Tag: testing

Kennedy Has a Fundraiser in the Middle of the Largest and Longest Measles Outbreak in Recent New York History

Remember when Andrew Wakefield went to Minnesota during their large measles outbreak?

It’s reminiscent of the NRA holding one of their conventions in a city after a big shooting, isn’t it?

Kennedy Has a Fundraiser in the Middle of the Largest and Longest Measles Outbreak in Recent New York History

While it seemed like a big outbreak at the time, those 13 cases would actually be considered rather small these days. In fact, a more recent outbreak in Minnesota, in 2017, had at least 79 cases!

And not surprisingly, anti-vaccine folks also visited the state to try and keep that outbreak going!

Do these folks ever learn?

Flash forward to 2019…

Since September of 2018, New York has seen over 332 cases of measles in two big outbreaks in Brooklyn and Rockland County.

So where does Robert F. Kennedy, Jr. choose to go for a fundraiser?

Where does he show up on TV to push his message about vaccine dangers?

Yup, New York City.

Lori Stokes: “Can I switch gears for a minute and talk about vaccines…”

Kennedy: “When I was a kid, we got three vaccines. That I took. My kids got 64 mandated vaccines.”

Rosanna Scotto: “How many? 64?”

Kennedy: “64”

Rosanna Scotto: “Wow!”

Kennedy: “Mandated doses. Today’s kids get 72, by the end of next year it will be 75. It’s all driven by profit. Most of these diseases are illnesses that you don’t need to be vaccinated for. “

Fox 5 Good Day New York

Wow indeed. That sounds like a lot because kids typically only get 13 vaccines that protect them against 16 vaccine-preventable diseases. We don’t even have 64 vaccines!

You only get to a number like 64 or 72 or 75 if you inflate the count to make it sound scarier.

In reality, if you count a yearly flu vaccine, kids get about 54 doses of vaccines through age 18.

Are any for diseases that you don’t need to be vaccinated for?

Which disease do you want your kids to get?

Do you want them to get tetanus, meningitis, epiglottitis, diphtheria, meningococcemia, cancer (hepatitis B and HPV infections) or to have grandchildren with congenital rubella syndrome?

Vaccines are safe, with few risks, and are necessary.

Ask yourself why folks like this are still allowed to push this kind of misinformation on folks, especially in the middle of an outbreak.

More on Kennedy’s Fundraisers

Where are the Saline Placebos?

Remember when anti-vaccine folks used to say that there were no double-blind, placebo-controlled randomized clinical trials for vaccines?

What happened once they realized that there actually were?

They moved the goal posts…

Where are the Saline Placebos?

Okay, they said.

So you have done double-blind, placebo-controlled randomized clinical trials when testing vaccines, but what placebo did you use?

Was it a pure saline placebo?

“Placebo Control – A comparator in a vaccine trial that does not include the antigen under study. In studies of monovalent vaccines this may be an inert placebo (e.g. saline solution or the vehicle of the vaccine), or an antigenically different vaccine. In combined vaccines, this may be a control arm in which the component of the vaccine being studied is lacking.”

WHO on the Guidelines on clinical evaluation of vaccines: regulatory expectations

Although no guidelines actually call for using a pure saline placebo, that’s all anti-vaccine folks will accept these days.

Why?

That’s their MO – or method of operation.

When one theory or myth gets squashed – they move to another.

They move the goalposts.

It doesn’t matter that there are often ethical and logistical problems with using pure saline placebos, that’s all they want to hear about it.

That they wouldn’t be satisfied and start vaccinating their kids if all vaccine studies started to use saline placebos should be evident when you consider that many vaccine studies have already used saline placebos!

There are many more vaccine studies that have used saline placebos and like other vaccine studies, have found vaccines to be safe and effective.

But how do you know that they used a real saline placebo and not some kind of saline solution with other stuff in it?

If it isn’t clear to you in the methods section of the study, go to the source – the original clinical trials record and it will be listed there.

What are you going to be worried about now?

More on Saline Placebos

Et Tu, Slate? Flaws with Their Questions About Gardasil

Questioning vaccines doesn’t make someone anti-vaccine.

Something is missing in this article about Gardasil testing in Slate...
Something is missing in this article about Gardasil testing in Slate…

Doing a poor job of it and making folks scared to get vaccinated and protected?

I’ll let you decide what to call them…

Slate Investigates the Gardasil Clinical Trials

So after an eight-month long investigation, a journalist for Slate thinks he has evidence that the clinical trials that helped get Gardasil approved by the European Medical Agency were flawed.

What was the problem?

