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Some key points from the #Pfizer vaccine trial announcement today.
1. They anticipate having a median of 2 months follow-up in time to apply for EUA late in November.
2. Final analysis when 164 cases have accrued. December, presumably.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against
1. They anticipate having a median of 2 months follow-up in time to apply for EUA late in November.
2. Final analysis when 164 cases have accrued. December, presumably.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against
3. 50 million doses available (globally) by end of year.
(1.3 Billion for 2021).
4. 39K have already received 2nd dose. (4K still awaiting 2nd dose).
5. Their interim results reflect efficacy at 28 days after first dose.
6. NO SERIOUS SAFETY CONCERNS REPORTED!
(1.3 Billion for 2021).
4. 39K have already received 2nd dose. (4K still awaiting 2nd dose).
5. Their interim results reflect efficacy at 28 days after first dose.
6. NO SERIOUS SAFETY CONCERNS REPORTED!
7. 42% of global participants and 30% of U.S. participants have racially & ethnically diverse backgrounds.
8. The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2.
8. The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2.
Points of my own here:
1. Efficacy may be higher than 90%. Some vaccinated individuals who eventually test positive for Sars-CoV2 may have been false negatives earlier.
2. We know nothing about durability of immunity. This will take time. But this first step is critical.
1. Efficacy may be higher than 90%. Some vaccinated individuals who eventually test positive for Sars-CoV2 may have been false negatives earlier.
2. We know nothing about durability of immunity. This will take time. But this first step is critical.
3. Subgroup analysis will be very important. We need to know how effective this is for different age groups, different ethnic and racial groups, etc. This will take time.
4. We need long term safety data: it is good that trial will continue to track for 2 years after 2nd dose.
4. We need long term safety data: it is good that trial will continue to track for 2 years after 2nd dose.
We have a LOT of hard work. Assuming this candidate is highly effective and safe, we need:
1. To protect the most vulnerable, first; and then to distribute EQUITABLY.
2. To restore faith in institutions, in science, in scientists so that vaccine hesitancy can be minimized.
1. To protect the most vulnerable, first; and then to distribute EQUITABLY.
2. To restore faith in institutions, in science, in scientists so that vaccine hesitancy can be minimized.
This is a mammoth undertaking. A successful vaccine & vaccination program can return our lives to normal. But this is no ordinary vaccine; and we have seen just how poorly testing was advanced and distributed. We MUST plan NOW to ensure that every life is protected. /end
