Pfizer and its German partner said on Tuesday that they have presented data related to the results of a COVID-19 vaccine trial in children under the age of 5.
Pfizer and BioNTech sent the data to the US Food and Drug Administration (FDA).
The data is from a Phase 2/3 trial examining the companies’ COVID-19 shot in children ages 5 to 11, an age group who currently cannot receive a COVID-19 vaccine in the United States.
The companies say the data showed a favorable safety profile and that the vaccine triggered antibody reactions in children. The children were given two doses of 10 micrograms each.
The companies have not released full results from the test. Results for another group being studied in the trial, children aged 6 months to 4 years, are expected to be released in the fourth quarter of this year. The companies plan to submit the test data to a peer-reviewed publication at some point.
While the data was submitted to the FDA, Pfizer and BioNTech have not yet formally asked for emergency use authorization for the vaccine. The companies expect to send formal submissions “in the coming weeks,” with plans for similar submissions to the European Medical Authority and other regulatory bodies, according to a press release.
The Pfizer vaccine is only authorized for use in children 12 to 15 years old. It is also approved for children between the ages of 16 and 17.
The other two vaccines authorized in the United States are approved only for adults 18 years of age and older.
About a month after Pfizer’s submission for that age group the FDA expanded the original emergency use authorization for children 12 to 15.
Companies are pushing for immunizations for children despite children at low risk of contracting severe cases of COVID-19, the disease caused by the CCP (Communist Party of China) virus. Federal health officials have also said they believe children should be vaccinated. They say that children can transmit the virus to those who are at high risk, including the elderly.
The FDA’s acting chief, Dr. Janet Woodcock, indicated earlier this month that the regulator would grant authorization for children. In a joint statement with another FDA official, Dr. Peter Marks, he said officials are “looking forward to seeing COVID-19 vaccines available for young children.”
Officials said the FDA will analyze data on shots for children and issue an emergency use authorization after carefully analyzing the data to evaluate benefits and risks.
This News Originally From – The Epoch Times