Could a Zika vaccine be too expensive?

One thing is for certain, where there is a pandemic, there is money to be made.

A French pharmaceutical company will do the final testing for a Zika vaccine developed last year by the U.S. Army at taxpayer expense, National Public Radio is reporting. If the testing goes well, the company will set the price for the U.S. market.

The question is: Will state governments be able to afford the French company’s asking price for a vaccine that U.S. Army helped bring to fruition?

Rebekah Gee, Louisiana’s secretary of health, told NPR that her state is in the middle of a financial crisis and is looking at cutting money allocated to fight the Zika virus carried mainly by the Aedes aegypti — the B-52 of mosquitos.

“God forbid we have a Zika outbreak,” she told NPR.

The virus can inflict devastating birth defects for fetuses, including microencephaly, in which babies are born with underdeveloped brains and small heads. More birth defects related to the virus are expected in 2017 in Florida and throughout the U.S.

The total number of Zika cases reported in Florida in 2016 was 1,384. The total number of Zika cases reported in Florida for 2017 so far is 18.

Mosquito spraying was stepped up last summer once Zika hit Florida. (Richard Graulich / The Palm Beach Post)

The Centers for Disease Control & Prevention suggest that because the full effects of the virus are unknown, all pregnant women infected with Zika should receive postnatal imaging and a comprehensive newborn physical exam and hearing screen until a vaccine can be marketed.

The U.S. Army plans to grant an exclusive license to Sanofi Pasteur, Inc. to manufacture and sell the vaccine after it testing. Gee said the French pharmaceutical giant could set a price that is too high for states like Louisianna.

NPR reports that Gee is just one among a growing number of public officials and activists expressing concern. They want Sanofi to agree in writing to show restraint when it sets the price for the vaccine.

Doctors without Borders and Knowledge Ecology International have asked the Army to delay granting Sanofi the exclusive license until the company agrees to reasonable price terms. Former Democratic Presidential candidate, U.S. Sen. Bernie Sanders and Louisiana Gov. John Bel Edwards have

Former Democratic Presidential candidateU.S. Sen. Bernie Sanders and Louisiana Gov. John Bel Edwards have also asked the Army to get such a guarantee.

“If the American public funds the life-saving intervention, we need price protections for states that have to foot the bill,” Gee says.

Louisianna is in such a tight financial bind, Gee says, lawmakers will have to choose between funding for K-12 education and the Zika vaccine.

Jamie Love, director of Knowledge Ecology International, a non-profit public interest group, said the inventors of the vaccine are all federal employees whose salaries are paid by the U.S. taxpayer. Furthermore, the U.S. Army did all the Phase I research and testing so there is no research and development cost to Sanofi.

Sanofi told NPR that it has incurred a substantial cost, dedicating 60 scientists full time to the Zika vaccine.

If plans remain, the Department of Health and Human Services will give Sanofi $43 million for a Phase II trial. This will determine the success rate of the vaccine and any side-effects. If the vaccine passes, then the agency will then give another $130 million to Sanofi for a Phase III trial.

To read all of the NPR story on the Health News Florida website, click here.

Breakthrough: new vaccines take aim at mosquito-borne illness


A vaccine to combat the Zika virus is now undergoing clinical testing.

And in Africa, people will actually start receiving the world’s first vaccine against malaria next year which the World Health Organization claims will save tens of thousands of lives.

To work, the vaccine needs to be given once a month for three months with a fourth dose 18 months later. The three countries involved in the trial are Ghana, Kenya and Malawi and involve more than 750,000 children between the ages of 5 and 17 months, according to the BBC.

“The world’s first malaria vaccine is a real achievement that has been 30 years in the making,” said Seth Berkley, the chief executive of Gavi, The Vaccine Alliance which is helping to fund the study.

“Malaria places a terrible burden on many of the world’s poorest countries, claiming thousands of lives and holding back economies.”

The Palm Beach Post on this blog reported earlier this month that the National Institute of Allergy and Infectious Diseases has announced that vaccination trials have begun using an experimental DNA serum.

The trial aims to enroll at least 2,490 healthy participants in areas of confirmed or potential active mosquito-transmitted Zika infection, including the continental United States and Puerto Rico, Brazil, Peru, Costa Rica, Panama, and Mexico.

“A safe and effective Zika vaccine is urgently needed to prevent the often-devastating birth defects that can result from Zika virus infection during pregnancy,” NIAID Director Anthony S. Fauci said on March 31.

“Evidence also is accumulating that Zika can cause a variety of health problems in adults as well. This trial marks a significant milestone in our efforts to develop countermeasures for a pandemic in progress.”

The Centers for Disease Control & Prevention released a report that 15 of infants were born with birth defects in pregnancies with a confirmed Zika virus infection in the first trimester. “These findings highlight why pregnant women should avoid Zika virus exposure,” the report stated.

The CDC suggest that because the full effects of the virus are unknown, all pregnant women infected with Zika should receive postnatal imaging and a comprehensive newborn physical exam and hearing screen.

