Tag: Canada

Where Is Measles on the Rise?

We have been hearing a lot about ongoing measles outbreaks in the United States this year.

Brooklyn. Rockland County. The Pacific Northwest.

Think 2018 was a big year for measles? It was the second highest number of cases since 1996.

How will 2019 shape up?

Consider that it isn’t even the end of January yet is only May and we have already had more cases, 74 92 273 900+, than we had any years since 1994.

Not surprisingly, this isn’t just happening in the United States.

Where Is Measles on the Rise?

In fact, if you understand that the endemic spread of measles was eliminated in the United States in 2000 and that outbreaks are started by folks with measles who travel in or out of the country, then it makes sense that more measles here likely means that there is more measles somewhere else.

Unfortunately, this year, that somewhere else seems to be just about everywhere.

Japan is off to the fastest start in 10 years, with 486 cases so far this year, surpassing 2009, when they ended up with over 700 cases.
Japan is off to the fastest start in 10 years, with 486 cases so far this year, surpassing 2009, when they ended up with over 700 cases.

Are you planning a trip to Europe anytime soon?

With so many measles cases in Europe, it shouldn’t be a surprise to anyone that there are so many deaths.

You should know that their measles outbreaks aren’t over. There are ongoing outbreaks in France, Lithuania, Poland, Romania, Bulgaria and Germany.

“Between 1 April 2018 and 31 March 2019, 30 EU/EEA Member States reported 11 383 cases of measles, 8 396 (74%) of which were laboratory-confirmed. None of the countries reported no cases. The highest number of cases were reported by Italy (2 107), France (2 028), Romania (1 390), Greece (870), United Kingdom (860), Poland (828), Germany (733) and Slovakia (714)…

Twenty-two deaths attributable to measles were reported to TESSy during the 12-month period in Romania (14), Italy (5), France (2) and Greece (1).”

Monthly measles and rubella monitoring report May 2019

Where else are we seeing measles?

  • at least 4,100 cases in Israel, 2 deaths, and a case of encephalitis since 2018, with the majority of cases in Jerusalem, Beit Shemesh, Safed, and Betar Illit
  • over 31,056 cases and 415 deaths in the Philippines (2019)
  • nearly 2,000 cases in Vietnam (2018) and cases are increasing in Hanoi and Ho Chi Minh City already in 2019
  • in Madagascar, as of 3 of April there were 122,840 registered cases, and 1,233 reported deaths
  • at least 517 confirmed cases in the UK (through the 3rd quarter of 2018)
  • India remains the country with the most cases, with over 65,600 cases in 2018
  • a large outbreak in Thailand, with at least 4,327 cases and 4 deaths
  • an ongoing outbreak in Malaysia with over 1,934 cases and 6 deaths (2018)
  • an outbreak in Myanmar with over 1,300 cases and one death
  • at least 79 cases in the Republic of Korea (2019)
  • Ukraine continues to see a lot of cases, over 24,000, and some deaths
  • over 2,200 cases in Russia
  • Australia – 102 cases (2019)
  • Canada – 45 cases (2019)
  • outbreaks in Yemen, Nigeria, Sudan, and DR Congo
Conflict zones plus vaccine hesitancy contribute to measles outbreaks in the Philippines.
Conflict zones plus vaccine hesitancy contribute to measles outbreaks in the Philippines.

And over 16,000 confirmed measles cases, including 86 deaths, were reported in 12 countries of the Region of the Americas in 2018: Antigua and Barbuda (1 case), Argentina (14 cases), Brazil (9,898 cases, including 13 deaths), Canada (29 cases), Chile (2 cases ), Colombia (171 cases), Ecuador (19 cases), Guatemala (1 case), Mexico (5 cases), Peru (38 cases), the United States of America (350 cases), and the Bolivarian Republic of Venezuela (5,643 cases, including 73 deaths).

So far this year, cases have been reported from Argentina, the Bahamas, Brazil, Canada, Chile, Colombia, Costa Rica, Mexico, the United States of America, and the Bolivarian Republic of Venezuela.

Does it seem like measles is on the rise everywhere?

That’s because it basically is.

Since 2017, there has been a measles resurgence in three regions of the world and measles elimination milestones have not been met.

And as you can see, in almost all of these places where we are seeing more measles, we are seeing more people dying of measles?

That’s why it is important to get vaccinated.

There is even a recommendation to get an early MMR if you will be traveling out of the United States. Get vaccinated. Don’t bring home measles and start an outbreak.

More on the Resurgance of Measles

Updated May 17, 2019

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

Measles Deaths in the 21st Century

Breaking News – there are reports of two new deaths in Italy, including a young patient who died of measles encephalitis in 2017 and a young adult with leukemia just last month. (see below)

Measles is a big killer.

According to the WHO, “In 2015, there were 134,200 measles deaths globally – about 367 deaths every day or 15 deaths every hour.”

But it wasn’t that long ago, in 1980, that measles was causing at least 2.6 million deaths a year. And just 17 years ago, in 2000, measles caused about 777,000 deaths worldwide.

Measles Deaths in the 21st Century

While some experts doubt if we will ever truly eradicate measles, like we have done for smallpox, a lot of progress is being made on reducing measles outbreaks and deaths thanks to routine and supplemental immunizations.

Tragically, measles still kills.

“For every 1,000 children who get measles, one or two will die from it.”

