Pfizer began clinical trials of its covid vaccines in children under 12 on Wednesday, March 24. The same thing also undertaken by Moderna and AstraZeneca and to which Johnson & Johnson is also preparing, as soon as the trials on adolescents are finished. This was announced in recent days by the CEO of Pfizer himself Albert Bourla, through a message on Twitter: “We begin the clinical study of our anti-Covid vaccine on pediatric subjects between 6 months and 11 years”.
The company hopes to have the results of this study in the second half of 2021, and the vaccine could be licensed for children under 12 by early 2022.
Pfizer’s trial will test three different doses of the vaccine:
- 10 micrograms per injection
- 20 micrograms per injection
- 30 micrograms per injection
The doses will first be tested on children between the ages of 5 and 11, then from 2 to 4 and finally from 6 months to 2 years.
Younger children, who make up a significant portion of the total global population, will play a vital role in the ongoing fight against COVID-19. The phase 1/2/3 study will enroll approximately 4,644 children aged 6 months to 11 years in the United States and Europe.
Once Pfizer has determined the correct dose for each age group, the company will begin a trial on 4,500 children; two thirds will receive the real vaccine and one third will receive a placebo. This study will monitor the children’s immune response to the vaccine and look for side effects.
Children under the age of 15 represent 26% of the world population. They therefore believe that successfully vaccinating children will help protect against COVID-19 if the vaccine proves effective in that population.
In early March, Moderna also announced it had started a trial of its COVID-19 vaccine in children between the ages of 6 months and 11 years. Pfizer has a trial on children between the ages of 12 and 15, and Moderna has a trial on children between the ages of 12 and 17.
According to CNBC reports, Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he predicts US high school students could be vaccinated in the fall and elementary and middle school students in the first quarter of 2022. .
As was the case for the clinical study on adults, the vaccine will be tested according to a dosing plan that provides for the inoculation of two doses 21 days apart one from the other.
AstraZeneca began testing its vaccine in children / adolescents between the ages of 6 and 17 last February. The study is conducted by the University of Oxford and involves three other sites in the UK, St. George’s University Hospital in London, University Hospital in Southampton and the Royal Hospital for Children in Bristol.
The study, a phase II clinical trial called COV006, plans to involve a total of 300 children, of whom 240 will receive the anti-Covid vaccine and 60 a control serum against meningitis, called MenB, with the aim of evaluating safety and immune response. in healthy children and adolescents. The recruitment will take place in stages, with the experimentation starting with the administration of the vaccine to adolescents (12-17 years) and then moving on to the age group 6-11 years.
Pharmaceutical company Moderna has started a study that will test its Covid vaccine in children under 12, including six-month-olds, the company said. The study is expected to enroll 6,750 healthy children in the United States and Canada. According to the New York Times, Moderna spokesman Colleen Hussey declined to say how many had already signed up or received their first doses.
“There is a huge demand for information about vaccinating children and what it does,” said Dr. David Wohl, the medical director of the vaccine clinic at the University of North Carolina, who is not involved in the study.
In a separate study, Moderna is testing its vaccine on 3,000 children between the ages of 12 and 17 and could have results for that age group by the summer. The vaccine would therefore have to be licensed for use in children, so it would not be readily available.
Each child in Moderna’s office will receive two injections, 28 days apart. The study will be divided into two parts. In the first, children aged 2 to less than 12 years can receive two doses of 50 or 100 micrograms each. Those under 2 years old can be given two doses of 25, 50, or 100 micrograms.
In each group, the first children will receive the lowest doses and will be monitored for reactions before subsequent participants are given the highest doses. Then, the researchers will perform an interim analysis to determine which dose is safer.
Children in part 2 of the study will receive the doses selected from the analysis – or placebo injections consisting of salt water.
The babies will be followed for a year to look for side effects and measure antibody levels that will help researchers determine if the vaccine appears to provide protection. Antibody levels will be the main indicator, but researchers will also look for coronavirus infections, with or without symptoms.
Dr. Wohl said the study looked well designed and likely efficient, but questioned why the children only needed to be followed for one year, when the adults in Moderna’s study were followed for two years.
Johnson & Johnson also said it will test its coronavirus vaccine on infants and young children after first testing it in older children.
Article sources: Pfizer, Astrazeneca, Moderna, covid19vaccinetrial