BioNTech expects information on children ages 5 to 11 as early as finish of summer time
16-year-old Thomas Gregory will be vaccinated with the Pfizer-BioNTech Covid-19 vaccine by Nurse Cindy Lamica at UMass Memorial Health Care’s COVID-19 Vaccination Center at the Mercantile Center in Worcester, Massachusetts on April 22, 2021.
Joseph Precious | AFP | Getty Images
Data on how well the Pfizer-BioNTech Covid-19 vaccine works in children ages 5-11 could be available by the end of this summer, the scientist who helped develop the shot told CNBC.
If clinical trials go well and the Food and Drug Administration approves, young children could be vaccinated by the end of the year, said BioNTech Co-Founder and Chief Medical Officer Dr. Ozlem Tureci, late Thursday.
“We expect the data by the end of summer or fall this year. We will then submit it to the regulatory authorities and, depending on how quickly they react, we will receive approval by the end of the year to also immunize younger children.” ” She said.
In late March, Pfizer and BioNTech began a clinical trial testing their vaccine in healthy children aged 6 months to 11 years. This is a critical step in gaining regulatory approval to vaccinate young children and fight the pandemic.
In the first phase of the study, companies will determine the preferred dosage level for three age groups – between 6 months and 2 years, 2 and 5 years, and between 5 and 11 years. Dosages are assessed 11 first in children ages 5 to 11 before researchers move on to the other age groups, they said.
Since companies rate the older age group first, data on children under 5 could be “a little later,” Tureci told CNBC.
The two-dose vaccine is already approved for use in people aged 16 and over. Earlier this month, Pfizer and BioNTech asked the FDA to allow their Covid-19 vaccine to be given to children ages 12-15 in an emergency.
The companies announced in late March that the vaccine was 100% effective in a study of more than 2,000 adolescents. They also said the vaccine produced a “robust” antibody response in the children that outperformed that in a previous study in older teenagers and young adults. The side effects were generally consistent with those seen in adults, they added.
Vaccinating children is seen as critical to ending the pandemic. The nation is unlikely to achieve herd immunity – if enough people in a given community have antibodies to a given disease – until children can be vaccinated, health officials and experts say.
According to the government, children make up around 20% of the total US population. According to experts, between 70% and 85% of the US population must be vaccinated against Covid to achieve herd immunity 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.
Ugur Sahin, CEO of BioNTech, told CNBC on Thursday that he was “confident” that the vaccine would be effective against B.1.617, a highly contagious variant of coronavirus first identified in India.
Still, he said, people will likely need a third shot of his two-dose vaccine as immunity to the virus wanes. Researchers see a decrease in antibody responses to the virus after eight months, he added.
“If we give a boost, we could actually increase the antibody response beyond what we started with, and that could give us a real comfort of protection for at least 12 months, maybe 18 months,” said Sahin. “And that is really important at a time when all variants are coming.”
Sahin also said he anticipates demand for the shot will continue to rise, adding that the company will increase production capacity of the vaccine to 3 billion doses by the end of 2021. In December, Sahin expects the company’s production target to increase to 400 million cans per month.