
<h2 class="wp-block-heading" id="h-topline">TOPLINE</h2>



<p>Pfizer and BioNTech asked the U.S. Food and Drug Administration to authorize their jointly-developed Covid-19 shot for children under five, the companies&nbsp;<a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-emergency" target="_blank" rel="noreferrer noopener">announced</a>&nbsp;Tuesday, paving the way for the first vaccine roll out among young children to begin in a matter of weeks.</p>



<h2 class="wp-block-heading" id="h-key-facts">KEY FACTS</h2>



<p>Pfizer and BioNTech said the companies had initiated a “rolling submission” to the FDA asking it to expand its current Emergency Use Authorization for the companies’ Covid-19 vaccine to include children six months to four years old, and it expects to complete its submission in the coming days.</p>



<p>The companies submitted the data at the FDA’s request, Pfizer and BioNTech said.</p>



<p>The vaccine series for young children is expected to consist of three shots, but data on the third shot’s effectiveness isn’t available yet and will be submitted in the “coming months.”</p>



<p>The FDA could first authorize two shots, which Pfizer CEO Albert Bourla noted would let parents “begin a Covid-19 vaccination series for their children while awaiting potential authorization of a third dose.”</p>



<p>The FDA said in a&nbsp;<a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-advisory-committee-meeting-discuss-request-authorization-pfizer" target="_blank" rel="noreferrer noopener">statement</a>&nbsp;it will meet February 15 to discuss the shots, meaning authorization could come soon after that.</p>



<p>If approved, the shot will be the first authorized for use in children under the age of five in the U.S.</p>



<h2 class="wp-block-heading" id="h-crucial-quote">CRUCIAL QUOTE</h2>



<p>“As hospitalizations of children under five due to Covid-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Bourla said in a statement. “Ultimately, we believe that three doses of the vaccine will be needed for children six months through four years of age to achieve high levels of protection against current and potential future variants.”</p>



<h2 class="wp-block-heading" id="h-key-background">KEY BACKGROUND</h2>



<p>Though children are less likely to get seriously unwell from the coronavirus, they play an important role in spreading the virus to more vulnerable people and can, in rare cases, develop life-threatening&nbsp;<a href="https://www.forbes.com/sites/roberthart/2022/01/06/whats-driving-record-covid-hospitalizations-among-us-kids/?sh=7af1a75243c0">illness</a>&nbsp;from Covid-19. The FDA has already given Pfizer emergency approval for its shot in children ages five and up—including&nbsp;<a href="https://www.forbes.com/sites/annakaplan/2022/01/03/fda-authorizes-pfizer-booster-shot-for-children-ages-12-to-15/?sh=1daaee077e38">boosters</a>&nbsp;in those aged 12 to 15 in January—but the company encountered setbacks for its shot in younger age groups after clinical trials showed lower levels of immunity compared to that given to older age groups. The&nbsp;<a href="https://edition.cnn.com/2021/12/17/health/pfizer-vaccine-children/index.html" target="_blank" rel="noreferrer noopener">company</a>&nbsp;had reduced the amount of vaccine given to children to stave off any potential safety issues (it is standard practice to try and use the smallest dose possible) and amended the trial to add a third dose.&nbsp;</p>



<h2 class="wp-block-heading" id="h-what-to-watch-for">WHAT TO WATCH FOR</h2>



<p>Moderna. The Massachusetts-based biotech&nbsp;<a href="https://www.forbes.com/sites/masonbissada/2022/01/12/moderna-expects-vaccine-data-for-kids-ages-2-5-by-march/?sh=326461ad5a54">said</a>&nbsp;it hopes to report data on its Covid-19 vaccine for children ages two to five by March. If results are promising, the company said it will seek regulatory approval from the FDA. Moderna, which was&nbsp;<a href="https://www.forbes.com/sites/dereksaul/2022/01/31/moderna-receives-fda-approval-for-its-coronavirus-vaccine/?sh=49eef363203b">granted</a>&nbsp;full FDA approval for its shot in adults on Monday, has not yet secured authorization for teens in the U.S. after the regulator said it needed more time to examine a rare risk of heart inflammation after vaccination. This investigation is ongoing, though the European Medicines Agency&nbsp;<a href="https://www.ema.europa.eu/en/news/covid-19-vaccine-spikevax-approved-children-aged-12-17-eu" target="_blank" rel="noreferrer noopener">greenlit</a>&nbsp;the shot for use in children aged 12 to 17 in July.&nbsp;</p>



<h2 class="wp-block-heading" id="h-what-we-don-t-know">WHAT WE DON’T KNOW</h2>



<p>How many parents will let their young child get the shot. A Kaiser Family Foundation&nbsp;<a href="https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-january-2022-parents-and-kids-update/" target="_blank" rel="noreferrer noopener">poll</a>&nbsp;conducted in January found only 31% of parents of children under five will get them vaccinated right away, while another 29% said they’ll “wait and see.”</p>



