Re:America is plummeting down the global vaccination league ...
by tialaramex on Thursday August 05, 2021 @11:55AM
(#28075504)
Emergency Use Authorization is not an approval. The vaccines aren't approved medicines in the US. They have Emergency Use Authorization so that they don't need approval. If the US wants to continue using these vaccines after declaring the emergency over (perhaps months or even years from now), the FDA would need to approve them.
The standard (reasonable belief that the medicine "may" be effective) for EUA is lower than for approval (satisfactory proof that the medicine is effective) reflecting the emergency situation.
Hydroxychloroquine had EUA for COVID-19 until it was withdrawn. It remains an FDA approved medicine for malaria prevention, because the evidence showed it works for that and that did not change, but it did not have proof that it was effective when it received EUA for COVID-19, and it still didn't have such proof when the EUA was withdrawn.
New Zealand's medicines authority did not need an emergency process because New Zealand's civil government had resolved the emergency, albeit at considerable cost. They concluded that the vaccine under consideration (the Pfizer BioNTech vaccine) did by that point have proof of effectiveness.
In one sense our loss is their gain, they were able to guage the effectiveness of the vaccines on other people, who were in danger of death from COVID-19, to establish that it was safe to use on their own people who faced much less danger.
The standard (reasonable belief that the medicine "may" be effective) for EUA is lower than for approval (satisfactory proof that the medicine is effective) reflecting the emergency situation.
Hydroxychloroquine had EUA for COVID-19 until it was withdrawn. It remains an FDA approved medicine for malaria prevention, because the evidence showed it works for that and that did not change, but it did not have proof that it was effective when it received EUA for COVID-19, and it still didn't have such proof when the EUA was withdrawn.
New Zealand's medicines authority did not need an emergency process because New Zealand's civil government had resolved the emergency, albeit at considerable cost. They concluded that the vaccine under consideration (the Pfizer BioNTech vaccine) did by that point have proof of effectiveness.
In one sense our loss is their gain, they were able to guage the effectiveness of the vaccines on other people, who were in danger of death from COVID-19, to establish that it was safe to use on their own people who faced much less danger.