The way that they recorded possible side effects after folks were vaccinated.

“To track the safety of its product, the drugmaker used a convoluted method that made objective evaluation and reporting of potential side effects impossible during all but a few weeks of its years long trials.”

What made the method convoluted?

“In an internal 2014 EMA report about Gardasil 9 obtained through a freedom-of-information request, senior experts called the company’s approach “unconventional and suboptimal” and said it left some “uncertainty” about the safety results.

Merck, which is known as Merck Sharp & Dohme outside the U.S. and Canada, did not address the EMA’s safety concerns.”

When you read the internal 2014 EMA report about Gardasil 9, it is clear that Merck has a thorough response to each and every question that the EMA asked.

And those other quotes?

The EMA does state that:

  • “At all other time points in the study medical events were reported as “new medical history”. This is an unconventional and suboptimal study procedure.”
  • “While it is considered that the required safety data eventually has been made available for assessment, this feature of the study protocol brings some degree of uncertainty into safety assessment.”

So the EMA got the required safety data they were looking for, which is likely why Gardasil was approved in Europe.

They also said that “As the AE reporting procedure as seen at the inspection sites was in line with the approved protocol, the inspectors did not comment on it in the inspection reports. It was discussed with assessors during the course of the inspections, as in the inspectors’ opinion it is not an optimal method of collecting safety data, especially not systemic side effects that could appear long after the vaccinations were given.”

This case of a subject with POTS was reported as being "well characterized" by the EMA, even though it likely wasn't caused by her Gardasil shots.
This case of a subject with POTS was reported as being “well characterized” by the EMA, even though it likely wasn’t caused by her Gardasil shots.

But if it was suboptimal, how come they were able to record someone getting diagnosed with POTS 1,389 days after their third dose of vaccine?

I’m starting to understand why Dr. Yehuda Shoenfeld wasn’t quoted in the piece. He likely knew how it was going to be perceived…

“Imagining a link between HPV vaccination and CFS is not all that far-fetched, according to Dr. Jose Montoya, a professor of medicine at Stanford University and a CFS expert.”

Not far-fetched at all, which is why studies are done to see if there really is a link.

So even if part of the study design was suboptimal, the Slate piece shouldn’t have cherry picked those quotes and should have included these other big pieces of information:

  • A study in the UK using the MHRA’s Yellow Card passive surveillance scheme found no increase in reports of chronic fatigue syndromes following the introduction of Cervarix (another HPV vaccine)
  • In 2015, the EMA confirmed evidence that HPV vaccines do not cause complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS)
  • A large, nationwide register-based study from Norway found no indication of increased risk of chronic fatigue syndrome/myalgic encephalomyelitis following HPV vaccination
  • A large cohort study of over 2 million young girls in France found no risk for autoimmune diseases (including neurological, rheumatological, hematological, endocrine, and gastro-intestinal disorders)
  • A large cohort study of girls in Sweden with pre-existing autoimmune diseases found that HPV vaccination was not associated with increased incidence of new-onset autoimmune disease (49 types of autoimmune diseases)
  • A review of VAERS reports that “did not detect any unusual or unexpected reporting patterns that would suggest a safety problem” with HPV vaccination

The Slate piece does mention two of these studies, but just barely. One gets a single sentence and the other, half a sentence.

We see page after page of anecdotes of folks with supposed vaccine injuries, but the evidence that shows the vaccine is safe is almost buried and easy to miss. Many of the other studies seem to be left out.

And just because these patients have agonistic auto-antibodies, it doesn’t mean that they are from a vaccine.

“Five of the 14 POTS subjects and 2 of the 10 “healthy controls” recalled a respiratory infection in the 6 months prior to onset of their symptoms or inclusion in the study for the healthy controls.”

Li et al on Autoimmune Basis for Postural Tachycardia Syndrome

Lastly, what’s with calling cervical cancer uncommon???

“Cervical cancer is the 4th most common cause of cancer death in women worldwide, with tens of thousands of deaths in Europe each year despite the existence of screening programmes to identify the cancer early.”

European Medicines Agency

Downplaying the risks of vaccine-preventable diseases, while trying to scare folks about vaccines – that’s what gets you labeled as anti-vaccine.

The HPV vaccines are safe. They work and they are necessary. Don’t skip them.

What to Know About the Slate Gardasil Investigation

Although the study design for Gardasil used for licensing in Europe might have been suboptimal, that doesn’t really come across in this Slate piece, as it seems clear that it didn’t result in safety data being missed, and as post-licensure tests have confirmed, Gardasil is safe.

