Saturday, July 24, 2021

Where Is the Data?

 As the NY Times reports:

Biden administration health officials increasingly think that vulnerable populations will need booster shots even as research continues into how long the coronavirus vaccines remain effective. Senior officials now say they expect that people who are 65 and older or who have compromised immune systems will most likely need a third shot from Pfizer-BioNTech or Moderna, two vaccines based on the same technology that have been used to inoculate the vast majority of Americans thus far. That is a sharp shift from just a few weeks ago, when the administration said it thought there was not enough evidence to back boosters yet. On Thursday, a key official at the Centers for Disease Control and Prevention said the agency is exploring options to give patients with compromised immune systems third doses even before regulators broaden the emergency use authorization for coronavirus vaccines, a step that could come soon for the Pfizer vaccine.

 OK, so we said almost a year ago that annual vaccinations were necessary. BUT, and this is critical, we argued that most likely they would be updated with the latest antigen/antibody mix. 

The problem is that the CDC et al appear to have been grossly deficient in performing the data tracking and analysis of the current vaccines. It has been overly political and lacking in trust. The questions that need real data and answers is:

1. What is the antibody levels for segments of ethnicity, age, sex (yes XX and XY) which means 5X6X2 or 60 segments of at least 1,000 in each. Namely the CDC must track this set of cohorts, and it seems they just sit in Atlanta sipping mint juleps.

2. We also must understand the import of memory T cells. They reside in the epithelial cells and have a long lifetime. Assessing them can be invasive, costly and difficult but essential.

3. Adding additional Ag/Ab combos. Since we have the first such combo we should now have a viable mix. What has the CDC done here? Nothing apparently.

4. Why has the Moderna and Pfizer vaccines gotten final FDA approval! Hundreds of millions of doses and one would assume adequate data that approval would be timely and forthcoming. So what is the hold-up.

The shame is the CDC has failed to provide transparent data on the ongoing efficacy and sustainability. The organization is self protective and inward looking. Public Health is outward looking and instructive allowing the public to understand and have confidence. The problem is this is sorely lacking.