Pfizer Plans To Apply In September For OK To Vaccinate Kids As Young As 2
Pfizer is planning to seek authorization from the Food and Drug Administration for emergency use of its covid vaccine on kids aged 2 to 11. The agency is expected to clear the shot for adolescents from 12 to 15 as early as next week.
The New York Times: Pfizer To Seek Clearance In September For Vaccinating Children As Young As 2 Pfizer expects to apply to the Food and Drug Administration in September for emergency authorization to administer its coronavirus vaccine to children between the ages of 2 and 11, the company told Wall Street analysts and reporters on Tuesday during its quarterly earnings call. The company said it also plans to apply this month for full approval of the vaccine for use in people from ages 16 to 85. And it said it expected to have clinical trial data on the safety of its vaccine in pregnant women by early August. (Anthes, 5/5)
CNN: Pfizer To Seek Authorization For Covid-19 Vaccine For Children Ages 2 To 11 In September The company's vaccine safety and efficacy study in children age 6 months to 11 years old is still going. "We expect to have definitive readouts and submit for an EUA for two cohorts, including children age 2-5 years of age and 5-11 years of age, in September," Pfizer CEO Albert Bourla said, adding that the readout and submission for children 6 months to 2 years is expected in the fourth quarter of 2021. (Thomas, 5/4)
NPR: Pfizer Says FDA Will Soon Authorize COVID-19 Vaccine For 12-15 Age Group The U.S. Food and Drug Administration is expected to authorize the Pfizer-BioNTech COVID-19 vaccine for children 12 to 15 years old, a decision that could come by some time early next week. The vaccine is currently authorized only for people age 16 and older. A ruling should come "shortly," Pfizer Chairman and CEO Albert Bourla told investors in a conference call Tuesday morning. (Chappell, 5/4)
CNN: Fauci To Adolescents On The Fence About The Covid-19 Vaccine: 'Be Part Of The Solution' Dr. Anthony Fauci said he hopes children and teens won't hesitate when the US Food and Drug Administration authorizes a coronavirus vaccine for them. ... "You have the capability of protecting yourself as a young person, 12 to 15, but also knowing that you're not going to pass it on to someone else," Fauci told CNN's Wolf Blitzer on Tuesday. "You even want to call upon the young people to say, 'I want to protect myself, but I want to be part of the solution, not part of the problem.'" (Maxouris, Sanchez and Waldrop, 5/5)
In related pediatric news —
Fox News: Novavax COVID-19 Vaccine Study Now Includes Kids, Company Says Vaccine development company Novavax on Monday announced it has expanded its Phase 3 clinical trial for its COVID-19 vaccine to children between the ages of 12 and 17. The company said it's testing its COVID-19 vaccine — NVX-CoV2373 — on some 3,000 pediatric patients across 75 U.S. locations. The company is testing two doses of its vaccine candidate spaced 21 days apart. "Two-thirds of volunteers will receive intramuscular injections of the vaccine and one-third will receive placebo. A blinded crossover is planned to take place six months after the initial set of vaccinations to ensure that all trial participants receive active vaccine," the company said in a news release. "Participants will be monitored for safety for up to two years following the final dose." (Farber, 5/4)
Roll Call: Vaccinating Kids For COVID-19 Poses Additional Challenges For Officials Public health advocates who expect COVID-19 vaccines to become available for younger teens soon are concerned that a government-led distribution effort that may rely in large part on pediatricians could create glaring inequalities among children. With only three months before the next school year starts in some areas, advocates are calling on the Biden administration to develop a more detailed outreach strategy, encourage schools to offer shots and provide more funding to get kids vaccinated. (Cohen, 5/4)
Houston Chronicle: Houston Toddler First To Receive COVID Vaccine In Baylor, Texas Children's Trial For Young Kids Nathan Galvan has spent nearly his entire life in a pandemic. At just 16 months old, he has had little opportunity to socialize with anyone outside of his nuclear family. But that could soon change for Nathan, the first child in a Pfizer vaccine study run by Baylor College of Medicine and Texas Children’s Hospital. The study will evaluate the COVID-19 vaccine in children under 2. (Wu, 5/4)
AP: US Parents Excited Over Prospect Of Virus Shots For Children After more than a year of fretting over her 13-year son with a rare liver disease, Heather Ousley broke into tears when she learned that he and millions of other youngsters could soon be eligible for the COVID-19 vaccine. “This day is the best day in the history of days!!! I love this day!!!” she texted, joining other parents and educators in welcoming the news that the Food and Drug Administration is expected to authorize Pfizer’s vaccine by next week for children ages 12 to 15. (Hollingsworth and Richmond, 5/5)
Detroit Free Press: Should Kids Get COVID-19 Vaccines? Michigan Doctors Say Yes The U.S. Food and Drug Administration declined to comment Tuesday on how soon the agency could amend the emergency use authorization of Pfizer's COVID-19 vaccine to include children ages 12-15, telling the Free Press only that its review "is ongoing." "We can assure the public that we are working to review this request as quickly and transparently as possible," an FDA spokesperson said. In remarks about the nation's COVID-19 response Tuesday, President Joe Biden said that "the FDA and the FDA alone will make that decision." (Jordan Shamus and Hall, 5/4)
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