A panel of experts from the Food and Drug Administration (FDA), voted in favor of authorizing the Pfizer BioNTech COVID-19 vaccination for children aged 5-11 years.
The Vaccines and Related Biological Products Advisory Committee met live on Tuesday, Oct. 26, to discuss safety and efficacy for the Pfizer BioNTech COVID-19 vaccine in children.
After a day-long discussion on the benefits and risks of the vaccine being made available to young children, the panel unanimously voted for an emergency authorization. 17 of the 18 panel members voted for it. One abstained.
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According to presentations at the meeting, more than 1.9million cases of COVID-19 have been reported in the US by children aged 5-11 years old.
Multisystem inflammatory syndrome (MIS) is a serious, but rare, complication of COVID-19. This causes various parts of the body to become inflamed. It occurs more often in this age group that any other.
Pfizer presented the results of a clinical trial in which the vaccine was tested on more than 2,200 children aged 5-11 years old. The lower dose (10g) was administered 21 days apart, while the adult dose (30g) was administered 21 days apart. The FDA presented its own analysis of the data.
Data showed that 90.7 percent of children aged 5-11 received the vaccine. The vaccine was well-tolerated and safe, with few side effects comparable to those seen in older children.
Most common side effects were headache, fatigue, pain at the injection site and pain. Some children also experienced swelling of their lymph nodes. There were no reports of serious side effects from the vaccine.
The panel discussed the risks and benefits of myocarditis in children. This is a rare side effect that has been observed in very few people who have received mRNA vaccines from Moderna or Pfizer BioNTech.
The trial did not include any children with either condition. However, the trial was small so it is possible that some cases could develop once the vaccines are administered to a greater number of children.
Based on modeling data, it appears that the benefits of vaccination for this age group outweigh the risks.
The models show that COVID-19 rates may decline. However, they still have benefits. According to the presentation, those who are hospitalized for myocarditis following vaccination often fare better than those who were hospitalized by COVID-19.
Dr. Jay Portnoy (an allergist and immunologist at a Kansas City children's hospital, Missouri) stated at the meeting that he believes that the decision reached was the right one.
Portnoy stated that his hospital has been overcrowded for the past month with children in critical condition, many of whom are being treated in the ICU with COVID-19 infection.
He said, "I'm looking forward being able to actually prevent that." "I look forward to seeing my patients tomorrow at the clinic. They've been afraid that their children will get COVID. They can now look forward to some very good news.
If the FDA agrees with the panel and approves the vaccine, which it is likely to do, then the discussion goes to the Centers for Disease Control and Prevention.
The CDC's Advisory Committee on Immunization Practices (ACIP), meets on Nov. 2, and 3, to discuss pediatric approval for the vaccine. If this panel recommends that the vaccine be approved for children ages 5-11 and the CDC endorses the recommendation, then the vaccine could become available in November. The Pfizer-BioNTech vaccine has been approved for use only by people over 12 years old.
"COVID-19 is now a vaccine-preventable illness from my point of view and COVID has also been the 8th most fatal disease of children in this age group in the past year," stated Dr. Amanda Cohn (the Chief Medical Officer at the National Center for Immunizations & Respiratory Diseases) and Executive Secretary to the ACIP.
She stated that vaccination of this age group will prevent the death of ICU admissions and other serious long-term adverse effects in children who have been infected.
She said, "We will monitor myocarditis extremely carefully," while noting that there haven't been any deaths due to myocarditis and that most cases have fully recovered within weeks.
"I believe this age group should be given the same chance to get vaccinated as any other."
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Live Science originally published this article. You can read the original article here.
