Tag: Zika

Vaccine Fast Tracking

Like a few other vaccines, Gardasil underwent Fast Track approval by the FDA.

“This is the first vaccine licensed specifically to prevent cervical cancer. Its rapid approval underscores FDA’s commitment to help make safe and effective vaccines available as quickly as possible. Not only have vaccines dramatically reduced the toll of diseases in infants and children, like polio and measles, but they are playing an increasing role protecting and improving the lives of adolescents and adults.”

Jesse Goodman, MD, MPH, Director of FDA’s Center for Biologics Evaluation and Research

But that doesn’t mean that any corners were cut in getting it quickly approved or that the vaccine isn’t safe.

Vaccine Fast Tracking

The Fast Track process can help get new drugs and vaccines approved more quickly by the FDA because they have:

  • more frequent meetings with the FDA to discuss the drug’s development plan and to help ensure the collection of appropriate data needed to support drug approval
  • more frequent written communication from the FDA about such things as the design of the proposed clinical trials and the use of biomarkers
  • eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
  • a Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

In very simple terms, it is kind of like having a VIP pass at an amusement park. It gets you a guide and helps you jump to the front of many of the lines, but you still don’t get to operate the rides yourself.

Vaccine fast tracking doesn't mean that a vaccine gets approved too fast.
It is a myth that vaccine fast tracking means that a vaccine gets approved too fast.

Which vaccines have had Fast Track approval?

They include Gardasil, Vaxchora, a cholera vaccine, the MenB vaccines, and FluBlock, the flu vaccine that is made in insect cells.

Others that have Fast Track designation include vaccines for  anthrax (NuThrax anthrax vaccine adsorbed with CPG 7909 adjuvant), chikungunya, Clostridium difficile (Clostridium difficile toxoid vaccine), malaria, RSV, Zika, Ebola, Invasive
Staphylococcus aureus infections in surgical populations, Shigella (Flexyn2a), and Lyme disease. None are approved yet though.

And that all of these vaccines have Fast Track designation is a good reminder that it isn’t a guarantee of approval.

“With Fast Track designation, early and frequent communication between the FDA and the biopharmaceutical company is encouraged throughout the entire drug development and review process to help to quickly resolve any questions or issues that arise, potentially leading to an earlier approval and access by patients.”

Encouraging Vaccine Innovation: Promoting the Development of Vaccines that Minimize the Burden of Infectious Diseases in the 21st Century

It just puts them on a Fast Track to get approved if they meet all of the FDA requirements for safety and efficacy.

The ability to develop and approve new vaccines quickly is also important as we continue to face new emerging disease threats. Faced with a deadly global pandemic, everyone will be glad that we have the ability to Fast Track vaccines and other drugs.

More on Vaccine Fast Tracking

Which Vaccines Do You Get When You Join the Military?

The oral adenovirus vaccine is approved to prevent adenovirus infections in military populations.

Believe it or not, many vaccines are available that we don’t routinely get.

Some we only get if we travel, like vaccines for yellow fever and typhoid. Others we only get in high risk situations, like if you get exposed to a bat with rabies.

And one, the adenovirus vaccine, you can only get if you join the military.

Which Vaccines Do You Get When You Join the Military?

But don’t folks get a lot of vaccines when they join the military?

It depends…

Whether you join the Army, Navy, Air Force, Marine Corps, or Coast Guard, health personnel will evaluate your immunity status by checking your titers to routine vaccine-preventable diseases. So no, if you were wondering, it doesn’t seem like they just check the vaccine records that you might bring from your pediatrician.

And then once they assess your immunization or immunity status, you will get vaccinated:

  • upon accession – adenovirus, influenza, meningococcal, MMR, Tdap, and chicken pox
  • during the first or second half of collective training – hep A, hep B, and polio (if needed) and other vaccines based on risk

So, in addition to getting caught up on all routine vaccines that they might be missing, there are other “military vaccines” that they might need, including:

  • Adenovirus vaccine – given to enlisted soldiers during basic training
  • Anthrax vaccine – only military personnel with extra risk, although some civilians can get this vaccine too
  • Smallpox vaccine – only military personnel who are high risk and smallpox epidemic response team members, although some civilians can get this vaccine too
Which vaccines you get in the military might be determined by where you are getting deployed to.
Which vaccines you get in the military will likely be determined by where you get deployed.

Like the recommendations for civilians, other vaccines are mainly given to military personal if they have extra risk based on where they are being deployed.

