Black Friday Sale! Save huge on InvestingProGet up to 60% off

Pfizer submits data for COVID-19 vaccine use in younger kids

Published 09/28/2021, 06:52 AM
Updated 09/28/2021, 04:45 PM
© Reuters. FILE PHOTO: A woman holds a small bottle labeled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in front of displayed Pfizer logo in this illustration taken, October 30, 2020. REUTERS/Dado Ruvic
PFE
-
MRNA
-
BNTX
-

(Reuters) - Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) on Tuesday submitted initial trial data for their COVID-19 vaccine in 5-11 year olds and said they would make a formal request to U.S. regulators for emergency use in the coming weeks.

The U.S. Food and Drug Administration said earlier this month it would look to complete its data review for this age group as quickly as possible, likely in a matter of weeks rather than months. That could mean an authorization of the shot for children by the end of October, sources have told Reuters.

The companies, however, have yet to start the official process for authorization, which could slow the decision. According to the Wall Street Journal, the FDA may not make its decision until sometime between Halloween and Thanksgiving, citing a person familiar with the matter.

A Pfizer spokesperson said the company expects to start and complete its application very soon.

A decision on the vaccine's use in younger children is eagerly awaited by millions of Americans as coronavirus infections have soared in children to the highest point in early September, according to data from the American Academy of Pediatrics.

The vaccine, which is already authorized for 12 to 15-year- olds and fully approved for ages 16 and up, induced a strong immune response in the target age group in a 2,268-participant clinical trial, the companies said on Sept. 20.

The Pfizer-BioNTech vaccine was authorized for the 12-15 age group roughly a month after the companies filed for authorization. If the same timeline is followed for this application, younger children could start receiving their shots as soon as late October.

A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide.

While kids are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations that are more at risk of severe illness.

The companies said they plan to submit the data to the European Medicines Agency and other regulatory authorities. They also plan to submit data from the full late-stage trial for scientific peer-reviewed publication.

The FDA was not immediately available to comment.

Data from the companies' trial showed the two-shot vaccine generated an immune response in children that matched what was previously observed in 16-to-25 year olds. The safety profile was also comparable to the older age group, Pfizer said.

The drugmakers are also testing the vaccine in children aged 2-to-5 and those aged 6 months-to-2 years, with data expected in the fourth quarter.

© Reuters. FILE PHOTO: A woman holds a small bottle labeled with a

Moderna (NASDAQ:MRNA)'s COVID-19 vaccine is not yet authorized for use in adolescents in the United States, while it has gained authorization for that age group in Europe.

Both the Pfizer and Moderna vaccines have been linked by regulators to rare cases of heart inflammation in adolescents and young adults, particularly young men. Pfizer said no instances of heart inflammation were seen in the trial participants.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.