FDA Approves COVID-19 Booster Shot For Children As Young As 5

FDA Approves COVID-19 Booster Shot For Children As Young As 5

The Food and Drug Administration (FDA) approved new guidelines that allow children as young as five years old to get the COVID-19 booster shot, according to a Monday press release.
Photo Source: Unsplash. By Kate Anderson, DCNF.

The Food and Drug Administration (FDA) approved new guidelines that allow children as young as five years old to get the COVID-19 booster shot, according to a Monday press release.

The new guidelines were authorized this week to “more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19,” according to the press release.

As a result, the agency announced that it would be approving “a single dose of an updated mRNA COVID-19 vaccine” for children as young as five at least two months after they had received any other COVID-19 vaccine.

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“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the press release. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

Children 6 months and up to 4 years old that have been vaccinated previously against COVID-19 are also now eligible to receive one to two doses of the mRNA COVID-19 vaccine booster, according to the press release.

Children in the same age range can obtain two to three doses of the Pfizer-BioNTech COVID-19 Vaccine, or alternatively, two doses of the Moderna COVID-19 Vaccine booster.

What You Need to Know

  • Individuals 5 years of age and older regardless of previous vaccination are eligible to receive a single dose of an updated mRNA COVID-19 vaccine at least 2 months since the last dose of any COVID-19 vaccine. 
  • Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of an updated mRNA COVID-19 vaccine (timing and number of doses to administer depends on the previous COVID-19 vaccine received). 
  • Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated authorized Moderna COVID-19 Vaccine.
  • The FDA is confident in the safety and effectiveness of these updated vaccines and the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks.
  • Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines as described in the respective prescribing information or fact sheets.
  • The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants. Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine. 
  • The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet tomorrow (Sept. 12), to discuss clinical recommendations on who should receive an updated vaccine, as well as further considerations for specific populations such as immunocompromised and older individuals. 
  • Manufacturers have publicly announced that the updated vaccines would be ready this fall, and the FDA anticipates that the updated vaccines will be available in the near future.

Kentucky Sen. Rand Paul Goes Ballistic On Senate Floor Over Vaccine, Mask Rules

Republican Sen. Rand Paul of Kentucky slammed vaccine mandates during a Thursday speech on the Senate floor during which he tried to repeal a mandate for Senate pages.

Paul introduced a resolution to end vaccine and mask mandates for Senate pages, according to a Thursday release.

Paul asked for unanimous consent to pass the resolution, but Democratic Sen. Ben Cardin of Maryland objected, the Washington Examiner reported.

“It is the height of – the height of malpractice to subject young people to the greater risk of vaccination simply to satisfy mandates designed to protect bureaucrats from accountability. I’m told that the Democrats will object to this today. The Democrats will stand up and say they know better than your parents,” Paul said in a 25-minute speech on the Senate floor. “The Democrats will say they know better than these kids’ doctors. By golly, you want to be on the Senate floor, you have to have three vaccines. Guess what, I’ve got zero. I’m standing right here, zero vaccines.”

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“I had Covid in the first month of the disease. I likely would have gotten vaccinated, but I got the disease early on. Then all the evidence pointed towards immunity being gained from having the disease, so – being gained from having the disease,” Paul continued. “We recommended our elderly in-laws get the vaccine. The thing is, we made that choice. Here I sit without a vaccine.”

Paul also targeted mask mandates during his remarks, which came two days after Rosemary Hills Elementary School in Montgomery County, Maryland, imposed a mask mandate for certain students, citing the presence of COVID-19 cases in a letter sent to parents.

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“I won’t wear a mask because they don’t work either, yet then we’re telling them – in a month, are we putting them back in masks? The Democrats want everybody in masks,” Paul said. “They want the hysteria to return. Why? They don’t think any of us are smart enough to make our own decisions. They want to make the decision for us. The common man be damned, the working class be damned… Americans be damned.”

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