FDA advisors recommend Pfizer vaccine
Agency expected to issue Emergency Use Authorization within hours, first immunizations could start by Monday. But COVID-19 will keep spreading and killing people for months more.
A major milestone in the pathway towards the end of the pandemic:
FDA advisors delved deep into the data and concluded that the COVID-19 vaccine by Pfizer and BioNTech has more benefits than risks and should be made available via an Emergency Use Authorization.
Some advisors wanted the EUA to apply only for adults but the vote did not separate the age groups. Pfizer’s EUA application included 16 and 17 year olds, but some advisors wanted more safety data for younger people.
Much of the discussion centered on ethical challenges, including how more data can be collected about the vaccine after it becomes widely available. The agency is expected to grant the EUA as soon as this evening.
But the reality for nearly the entire nation is quite bad:
The latest update by the Covid Tracking Project indicates that the Midwest is starting to show some signs of a declining rate of acceleration and fewer hospitalizations, but the Northeast is getting worse. Despite some glimmers of hope, the data is overwhelmingly bad.
Rhode Island has gotten much worse, while the Dakotas appear to be improving somewhat.
The data is somewhat ambiguous because of holiday-related reporting lags.
Deaths among individuals in long-term care facilities (e.g., nursing homes) are mounting. They already represented the largest group.
Even scientists and some government officials are struggling with the magnitude of loss.
The CDC is ramping up its guidance for people to stay home — or close to home — for the December holidays.