Covid vaccine: Pfizer modifies protocol for trials to include 12-15 year olds1 min read . Updated: 13 Oct 2020, 11:32 AM IST
- US-based Pfizer originally planned for 30,000 participants, but in September expanded that to 44,000 people
Pfizer has modified the protocol for its late-stage study of its vaccine against the new coronavirus, this time to include more young participants. The company said that it's received permission from the Food and Drug Administration to include adolescents aged 12 through 15 in its global COVID-19 vaccine study.
US-based Pfizer originally planned for 30,000 participants, but in September expanded that to 44,000 people.
Canadian health authorities will start a real-time review of Pfizer's covid vaccine that it is developing with Germany's BioNTech SE. The companies said they would submit safety and efficacy data from the trial of their COVID-19 vaccine to Canada's health ministry under a rolling submission as and when it becomes available.
A rolling review allows researchers to submit findings in real time, without waiting for studies to conclude. .
The European Medicines Agency earlier this month launched real-time reviews of COVID-19 vaccines being developed by U.S. drugmaker Pfizer and Germany's BioNTech, following a similar announcement for AstraZeneca's.
Canada's health ministry in its attempts to accelerate a potential approval of a COVID-19 vaccine have also started a real-time review of AstraZeneca and Oxford University's vaccine candidate.
Meanwhile, Johnson & Johnson paused its Covid-19 vaccine study due to the unexplained illness of a participant.