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 the presentations at the meeting, children aged 5-11 years are responsible for more than 1.9million cases of COVID-19 in America and more than 8,300 related hospitalizations. Multisystem inflammatory syndrome (MISC) is a serious, but rare, complication of COVID-19. This condition causes various parts of the body to become inflamed such as the heart or lungs.
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 the vaccine was effective at preventing symptoms of COVID-19 in children aged 5-11 years. The vaccine was well-tolerated and safe, with few side effects comparable to those seen in older age groups. Most common side effects were headache, fatigue, and pain at the injection site. 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.
According to Dr. Hong Yang of the FDA, modeling data shows that the benefits of vaccination for this age group outweigh the risks. The models may show that the benefits of COVID-19 are less evident if they fall. However, these models also suggest that the benefits could still outweigh the risks. According to the presentation, those who have myocarditis following vaccination tend to fare better than those with COVID-19.
Dr. Jay Portnoy (an allergist and immunologist at a Kansas City children's hospital, Missouri) stated that he believes that the decision reached was the right one. Portnoy pointed out that his hospital has been filled for the past month with children in critical condition, many of whom are 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. 2/3 to discuss pediatric approval. 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 adults 12 years old and older.
Dr. Amanda Cohn is the Chief Medical Officer at the National Center for Immunizations, Respiratory Diseases (ACIP) and Executive Secretary. "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 over a year," she said. She stated that vaccination of this age group will prevent ICU admissions, death, and other serious long-term adverse effects in children infected.
She said that myocarditis will be closely monitored. However, she noted that there have been no deaths and almost all cases have fully recovered within weeks. "I believe this age group should be given the same chance to get vaccinated as any other.
Original publication on Live Science
