This week Pfizer and Biontech announced that their Coronavirus vaccine was 90% effective in preventing Covid-19 in participants in their Phase 3 study. In comparison the Flu vaccine on average is 40% effective.
The 3 phase studies include:

Phase I: Small-scale safety trials: Tests on a small number of people for safety, dosage, and efficacy

Phase II: Expanded safety trials: Tests expanded to hundreds of people
Phase III: Large-scale trials: Tests expanded to thousands of people with some receiving a placebo, to test for safety, dosage, and efficacy, as well as side-effects in a larger population

 Upon completion of all three phases of clinical development a Biologics License Application (BLA) would be submitted. The license application must provide the FDA reviewer team (medical officers, microbiologists, chemists, biostatisticians, etc.) with the efficacy and safety information necessary to make a risk/benefit assessment and to recommend or oppose the approval of a vaccine.

“Following FDA’s review of a license application for a new indication, the sponsor and the FDA may present their findings to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA expert committee (scientists, physicians, biostatisticians, and a consumer representative) provides advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication.” These steps are defined in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug and Cosmetic Act.

Governor Cuomo, after having released his March 25th directive to “Nursing Home Administrators, Directors of Nursing, and Hospital Discharge Planners”, which resulted in thousands of deaths of at risk elderly now has decided New Yorkers will not get the Coronavirus vaccine with the rest of the country. You may recall in October during the Governor’s self-congratulatory book tour for his “American Crisis” he announced even after the FDA had granted approval he was going to enlist his own “experts” to review the “federally approved COVID-19 vaccine before distributing the drug to millions of New Yorkers, arguing Monday he doesn’t think the FDA and CDC’s recommendations are “safe.” The New Yorkers whose relatives died as a result of the Governor’s March 25th directive would probably be very skeptical of his latest edict.

Maybe it’s time to move out of New York State if you want to be vaccinated since the Governor’s actions certainly appear to be political, especially when he stated “it’s bad news that Pfizer Coronavirus vaccine progress came during the Trump administration.”