Pfizer and BioNTech submit data for COVID-19 vaccine approval in children

Covid19 vaccination
FILE PHOTO: A woman holds a small bottle labelled with a “Coronavirus COVID-19 Vaccine” sticker and a medical syringe in this illustration taken October 30, 2020. REUTERS/Dado Ruvic/File Photo

On Tuesday, drugmakers Pfizer and BioNTech commenced submission of data to the US Food and Drug Administration to authorise 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 immunising this age group would be key and paramount to keeping schools and education environments and reduce the effect of the pandemic.

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

Remember that, just a week ago, both companies released the findings of a global clinical trial, which demonstrated that the vaccinations were safe and induced an extensive immune reaction that prevented the coronavirus from entering cells.

Children in the age group were given a two-dose regimen of 10 micrograms in the vaccine trial, as opposed to older age groups who were given a 30-microgram dose regimen. 21 days had elapsed between the two injections.

But in the United States, the Pfizer vaccine has been completely approved for administration since August and is now available for younger children who have been prescribed by a doctor to get the shot.

Authorities, on the other hand, have advised doctors not to prescribe it until the drug’s safety data has been made publicly available.

The Food and Drug Administration has stated that a thorough examination will be conducted following the formal submission of the trial results. According to the firm, the assessment will most likely last “a matter of weeks rather than several months.”

The two pharmaceutical companies, Pfizer and BioNTech, are also attempting to obtain permission for vaccines for children aged 5-11 years, as well as vaccines for infants aged six months to two years and children aged two to five years old.

It is possible that the statistics for these organisations will be available as early as the “fourth quarter” of the year, according to information provided by the corporations.

In total, 4,500 children ranging in age from six months to eleven years were enrolled in the study, which took place in the United States, Finland, Poland, and Spain.

This follows the FDA’s approval of booster shots of Covid-19, manufactured by Pfizer and BioNTech, for adults 65 years and older, as well as other vulnerable and immunocompromised citizens, six months after they have completed their first two doses of the vaccine.

A vaccine advisory committee convened by the Food and Drug Administration (FDA) two weeks ago unanimously decided that booster shots should be given to elderly Americans and those who are particularly vulnerable and at high risk of suffering from severe sickness if they get the virus.

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