# U.S. FDA backs Pfizer’s COVID-19 booster shot for 12- to 15-year-olds Author: Pal Sinha, Barnali Author URL: https://financedigest.com/author/pal-sinha-barnali Published: 2022-01-03 Category: NEWS Category URL: https://financedigest.com/category/news Meta Title: FDA Authorizes Pfizer COVID-19 Boosters for Children and Meta Description: FDA approves third dose of Pfizer-BioNTech COVID-19 vaccine for kids 12 to 15 years old, providing extra protection against Omicron variant. Boosters now URL: https://financedigest.com/u-s-fda-backs-pfizers-covid-19-booster-shot-for-12-to-15-year-oldshtml ![undefined](https://prod.superblogcdn.com/site_cuid_cm5qst7v3003gwirgwqtxn8i8/images/2022-01-03t150609z1lynxmpei020firtroptp4health-coronavirus-usa-children-1736836524516-compressed.jpg) By Ahmed Aboulenein and Ankur Banerjee WASHINGTON (Reuters) -The U.S. Food and [Drug Administration on Monday authorized the https://www.fda.gov/media/150386/download use of a third dose of the Pfizer](https://www.financedigest.com/bristol-myers-pfizer-abbvie-drugs-likely-to-face-u-s-price-negotiation.html "Bristol Myers, Pfizer, AbbVie drugs likely to face U.S. price negotiation") and BioNTech COVID-19 vaccine for children ages 12 to 15, and narrowed the time for all booster shots by a month to five months after the primary doses. The agency also authorized a third [shot for children](https://www.financedigest.com/germanys-vaccine-panel-says-one-covid-shot-enough-for-children.html "Germany’s vaccine panel says one COVID shot enough for children") aged 5 through 11 years who are immunocompromised. The regulatory decisions come as schools reopen in much of the country, and as [COVID-19 cases surge](https://www.financedigest.com/stocks-on-worst-run-in-18-months-amid-global-covid-19-surge.html "Stocks on worst run in 18-months amid global COVID-19 surge") due to the Omicron variant of the virus, with health authorities warning that its high transmissibility could overwhelm many health systems. The U.S. Centers for Disease Control and Prevention is expected to weigh in on the changes this week, [according to the New York Times](https://www.financedigest.com/us-homeowners-premium-set-to-surpass-90bn-for-the-first-time-according-to-annual-aon-study.html "US homeowners premium set to surpass bn for the first time, according to annual Aon study"). The CDC was not immediately available for comment. Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help [provide better protection](https://www.financedigest.com/banks-can-provide-a-protective-shield-to-defend-customers-from-cyber-attack.html "Banks can provide a protective shield to defend customers from cyber attack") against both the Delta and Omicron variants,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. The U.S. government has been urging vaccinated Americans to get boosters and for the unvaccinated, who are at much higher [risk of severe COVID-19 and death](https://www.financedigest.com/risking-death-at-sea-rohingya-muslims-seek-safety-in-indonesia.html "Risking death at sea, Rohingya Muslims seek safety in Indonesia"), to be inoculated. So far, 62% of the eligible U.S. population is considered fully [vaccinated with a third of them also having received a booster](https://www.financedigest.com/israels-covid-19-vaccine-boosters-show-signs-of-taming-delta.html "Israel’s COVID-19 vaccine boosters show signs of taming Delta") dose. In making its decision, the FDA said it reviewed real-world [data](https://www.financedigest.com/interoperability-of-data-to-accelerate-the-flu-vaccines-market.html "Interoperability of data to accelerate the Flu Vaccines Market") from Israel, including safety data from more than 6,300 individuals aged 12 through 15 years who received a booster dose of the Pfizer-BioNTech vaccine at least 5 months following completion of the primary two-dose vaccination series. There were no new cases of a [rare type of heart inflammation reported](https://www.financedigest.com/pmrs-report-on-global-rare-disease-treatment-market.html "PMR’s Report on Global Rare Disease Treatment Market") to-date in these individuals, the FDA said. Laboratory tests have shown that two doses of the Pfizer-BioNTech and Moderna [vaccines generate low immune](https://www.financedigest.com/immunization-campaigns-to-boost-the-demand-for-vaccines.html "Immunization Campaigns To Boost The Demand For Vaccines") responses against Omicron, while the addition of a booster appears to restore protection against the highly-mutated variant. Two shots of the mRNA vaccine are about 35% effective against infection from the Omicron variant, but a booster dose restores effectiveness to 75%, according to the CDC, based on data from [South Africa](https://www.financedigest.com/ancs-failed-foreign-policy-hurting-south-africa.html "ANC’s failed foreign policy hurting South Africa") and the United Kingdom. The FDA said authorizing the shot at 5 [months instead of 6 may provide](https://www.financedigest.com/independent-study-finds-infinidat-storage-can-provide-customers-125-roi-over-three-years-and-payback-in-less-than-six-months.html "Independent Study Finds INFINIDAT Storage Can Provide Customers 125% ROI Over Three Years and Payback in Less than Six Months") better protection sooner against Omicron. Dr. Eric Topol, director of the Scripps Research Translational Institute in La Jolla, California, said a third shot is essential to protect against Omicron for severe disease. A good [thing here is also the change on the timing](https://www.financedigest.com/it-is-time-insurers-act-smart-by-making-legacy-systems-a-thing-of-the-past.html "It is time insurers act smart, by making legacy systems a thing of the past") of the booster to five months instead of six. That’s a big step for this country, which has been resistant to the data,” he added. Countries including the United Kingdom and Israel have narrowed their window for [boosters from six months to three or four following the second shot](https://www.financedigest.com/fda-advisers-back-the-same-covid-vaccine-for-initial-shots-boosters.html "FDA advisers back the same COVID vaccine for initial shots, boosters") to try to fight the spread of the easily transmitted Omicron variant. Amesh Adalja, a senior scholar at the Johns Hopkins Institute for Health Security, said he does not believe a [boosters is necessary for most people since two doses of the vaccine](https://www.financedigest.com/u-s-cdc-signs-off-on-moderna-jj-covid-19-vaccine-boosters-mix-and-match-shots.html "U.S. CDC signs off on Moderna, J&J COVID-19 vaccine boosters, mix-and-match shots") have been effective at preventing hospitalizations and severe disease in all but older people. “When I work at the hospital, I don’t see patients there because they lack a booster, I see patients because they lack first and second doses,” Adalja said. (Reporting by Ankur Banerjee and Manas Mishra in Bengaluru and Ahmed Aboulenein in Washington DC; Editing by Sriraj Kalluvila and Bill Berkrot) --- This blog is powered by Superblog. Visit https://superblog.ai to know more. ---