Tag: vaccine development

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?

Why Aren’t Vaccines Regulated like Drugs?

Have you ever heard the argument that vaccines aren’t held to the same standards as drugs, food, or other products?

“Vaccines are not held to the same double blind gold standard of clinical testing as other pharmaceutical drugs because they are considered biological products under the Public Health Federal Food, Drug and Cosmetic Act. They meet the same standards as cosmetics.”

20 VACCINE “FACTS” you need to know to make an informed decision

Placebos, liability, testing – these are all arguments that anti-vaccine folks try to use to scare parents into thinking that vaccine development isn’t well regulated and vaccines aren’t held to the same standard as drugs.

Why Aren’t Vaccines Regulated like Drugs?

Would you be surprised to learn that part of their argument is true?

Even after approval by the FDA, a vaccine still has to be reviewed by the ACIP before it is put on the immunization schedule.
Even after approval by the FDA, a vaccine still has to be reviewed by the ACIP before it is put on the immunization schedule.

No, not the part that vaccine development isn’t well regulated!

“Current authority for the regulation of vaccines resides primarily in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug and Cosmetic Act.”

Vaccine Product Approval Process

Federal regulations and rules ensure that our vaccines are safe.

  • Public Health Service Act (42 USC 262-63) §351
  • Food, Drug, and Cosmetic Act (21 USC 301-392)
  • Title 21 Code of Federal Regulations (CFR) 600-680 – standards for biological products
  • Title 21 CFR 314 (21 CFR 601.25[d][2], specific to biologicals – ensures adequate and well-controlled clinical trials
  • Title 21 CFR 312 – investigational new drug application (IND)
  • Title 21 CFR 210-211 – good manufacturing practices
  • Title 21 CFR 58 – good laboratory practices
  • Title 21 CFR 56 – institutional review boards
  • Title 21 CFR 50 – protection of human subjects
  • Prescription Drug User Fee Act (PDUFA) of 1992, 2002, and 2007
  • Food and Drug Agency Modernization Act (FDAMA) of 1997
  • Food and Drug Agency Amendments Act (FDAAA) of 2007

I meant the part that vaccines aren’t regulated like drugs.

While both vaccines and prescription drugs are regulated by the FDA, that work occurs within two different centers of the FDA:

  • Center for Biologics Evaluation and Research (CBER) – vaccines
  • Center for Drug Evaluation and Research (CDER) – over-the-counter and prescription drugs

Both centers work to make sure we have safe and effective vaccines and drugs to keep us healthy, even if there are some differences in how they do it.

“Vaccine clinical development follows the same general pathway as for drugs and other biologics.”

Vaccine Product Approval Process

That’s right, vaccines and drugs go through the same types of clinical trials.

After completing the three phases though, vaccine developers must then apply for a Biologics License Application (BLA), which is reviewed by a multidisciplinary FDA reviewer team. This is also when their manufacturing facility gets inspected.

“Following FDA’s review of a license application for a new indication, the sponsor and the FDA may present their findings to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA expert committee (scientists, physicians, biostatisticians, and a consumer representative) provides advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication.”

Vaccine Product Approval Process

Once approved and licensed, the FDA and CDC continue to work to make sure the vaccine is safe, including having some vaccines undergo undergo Phase 4 studies and monitoring for side effects through VAERS and the Vaccine Safety Datalink.

And then, even after approval by the FDA, new vaccines aren’t put on the immunization schedule until a review and approval by the Advisory Committee on Immunization Practices (ACIP).

“Canada, like many other countries, exercises tight regulatory oversight over vaccines because they are usually given to very large numbers of healthy individuals. Vaccines in Canada are subject to the Food and Drugs Act and the Food and Drug Regulations. Vaccines are regulated under a specific set of regulations for a subset of drugs known as biologic drugs.”

The Regulation of Vaccines for Human Use in Canada

It is also important to keep in mind that this process doesn’t just happen in the United States.

Still wondering why vaccines aren’t regulated like drugs?

“Vaccine development differs from drug development in several important ways. First, because vaccines are preventive and are given to healthy individuals – often children – they require very large clinical trials, leading to increased research and development costs. Second, vaccines are biological products that can be very complex to manufacture and are subject to stringent quality control standards, resulting in much higher capital costs. Third, unlike drugs, vaccines have no secondary markets, making it unlikely that manufacturers will generate additional profits beyond the initial target markets. Finally, unlike generic drugs, which only need to demonstrate adherence to a pre-established development process, vaccines are biologicals that require full re-development to demonstrate their equivalence. (World Health Organization, 2014). Each manufacturer is required to invest in the full regulatory approval process for their vaccine products.

Myths and Facts about Vaccine Product Price and Procurement

It’s only because vaccines are more strictly regulated than drugs and other products.

Vaccines are safe and necessary.

More on Vaccine Regulation