New feature! Podcast version of FDA approval of Pfizer Vaccine
I hope you will take a listen and give me feedback
I’m experimenting with some other features on Substack. The first is to do an audio version of the post.
Don’t expect this to be fancy. I just read it into my computer, went on some asides on the issues and hit post. No edits. One and done.
I mostly read the text below from last week’s post about the the FDA approval of the Pfizer vaccine. But it’s just a guide, not a transcript.
The references I mention are all at the bottom in the “Links to Sources.”
I actually don’t know how you listen to this on podcast sites so I hope you can figure that out on your end. If you figure it out, lemme know so I can update instructions here!
I opened up the comments to all subscribers so you can give me your feedback.
Do you like this audio feature? Should I add it to every post or occasional?
If you like it, what way can I improve this so it’s easier to listen? Content, tech and distribution.
If you don’t like it, is there a way to improve that will make you get what you want from it?
Thank you for taking the time to listen and give me feedback! -Emily
Did FDA Approval of Pfizer Vaccine Change Minds?
When I started working at the FDA in August 2020, polls showed that only half of Americans would get the vaccine after it was authorized. A year later, the polls proved accurate as only 52% of the country has been fully vaccinated.
But now that the FDA has approved the vaccine, will people change their minds? Some, maybe, but that wasn’t the point.
FDA approval for vaccine mandates
Pres. Joe Biden has been determined to break through the vaccine ceiling. He tried twisting unvaccinated arms to get the shot through blame, shame and bribery. The needle barely moved on vaccination rates, or in arms.
So Joe has switched to just forcing people, and FDA approval of the Pfizer vaccine was key to the plan.
“If you’re a business leader, a non-profit leader, a state or local leader who has been waiting for full FDA approval to require vaccinations, I call on you now to do that — require it,” said Biden at the White House on Monday.
“Do what I did last month and require your employees to get vaccinated or face strict requirements.”
Biden explained how mandates have worked well for his goals:
“The good news is that people are getting vaccinated. For the past several weeks, my administration has imposed new vaccine requirements on federal workers, the armed forces, people who work in federal medical facilities, and nursing home workers. Governors, mayors, and private sector leaders have done the same.
Why FDA approval matters for the unvaccinated
The conventional wisdom here in DC has been that FDA final approval of a COVID vaccine will lead more people to voluntarily get the shot.
There has consistently been about 20% of the population who are just not getting the vaccine. Polls show that might be the case for an estimated 10-20% of people who are “wait and see” about side effects and safety. Here’s what it looks like in the Kaiser poll:
Washington wrongly believes the unvaccinated are stupid, MAGA-hat-wearing conservatives. But as I’ve written, it’s the young and healthy who don’t want to get vaccinated because they don’t need it.
These people (like me) aren’t waiting for the FDA. We’ve made our decisions. But, Pres. Biden said he’s not taking no for an answer.
That’s the real reason the FDA decision matters — it enables the government to pressure states and employers to mandate vaccines. The military, federal government, hospitals and more and more corporate employers are telling people to get vaccinated or be tested for COVID frequently.
And now it looks like the numbers have hardened and the only way to move them is give cover to the employers and military to make them do mandates.
Why FDA approval matters for the old and sick
A year ago, when I studied the Kaiser poll to figure out what we needed to do from the Trump administration to help the public believe that the vaccine would be safe, the numbers looked bad because senior citizens weren’t going to get the shot. Back then, only 62% of senior citizens planned to get vaccinated.
The authorization in December 2020 clearly made a difference for them because 80% are fully vaccinated now. This is good news because our parents and grandparents are safe from severe illness and death from COVID and mostly back to normal life after being stuck at home for a year.
Please read all the FDA information online at the link in sources at the bottom.
The FDA decision to approve Pfizer’s vaccine is important. It says that the scientists have dug into the 22,000 individual cases, data and inspected manufacturing plants and find the vaccine is safe from severe side effects.
The acting FDA Commissioner Janet Woodcock said Monday on a call with reporters (in Youtube below) that by working “around the clock” on Pfizer’s biologics license application (BLA) in just three months. She said this is an “unprecedented timeline” given the volume of review and the meticulous manner in which it was done. Woodcock said the FDA in “no way sacrificed scientific standards.”
Woodcock also said:
“We know that vaccine approval holds the promise of altering the course of the pandemic in the United States and for some an FDA approved COVID vaccine may instill in them the confidence to go and get vaccinated.”
The Pfizer vax brand name is now Comirnaty (koe-mir’-na-tee) and was approved for ages 16 and older. The emergency use authorization will remain in effect for younger kids and the shots already distributed. The Moderna and Johnson & Johnson vaccines are still under review for FDA approval but likely to come soon.
People with underlying health conditions (comorbidities such as obesity) who chose to get vaccinated this year are largely avoiding hospitalization from COVID. Few (or no) vaccinated people are dying from the virus. People in this category who were waiting for FDA approval can feel comfortable going ahead with it.
There are more breakthrough cases among the vaccinated, but Pfizer believes its booster this shot will get the antibodies back up to previous levels of efficacy.
FDA vaccine approval and your decision
I AM NOT A DOCTOR OR A SCIENTIST. If you want to know about the safety, efficacy and necessity of the vaccine, please read the FDA approval and talk to a doctor and your family.
In my personal opinion, people over the age of 65-years-old and those who have an underlying health condition (including obesity) should get vaccinated to prevent being hospitalized or possible die after being infected with COVID.
If you’ve already had COVID, up to you and your doctor to know if your health is good enough that natural immunity is enough to fight a serious case of COVID if you’re reinfected. For most people, natural immunity is just as good or better than the mRNA vaccine. (A well-respected recent study on this is linked in the sources.)
For the rest of us, Biden has made it harder to avoid the shot. The CDC should track how many of the people who will get vaccinated by choice and by government or employer mandate. The agency won’t do this but the pollsters may look into it.
The FDA announcement isn’t changing minds, but it’s changing America. We are now a country in which the president can use his power to force people to get a vaccine. Personal choice and individual liberty is under assault in our bodies and health.
Thank you for signing up for my Substack newsletter. Keep in mind that paid subscribers fund my independent reporting. -Emily
LINKS TO SOURCES
FDA NEWS RELEASE- Coronavirus (COVID-19) Update: August 24, 2021 FDA- Comirnaty INFO (Pfizer vaccine) FDA- Comirnaty and Pfizer-BioNTech COVID-19 Vaccine FDA- Woodcock bio PFIZER-BIONTECH — COVID-19 VACCINE COMIRNATY® RECEIVES FULL U.S. FDA APPROVAL FOR INDIVIDUALS 16 YEARS AND OLDER- Monday, August 23, 2021 CDC- COVID-19 Vaccinations in the United States White House - Remarks by President Biden on the COVID-19 Response and the Vaccination Program- AUGUST 23, 2021 Poll- KFF - COVID-19 Vaccine Monitor: June 2021 Poll - Kaiser - How Full FDA Approval Could Spur Vaccination-Aug 13, 2021 Poll- Gallup AUGUST 6, 2021 About One in Five Americans Remain Vaccine-Resistant Poll- Gallup Oct. 2020 - Americans' Readiness to Get COVID-19 Vaccine Falls to 50%