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Vaccine adverse events are very rare – vast benefits outweigh risks

Like all medical procedures, devices, and pharmaceuticals, vaccines are not perfect – there are rare vaccine adverse events. What matters is that the benefits, not only medically but also economically, outweigh any risks. As far ask I know, no perfect medical procedures, devices, or pharmaceuticals, none, that are perfectly safe or perfectly effective. Sometimes the ratio is small.

For example, there are chemotherapy drugs that only add a few months to a patient’s life, usually with substantial side effects to the medication. Yet, if you ask a patient whether it was worth it, to spend just a few extra months with their children and loved ones, the value becomes nearly incalculable.

But mostly, the FDA and other regulatory agencies demand that new products and procedures must meet or exceed the safety, and meet or exceed the financial and health benefits of currently acceptable versions. Actually, the FDA examines a lot more than that.

They check the packaging, shelf life, instructions, manufacturing practices, and so much more, it would take a book to explain it (and there probably are several). It may not be a perfect process, but it’s better than what we had 100 years ago, and it continues to improve every single day. People tend towards a form of confirmation bias where they remember where a drug may have been found to be dangerous (the best example is Vioxx).

But they forget about the millions of medications and devices that save lives or measurably improve the standard of living. 

Read More »Vaccine adverse events are very rare – vast benefits outweigh risks
vaccine safety

Vaccine safety – a huge systematic review says they don’t cause autism

Not that most of us need to be convinced, but there’s another huge systematic review that examined vaccine safety. Unsurprisingly, it shows that there are no major safety signals post-vaccination, plus no vaccine is linked to autism.

It’s ironic that this study is a high-quality systematic review and meta-analysis, the top of the hierarchy of biomedical research, while anti-vaxxers rely upon retracted articles published in predatory journals.

So, I want to do a quick review of this new article so that we can continue to support the settled science of vaccine safety.

Read More »Vaccine safety – a huge systematic review says they don’t cause autism
June 2020 ACIP meeting

June 2020 ACIP meeting – meningococcal, influenza, COVID-19 vaccines

This article about the June 2020 ACIP meeting 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 disease.

During June 2020, the Advisory Committee on Immunization Practices (ACIP) held its second annual meeting for the year. Because we are in the middle of the COVID-19 pandemic, and traveling is challenging for many – including, I suspect, for several of the Committee members, not all of which live near Georgia – the meeting, like most conferences this year (those which were not canceled) was held virtually. The CDC still provided an opportunity for oral comment, though there were some logistical challenges with their new system.

The June 2020 ACIP meeting discussed meningococcal vaccines, influenza vaccines, and then had the opportunity for public comment. The entire afternoon was devoted to COVID-19 and COVID-19 vaccines.

As with previous meetings, ACIP is a geek’s dream meeting and everyone else’s – except the experts, and I suspect – hope – most experts are geeks –  boredom feast. I learned a lot.

One of the most important lessons is that the committee takes vaccine safety very, very seriously. The other is that decisions on vaccines – like most policy decisions – are always made on incomplete knowledge. We never know everything. That is where expert judgment comes in. Incomplete knowledge does not mean there is not enough knowledge to assess benefits/risks, though any such assessment should be reassessed when new knowledge comes in.

Finally, it’s important to remember – and something the anti-vaccine observers of these meetings seem unaware of, but that doctors treating patients likely are not – that a decision not to use a vaccine is a decision with costs and risks – the costs and risks of the disease the vaccine prevents.

The choice is never between no risk and the vaccine because we don’t have vaccines unless a disease causes substantial mortality and morbidity. The choice is always whether, given the information, an informed decision can be made and which risks that information suggests are higher – those of the vaccine or those of not vaccinating.

Finally, my notes are over 14 pages of text for the June 2020 ACIP meeting, and that’s because my computer crashed at the end and I lost my last two pages of notes, which is really frustrating – and I have 153 screenshots of slides (yes, I am surprised too). I really want this post to be shorter. So I’m going to try and be very brief, and I’m happy to share my full notes, just email me at reissd@uchastings.edu.Read More »June 2020 ACIP meeting – meningococcal, influenza, COVID-19 vaccines

vaccine recommendations

ACIP vaccine recommendations – updates for HPV, HepA, MenB, flu

On 26-27 June 2019, the CDC’s Advisory Committee for Immunization Practices (ACIP) updated vaccine recommendations for several vaccines including the human papillomavirus (HPV), hepatitis A (HepA), and serogroup B meningococcal disease (MenB). These vaccine recommendations do not become official until they are published in the CDC’s peer-reviewed journal, Morbidity and Mortality Weekly Report (MMWR)

This article will review the ACIP process and new recommendations.Read More »ACIP vaccine recommendations – updates for HPV, HepA, MenB, flu

meningococcal vaccine

Meningococcal vaccine to prevent meningitis approved for 1-9 year olds

A new powerful meningococcal vaccine that trains the immune system to attack the bacteria that can lead to deadly meningitis has now been approved by the FDA for 1-9-year-old children. This is not going to warm the hearts of the anti-vaxxers who think that there are too many vaccines.

Let’s take a look at this vaccine and the disease it prevents, just so parents know that they can protect their children.