CDC – Complications of Measles

And it is not just in developing countries that don’t have access to vaccines or adequate levels of vitamin A or modern healthcare. It should also be obvious, when you look at the cases below, that you don’t have to wait for there to be a 1,000 people in an outbreak for there to be a death. It could be the first person in the outbreak or you might see three deaths between cases 3,000 to 4,000.

Dr. Bob Sears actually reassured parents that measles wasn't deadly in developed countries, neglecting to mention the dozens of people who have died in outbreaks in Europe - another well-nourished population with lower vaccination rates than the U.S.
Dr. Bob Sears actually reassured parents that measles wasn’t deadly in developed countries, neglecting to mention the dozens of people who have died in outbreaks in Europe – another well-nourished population with lower vaccination rates than the U.S.

During the 2010 and 2011 outbreaks in Europe, after all, with about 30,000 cases of measles each year, there were at least 28 deaths. It’s worse now…

The National Center for Communicable Disease Control and Control in Romania is now reporting 59 measles deaths.
The National Center for Communicable Disease Control and Control in Romania is now reporting 59 measles deaths.

In the last few years, there are reports of at least 118 deaths in the measles outbreaks across Europe, including:

  • the death of a 10-month-old unvaccinated child in Bulgaria (among just 163 cases)
  • four deaths in France – a 16-year-old unvaccinated girl from Nice, who died in Marseille, a 32-year-old unvaccinated women in Poitiers, a 26-year-old with immune system problems who was probably infected by an unvaccinated relative, and a 16-year-old in Bordeaux, an immunosuppressed girl who had received a heart transplant when she was 2 years old. Three of the deaths have occurred in 2018 and there have been just 2,567 reported cases since November 2017.
  • the death of a 37-year-old partially vaccinated women (the mother of 3 kids) in Essen, Germany (among about 866 cases)
  • four deaths in Greece, where there have been 2,830 cases – including an 11-month-old unvaccinated infant, a 35-year old partially vaccinated mother, an unvaccinated 17-year-old, and a vaccinated, but immunosuppressed 18-year-old.
  • at least twelve deaths in Italy (four in 2017 and six in 2018, among just 7,649 cases), including a 6-year-old boy with leukemia who reportedly caught measles from an unvaccinated sibling. The other deaths included an unvaccinated 9-year-old girl, a 16-month-old, a man with a compromised immune system, a 27-year-old woman, a 25-year-old woman, and a 10-month-old boy.
  • two deaths in Kosovo, including a baby who died in a hospital in Pristina.
  • the death of a 17-year-old girl who was not vaccinated in Portugal (among just 31 cases)
  • 59 deaths in Romania, almost all unvaccinated children without preexisting conditions, including a three week old baby (among 14,142 cases since January 2016)
  • at least 15 deaths in Serbia (among about 5,598 cases), including a 20-year-old unvaccinated man, a two year old boy and mother, an unvaccinated 4-year-old, and a previously healthy, unvaccinated 30 year old woman.
  • one death in Spain
  • the death of a vaccinated man who was being treated for leukemia in Switzerland (among just 69 cases)
  • 17 deaths in Ukraine – eleven children and six adults, including an unvaccinated toddler who died at a children’s hospital in Odessa and a 10-month old (among about 24,000 cases, mostly unvaccinated children). This includes five deaths in 2017 – three children and two adults, among about 4,782 cases.

Unfortunately, measles cases continue to rise in most of these countries and many others…

The latest deaths – a young patient who died of measles encephalitis in 2017 and a young adult with leukemia just last month.

Outside of the EU, cases of measles and deaths include:

  • 3,150 cases in Israel and 2 deaths in 2018
  • 4,168 in the Philippines and 13 deaths in 2018
  • 13,817 cases in the DR Congo with at least 178 deaths
  • 2,246 cases in Ethiopia
  • 1,891 cases in South Sudan with at least 16 deaths
  • 1,527 cases in Guinea with at least 2 deaths
  • 10 deaths of children in Bangladesh
  • 40 deaths of infants in Indonesia
  • 17,772 cases in Nigeria with at least 105 deaths
  • 20 deaths and dozens of hospitalizations in Pakistan
  • about 1,735 cases and 10 deaths in Brazil
  • at least 97 deaths in Venezuela, including 53 deaths among Warao and Yanomami indigenous people

And although there haven’t been any deaths, there are also outbreaks in:

  • Japan – 282 cases (2018)
  • UK – 2171 cases (unconfirmed)
  • Canada – 29 cases (2018)
  • Australia – 91 cases (2019)
  • Argentina, Colombia, Ecuador, Mexico, Peru

Are you planning a trip to Europe any time soon? How about Indonesia or DR Congo, for which the CDC has also issued travel health notices? Even if you aren’t, as these outbreaks rise, it increases the chances that another traveler will bring measles home and expose someone in your community, starting an outbreak.

And while we deal with folks who simply don’t want to vaccinate and protect their kids, no one should lose sight of the fact that “In 2015, there were 134,200 measles deaths globally – about 367 deaths every day or 15 deaths every hour.”

What To Know About Measles Deaths

Kids are still dying of measles and the big take away should be that it doesn’t take thousands of cases for there to be a death and it can happen to a healthy child in a developed country with modern healthcare.

Get Educated. Get Vaccinated. Stop the Outbreaks

More Information About Measles Deaths

Updated November 7, 2018

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