Pfizer applies for full FDA approval of boosters, side effects and timeline explained


In this March 2021 photo provided by Pfizer, vials of the Pfizer-BioNTech COVID-19 vaccine are prepared for packaging at the company’s facility in Puurs, Belgium. Pfizer is about to seek U.S. authorization for a third dose of its COVID-19 vaccine, saying Thursday, July 8, 2021, that another shot within 12 months could dramatically boost immunity and maybe help ward off the latest worrisome coronavirus mutant. (Pfizer via AP)

RALEIGH, N.C. (WNCN)- Just days after the FDA granted full approval of the Pfizer vaccine, the company is now asking for full approval of its booster shots.

When it comes to side effects, the company reported a majority were mild to moderate for the booster. The most common were injection site pain, fatigue, headache, muscle and joint pain, and chills. Those side effects were similar to reports for dose two.

Severe side effects are rare, although Pfizer did not provide numbers to show how rare. However, it did say any adverse side effect would happen within a hour of injection.

Although rare under the first two doses, severe side effects could include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness and weakness.

The most common side effects for all COVID-19 vaccines are:

  • swelling, redness, and pain at injection site
  • fever
  • headache
  • tiredness
  • muscle pain
  • chills
  • nausea

When will Pfizer boosters get full approval?

For it’s initial full approval, it took the FDA four months to give full approval.

If Pfizer applied for it via a Priority Review, the FDA would need to make a decision within six months rather than the typical 10-month waiting period.

The approval could happen even faster for boosters. The White House has already said they want to start giving boosters by September 20.

People would be eligible for their third dose eight months after their second dose. That means healthcare providers, residents of long-term care facilities and other older adults would be first up.

What about Moderna and Johnson and Johnson?

Moderna announced Wednesday they have completed their application process for full FDA approval. They found their vaccine was still 93 percent effective six months after a second dose.

The company has not announced when it will submit for full approval of its booster. As with the Pfizer vaccine, the White House wants people to get their boosters eight months after dose two starting next month.

Additionally, Johnson and Johnson has reported they will file for full approval by the end of the year, but the company published an update on their booster this week.

The company said their research showed people who got a second dose of their vaccine saw nine times higher antibodies. Their booster would come eight months after the first dose.

J&J has made no announcement on when they may seek full approval for their booster.

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