Tag: immunity

What Does “Design Defect” of a Vaccine Mean In the Iowa Bill to Require Vaccine Manufacturers to Waive Immunity from Lawsuits?

Beats me. Sorry, just kidding. I’m just a little bleary from looking at the web sites about the definition of “design defect” related to vaccines as it applies to the Iowa bill to make vaccine manufacturers waive their immunity from lawsuits about vaccine related injuries.

I am sympathetic to anyone who in fact has suffered a vaccine related injury.

That term “design defect” has been bugging me for days now and I just found out that this has been the subject of states vs federal legal wrangling for years. I’m not up to explaining all the legalese but there is a really tangled trail of cases in Georgia and Pennsylvania roughly around 15 years ago that ultimately led to a U.S. Supreme Court decision saying, essentially, the Vaccine Injury Compensation Program and the federal Childhood Vaccine Injury Act of the 1980s preempts all state level vaccine design defect claims.

I think that explains why the Iowa bill says that vaccine manufacturers have to waive their immunity from suits if they want Iowans to get their vaccines.

I can hear the groans and shouts of dissent even as I write this. Hey, you can’t make this up. Talk to your legislator or lawyer about it.

I’m not sure why Iowa would want to repeat the grind that Georgia and Pennsylvania went through which led to the conclusion that you can file vaccine design defect claims at the state level and not have to repeat history which would likely lead to any decisions made there being reversed in federal court.

And I’m not sure why any vaccine manufacturer would want to fight that battle in Iowa either. They might just steer around us and take their vaccines elsewhere.

The beginning of the Georgia story.

The end of the Georgia story.

The beginning and the end of the Pennsylvania story.

Vaccines aren’t perfect. They are neither 100% safe nor 100% effective. However, I support having vaccines available to help keep us healthy and the right to choose getting a vaccine. That’s why I don’t support a bill that I believe would make them less accessible.

CDC ACIP Meeting on Covid 19 Vaccine Additional Dose

The CDC ACIP meeting on February 28, 2024 on the proposal of a Spring booster of the Covid 19 vaccine was interesting and confusing. Initially right after the morning presentations, we were a little confused about whether the committee was targeting only those who got the vaccine booster last fall or everybody. That didn’t make much sense given the concern about low overall uptake of the vaccine.

The presenters also mentioned that getting the Spring Covid booster would be part of a shared clinical decision-making discussion with your doctor, similar to that recommended for the RSV vaccine. That was bewildering because we think that’s part of the reason some people might skip the RSV vaccine, given the news reports last year pointing out you had to have a prescription from a medical provider in some states to get it.

I was pretty interested in learning more about T-cell immunity given the concern about waning which of immunity from vaccines over a few months, which I think was based on neutralizing antibodies from B cells. I thought the CDC web site link to an article about the T-cell immune response suggested that cell mediated immune responses might mean that our immunity might not be waning that quickly. However, one of the presentations, “Evidence to Recommendation” showed a slide indicating that your T-cell immunity gets weaker with age (ref. de Candia P, Prattichizzo F, Garavelli S, Matarese G. T Cells: Warriors of SARS-CoV-2 Infection. Trends Immunol. 2021 Jan;42(1):18-30. doi: 10.1016/j.it.2020.11.002. Epub 2020 Nov 13. PMID: 33277181; PMCID: PMC7664351.)

I’ve read other articles, one of them on the CDC website, which says you may have more durable immunity provided by T-cells, but if I read it carefully, the authors hedge and say that T-cell adaptive immunity may not be as strong when you’re older. (Moss, P. The T cell immune response against SARS-CoV-2. Nat Immunol 23, 186–193 (2022). https://doi.org/10.1038/s41590-021-01122-w).

Later in the afternoon, the committee voted that those who are 65 years old and older should get the spring dose. There was no further discussion of limiting it to only those who got the Covid vaccine in the fall of 2023. There was also no discussion of the shared clinical decision-making detail. The committee upvoted the resolution with a majority.

And yet, the voting question did say: ACIP recommends that persons greater than or equal to 65 years of age “should” (which was changed from “may”) receive an additional dose of 2023-2024 Formula COVID-19 vaccine. The “additional dose” means in addition to the vaccine (monovalent XBB.1.5) given last fall. That’s a relatively select group, when you take the subset of those who are 65 and older.

However, the slides in the “Evidence to Recommendation” had recommended there should be shared clinical decision-making, meaning that you should discuss getting the vaccine with your doctor. However, according to the STAT NEWS article summary of this meeting, substituting the word “should” for “may” would make the conversation with a doctor unnecessary.

Finally, there was no discussion at all of changing the 5-day isolation precaution for those testing positive for Covid-19. If the committee were planning to drop that, as many news agencies recently reported, I would think they’d have discussed it at length at the meeting.

The CDC Director will have to sign off on the additional Covid-19 shot before it’s official.

2/29/2024 Update: CDC Director endorsed the additional dose yesterday.

ACIP Meeting on Covid-19 Vaccines and Boosters Held on April 20, 2022

I got to listen to some of the presentations yesterday during the ACIP meeting on Covid-19 vaccines and boosters. My impression is that there seems to still be some discussion about what the most important goals of the vaccination program. Is it to prevent severe disease, hospitalization, and death? Or is it to prevent infection altogether?

It’s not lost on me that even mild infection with Covid-19 can lead to a chronic (“long haul”) syndrome. On the other hand, it doesn’t sound plausible that a vaccine to prevent infection would even be possible, given that so many people remain unvaccinated. That’s part of the context for the rise of variants that can lead to vaccine-resistant strains. That can lead to boosters and what some ACIP committee members are now afraid might lead to a new vogue term-“booster fatigue.”

Sena and I are now immunized as far as we can go, with 4 doses. We’re hoping for a new vaccine that is safe, effective against variants, and doesn’t involve boosting every few months.

We focus a lot on vaccines. But the other side of the risk of getting infected and sick are a part of host immunity. It gets weaker as we get older. It’s weak in those who are immunocompromised for other reasons, including things like underlying diseases and organ transplantation.

Looking at other ways to prevent disease with Covid-19, such as new medications that might counter the decline of the immune system as we age, and any other innovations are also important.