<h2 class="wp-block-heading" id="h-tangent">TANGENT</h2>



<p>Novavax&nbsp;<a href="https://www.forbes.com/sites/zacharysmith/2022/01/31/novavax-asks-fda-to-authorize-its-non-mrna-covid-vaccine/?sh=49b274834183">asked</a>&nbsp;the FDA to grant it emergency authorization for its protein-based Covid-19 vaccine on Monday. The shot is already endorsed by the World Health Organization and regulators in Australia, South Korea and Europe.&nbsp;</p>



<h2 class="wp-block-heading" id="h-further-reading">FURTHER READING</h2>



<p><a href="https://www.theguardian.com/world/2022/jan/29/us-parents-kids-under-five-covid-vaccine" target="_blank" rel="noreferrer noopener">‘We are so tired’: US parents and doctors say kids under five left behind in Covid vaccine race</a>&nbsp;(Guardian)</p>



<p><a href="https://www.forbes.com/sites/alisondurkee/2021/11/03/kids-ages-5-11-are-now-eligible-for-covid-vaccines-but-polls-suggest-many-parents-wont-let-their-child-get-the-shot/?sh=6e24794d5f76">Kids Ages 5-11 Are Now Eligible For Covid Vaccines—But Polls Suggest Many Parents Won’t Let Their Child Get The Shot</a>&nbsp;(Forbes)</p>



<p><a href="https://www.forbes.com/sites/roberthart/2022/01/06/whats-driving-record-covid-hospitalizations-among-us-kids/?sh=7af1a75243c0">What’s Driving Record Covid Hospitalizations Among U.S. Kids</a>&nbsp;(Forbes)</p>



<p><strong><em>By Robert Hart, Forbes Staff </em></strong></p>



<p><strong><em>By Alison Durkee, Forbes Staff </em></strong></p>


A doctor is injecting a vaccine to a baby boy

Pfizer Asks FDA To Authorize Its Covid Shot For Kids Under 5


<p><meta charset="utf-8">TOPLINE Pfizer says its Covid-19 vaccine is more than 90% effective against infection for children between the ages of 5 and 11, according to briefing documents shared by the Food and Drug Administration (FDA) Friday morning as its regulators prepare to release their opinion on giving the jab to young kids.</p>



<h2 class="wp-block-heading" id="h-key-facts">KEY FACTS</h2>



<p>The briefing documents included the results of a trial by Pfizer of about 2,250 children who were either given two shots of a low-dose vaccine (about a third of the amount given to teens and adults) or a placebo.</p>



<p>Just three of the children inoculated with Pfizer’s vaccine developed the virus compared to 16 of those who received the placebo, making the vaccine about 90.7% effective.</p>



<p>The trial shored up no safety issues (though it wasn’t large enough to identify cases of rare heart inflammation) and suggested young children given the vaccine develop the same levels of antibodies as teenagers and young adults who received full doses of the vaccine.</p>



<p>The FDA released these documents as its regulators are expected to post online their written assessment of the data that’s been provided by Pfizer as early as Friday morning.</p>



<h2 class="wp-block-heading" id="h-what-to-watch-for">WHAT TO WATCH FOR</h2>



<p>The response from the FDA regulators will give critical insight into how the agency will rule in authorizing the vaccine for this demographic. Members of its advisory panel, the Vaccines and Related Biological Products Advisory Committee, are set to meet Tuesday to vote on their recommendations for authorization.</p>



<h2 class="wp-block-heading" id="h-key-background">KEY BACKGROUND</h2>



<p>Though it is still extremely rare for young people to die from Covid-19, record numbers of children being hospitalized with the virus during the summer and fall delta wave exacerbated calls to make vaccines available for young children. A study released by the Centers for Disease Control and Prevention (CDC) earlier this week found Pfizer’s jab to be 93% effective at preventing hospitalizations among those between 12 and 18.</p>



<h2 class="wp-block-heading" id="h-further-reading">FURTHER READING</h2>



<p><a href="https://www.forbes.com/sites/alisondurkee/2021/10/19/pfizers-covid-vaccine-93-effective-at-preventing-teen-hospitalizations-cdc-study-finds/">“Pfizer’s Covid Vaccine 93% Effective At Preventing Teen Hospitalizations, CDC Study Finds”</a>&nbsp;(Forbes)</p>



<p><a href="https://www.forbes.com/sites/masonbissada/2021/10/20/vaccinated-teens-90-less-likely-to-contract-delta-variant-in-first-few-weeks-after-second-dose-study-finds/?sh=2896ae5c1efa">“Vaccinated Teens 90% Less Likely To Contract Delta Variant In First Few Weeks After Second Dose, Study Finds”</a>&nbsp;(Forbes)</p>



<p><a href="https://www.forbes.com/sites/alisondurkee/2021/10/20/heres-how-the-white-house-plans-to-distribute-childrens-covid-vaccines/">“Here’s How The White House Plans To Distribute Children’s Covid Vaccines” </a>(Forbes)</p>



<p><strong><em>By Jemima McEvoy, Forbes Staff</em></strong></p>


Tag: Vaccine for Children

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Pfizer Asks FDA To Authorize Its Covid Shot For Kids Under 5

Pfizer Says Its Covid Vaccine Is 91% Effective At Preventing Infection For Young Kids