We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
FDA Panel Recommends Pfizer & Moderna COVID Jabs for Young Kids
Read MoreHide Full Article
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on Wednesday to recommend the approval of Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna’s (MRNA - Free Report) 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.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
FDA Panel Recommends Pfizer & Moderna COVID Jabs for Young Kids
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on Wednesday to recommend the approval of Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna’s (MRNA - Free Report) 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.