Pfizer Inc., on 22 November, announced that the follow-up data from their phase 3 clinical trials shows that their COVID-19 vaccine has a 100 percent efficacy against illness in the long term in adolescents aged 12 to 15 years.
The follow up results, according to a statement released by the company, also did not identify any safety concerns.
The company also announced that they planned to submit this data to the concerned health authorities for full regulatory approval of the vaccine in this age group in the U.S. and worldwide.
Currently, the vaccine has been approved by the US FDA for restricted use in this age group under EUA (Emergency Use Authorization).
The Follow Up Results
A safety follow up of participants of the phase 3 clinical trials was conducted by Pfizer 6 months after they were given the second dose.
According to the company, "the adverse event profile was generally consistent with other clinical safety data for the vaccine, with no serious safety concerns observed."
"This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed."Albert Bourla, Chairman and Chief Executive Officer, Pfizer
Case studies of 2,228 trial participants of the clinical trial were analysed over the course of the 6 months after primary vaccination (2 doses), and the results were found to be consistent with the earlier released trial results.
The efficacy was also found to be consistent across sexes, ethnicities, races, and those with comorbidity status.
The company has said that it also plans to release this data for peer review soon.
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