Pfizer-Valneva Lyme disease vaccine to start phase 3 clinical trials

Pfizer lyme disease vaccine

We have some good news today, the Valneva Lyme disease vaccine, which will be distributed by Pfizer, is going to commence phase 3 clinical trials in the USA and Europe. For those of you who live in areas where Lyme disease is endemic, I’m sure you can’t wait.

This article will quickly review Lyme disease, the new vaccine, and how you might be able to volunteer for the clinical trials. Yes, you might be able to volunteer for the phase 3 clinical trials.

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Brook Jackson False Claims lawsuit against Ventavia COVID-19 vaccine clinical trial

pexels-photo-5878514.jpeg

This article about the Brook Jackson lawsuit claiming false payment claims for the Pfizer COVID-19 vaccine was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about vaccination’s social and legal policies. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

Brook Jackson worked as an operator of three of Pfizer’s COVID-19 vaccine clinical trials sites for 18 days. Based on what she saw, she brought suit against the operator – Ventavia, the company that hired clinical trials site operators, ICON PLC., and Pfizer in the name of the United States under the False Claims Act. Jackson’s lawsuit claims, if true, may show that Ventavia had many issues in running the trial.

But they do not show fraud in relation to claims of payment from the federal government, which is the heart of a False Claims claim, and that alone should probably lead to her lawsuit being dismissed. The False Claims Act is not a catch-all tool for violation of FDA regulations. 

Again, even if true, they do not show a problem with Pfizer’s vaccine, a vaccine for which there is now extensive independent data on safety and effectiveness. 

Continue reading “Brook Jackson False Claims lawsuit against Ventavia COVID-19 vaccine clinical trial”

Brook Jackson False Claims lawsuit against Ventavia COVID-19 vaccine clinical trial

close up view of a vaccine vial

This article about the Brook Jackson lawsuit claiming false payment claims for the Pfizer COVID-19 vaccine was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about vaccination’s social and legal policies. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

Brook Jackson worked as an operator of three of Pfizer’s COVID-19 vaccine clinical trials sites for 18 days. Based on what she saw, she brought suit against the operator – Ventavia, the company that hired clinical trials site operators, ICON PLC., and Pfizer in the name of the United States under the False Claims Act. Jackson’s lawsuit claims, if true, may show that Ventavia had many issues in running the trial.

But they do not show fraud in relation to claims of payment from the federal government, which is the heart of a False Claims claim, and that alone should probably lead to her lawsuit being dismissed. The False Claims Act is not a catch-all tool for violation of FDA regulations. 

Again, even if true, they do not show a problem with Pfizer’s vaccine, a vaccine for which there is now extensive independent data on safety and effectiveness. 

Continue reading “Brook Jackson False Claims lawsuit against Ventavia COVID-19 vaccine clinical trial”

Second COVID vaccine booster now or wait for the new vaccine?

second COVID-19 vaccine booster

Someone asked me the other day whether she should get the extremely safe second COVID-19 vaccine booster now or wait for the new Omicron-adapted vaccines that are coming in the fall from Pfizer and Moderna. I didn’t know the answer, so I thought I would investigate. Maybe it will help you or someone you know with that decision too.

The actual answer is a bit complicated, but there appear to be some good, solid recommendations coming from people who are experts in containing this pandemic. Let’s take a look.

By the way, this old dinosaur got his first Moderna booster in October 2021 and received his second booster (this time Pfizer) in April 2022. I do practice what I rant about here!

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Combined flu and COVID vaccines associated with mild reactions

COVID-19 flu vaccines

A new study examined the incidence of mild reactions after individuals have received the flu and COVID-19 vaccines at the same time. The researchers did not find anything to be of concern, but I always like to get ahead of a story and discuss it so I (and you) are prepared to deal with the inevitable anti-vaccine meme or trope.

Since COVID-19 cases will probably be increasing this fall (in fact, it’s already increasing), we will probably need another booster this fall. And that’s about the time most of us get our flu shot, so researchers wanted to know if there were any issues when getting both the flu and COVID-19 vaccines. Spoiler alert — not really.

