Pfizer and BioNTech, two pharmaceutical companies, announced Monday morning the results of a clinical study testing their covid-19 vaccine on children aged 5-11 years old. The vaccine is safe and generates strong immune responses in the participants. This should indicate its effectiveness. Although the findings are not yet available to the public the companies intend to submit the data to regulators in the U.S. to obtain vaccine authorizations for this age group.
The Pfizer/BioNTechs vaccine won emergency authorization in the U.S. during the winter. It has since been the first time that all Americans over 16 have had their food and drug administration fully approve it. The vaccine was approved earlier this year for children aged 12-16 years. Pfizer stated that it will seek authorization for younger children by 2021.
Cuba, Cambodia, and other countries have approved or authorized the use of covid-19 vaccinations for children under 2 years old. The World Health Organization advised countries to delay for now. While the WHO and FDA have acknowledged that there is not enough data to ensure vaccine safety for children younger than 12, these countries argue that children will be more likely to contract covid-19 if they are allowed to continue to receive the vaccine. The pivotal trial data for a vaccine that Pfizers has presented is the first to be presented for children aged 5-11 years.
Phase 2/3 involved more than 2,200 children aged between 6 and 12 years in the United States, Finland Poland, Poland, Spain, who were given a low dose version of the two shot vaccine or placebo. The dose was only one-third that given to adults. The vaccine was safe in these children, according to the company. CNN was told by the company that there were no cases of myocarditis. This is a rare risk that can be seen in young men and teens who have received an mRNA vaccination. Participants were also reported to have levels of neutralizing antibodies similar to those found in people who had been vaccinated between 16 and 25 years. This indicates that the vaccine should provide the same protection against illness and death to these children.
These trial results are a solid foundation for seeking approval of our vaccine for children aged 5-11 years. We plan to submit them to FDA and other regulators with urgent, Albert Bourla (Pfizer CEO and Chairman) stated in a statement.
Important to note is that the results of any scientific research have not been vetted by scientists outside of the lab. Some experts have raised questions that still need to be answered. Pfizer, for instance, conducted a Phase I trial with children between the ages of 5 and 12 to test out three doses. They then settled on the current dosage. A smaller dosage was also being tested in the trials for children below 5. It is worth asking if there was any evidence of decreased safety in higher-dose groups. The question remains, however, if the measured antibody levels in this trial really reflect the vaccine's real-world effectiveness against covid-19 among these children.
While some of these concerns may not be addressed immediately, once the vaccine has been approved for this age group of children, others will be addressed once the data from the clinical trials is available to regulators. Things are looking good for the moment. Reuters reported this month that vaccines for children aged 5-11 could be approved as soon as next month. Pfizer said it will present data from its trials with children ages 2-6 years and 6 months to 2 year olds by 2021.