Update on the COVID-19 : The FDA has approved the bivalent COVID-19 vaccines from Moderna and Pfizer-BioNTech for use as booster doses in child and youth populations.

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Update on the COVID-19
Update on the COVID-19

In order to allow their administration as a single booster dose to groups of children and teenagers, the U.S. Food and Drug Administration (FDA) today revised the Emergency Use Authorizations (EUAs) of the bivalent COVID-19 vaccines from Moderna and Pfizer-BioNTech. The bivalent COVID-19 vaccine from Moderna is approved for delivery to children aged 6 and older at least two months following the end of the primary vaccination schedule or a booster shot.

These bivalent COVID-19 vaccines contain both an mRNA component shared by the BA.4 and Omicron variant lineages and an mRNA component from the parent strain to promote an immune response that is broadly protective against COVID-19. BA.5 to offer improved defence against COVID-19 brought on by omicron variants. The genetic information known as mRNA found in these vaccinations instructs cells to create the unique “spike” protein of the original viral strain as well as the BA.4 and BA.5 omicron variant lineages. The BA.4 and BA.5 spike proteins are the same.

“As children have returned to school in person and people are returning to pre-pandemic work or activities, there is potential for increased risk of exposure to the virus that causes COVID-19. “Vaccination remains the most effective measure to prevent serious consequences of COVID-19, such as hospitalization and death”, “While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have contracted the disease and been hospitalized. Children may also experience long-term effects, even after initially mild illness. We encourage parents to consider the primary vaccination schedule for children and follow up with an updated booster dose when they meet the requirements or conditions.”

Dr. Peter Marks, MD, Ph.D.

With today’s approval, the monovalent COVID-19 vaccine made by Pfizer-BioNTech is no longer approved for use as a booster dose in children ages 5 to 11. The COVID-19 vaccines from Moderna and Pfizer-BioNTech are still authorised for use in the standard immunisation schedule for people six months of age and older.

FDA relied on previously evaluated safety and immune response data from a clinical study in adults with a booster dose of a bivalent vaccine against COVID-19 that contained a component of the original strain of SARS-CoV-2 and a component of the BA.1 omicron lineage for each of the bivalent COVID-19 vaccines authorised today. The FDA supports vaccines that contain a component of the BA.4 and BA.5 omicron variant lineages because it finds these facts to be pertinent. The immune response and safety results from clinical investigations of monovalent mRNA vaccines against COVID-19, including as booster doses in paediatric age groups, have also been assessed and taken into consideration by the FDA.

What You Should Know About Moderna’s Authorization for the Bivalent COVID-19 Vaccine

  • Based on prior FDA analysis published in Immune Response and Safety Data from a Clinical Study in Adults 18 Years of Age and Older Who Received a Booster Dose of Moderna’s Investigational Bivalent COVID-19 Vaccine Containing a Parent-Strain Component of SARS-CoV-2 and a Component of the BA.1 omicron Lineage, the data supporting FDA authorization of a single booster dose of Moderna’s bivalent COVID-19
  • The licence for the 12- to 17-year-old age range is similarly based on the monovalent COVID-19 vaccine produced by Moderna’s efficacy in this age group after a single booster dose. About 250 clinical trial participants in this age range who received a single booster dose of Moderna’s COVID-19 vaccine at least five months after finishing a core regimen were included in the FDA analysis to compare immune responses. the standard two-dose vaccination schedule of Moderna’s COVID-19 vaccine in a prior study, which indicated that the vaccine was successful in preventing COVID-19, with immunological responses among over 300 clinical trial participants, aged 18 to 25, who had received the vaccine.
  • The authorisation for the monovalent COVID-19 vaccine manufactured by Moderna is likewise based on the monovalent COVID-19 vaccine’s efficacy in the age group of 6 to 11 years. About 100 clinical trial participants, aged 6 to 11, who received a single booster dose of Moderna’s COVID-19 vaccine at least six months later were compared in the FDA analysis for their immune responses. to complete a two-dose primary vaccination schedule of the vaccine against immune responses among approximately 300 clinical trial participants, ages 18 to 25, who had received a two-dose primary vaccination schedule of the COVID-19 vaccine from Moderna in a prior study that discovered the vaccine to be effective in preventing COVID-19. In the age category of 6- to 11-year-olds, the immune response to the booster dose of Moderna’s COVID-19 vaccine was equivalent to the immunological response to the two-dose initial vaccination schedule in study participants.
  • Approximately 1,300 volunteers, aged 12 to 17, who got a booster dose of Moderna’s monovalent COVID-19 vaccination were used to assess the safety of the vaccine. 1,300 participants, aged 6 to 11, who received a booster dose of Moderna’s monovalent COVID-19 vaccine at least six months after the second dose of the primary vaccination schedule. Moderna was administered at least five months following the second dose of the primary vaccination schedule. Pain, fatigue, and fever were the side effects of Moderna’s monovalent COVID-19 vaccination that participants in clinical trials for both age groups reported experiencing the most after a booster dose.
  • Similar side effects to those observed by recipients of Moderna’s monovalent COVID-19 vaccination may occur in those who receive the bivalent vaccine.
  • Because these vaccines are produced using the same technology, data from Moderna’s monovalent COVID-19 vaccine is applicable to Moderna’s bivalent COVID-19 vaccine.

What You Should Know: Authorization for the Pfizer-BioNTech Bivalent COVID-19 Vaccine

  • Based in part on a previous FDA analysis of data Immune Response and Safety in a Clinical Study in Adults 55 Years of Age and Older Who Received a Booster Dose of a Pfizer-BioNTech Investigational Bivalent COVID-19 Vaccine Containing a Component of the Parent Strain of SARS-CoV-2 and a Component of the BA.1 omicron Lineage, the data supporting authorization of a single booster dose of the bi The FDA’s past examination of the safety and efficacy data for a booster dose of Pfizer-monovalent BioNTech’s COVID-19 vaccination in children aged 5 to 11 is also a factor in the authorisation.
  • Similar side effects to those described by recipients of the Pfizer-BioNTech monovalent COVID-19 vaccine may occur in recipients of the Pfizer-BioNTech bivalent COVID-19 vaccine.
  • For recipients, carers, and medical professionals, fact sheets on the bivalent COVID-19 vaccines contain details on potential side effects as well as the dangers of myocarditis and pericarditis.

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