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COVID-19 vaccine facts and debunking myths — the semi-complete list

COVID-19 vaccine facts

There are so many myths about the COVID-19 vaccine, I wanted to post some facts about the new vaccines which we can use for debunking purposes. I used to think that the HPV vaccine brought the most hatred and misinformation from the anti-vaccine world, but it’s clear that the new COVID-19 vaccines are their new targets.

This article will only focus on the five vaccines that I believe will eventually receive FDA or European Medicines Agency (EMA) approval – Pfizer, Moderna, AstraZeneca, Johnson & Johnson (JNJ Janssen), and Novavax vaccines. I remain unconvinced that any vaccine made in China or the Russian Sputnik V vaccine will ever get approved by countries with robust drug regulatory agencies. However, if they are, I will certainly add them to a future iteration of this list.

I’m going to make this in a basic chart form for ease of use in finding COVID-19 vaccine facts and myths. I will link to supporting evidence wherever relevant.

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FDA, CDC, and COVID-19 vaccines — who does what?

FDA CDC COVID-19 vaccines

This article about the role of the CDC and FDA concerning COVID-19 vaccines was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

I write this right after the FDA expert advisory committee, Vaccines and Related Biological Products Advisory Committee (VRBPAC), voted unanimously that the benefits of both Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children 6 months to 5 years of age outweigh their risks, clearing a smooth path for FDA to grant emergency use authorization (EUA) to these vaccines. I was asked about the division of labor between CDC and FDA on COVID-19 vaccines, and it seems like something worth setting out.

So this is a short post about the relative roles of the FDA and CDC in getting COVID-19 vaccines to people in the USA. It is not a full picture of how vaccines get to us; there is a lot more to that. I am not even going into the full requirement for approving or authorizing a vaccine; just who does what. But this piece of the puzzle can be useful by itself.

For those looking for a full description of the vaccine approval process, I recommend either the Skeptical Raptor’s post on that topic or the description by the Vaccine Education Center of the Children’s Hospital of Philadelphia.  

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The risk of Guillain-Barré syndrome after COVID mRNA vaccines is low

Guillaine-Barré COVID-19 mRNA vaccines

I keep reading anti-vaccine commentary that Guillain-Barré syndrome had been linked to the COVID-19 vaccines according to a deep dive into the VAERS database. Those of you who read my works know that I am apt to dismiss almost any claim that is based on VAERS. it is not built to show correlation let alone causation between Guillain-Barré syndrome and COVID-19 vaccines.

However, as I have said before VAERS can send a safety signal that should be investigated more thoroughly. And that’s what a vaccine research team did — they went to a better vaccine safety database and performed a thorough study. And what they found is that the COVID-19 mRNA vaccines, from Pfizer and Moderna, were not linked to Guillain-Barré syndrome. However, they did find a link to the JNJ COVID-19 vaccine, which confirms what was being discussed a few months ago.

Let’s take a look at this study so that we can at least partially debunk anti-COVID-19 vaccine claims.

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New vaccines wishlist — I am looking beyond COVID-19

new vaccines

I once was accused of not being opposed to any vaccine on the market, but little did they know I have a wishlist for new vaccines that goes beyond all that. Believe it or not, there are pathogens out there that still have a deleterious effect on the health of mothers, children, and everyone.

I just wanted to spend a bit of time talking about some of the diseases where new vaccines could improve health outcomes in significant ways. Let’s take a look at some of them.

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Pfizer-Valneva Lyme disease vaccine — phase 2 pediatric trials results

lyme disease vaccine

I have previously discussed a Lyme disease vaccine candidate from Pfizer and Valneva that is starting a phase 3 clinical trial. However, the companies are keeping us updated with their phase 2 results, and there has been exciting news — the pediatric trial (in 5-17-year-olds) showed strong immunogenicity for the new Pfizer-Valneva vaccine.

Of course, dogs have had access to a Lyme disease vaccine, but there has not been a vaccine available for humans for over 20 years. It’s not that dogs are more important than humans (though many of us might argue that point), but about 20 years ago, the anti-vaxxers got the vaccine pulled from the market, one of their few “successes” in getting rid of useful vaccines.

But a small company, Valneva, in partnership with Pfizer, has developed a new vaccine that will be entering Phase 3 clinical trials real soon. Hopefully, we’ll have it in just a few more years.

Let’s first take a look at this disease, and then we will review the vaccine itself along with new results.

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