US-based pharmaceutical giant Pfizer Inc said on March 31 that its vaccine against coronavirus was found to be 100 percent effective on children aged between 12 and 15.
The absolute efficacy of the vaccine was recorded in the third phase of clinical trials on the minors, the company said in a statement.
Pfizer, along with the vaccine's co-developer - Germany's BioNTech - would apply for the regulatory clearance before the American and European health regulators.
The full set of trial data would be submitted to the Food and Drug Administration (FDA) and the European Medicines Agency "at the earliest", Pfizer CEO Albert Bourla said.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” the press release quoted Bourla as saying.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
"The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant," said Ugur Sahin, CEO and Co-founder of BioNTech.
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The trial enrolled 2,260 adolescents - 12 to 15 years of age - in the United States. In the trial, 18 cases of COVID-19 were observed in the placebo group versus none in the vaccinated group, the company claimed.
Pfizer and BioNTech plan to submit the data for scientific peer review for potential publication, the statement added.
In the past week, Pfizer and BioNTech dosed the first healthy children in a global study to further evaluate the safety, tolerability, and immunogenicity of their vaccine in children aged between 6 months to 11 years of age.
The study is evaluating the safety, tolerability, and immunogenicity of the vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: children aged 5 to 11 years, 2 to 5 years, and 6 months to 2 years. "The 5 to 11-year-old cohort started dosing last week and the companies plan to initiate the 2 to 5-year-old cohort next week," Pfizer said.