A Covid-19 booster shot for children aged 5 to 11 could be rolled out soon.Pfizer and BioNTech have released clinical data for their messenger RNA vaccine from a study of children aged 5 to 11 and based on these Preliminary results The companies said they plan to apply for emergency authorization for a third injection for this age group.
Booster data less than six months after FDA release Authorize The Pfizer/BioNTech vaccine is for children 5 to 11 years old. 10 mcg vaccine dose ratio 30-mcg version of the vaccine approved for adults.
A Phase 2/3 study is evaluating booster doses in 140 children. These study participants received their third injection approximately six months after the second dose of the initial two-injection regimen. Early results showed a six-fold increase in neutralizing antibodies against the original, unmutated version of SARS-CoV-2, the companies reported on April 14. A subgroup of 30 blood samples from the study was tested against omicron variants. According to preliminary results, neutralizing antibody levels against this variant were increased 36-fold.
When Pfizer and BioNTech reported the latest pediatric data on their Covid vaccines, they said they expected to submit an emergency authorization application for a booster dose for children in the coming days. They added that they plan to share the data soon with the European Medicines Agency and other regulators around the world.
More than 10,000 children under the age of 12 participated in clinical trials evaluating Pfizer and BioNTech’s Covid vaccines. The vaccines continued to be well-tolerated in the latest data cuts, with no new safety signals observed, the companies reported. The number of U.S. children who can receive booster immunizations with Pfizer and BioNTech vaccines remains low. According to the Centers for Disease Control and Prevention, only 3 percent of children ages 5 to 11 are fully vaccinated.
The past week has seen other developments in Covid-19 vaccines, drugs and diagnostics. Here’s a recap of the news.
— More than 400 testing and sample collection devices received FDA Emergency Use Authorization for Covid-19.The agency has Authorize First Works by analyzing breathing. The InspectIR COVID-19 Breathalyzer was developed by a company called InspectIR Systems and is not intended for home use. The device is about the size of a piece of carry-on luggage, and the test must be performed by a healthcare professional. It uses mass spectrometry to analyze breath samples and produce results within three minutes.
The FDA said the InspectIR diagnosis was evaluated in a study that included 2,409 people, both symptomatic and asymptomatic. The sensitivity of the diagnosis, the percentage of positive samples correctly identified, was 91.2%. The specificity of diagnosis, the percentage of negative samples correctly identified, was 99.3%. A follow-up study of the omicron variant produced similar results, the FDA said.
— Covid-19 vaccine developed by Valneva approved Conditional Marketing Authorization For adults aged 18 to 50 in the UK. The vaccine, called VLA2001, consists of whole inactivated particles of SARS-CoV-2 and two adjuvants that enhance the immune response. It is the only vaccine of its kind to enter clinical trials in Europe.
— Regeneron Pharmaceuticals faces delay in seeking regulatory approval for Covid-19 antibody drug As treatment for non-hospitalized patients and prophylactic use in some individuals.U.S. Food and Drug Administration Expanded censorship Drug, REGEN-COV, three months; decision now expected on July 13. According to the Tarrytown, N.Y.-based company, additional discussions on preventive use require the submission of additional data, which will require additional time to review. No new clinical studies were requested.
The Regeneron drug combines two antibodies, casirivimab and imdevimab. The drug cocktail received an emergency use authorization in late 2020; its ineffectiveness for the new variant led the agency to withdraw the authorization. Meanwhile, the company continues clinical development of next-generation antibodies that it hopes will be effective against currently prevalent variants of interest.
– FDA placed a clinical hold In a Phase 2/3 trial of Ocugen’s Covid-19 vaccine Covaxin. The move comes as the company evaluates the World Health Organization’s Call for suspension of supply The vaccine’s manufacturing flaws came after the agency discovered manufacturing flaws at Bharat Biotech, the Indian company that developed the vaccine. Ocugen, headquartered in Malvern, Pennsylvania, owns the exclusive rights to Covaxin in the United States.
Image: appledesign, Getty Images
