In the wee hours of Tuesday morning, when nothing good ever happens, a panel that oversees US clinical trial safety said AstraZeneca's vaccine results may include "outdated and potentially misleading" data.
The statement arrived hours after the drugmaker announced its two-shot vaccine was 79% effective in US trials.
What's the hangup? AstraZeneca's
data cut off after Feb. 17, and the panel says it's seen more recent
data that the vaccine is closer to 69%–74% effective. One of its members
compared AstraZeneca's announcement to telling your mother that you aced a class when you only got an A on the first quiz.
It's unclear if the warning will delay AstraZeneca's plans
to file for authorization in the coming weeks. If authorized, it would
add another 50 million doses to US vaccination efforts in the first
month...
If officials want them. The
Biden administration says current supplies can vaccinate all adults
before June. AstraZeneca's vaccine is less effective than Pfizer's and
Moderna's vaccines and (pending further data) potentially also Johnson
& Johnson's one-shot option.
Add this to the growing list
While
AstraZeneca's vaccine has been authorized in 70+ countries, the rollout
has faced Galaxy Note 7-level challenges. The vaccine’s creators talked a big game even before starting trials, and when those kicked off...
- They were temporarily suspended after two subjects developed rare neurological symptoms. No connection to the vaccine was found.
- A mistake resulted in some patients receiving half-doses. That trial posted better results, which researchers failed to clearly explain.
- Early results also lacked comprehensive data on efficacy for adults 65+.
There were
also production issues. Europe, which made AstraZeneca’s offering a
pillar of its vaccination strategy, got a third of what it was promised.
Over a dozen countries paused AstraZeneca shots after three dozen
recipients developed blood clots (but EU regulators said it's safe last
week). And South Africa is selling its doses after a trial showed AstraZeneca's shots are less effective against the new dominant strain there.
Big picture: Vaccine
hesitancy, in the US and abroad, started out higher than public health
officials wanted. Every delay and setback threatens to diminish public
confidence further.
|
No comments:
Post a Comment