The FDA health officials, in briefing documents published on Sunday, said that
Pfizer
PFE
and its Germany-based partner
BioNTech
’s
BNTX
mRNA-based COVID-19 vaccine was safe and effective for use in kids six months to under five years of age.
Kids under five years of age are not yet authorized for getting any COVID-19 vaccine in the United States, even as a primary regimen.
Pfizer and BioNTech are seeking approval for their mRNA-based COVID-19 vaccine for children six months to under five years of age as a three-dose vaccine. The vaccine elicited a strong immune response, high efficacy and a favorable safety profile when given as a three-dose vaccine to children six months to under five years of age in clinical studies
Top-line data from a phase II/III study showed that the three-dose vaccine was as effective in the 6- to 24-month-old population and the 2- to under 5-year-old population as the second dose in the 16- to 25-year-old population. The vaccine’s efficacy was 80.3% in the above-mentioned age group. This vaccine efficacy, a secondary endpoint in the study, was observed in the descriptive analysis of three doses while the Omicron variant remained dominant.
The FDA reviewers said that the available data supports Pfizer and BioNTech’s vaccine’s effectiveness in preventing COVID infection in this age group as a three-dose primary series.
Pfizer’s formulation of a booster dose for these youngest children is 3-µg, which is one-tenth of the dose strength for adults.
Pfizer’s stock is down 9.5% this year so far against an increase of 5.5% for the
industry
.
Image Source: Zacks Investment Research
Germany-based BioNTech’s shares are down 48.3% this year so far compared with the
industry
’s decrease of 28.8%.
Image Source: Zacks Investment Research
Rival
Moderna
’s
MRNA
mRNA-based vaccine is also not yet authorized for use in kids under 6 years of age. Moderna has also filed data with the FDA, seeking emergency approval for two 25-µg doses of its vaccine in children six months to under six years of age. Its two-dose vaccine was 37%-51% effective in this age group in an analysis when the Omicron variant was circulating. Last week, similar briefing documents for Moderna’s vaccine were released, which said that the vaccine works safely and effectively in children six months to under six years of age.
The FDA’s Vaccines and Related Biological Products Advisory Committee is due to meet on Wednesday to vote on whether Pfizer/BioNTech and Moderna’s vaccine should be approved for this age group. The FDA will then give its decision on whether to approve the vaccine. If the FDA approves both or either of Pfizer/BioNTech or Moderna’s vaccines and Centers for Disease Control and Prevention recommends then, President Biden expects vaccinations to begin in kids under the age of 5 as soon as Jun 21.
Pfizer/BioNTech’s vaccine is already authorized for use in people aged 5 and older, while that of Moderna is authorized for adults 18 years and older.
The committee will also meet on Tuesday to consider Moderna’s application to authorize its vaccine for kids aged 6 to 17.
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