More on the Slate Gardasil Investigation

How Are Vaccines Really Made?

Do you know how vaccines are made?

A lab worker injects flu virus into an egg, one of many steps in making our flu vaccines.
A lab worker injects flu virus into an egg, one of many steps in making our flu vaccines. Photo courtesy of the FDA

When we say that chickens are used to make flu vaccine, do you think that means that live chickens are actually infected with the flu to make the vaccine?

They aren’t.

Just like live monkeys aren’t injected with the polio virus to make the polio vaccine.

Those are just myths you see in vaccine scare videos on anti-vaccine websites.

How Are Vaccines Really Made?

So how are vaccines really made?

It depends, after all, there are a lot of different types of vaccines.

But instead of monkey cages and chicken coops in the labs of today’s vaccine manufacturers, you will find clean rooms with large scale, stainless steel bioreactors, master cell banks, seed fermenters, microcarriers, centrifuges, filtration and chromatography equipment, and filling and lyophilization equipment.

Do you picture a series of these large scale, stainless steel bioreactors when you think about how vaccines are made?
Do you picture a series of these large scale, stainless steel bioreactors when you think about how vaccines are made?

That doesn’t sound so scary or shocking, does it?

What’s shocking about the whole process of making a vaccine?

It takes a long time. Often one to three years! And that’s after all of the time that went into the research, testing, and licensing of the vaccine.

“Viruses are grown in cells, which can be either primary cells, such as chicken fbroblasts (e.g., yellow fever vaccine), or continuous cell lines, such as MRC-5 (e.g., hepatitis A vaccine). Bacterial pathogens are grown in bioreactors using medium developed to optimize the yield of the antigen while maintaining its integrity. Recombinant proteins can be manufactured in bacteria, yeast, or cell culture. ”

Plotkin’s Vaccines (Seventh Edition)

The only other shocking thing about making vaccines is how boring it all is, at least if you aren’t into biology, with most vaccines using the same basic steps:

  • decide on the type of antigen – vaccines can be made of attenuated live viruses, inactivated viruses or bacteria,  or just part of the virus or bacteria (subunit and conjugate vaccines)
  • generate an antigen – this is the thing in the vaccine that will stimulate an immune response and protect your child. It used to be what anti-vaccine folks were concerned about until we explained that kids today are exposed to far fewer antigens, even though they get more vaccines and more protection.
  • release and isolate the antigen – the antigen was either growing in cells or other medium and in this step, as much of the antigen is collected as possible.
  • purify the antigen – multiple steps are involved in removing many of the vaccine ingredients or excipients that were used up to this step by precipitation, ultrafiltration, and column chromatography, etc. That’s why many are said to remain only in residual amounts, like formaldehyde.
  • strengthen the antigen – in this step, an adjuvant might be added.
  • combine all of the ingredientsstabilizers and preservatives might also be added in this step.
  • last steps – finished vaccine is put in vials and syringes and then packaged
  • lot release and distribution – each lot is tested before it is released to make sure it meets FDA standards for potency, safety, and sterility.

None of that sounds as scary as injecting monkeys with smallpox, watching them die, and then harvesting their infected kidney cells though, does it? If you have watched any of the anti-vaccine scare videos, hopefully the first thing that came to mind is that the smallpox vaccine isn’t actually made with the smallpox virus! It is, of course, made with vaccinia virus and wouldn’t cause anyone, whether a monkey, cow, or person to actually get smallpox. And if you haven’t figured it out by now, monkeys aren’t used to make smallpox vaccines.

“Both vaccines are derived from the New York City Board of Health strain of vaccinia, but Dryvax was grown on the skin of calves and then essentially freeze-dried for storage. It was licensed by FDA in 1931 but is no longer manufactured. ACAM2000, a “second generation” smallpox vaccine, is derived from a clone of Dryvax, purified, and produced using modern cell culture technology.”

FDA on ACAM2000 (Smallpox Vaccine) Questions and Answers

In fact, most of today’s vaccines are made in bioreactors, not in cows or monkeys.

Flu vaccine is mostly still made using chicken eggs, specifically 11-day-old embryonated chicken eggs. The flu viruses are passed into the eggs, incubated for a time to allow them to grow, and then harvested, inactivated, and purified.

How purified do they get? So purified that even people with egg allergies can get a flu vaccine these days.

Vaccines are safe. Vaccines are made safely.

What to Know About How Vaccines Are Really Made

Vaccines are made using a very safe and scientific process that is heavily regulated that will neither scare nor shock you.

More on How Vaccines Are Really Made