Read More »Meningococcal vaccine to prevent meningitis approved for 1-9 year olds
adult vaccines

Adult vaccines – the CDC wants to save adult lives too

Generally, when I write about vaccines, it’s about protecting children’s lives from vaccine preventable diseases. That itself is a noble goal for vaccines. But in case you didn’t know, there is also a CDC schedule for adult vaccines, which is as important to adults as they are to children.

Vaccines have one purpose – to protect us and those whom we love from potentially deadly and debilitating diseases. Many of us in the blogosphere have talked about the children’s schedule a lot, often to debunk claims of people who are ignorant of science, and think that the children’s vaccine schedule is causing undue harm. Yeah our intellectually deficient president, Donald Trump, thinks he knows more than the CDC, but that’s a problem shared by many vaccine deniers.

One adult vaccine I push regularly is the flu vaccine. It protects adults, pregnant women, the elderly, children, and healthy young adults from a severe infection that hospitalizes and kills more people every year than you’d think. Because flu is not really a serious disease, in some people’s minds, a lot of people decide that they don’t need the vaccine. They’d be wrong.

Just in case you were wondering, there is more to adult vaccines than just flu vaccines. There are several other vaccines indicated for adult use, including those adults with underlying health issues like diabetes, HIV and heart disease – unfortunately, the uptake for adult vaccines is depressingly low. Let’s take at the low uptake and the recommended adult vaccines schedule.

Read More »Adult vaccines – the CDC wants to save adult lives too

Why we vaccinate: to prevent meningococcal disease

Meningitis-baby-watch

Update of 24 September 2013 article to address outbreak at Princeton University.

Meningococcal disease usually refers to a group of diseases caused by the bacteria, Neisseria meningitidis, typically known as meningococcus. The most common illness arising from the bacterial infection is meningococcal meningitis (or just meningitis, even though there are non-bacterial forms meningitis, unrelated to this form). In meningococcal meningitis, the lining of the brain and spinal cord have become infected with these bacteria. These bacteria also have a causative role in other serious infections, such as bacteremia or septicemia, which are blood-borne infections.

Meningococcus bacteria are easily spread through the exchange of respiratory and throat secretions. The bacteria can pass quickly from one individual to another in close quarters, for example, schools and dormitories. Although the disease can be very serious, it can be treated with antibiotics that prevent the more severe forms of the illness and can reduce the spread of infection from person to person. 

If meningococcus isn’t treated quickly (or prevented by vaccines), the disease can be disabling or even fatal. And if the infection spreads to the blood, the consequences can be quite severe, requiring hospitalization. Meningococcal disease cannot be treated at home with over the counter or woo-based remedies. In fact, the symptoms of the early stages of the infection can mimic less dangerous infections, and require a physician’s diagnostic tools to rule out other less-serious infections.Read More »Why we vaccinate: to prevent meningococcal disease

Save children from risks–vaccinate and keep them away from guns

Vaccine deniers are basically clueless about science. They invent stuff about the immune system, while missing how a vaccine induces a long-lasting immune response. They conflate correlation with causality, an important distinction if you’re going to understand epidemiology. They deny… Read More »Save children from risks–vaccinate and keep them away from guns

West Virginia occasionally gets it right

constitution-us

West Virginia isn’t frequently lumped together with the more progressive states in the country. But sometimes, there are surprises.

I admit that I keep up with all kinds of news articles dealing with vaccines and vaccinations; especially since the new health care reform tax credit was enacted. I read about new vaccines in development. I read about new vaccine technologies that might prevent autoimmune diseases, like Type 1 diabetes. And I read articles about vaccinations from community newspapers, like this story in a local West Virginia newspaper, where I’m reminded of how advanced West Virginia is, at least with respect to vaccines:

Beginning last year, and continuing every year after, older students entering the seventh and twelfth grade will have shot requirements that must be met before the start of the school year.

Seventh and twelfth grade students will not be allowed to attend school this fall without proof of these immunizations. It is important that once you receive the vaccines and the providers update your immunization record, that the school nurse is sent a copy of the vaccines for their records.

The Mason County Health Department recently sent out a reminder that seventh grade students must show proof of a booster dose of Tdap (tetanus, diphtheria, pertussis) vaccine and one dose of meningococcal/meningitis vaccine. Twelfth grade students also must show proof of a dose of Tdap (ususally obtained at age 11-12 years) plus at least one dose of meningococcal/meningitis vaccine after the age of 16 years. If the student received a meningococcal vaccine prior to the age of 16, a second meningococcal vaccine will be required for the twelfth grade.Read More »West Virginia occasionally gets it right

2012 Top Ten list for new drug approvals

pharmaceutical researchThe US Food and Drug Administration recently announced (pdf) that it had cleared 35 new drugs during 2012, of which 31 were novel therapies. This is in addition to the literally hundreds of approvals for changes in already approved drugs for changes in packaging, manufacturing, and dozens of other reasons. 

In no particular order, here are the top 10 most interesting of the approvals based on my subjective viewpoint, which includes innovativeness, seriousness of disease, and other random factors. In others, no different in importance than all those end-of-year top 10 movie lists. So here we go:Read More »2012 Top Ten list for new drug approvals