Tag: clinical trials

Are There Any Long-Term Studies On Vaccine Safety?

Vaccines are evaluated for safety in studies when they get approved.

Is that enough?

“I would like to see us do more long-term safety research studies on these large groups of children, so then we can determine that they are safe in the long-term.”

Bob Sears

Apparently not for everyone…

Are There Any Long-Term Studies On Vaccine Safety?

Of course, vaccines continue to be evaluated for safety after they approved, using passive and active vaccine safety systems and long-term post-marketing safety studies.

“We learn about a vaccine’s safety during clinical trials before it is licensed, and monitor it continually as millions of doses are administered after it is licensed. We also know there is not a plausible biologic reason to believe vaccines would cause any serious long-term effects. Based on more than 50 years of experience with vaccines, we can say that the likelihood that a vaccine will cause unanticipated long-term problems is extremely low.”

Parents’ Guide to Childhood Immunizations

These long term studies on vaccine safety have looked at:

Have you heard about these studies before?

When they talk about SV40, do anti-vaccine folks mention this long-term study?
When they talk about SV40, do anti-vaccine folks mention this long-term study?

Probably not.

Anti-vaccine folks either aren’t aware of, or just don’t want you to know about these types of long-term studies.

It’s easier to scare you away from vaccinating and protecting your kids if they make you believe that vaccines aren’t tested together, aren’t tested with placebos, aren’t tested vs unvaccinated kids, and aren’t tested for long periods of time.

They are!

More on Long-Term Studies On Vaccine Safety

Is the MMR Vaccine Licensing Being Called into Question?

Why do some folks think that the MMR vaccine licensing is being called into question?

Yup. That’s what the usual suspects are trying to make you think.

Is the MMR Vaccine Licensing Being Called into Question?

Taking advantage of the fact that many sites publish all press releases, these folks want you to think that a major news site is following their latest bombshell, which of course is just another dud.

The MMR was licensed in 1971. The ICAN papers are from 1978…

You mean there really isn’t an FDA coverup?

“Clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that M-M-R II is highly immunogenic and generally well tolerated.”

MMR II Package Insert

Not only is the package insert very transparent about the studies used to approve the MMR II vaccine they are talking about, since only a minor change was made to the original MMR vaccine, which was approved in 1971, it isn’t surprising that larger trials weren’t required at the time.

So there were earlier, larger trials?

Yup.

But did they use a saline control group?

Nope.

A Vaccinated vs Unvaccinated Study - Stokes et al on Trivalent combined measles-mumps-rubella vaccine. Findings in clinical-laboratory studies.
A Vaccinated vs Unvaccinated Study – Stokes et al on Trivalent combined measles-mumps-rubella vaccine. Findings in clinical-laboratory studies

The control group was actually unvaccinated.

It is also important to keep in mind that this study, and a few other MMR studies, followed much, much larger studies of the individual measles, mumps, and rubella vaccines.

“The large majority of children in the United States have been vaccinated against measles and a sizable portion have been given mumps and rubella vaccines. It is estimated by us based on vaccination distribution that about 41 million children have received measles vaccine, 7 million mumps vaccine, and 21 million rubella vaccine. The combined triple vaccine provides a simple, safe, and effective immunization procedure using a single vaccine dose against three important diseases in children who have not yet been immunized.”

Stokes et al on Trivalent combined measles-mumps-rubella vaccine. Findings in clinical-laboratory studies.

Much larger double-blind, placebo-controlled studies of the individual measles, mumps, and rubella vaccines.

This is why you don’t routinely do vaccinated vs unvaccinated studies anymore. It is unethical to let kids get measles, mumps, rubella or other diseases.

The bottom line is that the measles (1968), mumps (1967), and rubella (1969) vaccines were safe when they were approved by the FDA.

The MMR (1971) was safe when it was approved by the FDA.

And MMR-II (1978) was safe when it was approved by the FDA.

Since then, there have also been studies showing that getting a second dose of MMR-II is safe and effective and that ProQuad, the combination measles, mumps, rubella, and chickenpox vaccine is safe and effective, although it is associated with a small increased risk of febrile seizures if given as a first dose.

There is no FDA coverup. No bombshell.

Just anti-vaccine folks continuing to try and scare you away from vaccinating and protecting your kids.

More on the Licensing of the MMR Vaccine

Making a Better Pertussis Vaccine

So we know that we need a better pertussis vaccine.

DTaP and Tdap just aren’t doing the job that they should be doing.

Whooping Cough is back, again.
Whooping Cough is back, again.

So when will we get one?

Making a Better Pertussis Vaccine

Since anti-vaccine folks are always talking about the 300 new vaccines in the pipeline, you would think that we would have had several new pertussis vaccines by now…

Unfortunately, we don’t.

What we do have is some good candidates, including:

  • new acellular pertussis vaccines, either with more antigens or an adjuvant
  • a new live attenuated nasal vaccine, BPZE1
  • new whole-cell vaccines with reduced endotoxin contents (so should have fewer side effects that then original whole-cell pertussis vaccine – DTP)

Before you get too excited, keep in mind that none of these vaccines will be available in your pediatrician’s office any time soon. Developing a new vaccine takes a lot of time.

BPZE1 has started phase 2a trials though.

What do we do until we get new pertussis vaccines?

“We should be more vigilant than we have been in the past to recognize and treat pertussis in all age groups so that transmission to young infants is reduced. Most important (although not discussed in this review) is to ensure that all pregnant women receive the Tdap vaccine between 27 and 36 weeks’ gestation with each pregnancy. Also, we should consider routinely administering Tdap vaccine every 3 years to all adolescents and adults who were primed with a DTaP vaccine.”

James D. Cherry on The 112-Year Odyssey of Pertussis and Pertussis Vaccines—Mistakes Made and Implications for the Future

We should keep using the pertussis vaccines we have!

Vaccines work, even when they aren’t as effective as we would like.

More on Making a Better Pertussis Vaccine

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