Pfizer Says Its Vaccine is 90.7% Effective Against Symptomatic Covid-19 In Children Ages 5 To 11

Bridgette Melo, 5, holds the hand of her father, Jim Melo, during her inoculation of one of two reduced 10 ug doses of the Pfizer BioNtech COVID-19 vaccine during a trial at Duke University in Durham, North Carolina September 28, 2021 in a still image from video. Video taken September 28, 2021. Shawn Rocco/Duke University/Handout via REUTERS NO RESALES. NO ARCHIVES. THIS IMAGE HAS BEEN SUPPLIED BY A THIRD PARTY.

In a new document posted ahead of a key meeting of the US Food and Drug Administration’s vaccine advisers, Pfizer says its vaccine is safe and 90.7% effective against symptomatic Covid-19 in children ages 5 to 11.

In the trial, which included around 2,000 children, there were three Covid-19 cases among the group that received the vaccine and 16 cases in the placebo group. In the trial, twice as many children received the vaccine as the placebo.

Pfizer/BioNTech are seeking FDA emergency use authorization of a two-dose regimen of their 10-microgram dose for children ages 5 to 11. The two doses would be administered three weeks apart. Last month, Pfizer released details of a Phase 2/3 trial that showed its Covid-19 vaccine was safe and generated a “robust” antibody response in children ages 5 to 11. The trial included 2,268 participants ages 5 to 11.

Participants’ immune responses were measured by looking at neutralizing antibody levels in their blood and comparing those levels to a control group of 16- to 25-year-olds who were given a two-dose regimen with the larger 30-microgram dose. Pfizer said the levels compared well with older people who received the larger dose, demonstrating a “strong immune response in this cohort of children one month after the second dose.”

The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet October 26 to discuss whether to recommend the vaccine for authorization for those ages 5 to 11.

If authorized, this would be the first Covid-19 vaccine for younger children. The Pfizer/BioNTech vaccine is approved for people age 16 and older and has an EUA for people ages 12 to 15.

The data summarized from this Phase 2/3 study, which is enrolling children 6 months to 11 years of age, was for 2,268participants who were 5 to 11 years of age and received a 10 µg dose level in a two-dose regimen. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose.

This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.

Pfizer and BioNTech plan to share these data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible. For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group.

A request to the EMA to update the EU Conditional Marketing Authorization is also planned. Topline readouts for the other two age cohorts from the trial – children 2-5 years of age and children 6 months to 2 years of age – are expected as soon as the fourth quarter of this year.

Pfizer and BioNTech plan to share these data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible. For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group.

A request to the EMA to update the EU Conditional Marketing Authorization is also planned. Topline readouts for the other two age cohorts from the trial – children 2-5 years of age and children 6 months to 2 years of age – are expected as soon as the fourth quarter of this year. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.

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Source: Pfizer says its vaccine is 90.7% effective against symptomatic Covid-19 in children ages 5 to 11 – ABC17NEWS

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Other Sources:

Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com

or by calling 1-800-438-1985.

Please click here for full Prescribing Information (16+ years of age). Please click here for Fact Sheet for Vaccination Providers (12+ years of age)

Public Assessment Report Authorisation for Temporary Supply COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA) concentrate for solution for injection (PDF). Regulation 174 (Report). Medicines and Healthcare products Regulatory Agency (MHRA). 15 December 2020. Archived (PDF) from the original on 16 December 2020. Retrieved 23 April 2021. Burger L (15 March 2020). “BioNTech in China alliance with Fosun over coronavirus vaccine candidate”. Reuters. Archived

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