – adj. international, involving the whole world

vulnerable – adj. easily injured or injured