This is not a paywall.

Register for free to continue reading.

The news sucks. But your reading experience doesn't have to. Help us improve that for you by registering for free.

Please create a password or click to receive a login link.

Please enter your password or get a login link if you’ve forgotten

Open Sesame! Thanks for registering.

First Thing, Daily Maverick's flagship newsletter

Join the 230 000 South Africans who read First Thing newsletter.

A South African Hero: You

There’s a 99.7% chance that this isn’t for you. Only 0.3% of our readers have responded to this call for action.

Those 0.3% of our readers are our hidden heroes, who are fuelling our work and impacting the lives of every South African in doing so. They’re the people who contribute to keep Daily Maverick free for all, including you.

We need so many more of our readers to join them. The equation is quite simple: the more members we have, the more reporting and investigations we can do, and the greater the impact on the country. We are inundated with tip-offs; we know where to look and what to do with the information when we have it – we just need the means to help us keep doing this work.

Be part of that 0.3%. Be a Maverick. Be a Maverick Insider.

Support Daily Maverick→
Payment options

Pfizer submits Covid shot for kids under 5 for FDA auth...

Business Maverick

Business Maverick

Pfizer submits Covid shot for kids under 5 for FDA authorisation

A child receives a dose of the Pfizer-BioNTech COVID-19 vaccine in West Bloomfield, Michigan, US, on Thursday, November 4, 2021. Younger children, ages 5 to 11-year-old, across the U.S. are now eligible to receive Pfizer's Covid-19 vaccine, after the head of the Centers for Disease Control and Prevention granted the final clearance needed for shots to begin.
By Bloomberg
02 Jun 2022 0

The pharmaceutical company has asked US regulators to clear its Covid-19 vaccine for emergency use in children under age 5, an effort to extend protection against the virus to the country’s youngest.

Pfizer and BioNTech SE finalised their rolling application to the Food and Drug Administration for emergency-use authorization of their vaccine in kids ages 6 months through to 4 years old, the companies said in a statement on Wednesday. The vaccine partners began the submission process in February.

Pfizer and BioNTech announced in late May that a three-shot regimen was highly effective and prompted a strong immune response in children under age 5, based on early results from a highly anticipated trial that is likely to pave the way for infants and toddlers to get immunised.

Read More: Pfizer Covid Shot Seems Protective for Children Under Five

The preliminary analysis found that the vaccine was 80.3% effective in preventing Covid infections among young children, with 10 infections occurring among all participants. Final results will be determined once 21 children enrolled in the study have been infected, according to the companies. 

In February, Pfizer and BioNTech launched a rolling review of data from the trial of 1,678 children under the age of 5. The three-dose vaccine regimen was well tolerated, with a safety profile similar to that of the placebo, and most side effects were mild or moderate.

The full submission includes data on the product’s safety, efficacy and ability to prompt an immune response. Children under the age of 5 were a given of series of three doses, each 3 micrograms, or 1/10th the amount given to adults. 

With the submission now complete, attention will turn to a forthcoming FDA advisory committee meeting on June 15. The panel of experts will convene to discuss the risks and benefits of the Pfizer-BioNTech and Moderna Inc. vaccines in the youngest children, and provide a recommendation to U.S. regulators as to whether or not they should be cleared for emergency use. 

Pfizer said the companies also plan to submit the data to the European Medicines Agency and other regulators around the world. BM



Comments - share your knowledge and experience

Please note you must be a Maverick Insider to comment. Sign up here or sign in if you are already an Insider.

Everybody has an opinion but not everyone has the knowledge and the experience to contribute meaningfully to a discussion. That’s what we want from our members. Help us learn with your expertise and insights on articles that we publish. We encourage different, respectful viewpoints to further our understanding of the world. View our comments policy here.

No Comments, yet

Please peer review 3 community comments before your comment can be posted