12-30-2020, 11:41 PM
I completely agree Goose. Here the FDA has done an exemplary job by making public the VRBPAC meetings and publishing the staff assessments in advance. While I am confident that the MHRA isn't being reckless, they are not doing a good job of explaining the rationales.
That being said, the efficacy data is quite a bit stronger than "giving some indication" of efficacy. Using hard endpoints, the drug does convincingly reduce the risk of COVID-19 infection. The 95% confidence intervals robustly exclude zero efficacy, meaning that the vaccines are significantly efficacious, and the lower bound of the confidence interval is above 30%, which was the FDA's bar. We might not for sure if it is 70% effective or 90% effective, but it is likely be above 50% effective, which is about what you get with your average flu vaccine. You are right, however, that the MHRA has not communicated this well, and people do need to know that they can still get COVID even if they have the vaccine (this is true also of the Pfizer/BioNTech and Moderna ones, though they get closer to 95% efficacy), so some degree of social distancing is still important in the midst of the pandemic. But all the vaccines will put a dent in the pandemic, and, promisingly, all of them seem to especially offer protection against more severe disease (requiring hospitalization, ICU admission, or causing death).
There are enough questions that I would understand a delay (especially with two highly effective vaccines already authorized), but I consider the MHRA to be aggressive but not reckless.
BC
That being said, the efficacy data is quite a bit stronger than "giving some indication" of efficacy. Using hard endpoints, the drug does convincingly reduce the risk of COVID-19 infection. The 95% confidence intervals robustly exclude zero efficacy, meaning that the vaccines are significantly efficacious, and the lower bound of the confidence interval is above 30%, which was the FDA's bar. We might not for sure if it is 70% effective or 90% effective, but it is likely be above 50% effective, which is about what you get with your average flu vaccine. You are right, however, that the MHRA has not communicated this well, and people do need to know that they can still get COVID even if they have the vaccine (this is true also of the Pfizer/BioNTech and Moderna ones, though they get closer to 95% efficacy), so some degree of social distancing is still important in the midst of the pandemic. But all the vaccines will put a dent in the pandemic, and, promisingly, all of them seem to especially offer protection against more severe disease (requiring hospitalization, ICU admission, or causing death).
There are enough questions that I would understand a delay (especially with two highly effective vaccines already authorized), but I consider the MHRA to be aggressive but not reckless.
BC