The companies posted a joint statement Tuesday, announcing that they had submitted Covid-19 data on children aged 5 to 11 for an initial review by the US FDA, but do not expect to request an emergency approval.
Officials plan to submit a formal request to the European Union to administer the vaccine in the coming weeks, according to a statement. The EMEA and other regulatory authorities will also receive submissions, the company said. It is the first time the FDA has received data for a Covid-19 vaccine for children under age 5. People ages 16 and older can receive the Pfizer/BioNTech vaccine and people aged 12 to 15 are eligible for a EUA.
Data For Kids 5 To 11 Years Old Are Submitted To The FDA
As of this writing, Albert Bourla, Pfizer’s CEO, did not know how long his process would take. During his speech at the Atlantic Festival, Bourla said he didn’t think it was appropriate for him to speculate about how long FDA will take to review the data. Taking as much time as they think is necessary to be comfortable is the best option, he said.
The Pfizer Covid 19 vaccine was shown to be safe and to produce a “robust” antibody response in children 5 to 11. It has been the subject of a Phase 2/3 trial since July. 2 268 children aged 5 to 11 were enrolled in the study, and the vaccine was administered in two doses over 21 days. The trials did not include adults or children with major health issues who received a 10-microgram dose.
Researchers measured immune responses by analyzing levels of neutralizing antibodies in participants’ blood and then compared them with the levels of a control group of 16- to 25-year olds who had been given two shots of a 30-microgram dose. The levels were comparable to those experienced by older adults who received the larger dose, showing that children responded well to the second dose one month later.
It was announced Tuesday by New York drug companies Pfizer as well as BioNTech that they intend to submit full Phase 3 trial data for publication with peer review. In certain cases, immunizations can be recommended for a two-month-old child based on research collected by the company and presented to the FDA.
Despite this, the approval of the project is based on how quickly the data is collected and how comprehensively the analysis is. The FDA granted Pfizer’s expedited licensing request for its Covid 19 vaccination on the 10th of May. Before prescribing shots for children at a young age, FDA representatives are encouraged to speak with their vaccine specialists.
The immunization consultation committee of the CDC will conduct a meeting to discuss whether or if the vaccination should be prescribed o suggested pursuant to FDA authorization.
A vaccine is expected to be available by the end of October, the director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci stated. FDA Commissioner Anthony Fauci said Tuesday that they take very seriously the importance of obtaining vaccines to children that have been proven to be safe and effective, including children aged seven to eleven.
While he is not attempting to rush FDA approval, he expects to see these experiments reviewed, and if successful, shots for young children eventually can be administered by month’s end.
Two more age groups will be evaluated for immune response and safety – two- to five-year-old children, and a 6-month to 2-year-old cohort. Results are expected “by the fourth quarter of this year,” Pfizer said on Tuesday.
