Thomas Gregory, 16, is inoculated by nurse Cindy Lamica with the Pfizer-BioNTech Covid-19 vaccine at the UMass Memorial Health Care COVID-19 Vaccination Center in the Mercantile Center in Worcester, Massachusetts on April 22, 2021.
Joseph Prezioso | AFP | Getty Images
If clinical trials go well and the Food and Drug Administration approves it, young children could get vaccinated by the end of the year, Dr. Ozlem Tureci, the co-founder and chief medical officer of BioNTech, told CNBC late Thursday.
“We expect the data at the end of the summer or autumn of this year. We will then file it with the regulators and, depending on how fast they react, by the end of the year we might get approval to also immunize younger children,” she said.
In late March, Pfizer and BioNTech began a clinical trial testing their vaccine on healthy 6-month to 11-year-old children, a crucial step in obtaining federal regulatory clearance to start vaccinating young kids and controlling the pandemic.
For the first phase of the trial, the companies will identify the preferred dosing level for three age groups – between 6 months and 2 years old, 2 and 5, and from 5 through age 11. The doses will be evaluated in children 5 through age 11 first before researchers move on to the other age groups, they said.
Because the companies are evaluating the older age group first, it’s possible data on kids under age 5 could come “a bit later,” Tureci told CNBC.
The two-dose vaccine is already authorized for use in people 16 and older. Earlier this month, Pfizer and BioNTech asked the FDA to allow their Covid-19 vaccine to be given to kids ages 12 to 15 on an emergency use basis.
The companies said in late March that the vaccine was found to be 100% effective in a trial of more than 2,000 adolescents. They also said the vaccine elicited a “robust” antibody response in the children, exceeding those in an earlier trial of older teens and young adults. Side effects were generally consistent with those seen in adults, they added.
Vaccinating children is seen as crucial to ending the pandemic. The nation is unlikely to achieve herd immunity — when enough people in a given community have antibodies against a specific disease — until children can get vaccinated, health officials and experts say.
Children make up around 20% of the total U.S. population, according to government data. Between 70% and 85% of the U.S. population needs to be vaccinated against Covid to achieve herd immunity, experts say, and some adults may refuse to get the shots.
In addition to testing the vaccine in young children, Pfizer and BioNTech are testing whether a third dose of the vaccine would provide a better immune response against new variants of the virus.
BioNTech CEO Ugur Sahin told CNBC on Thursday he is “confident” the vaccine is effective against B.1.617, a highly contagious coronavirus variant first identified in India.
Still, he said, people will likely need a third shot of its two-dose vaccine as immunity against the virus wanes. Researchers are seeing a decline in antibody responses against the virus after eight months, he added.
“If we provide a boost we could really amplify the antibody response even above the levels that we had at the beginning and that could give us real comfort for protection for at least 12 months, maybe 18 months,” he told CNBC. “And this is really important in a time where all the variants are coming in.”
Sahin also said he expects demand for the shot to continue to increase, adding the company is boosting the manufacturing capacity of the vaccine to 3 billion doses by the end of 2021. In December, Sahin expects the company’s manufacturing goal will go up to 400 million doses a month.