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 Prezioso | AFP | Getty Images
If the clinical trials go well and the Food and Drug Administration approves them, young children could be vaccinated by the end of the year, said Dr. Ozlem Tureci, BioNTech’s co-founder and chief medical officer, told CNBC 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.
At the end of March, Pfizer and BioNTech started a clinical study Testing the vaccine on healthy children, ages 6 months to 11 years old, 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 evaluated 11 first in children between the ages of 5 and 5 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 in place 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 said in late March that the vaccine was found to be 100% effective in a study with 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 He is “confident” that the vaccine is effective against B.1.617, a highly contagious coronavirus variant that was 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,” he told CNBC . “And that is really important at a time when all variants are coming.”
Sahin also said he expected demand for the shot to continue to rise, adding that the company would 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 climb to 400 million cans per month.