Comments by "Hobbs" (@hobbso8508) on "Pfizer Covid Vaccine: The Difference Between Emergency, Full Authorization" video.
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@brandona.deimel5155 They saw it coming and hedged their bets. People had seen an even like this coming for years, and preparing a vaccine early is the only way to get to market.
The co-founder of BioNTech designed the Pfizer vaccine in an afternoon on the 25th of January 2020. They made an agreement with Pfizer, and created the physical vaccine in a few weeks. Due to the simplicity of the vaccine the turnaround time was easy to keep short.
From there they were allowed by the FDA to do simultaneous pre-clinical trials, meaning they were doing cellular and animal testing at the same time. They were also putting billions behind the endeavour, allowing them to put hundreds of people on the task. Usually drug trials are done by a couple of scientists slowing working through the steps over years, but with the urgency they used massive funding to accelerate the testing, running hundreds and hundreds of plates a day knowing they would be at the front of the FDA queue.
By late April they already had clinical trial approval, with the phase 1/2 trials (combining them for speed) getting their first dose on the 23th of April and running until the 22nd of May.
Recipients were reviewed over the course of 6 months for side effects, but with no immediate problems they started their phase 2/3 clinicals (also combined) in 4 different countries, recruiting thousands as early as July and running to November.
EUA came through in December, and by them the earliest injection had been over 8 months ago, far past the 6 month threshold set on long-term side effects by the FDA given the urgency.
In February they started phase 3 trials on adolescents aged 12-15 and pregnant women at 24-32 weeks.
Now that it is fully approved the earliest injection was around 16 months ago. Earliest largescale trial was 14 months ago. They were testing it on cells and animals around 18 months ago.
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