N3-Not being fully approved by the FDA has been one of the primary arguments presented by folks who have questioned the efficacy of the COVID vaccines.
Not the only argument by any means, since the anti-vax sector presents a sea of reasons to eschew the injections via public meetings, social gatherings and most certainly social media.
While the news is unlikely to alter the stance of the more adamant no-vaxers it might spur those on the fence to hop off and go get their vaccination.
From our friends at DHD#10
Today the U.S. Food and Drug Administration (FDA) granted full approval to the Pfizer COVID-19 vaccine for the prevention of COVID-19 disease in individuals 16 years of age and older.
“For those in our communities who have been hesitant to get vaccinated due to concerns over the vaccine’s Emergency Use Authorization, we expect today’s announcement to boost people’s confidence” states Kevin Hughes, Health Officer at DHD#10. “Those individuals with remaining concerns are encouraged to consult with their primary care provider. “Vaccines are one tool in the toolbox to keep individuals and our communities safe” Hughes added.
In December of 2020, Pfizer was made available to individuals 16 years and older under an Emergency Use Authorization (EUA) which allowed for its use in response to the epidemic and is allowable in an emergency to prevent serious or life-threatening diseases or conditions when certain criteria have been met such as safety and efficacy. In May of 2021, this EUA was expanded to include individuals 12 to 15 years of age and again expanded in August of 2021 to include the administration of a third dose in certain immunocompromised individuals. With the approval of Pfizer’s vaccine, now brand named “Comirnaty” for individuals 16 years and older, the Pfizer EUA remains in effect for children 12 to 15 years of age and for the administration of a third dose in certain immunocompromised individuals. Pfizer has started the FDA application for full approval for their vaccine in these populations as well.
To date, over 5.4 million doses of the Pfizer vaccine have been administered in Michigan and 65% of the state have gotten at least their first dose of one of the three vaccines; in District Health Department #10’s jurisdiction 56.6% of all ages eligible have initiated vaccination. From January through July, unvaccinated residents in the state have accounted for a staggering 98% of COVID cases, 95% of hospitalizations and 96% of deaths.