F.D.A. panel endorses vaccines for kids

by | Oct 26, 2021 | Covid-19 WFIS updates, Education News, School Choice, Student Safety, WFIS News

Roughly a third of parents with elementary school children are eager to vaccinate their children, while a third prefer to wait.

NY Times Coronavirus Briefing Tuesday October 26, 2021

In a move eagerly awaited by many parents and educators across the U.S., an advisory committee to the F.D.A. recommend Pfizer’s coronavirus vaccine for 5- to 11-year-olds. If fully authorized, shots could be offered as early as next week.

The F.D.A.’s outside experts voted after regulators argued that thousands of children ages 5 to 11 have been hospitalized with Covid-19 and nearly 100 have died over the course of the pandemic. Seventeen committee members voted in favor of the pediatric dose; one abstained.

The F.D.A.’s outside experts voted after regulators argued that thousands of children ages 5 to 11 have been hospitalized with Covid-19 and nearly 100 have died over the course of the pandemic. Seventeen committee members voted in favor of the pediatric dose; one abstained.

The panel voted to give children of that age group a dose that is one-third of the strength given to people 12 and older, in two shots, three weeks apart.

The decision opens the way to inoculating 28 million children in the U.S. Polling has shown that roughly a third of parents with elementary school children are eager to vaccinate their children right away, while a third prefer to wait.

Here are some answers to some common questions about vaccines and children.

How effective is the Pfizer-BioNTech vaccine for children?   During clinical trials, the children who got the vaccine produced a strong immune response, comparable to the levels of antibodies seen in earlier studies of participants who were 16 to 25. But children in the 5- to 11-year-old group achieved this response with 10 micrograms of the vaccine, a third of the dose given to older children and adults. Pfizer presented trial data, saying its vaccine had an efficacy rate of 91 percent against symptomatic Covid-19.

 
What about side effects?    Side effects tend to be mild, and similar to those observed in young adults. At higher doses, researchers observed more side effects in younger children, including fever, headache and fatigue, although none were severe, experts said. After lowering the strength of the dose, researchers said they saw fewer side effects.
In rare cases, the vaccine has led to myocarditis, an inflammation of the heart, in young men. Federal health officials have said the heart condition tends to be mild and resolve quickly. None of the children involved in Pfizer’s clinical trial developed that heart condition, but this was expected given its rarity.
 
 
Why should children be vaccinated against Covid-19?    Nearly two million children between the ages of 5 and 11 have been infected, 8,300 have been hospitalized and nearly 100 have died over the course of the pandemic. Dr. Peter Marks, who heads the F.D.A.’s division that oversees vaccine approvals, told the F.D.A. panel that Covid is now one of the top 10 causes of death among children 5 to 11.
In The Times’s Opinion section, Lee Savio Beers, the president of the American Academy of Pediatrics, argued that a child vaccination campaign could help slow the spread of the disease to the unvaccinated and to more at-risk adults, reducing its toll on everyone.
 
 
For 11-year-olds on the cusp of turning 12, is it better to wait for the adult dose, or get the smaller dose right away? Does the weight or height of the child make any difference?
Five experts in immunology and infectious diseases agreed: The appropriate dosage for children is best determined by age, not size. So if your 11-year-old is able to get the shot starting in November, do it right away rather than waiting for your child to turn 12.
Weight is an important factor when you give a young child medication like Tylenol because there is a wide variation in weight from infancy throughout childhood and too much of the drug could be toxic. The optimal vaccine dose, however, is dependent on age and tailored to minimize potential side effects.
 
 
What comes next?    The F.D.A. typically follows the advice of its advisory panel, and the head of the agency will issue its final decision, typically within a few days.
Next, an advisory committee to the C.D.C. will review the F.D.A.’s decision and make recommendations, which the C.D.C. usually follows. The director of the C.D.C. will then issue the agency’s guidance. State health departments generally follow the recommendations of the C.D.C. Federal officials have said that if pediatric doses of the Pfizer vaccine are authorized, 15 million doses of vaccine will immediately be shipped to the states for distribution.