The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on Wednesday to recommend the approval of
Pfizer
PFE
/
BioNTech
BNTX
and
Moderna
’s
MRNA
vaccine for young children.
While 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, Moderna filed for the emergency approval of two 25-µg doses of its vaccine in children six months to under six years of age.
The committee members voted unanimously (21-0) for both Pfizer/BioNTech and Moderna’s vaccine saying the benefits of the vaccines outweigh the risks.
Kids under five years of age are not yet authorized to get any COVID-19 vaccine in the United States.
While Pfizer’s stock was up 1.2% on Tuesday, Moderna rose 5.7% and BioNTech 2.4%.
The FDA will now give its decision on whether to grant emergency use authorization to the vaccines. If the FDA approves both or either of Pfizer/BioNTech or Moderna’s vaccines and the Centers for Disease Control and Prevention recommends them, President Biden expects vaccinations to begin in kids under the age of 5 next week.
Pfizer and BioNTech’s 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. However, some committee members raised concerns that Pfizer and BioNTech’s COVID-19 vaccine did not show similar protection levels as a two-dose regimen. Last year in December, a pre-specified immunogenicity analysis of data from the phase II/III study in children aged six months to five years showed that the COVID-19 vaccine, as a two-dose regimen, failed to demonstrate non-inferior immunogenicity levels in the two to five years age group compared to 16 to 25 years aged individuals.
Another concern was that Pfizer and BioNTech’s dose for the under-five age group is too low. Pfizer’s formulation of a booster dose for these youngest children is 3-µg, which is one-tenth of the dose strength for adults.
Moderna’s two-dose vaccine was 37%-51% effective in this age group in an analysis when the Omicron variant was circulating.
Both Pfizer/BioNTech and Moderna’s vaccines were said to be safe and effective, according to the FDA briefing documents prepared for the advisory panel.
Pfizer/BioNTech’s vaccine is already authorized for use in kids aged 5 and older, while that of Moderna is authorized for adults 18 years and older.
On Tuesday, the VRBPAC committee also recommended approving Moderna’s application to authorize its vaccine for kids aged 6 to 17.
A challenge in the rollout of the vaccines for the under 5 age group will be to convince parents to get their kids inoculated.
Special Report: The Top 5 IPOs for Your Portfolio
Today, you have a chance to get in on the ground floor of one of the best investment opportunities of the year. As the world continues to benefit from an ever-evolving internet, a handful of innovative tech companies are on the brink of reaping immense rewards – and you can put yourself in a position to cash in. One is set to disrupt the online communication industry. Brilliantly designed for creating online communities, this stock is poised to explode when made public. With the strength of our economy and record amounts of cash flooding into IPOs, you don’t want to miss this opportunity.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.
Click to get this free report
