Tag: vaccine development

Are Vaccines Only Tested for 4 or 5 Days?

Where do some folks get the idea that vaccines are only tested for 4.5 days?

Anti-vax protestors often carry signs that say vaccines are only tested for 4.5 days. Don't believe them.
Anti-vax protestors often carry signs that say vaccines are only tested for 4.5 days. Don’t believe them.

The usual suspects…

Are Vaccines Only Tested for 4 or 5 Days?

But who gave them the idea to put it on their sign?

Again, the usual suspects…

Did the idea that vaccines are only tested for 4.5 days come from JB Handley, Children’s Health Defense Director and Co-Founder of Generation Rescue?
Did the idea that vaccines are only tested for 4.5 days come from JB Handley, Children’s Health Defense Director and Co-Founder of Generation Rescue?

Before we actually look to see if the original clinical trials for the hepatitis B vaccines only “solicited adverse reactions” for four or five days after vaccination, lets see what the safety studies have shown since these vaccines were approved in the 1980s.

These and other studies have shown that the hepatitis B vaccines are safe.

What about the idea that we only know what happens in the first four or five days after the vaccine is given?

Hepatitis B Vaccine Safety Testing

That’s not true. There are plenty of long term studies and safety studies typically collect safety information for weeks and months after a child is vaccinated.

“Open-ended diaries were provided to the parent(s) or guardian of the child before the vaccination program began in which to record any health problems that occurred 1 month before and 1 month following each of the 3 doses of vaccine, whether or not a health professional was consulted.”

De Serres et al on Importance of attributable risk in monitoring adverse events after immunization: hepatitis B vaccination in children.

Still, it is important to note that the further you get from a vaccination, the less likely that an adverse event is actually going to be caused by the vaccine though.

Consider the study by De Serres, Importance of attributable risk in monitoring adverse events after immunization: hepatitis B vaccination in children, in which they looked at the reports of adverse events both before and after vaccination and concluded that “postimmunization incidence systematically overestimates the risk of adverse events.”

Vaccines are tested very carefully, starting with small phase I and phase II trials, before moving to larger and longer lasting phase III trials.
Vaccines are tested very carefully, starting with small phase I and phase II trials, before moving to larger and longer lasting phase III trials.

It is also very important to note that like other vaccines, the hepatitis B vaccine was well tested before it was approved.

Although this was an efficacy trial, it included a double blind, placebo control and the researchers did notice any side effects.
Although this was an efficacy trial, it included a double blind, placebo control and the researchers did notice any side effects.

And many of the studies did include a placebo group.

A lot of folks in the placebo group for the hepatitis B vaccine trials got hepatitis B.
A lot of folks in the placebo group for the hepatitis B vaccine trials got hepatitis B.

Unfortunately, a lot of the folks in the placebo groups ended up getting hepatitis B.

In one study, Hepatitis B vaccine: efficacy in high-risk settings, a two-year study, which included an unvaccinated control group – “The control group was comprised of 31 patients and 24 staff members who had not been in contact with HBV until they entered the units and who did not wish to be vaccinated.”

What happens when you do a vaccinated vs unvaccinated study?
What happens when you do a vaccinated vs unvaccinated study?

Importantly, this study found “no local or general reaction to the immunization. A monthly biological and clinical survey of the vaccinated subjects showed no evidence of complication due to vaccination, especially no sign of auto­immunity.”

So why do we still hear the myth that vaccines are only tested for 4.5 days?

Anti-vax folks need to convince their followers that vaccines aren’t safe.

A careful look at all that went into the development of the hepatitis B vaccines shows that they are.

It also shows that vaccines are very necessary.

More on Hepatitis B Vaccine Safety Testing

Are There Generic Vaccines?

We are used to drugs becoming generic once they have been around for a while, which may have you wondering if we have generic vaccines too.

“Who owns the patent on this vaccine?
Well, the people, I would say. There is no patent. Could you patent the sun?”

Jonas Salk

In addition to vaccines that don’t have patents, others have lost their patent protection, which typically lasts for only 20 years, so it seems like we could have generic vaccines.

Are There Generic Vaccines?