  • Cholera – only military personnel with extra risk based on deployment or travel to endemic areas
  • Japanese encephalitis – only military personnel with extra risk based on deployment or travel to endemic area in Eastern Asia and certain western Pacific Islands
  • Rabies vaccine – pre-exposure vaccination is only for military personnel with animal control duties or with extra risk based on deployment, including special operations personnel
  • Typhoid vaccine – only military personnel with extra risk based on deployment or travel to typhoid-endemic areas and other areas with poor sanitation.
  • Yellow fever vaccine – only military personnel with extra risk based on deployment or travel to yellow-fever-endemic areas in sub-Saharan Africa and tropical South America.

These are the same vaccines that we would get if we traveled to high risk areas.

 

Military Vaccines in Development

It shouldn’t be a surprise that the military does research on infectious diseases and vaccines.

Members of the military are often put at great risk for known and emerging diseases, like Ebola, Zika, and malaria.

That’s why some vaccines might have been given as an investigational new drug in special situations, typically when “individuals who have a high occupational risk – laboratory workers, facilities inspectors, vaccine manufacturers and certain military response teams.”

These vaccines, which were initially developed at US Army labs, are no longer being produced, but have included:

  • Argentine hemorrhagic fever (Junin virus) vaccine
  • Chikungunya fever vaccine
  • Eastern equine encephalitis vaccine
  • Q fever vaccine
  • Rift Valley fever vaccine
  • Tularemia vaccine
  • Venezuelan equine encephalitis vaccine
  • Western equine encephalitis vaccine

Today, the Walter Reed Army Institute of Research (WRAIR) “is a leader in global efforts against the world’s most pervasive and high impact infectious diseases.”

WRAIR is working on vaccines for HIV, Ebola, MERS, and Zika.

What to Know About Military Vaccines

You will need some extra vaccines when you enlist in the military, but how many will depend on if you are up-to-date when you join and your area of responsibility. So there is no one-size-fits-all military immunization schedule.

More on Military Vaccines

 

Can Vaccines Cause Guillain-Barre Syndrome?

People with Guillain-Barré syndrome develop the rapid onset of muscle weakness and then paralysis. They may also have numbness and a loss of reflexes.

Unlike some other conditions that cause weakness and paralysis, GBS is a symmetrical, ascending paralysis – it starts in your toes and fingers and moves up your legs and arms.

What Causes Guillain-Barré Syndrome?

If you want to avoid GBS, skip raw milk, not your vaccines.
If you want to avoid GBS, skip raw milk, not your vaccines. (CC BY 2.0)

GBS is an autoimmune disorder and often starts after a viral or bacterial infection, especially one that causes diarrhea or a respiratory illness.

One of the biggest risk factors is a previous Campylobacter jejuni infection, that is often linked to drinking raw milk, eating undercooked food, drinking untreated water, or from contact with the pet feces.

In less half of cases, no specific cause is found.

Fortunately, although progress can be slow, many people with GBS recover.

Can Vaccines Cause Guillain-Barré Syndrome?

Guillain-Barré syndrome is actually a table injury for the seasonal flu vaccine.

“On very rare occasions, they may develop GBS in the days or weeks after getting a vaccination.”

CDC on Guillain-Barré syndrome and Flu Vaccine

It is not common though.

For example, the increased risk of GBS after getting a flu vaccine is thought to be on the order of about one in a million – in adults.

Flu vaccines have not been shown to cause GBS in children.

“The risk of GBS is 4–7 times higher after influenza infection than after influenza vaccine. The risk of getting GBS after influenza vaccine is rare enough that it cannot be accurately measured, but a risk as high as one case of GBS per 1 million doses of flu vaccine cannot be reliably excluded.”

Poland et al on Influenza vaccine, Guillain–Barré syndrome, and chasing zero

It is also important to keep in mind that you are far more likely to get GBS after a natural flu infection than after the vaccine, plus the flu vaccine has many other benefits.

What about other vaccines?

“In this large retrospective study, we did not find evidence of an increased risk of GBS following vaccinations of any kind, including influenza vaccination.”

Baxter et al on Lack of association of Guillain-Barré syndrome with vaccinations

No other vaccines that are currently being used routinely have been associated with Guillain-Barré syndrome.

In fact, many studies do not even find an association between GBS and the flu vaccine.

What to Know About Guillain-Barré Syndrome and Vaccines

Guillain-Barré Syndrome may be associated with the flu vaccine in adults in about 1 in a million cases, but does not occur with any other vaccines, and occurs far more commonly after a natural flu infection.

More on Guillain-Barré Syndrome and Vaccines