Approval of the Pfizer COVID Vaccine: What You Need to Know

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On August 23, 2021, the U.S. Food and Drug Administration gave its first full approval of a vaccine for the prevention of COVID-19. Previously, the Pfizer-BioNTech COVID-19 vaccine was available under emergency use authorization.

That means that the vaccine has been fully cleared for use in people ages 16 and older. The vaccine can also still be used under emergency use authorization for kids ages 12 to 15.

Path to Improved Health

A clinical trial of the vaccine found that it was 91% effective in preventing COVID-19 disease. Reported side effects from the vaccine include:

  • Pain, redness and swelling in the injection site
  • Fatigue, headache, muscle or joint pain
  • Chills
  • Fever

The Centers for Disease Control (CDC) reports that COVID-19 vaccines can protect against severe disease and death from COVID-19. That also includes the Delta variant.

Many people have been hesitant to get the vaccine over concerns about its safety. More than 204 million people in the U.S. have received COVID-19 vaccines. The vaccines have undergone the most intensive safety monitoring in U.S. history, according to the CDC.

Fully vaccinated people sometimes do still get infected with COVID-19. This is called a breakthrough infection. But even then, the vaccine keeps the symptoms milder and lasting for a shorter time. It can also prevent hospitalization and death from the virus.

Things to Consider

The CDC is recommending booster shots for those who have been fully vaccinated for COVID with either the Pfizer or Moderna vaccines but who have compromised or weakened immune systems. They sometimes do not build enough protection with the first dose, so a booster may be needed.

Conditions that may require a booster shot include:

  • People with severely compromised immune systems
  • Recipients of organ or stem cell transplants
  • People with advanced or untreated HIV infections
  • Those who are receiving cancer treatment
  • People taking medications that weaken the immune system

Officials are also considering booster shots for everyone already fully vaccinated with either the Pfizer or Moderna vaccines. If approved, the plan is expected to begin in the fall. You may be eligible for a booster starting 8 months after you received your second dose of the vaccine.

Questions to Ask Your Doctor

  • What’s the difference between a full approval and an emergency approval of the vaccine?
  • What are some of the side effects of the vaccine?
  • Is the vaccine dangerous?
  • Do I need to get a booster shot?

Resources

American Academy of Family Physicians: COVID-19 Vaccine

Centers for Disease Control and Prevention: COVID-19

The U.S. Food and Drug Administration: Coronavirus Disease 2019