And we have.

Consider that once upon a time:

  • the Texas Department of Health Resources made up to 7 different vaccines
  • the University of Illinois made a BCG vaccine
  • the Michigan Department of Public Health made up to 8 different vaccines
  • Massachusetts Public Health Biological Laboratories (Mass Biologics) made several vaccines

These included many generic vaccines, including DPT and IPV.

In addition to Tenivac, made by Sanofi Pasteur, MassBiologics makes a generic Td vaccine.

In fact, the Massachusetts Public Health Biological Laboratories continues to make the last remaining generic vaccines, DT and Td.

Why Aren’t There More Generic Vaccines?

Couldn’t more pharmaceutical companies make vaccines, including more generic vaccines, so that they could be less expensive?

“In sum, although patent protection remains the major barrier to the production of affordable small-molecule generics, access to trade-secret–protected information and know-how present major additional obstacles to generic production of vaccines.”

Improving Global Access to New Vaccines: Intellectual Property, Technology Transfer, and Regulatory Pathways

Unfortunately, unlike drugs, patents aren’t the only issue when making a generic vaccine. You also need the expertise, investment, and studies to prove that your generic vaccine is as safe and effective as similar vaccines.

More on Generic Vaccines

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

Did Gregory Poland Really Say That MMR Vaccines Can’t Prevent Measles Outbreaks?

One of the pillars of the anti-vaccine movement is their belief that vaccines don’t even work.

They even think that they have graphs to prove it! They don’t…

Did Gregory Poland Really Say That MMR Vaccines Can’t Prevent Measles Outbreaks?

To help them try and argue their point, they also seem to like to cherry pick and misuse quotes from real experts.

Anti-vaccine propaganda from Lawrence Solomon.
Is that what Dr. Poland said?

In 2012, Gregory Poland, the Editor-in-Chief of the journal Vaccine, did publish the article, The Re-Emergence of Measles in Developed Countries: Time to Develop the Next-Generation Measles Vaccines?

No where in the article does he say that the measles vaccine can’t prevent measles outbreaks.

He is just saying that since the vaccine isn’t 100% effective and because measles is so contagious, that it can’t prevent all measles outbreaks.

“Thus, measles outbreaks also occur even among highly vaccinated populations because of primary and secondary vaccine failure, which results in gradually larger pools of susceptible persons and outbreaks once measles is introduced.”

Poland et al on The Re-Emergence of Measles in Developed Countries: Time to Develop the Next-Generation Measles Vaccines?

And we likely won’t be able to eradicate measles with our current measles vaccine, “even though measles can be controlled, and even eliminated in some regions for defined periods of time.”

“Thus, while an excellent vaccine, a dilemma remains.”

Poland et al on The Re-Emergence of Measles in Developed Countries: Time to Develop the Next-Generation Measles Vaccines?

The dilemma is that measles is still around and that people who are too young to be vaccinated, too young to be fully vaccinated, and those with immune system problems who can’t be vaccinated sometimes get measles, in addition to folks who are intentionally unvaccinated.

With a better vaccine, fewer people would get caught up in outbreaks that are typically triggered by folks who are intentionally unvaccinated.

Remember, most outbreaks are traced back to someone who is unvaccinated. This is the person Dr. Poland is describing when he says “once measles is introduced,” as the endemic spread of measles has been eliminated in the United States. All cases are reintroduced from outside the country, typically when someone who is intentionally not vaccinated travels overseas and then returns with measles while they are still contagious.

“But he also said that sometimes people who oppose the vaccines will pick out one sentence in the scientific study and extrapolate it to mean things that it does not mean… He said that measles is the most contagious disease that we know, and yet we found that fear and ignorance is more so.”

Senator Carla Nelson on The Anti-vaxxers Might Wish that What was Lost had not been Found

Unfortunately, a better measles vaccine still won’t protect us from anti-vaccine propaganda.

Vaccines are safe, with few risks, and necessary. Get vaccinated and stop the outbreaks. You don’t have to wait for a new measles vaccine…

More on Did Gregory Poland Say That MMR Vaccines Can’t Prevent Measles Outbreaks?