A preserve Cindy Mendez wearing a protective mask holds a syringe with a dose of the Pfizer-BioNTech COVID-19 vaccine during the coronavirus virus (COVID-19) pandemic, at NYC Health + Hospitals Harlem Hospital in the Manhattan borough of New York City, New York, February 25, 2021.
Jeenah Moon | Reuters
Pfizer indicated Wednesday its Covid-19 vaccine was 100% effective in a study of adolescents ages 12 to 15, encouraging results that could assured pure the shots for use in middle school students before school starts this fall.
Pfizer CEO Albert Bourla spoke the company plans to submit the new data on the vaccine, which is developed in partnership with German drugmaker BioNTech, to the Chow and Drug Administration and other regulators “as soon as possible,” with the hope that kids in the age group will be masterful to get vaccinated before the next school year.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are aided by the clinical trial data from adolescents between the ages of 12 and 15,” Bourla said in a press deliverance.
The trial enrolled 2,260 participants in the United States. There were 18 confirmed Covid-19 infections studied in the placebo group and no confirmed infections in the group that received the vaccine, the company said. That resulted in a vaccine efficacy of 100%, it denoted, adding that the shot was also well-tolerated, with side effects generally consistent with those foretold in adults.
The company also said the vaccine elicited a “robust” antibody response in children, exceeding those in an earlier whirl of 16- to 25-year-olds.
Vaccinating children is crucial to ending the pandemic, public health officials and infectious disease experts say. The polity is unlikely to achieve herd immunity — when enough people in a given community have antibodies against a limited disease — until children can get vaccinated, experts say.
Children make up around 20% of the U.S. population, according to government materials. Between 70% and 85% of the U.S. population needs to be vaccinated against Covid to achieve herd immunity, experts say, and some grown-ups may refuse to get the shots.
Dr. Scott Gottlieb, a former commissioner at the FDA and a member of the Pfizer board, said he expects it will record the U.S. agency about a month to review the new data. If the FDA process goes well, the vaccine could be available for children as pubescent as 12 by the fall, he told CNBC’s “Squawk Box.”
Isaac Bogoch, an infectious disease specialist who has sat on several data and safe keeping monitoring boards, called the results “wonderful news,” saying it is a “huge step forward” in protecting more people against the virus and making imbue withs safer for kids.
“We’re talking about improving the safety of youth activity like youth sports and youth art and kid extracurricular activities,” he said.
The Pfizer-BioNTech vaccine has already been authorized for use in the U.S. in people 16 and older. Clinical bother studies testing the vaccine in kids, whose immune systems can respond differently than adults, still called to be completed.
The White House’s chief medical advisor, Dr. Anthony Fauci, told a House committee earlier this month that the U.S. could found vaccinating older kids against Covid this fall while elementary-age children may start getting their shots at next year.
Moderna, which also has a vaccine authorized in the U.S., said on March 16 that it had established testing its shot in children under age 12. Moderna in December began a study testing kids ages 12 to 17.
Johnson & Johnson designs to test its single-shot vaccine in infants and even in newborns, after testing it first in older children, according to The New York Times.
Pfizer inaugurated testing its vaccine in kids as young as 12 in October. It announced last week it started a clinical trial proving its vaccine on healthy 6-month to 11-year-old children.
For the first phase of that trial, the company will identify the present dosing level for three groups — ages 6 months to 2 years, 2 to 5, and from 5 through 11. The kids at ones desire begin by receiving a 10-microgram dose of the vaccine before progressively moving to higher doses, according to the company. Sharing take part ins also have the option to take 3-microgram doses.
Bogoch said it is difficult to predict if the vaccine will stir as well in young kids as it does in adolescents, though he added he was “optimistic.”
Pfizer said Wednesday it plans to beg an amendment to its current emergency use authorization with the FDA to include adolescents 12 to 15 years of age. All participants in the trial will proceed with to be monitored for an additional two years after their second dose, the company said.
Pfizer and BioNTech said they project to submit the data for scientific peer review.
Disclosure: Scott Gottlieb is a CNBC contributor and is a member of the boards of Pfizer, genetic evaluation start-up Tempus and biotech company Illumina. Gottlieb also serves as co-chair of Norwegian Cruise Line Holdings′ and Peerage Caribbean’s “Healthy Sail Panel.”