On Tuesday, drugmakers Pfizer and BioNTech commenced submission of data to the US Food and Drug Administration for their authorisation of their COVID-19 vaccine for children of ages 5- 11 (five to 11).
This was a progressive move considering the increased number of infections amongst children, who have been infected in huge numbers since the emergence of the Delta variant.
Medical experts have claimed severally that immunizing this age group would be key and paramount to keeping schools and education environments and reduce the effect of the pandemic.
What they are saying
In a statement released on Tuesday, the company stated that, “These data have been shared with the FDA for the Agency’s initial review”.
In addition, “A formal submission to request Emergency Use Authorization (EUA) of the companies COVID-19 vaccine in children 5 to <12 years of age is expected to follow in the coming weeks,” they added, with submissions to the European Medicines Agency and others also planned.
Recall that, a week ago, both companies announced results from a global clinical trial showing that the vaccines were safe and evoked a robust response of neutralizing antibodies, which stop the coronavirus from entering cells.
In the trial conducted for the vaccine, Children in the age group were given a two-dose regimen of 10 micrograms, compared to the 30 micrograms for older age groups. The shots were given 21 days apart.
In the United States however, the Pfizer vaccine has been fully approved since August for administration and has been available for younger children following doctor’s prescription.
However, authorities have cautioned doctors against its prescription until its safety data is made publicly available.
The Food and Drug Administration has said a complete review will be initiated after the formal submission of the trial data. It said that the review will likely last for “a matter of weeks rather than months.”
In addition to seeking the approval for vaccines for 5-11 year old kids, the two drugmakers, Pfizer and BioNTech, are also looking to seek approval for vaccines for infants aged six months to two years, and on children aged two to five.
According to information provided by the companies, the data for these groups may come as soon as the “fourth quarter” of the year.
In total, 4,500 children aged six months to 11 years were enrolled in the United States, Finland, Poland, and Spain.
What you should know
This comes after the FDA authorized booster shots of Pfizer and BioNTech’s Covid-19 for people who are 65 years and older and other vulnerable and immunocompromised citizens six months after they complete their first two doses.
The FDA’s Vaccines Advisory Committee, two weeks ago, agreed unanimously to give boosters to older Americans and those who are highly vulnerable and are at high risk of suffering from severe illness should they contract the virus.