Tag: FDA

new complications for COVID vaccines in the US

(COVID Photo by Martin Sanchez on Unsplash)

Last week, after reading a newsletter from Your Local Epidemiologist founded by Dr. Katelyn Jetelina, I got a COVID vaccination. I will be going to my annual poetry residency with the Boiler House Poets Collective at The Studios at MASS MoCA in early October and wanted my immunity to be as strong as possible while I’m there.

The newsletter had warned that there might be label changes coming from the US Food and Drug Administration that would impact the availability of COVID vaccines and that it might be advisable to get the vaccine soon, especially for people younger than 65.

I’m glad I took action.

Yesterday, the Food and Drug Administration changed the guidelines, making it more difficult for people under 65 to qualify for COVID vaccines without consulting their doctor. In response, CVS and Walgreens, whose pharmacies are a major source for vaccinations to the public, suspended giving any COVID vaccines to anyone in sixteen states, including mine, unless you have a prescription from a health provider. Part of the confusion is that the Centers for Disease Control and Prevention has yet to issue its guidance and just suffered the loss of its top leadership through firing and resignations, grounded in the fact that they were being pressured to put forward recommendations not backed by scientific research.

That’s what happens when you have a Health and Human Services Secretary like Robert Kennedy, Jr., who does not have a background in medicine and disrespects rigorous scientific inquiry.

The fact is that COVID-19 vaccines have been rigorously tested and are safe and effective, cutting down on infection rates and keeping most people from becoming seriously ill and needing hospitalization. Serious side effects are very rare, so the benefits of receiving the vaccine outweigh the risks.

Tragically, vaccines have been politicized in the US, which has cost lives. The death rate from COVID-19 for Republicans is higher than for the population as a whole because of this.

I urge everyone with questions to talk to a trusted medical professional about the research and science behind vaccines. Don’t fall for the misinformation coming from Kennedy and the people he has put in place at the CDC and FDA who disregard valid scientific findings.

You can also look for recommendations from medical associations, such as the American Academy of Pediatrics.

Don’t let misinformation keep you from taking the best care possible of your and your family’s health.

One-Liner Wednesday: Project 2025 and mifepristone

Project 2025, the lengthy document spearheaded by the Heritage Foundation to lay out plans for the “conservative president” they expect to be elected this year and which mirrors Trump’s Agenda 47 and the Republican party platform, would direct the FDA to reverse the current approvals of mifepristone nation-wide, restricting medication abortion, miscarriage care, and other uses, even though the medication has proven to be safe and effective. (p. 458)

Join us for Linda’s One-Liner Wednesdays! Find out more here: https://lindaghill.com/2024/08/14/one-liner-wednesday-closed-for-the-season/

progress for Pfizer

Today is an important day for the Pfizer/BioNTech coronavirus vaccine.

In the United Kingdom, the first doses are being given, predominantly to those over the age of eighty. The recipients will need a second dose in three weeks.

In the United States, the Food and Drug Administration has published a 53-page review of the Pfizer/BioNTech data and confirmed the findings of safety and 95% efficacy. This clears the way for a public hearing on Thursday and possible emergency use authorization within days. Distribution will start within 24 hours of approval.

It is good that so much of the data is now public because you can see that the vaccine is safe and effective across different age, racial, and comorbidity groups. There is also evidence that some protection develops from the first of the two doses, although the highest level of protection begins about a week after the second dose.

As a Pfizer trial participant, I expect to hear back from the researchers shortly after the approval goes through. Pfizer plans to offer the vaccine to people in the placebo group in order to continue their long-term study on efficacy and safety. Among our family in the study, we expect that we have two who have already received two doses of the vaccine and one who is in the placebo group.

I can assure you that the suspected placebo person is anxious to join the vaccine group as soon as possible!