Pfizer aiming for emergency approval for vaccine for children aged 5-12

Pfizer aiming for emergency approval for vaccine for children aged 5-12

Pfizer-BioNTech is expected to seek emergency use authorisation for its COVID-19 vaccine in children aged 5-11 years by early October. It will be followed by application for emergency approval for the vaccine for children as young as six months in November.

As of now, the pharma is conducting phase 3 trials of its vaccine on children aged between six months and 11 years.

Addressing an industry conference recently, a Pfizer executive expressed confidence in achieving safe and immunogenicity data for children aged 5 to 11 by the end of September, while data for the youngest group (6 months-5 years) is expected to generate by the end of October.

As soon as successful results are achieved in the trials, the drug maker will file an application for emergency use of its vaccine or both age groups.

"It come for children aged 5 to 11 in early October assuming the data is positive. The emergency authorisation application for the youngest age group (6 months to 5 years) could follow in a month shortly thereafter, if again the data is positive," said Pfizer’s chief financial officer Frank D'Amelio at the Morgan Stanley 19th Annual Health Conference.

After the applications are submitted, the US Food and Drug Administration will be taking time to review the trial data. According to former FDA Commissioner and Pfizer board member Scott Gottlieb, the process could take upto four to six weeks.

Notably, the vaccine is already being administered to children aged 12 and above in the UAE since mid-May. As per statistics, the vast majority has either suffered mild symptoms or none at all. But they can, do contract and transmit Coronavirus after taking the vaccine if there is carelessness in adhering to pandemic-related safety measures.

A recent study published in the Pediatrics journal stated that COVID-19 led to more complications than flu among children with underlying health conditions including asthma and obesity due to increased health risks. The research pointed out that pneumonia, hypoxia and even lack of oxygen occurred more frequently in case of COVID-19 infections than seasonal flu.

Reportedly, the United States is witnessing a surge in childhood admissions to hospitals in recent weeks due to the emergence of Delta variant of the virus. A large study conducted by the British Medical Journal in the UK, at least one in seven children (14%) are experiencing COVID-19 symptoms even 15 weeks after recovery. A research by the UCL Great Ormond Street Institute of Child Health explained the most common symptoms of long COVID such as headache, fatigue and shortness of breath.

“For those reasons, one of transmissibility, one of the seriousness of the disease and one of uncertainty about long-range consequences, I come down strongly on ultimately vaccinating our children," said Dr Anthony Fauci, leading infectious disease expert in the US in a lecture at the London School of Hygiene and Tropical Medicine.


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