Early in the morning, Pfizer announced the results of a Phase III study testing the vaccine in 2,260 adolescents between the ages of 12 and 15. The company announced that the vaccine had strong protection and minimal side effects. Should the FDA give Pfizer emergency vaccine approval for the vaccine, which the company says it will apply shortly, it would be particularly important right now, as youth cases are driving a fourth surge in cases in the US.
Pfizer’s trial results are due to increasing concerns about Covid-19 in children and adolescents. They get sick faster and more seriously, mostly due to the variants, which leads to an influx of young patients who need to be hospitalized. The threat of this spike makes it difficult for President Biden to meet his self-imposed late April deadline to get students back into a pure learning environment. Another difficulty: some states are removing the limits of school education.
Pfizer’s early results showing greater than 90% effectiveness in preventing Covid-19 have now been backed up by a CDC study of effectiveness in the field. The vaccine is given in two doses approximately three weeks apart, with 90% effectiveness occurring one week after the second dose.
Like its competitor from Moderna, the Pfizer vaccine is based on mRNA technology. The CDC said these vaccines “teach our cells how to make a protein – or even a piece of a protein – that triggers an immune response,” which then prepares the body to respond when it encounters the actual virus . In this case, that piece is a harmless copy of the spike protein that the coronavirus uses to infect cells.
The vaccine, developed by US-based Pfizer and its German partner BioNTech, was one of the first to receive emergency approval: UK regulators granted approval on December 2, 2020, and the US followed shortly after on December 12.
Pfizer has enrolled 2,260 12- to 15-year-olds in the United States for the Phase III study. The 18 cases of Covid diagnosed during the study were in the placebo group. Antibody rates and side effects were similar to the studies in adults, whose participants had strong immune responses and generally mild side effects.
Ugur Sahin, CEO and Co-Founder of BioNTech, said: “The first results we saw in the youth studies suggest that children are particularly well protected by vaccinations, given the trends we have been regarding over the past few weeks Having seen the spread, the UK variant B.1.1.7 is very encouraging. It is very important that they can get back to school and meet friends and family while they and their loved ones are protected. “
The next stages
The Pfizer study is divided into different age groups: 6 months to 2 years; 2 to 5 years; and 5 to 11. Pfizer gave the first doses in the youngest group last week. The older children have already received their recordings. The toddler-through-kindergarten group is scheduled to be vaccinated next week.
Other vaccine manufacturers are also testing young people.
Moderna is testing two groups of young people. It has 3,000 teenagers between the ages of 12 and 17 enrolled. On March 16, it started a dose-test study for babies 6 months old to children 11 years old. In February, Oxford University announced its intention to extend the process to young people aged 6-17. For more information on the Oxford Trial, please visit the FAQ page.
Johnson & Johnson has announced that it will be testing its vaccine in children.
Pediatricians emphasize why children need to be vaccinated; It’s all about herd immunity.
“It is extremely important to conduct these vaccine studies in children,” said Dr. Stephen Spector, Professor of Pediatrics at the University of California Medical School, San Diego, in an interview with Chemical and Engineering News. He is leading a Moderna process. “Herd immunity – the point at which enough people have achieved immunity to largely stop transmission – requires immunization of at least 70-80% of the population,” he said. “To achieve herd immunity, we have to immunize children.”
When can young people expect vaccinations?
It’s too early to give solid answers, but autumn looks promising, according to Albert Bourla, chairman and CEO of Pfizer. In the test press release, he outlined the company’s plans:
“We plan to submit this data to the FDA and other regulatory agencies around the world in the coming weeks as a proposed change to our emergency clearance in the hopes of starting vaccination for this age group before the start of the next school year.”
Sean Marsala is a Philadelphia, Pennsylvania-based health journalist. He loves technology, usually reads, surfs the internet, and explores virtual worlds.