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1. It's a real pity the UK drug regulator, MHRA, doesn't hold public advisory committee meetings to assess #Covid vaccines, in the way @US_FDA does. Would have been fascinating to listen to a detailed analysis of the AstraZeneca-Oxford vaccine's emergency use application.
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2. The vaccine is a critical part of the global #Covid vaccination strategy. Oxford's goal was to make a vaccine manufacturers around the world could make cheaply; they're to be highly commended. The project, though, has suffered from serious missteps. https://www.wsj.com/articles/astrazeneca-and-oxfords-bumpy-partnership-hangs-over-covid-vaccines-future-11609336498
3. Today the UK regulator approved the AZ-Ox vaccine for use in Britain. It's estimated to be about 70% effective, but the confidence intervals on that are wider than those for the Pfizer & Moderna vaccines. It works, but how well exactly is still a bit unclear.
4. The AZ-Ox vaccine wasn't approved for people under 18 yrs — no data.
There are also no real data on the vaccine's safety in pregnant or lactating people. But MHRA does not advise against vaccination of pregnant people; suggests it could be used when benefits outweigh risks.
There are also no real data on the vaccine's safety in pregnant or lactating people. But MHRA does not advise against vaccination of pregnant people; suggests it could be used when benefits outweigh risks.
5. MHRA recommends the AZ-Ox vaccine be given in 2 doses, between 4 & 12 weeks apart. That's an odd & probably unwieldy interval. There are hints this vaccine may work better with a longer interval between shots. How workable that is in the real world remains to be seen.
6. One of the terrific things about the AZ-Ox vaccine is it doesn't need ultracold chain. It should be stored at fridge temp before use, & can be kept at room temperature (not above 25 C) while a vial is in use. Huge advantage over the Pfizer & Moderna vaccines.
7. It should be noted the data used to authorize use of the AZ-Ox vax in the UK was drawn mainly from adults 64 and younger who were white. The lack of range and diversity in this trial is in marked contrast to the #Covid vaccine trials being run in the U.S.
8. Last point: Like the Pfizer & Moderna vaccines, this is reactogenic. Short term discomfort is common. Headache, muscle aches, nausea, fatigue, chills & injection site pain each reported by at least 1 in 10 people vaccinated. Vomiting & fever were reported by at least 1 in 100.