CDC: Type 2 diabetes increasing with tweens, teens

Our fast-food nation is taking a toll on our children.

Type 2 diabetes was once considered a disease mostly confined to the adult population, but the CDC says it is now firmly established in the teen and tween populations in the United States.

The Centers for Disease Control & Prevention says in New England Journal of Medicine the increase in type 2 diabetes corresponds with the increase in childhood obesity, which has tripled since the 1970s.

Photo: Health Aiken, Creative Commons.

The study, funded by the CDC and the National Institutes of Health, found that type 2 diagnosed cases increased by 4.8 percent between from 2002 to 2012.

Type 1 diabetes is the most common form of the disease in youngsters where the pancreas produces no or too little insulin, a hormone that allows sugar to enter cells to produce energy.

Type 2 diabetes used to be known as adult-onset diabetes. It is characterized by high blood sugar and insulin resistance and is thought to be brought on a combination of lifestyle and genetic factors. Extra body fat makes it hard for cells to use insulin.

Those who have diabetes often have to take insulin shots to regulate their blood sugar. The disease also costs an average of $13,700 per year.

In 2012, The American Diabetes Association estimated the total costs of diagnosed diabetes was $245 — a 41 percent increase over a five-year period.

This figure represented a 41 percent increase over a five-year period.

To read more about the latest report, click here to read a Los Angeles Times report that delved into all the study’s findings.

Injecting insulin. Photo: Tess Watson, Creative Commons.

 

 

New report says 1 in 5 Americans have cancer-causing HPV

The human papillomavirus  – or HPV – is the most common sexually transmitted infection in the United States.  There are 150 distinct types, two of them are responsible – according to the Centers for Disease Control & Prevention – for 70 percent of cervical cancer

The CDC announced last week that nearly half of U.S. adults have caught HPV. That is nearly 80 million Americans and about 20 percent of them — or 1 in 5 — have the kind the causes cancer. Other types of HPV cause genital warts.

 

 

About 45 percent of Americans ages 18 to 59 had some form of genital human papillomavirus. The report released last Thursday is the most complete look at how common HPV is among adults.

More concerning, about 25 percent of men and 20 percent of women had certain strains that carry a higher risk of cancer.

Vaccinations against HPV first became available in 2006, aimed at protecting kids before they become sexually active.

Geraldine McQuillan, a senior infectious disease epidemiologist with the CDC and the lead author of the report, said researchers were surprised to see the number of adults who had high-risk genital HPV.

Previous data estimated that 15 percent of adult females had high-risk HPV.

“The next step is to increase awareness of the high prevalence of high-risk genital and oral HPV in our general US population so individuals will realize that this is a serious problem and they will get their children vaccinated in early adolescence before they become sexually active,” McQuillan told CNN.

Update: County Health official: Zika-related birth defects to increase

Sick of hearing about Zika already? Get used to it as more birth defects related to the virus are expected in 2017 in Florida and throughout the U.S.

This summer, there will be a full-court press by health officials against Zika.

“It’s not something to be taken lightly,” said Dr. Alina Alonso, head of the Palm Beach County Health Department, in an interview with The Palm Beach Post.

“The main emphasis again is going to be on pregnant women. The CDC expects to see a 20-fold higher proportion of Zika-affected birth defects compared to those that were seen in the 2013-14, before Zika came to the Americas.”

Before 2014, there were three cases of Zika-caused microcephaly for every 1,000 births. That number is now up to 60 cases per 1,000. “That’s a large increase,” Alonso said.

Dr. Alina Alonso, head of the Palm Beach County Health Department says pregnant women with Zika are being tracked.

Microcephaly is a rare neurological condition in which an infant’s head is significantly smaller than normal.

On Friday, the Centers for Disease Control & Prevention released a report that 15 of infants were born with birth defects in pregnancies with a confirmed Zika virus infection in the first trimester. “These findings highlight why pregnant women should avoid Zika virus exposure,” the report stated.

The CDC suggest that because the full effects of the virus is unknown, all pregnant women infected with Zika should receive postnatal imaging and a comprehensive newborn physical exam and hearing screen.

So as the summer comes barreling down the calendar, the focus of health officials will be on the mosquito-borne virus that causes severe birth defects. More than 2,000 cases have been recorded in Florida.

Alonso said she dispatched teams last summer that went door-to-door in neighborhoods about Zika. “We were very pro-active,” she said. “I expect to see more cases because the mosquito is already established here in our environment.”

The Aedes aegypti is the main culprit that carries Zika. It also can transmit dengue fever, chikungunya, Zika fever and yellow fever viruses.

The Health Department will work with doctors to continue a registry of pregnant women who are positive with Zika. “We will see if they have healthy babies or affected babies,” she said.

Alonso said the best prevention, of course, would be a vaccine, but until then citizens have to practice prevention whether it is draining standing water or using repellant. About 80 percent of people who contract the virus don’t exhibit any symptoms of fever, rash, body aches. But for those that do, Zika can have serious, even neurological, consequences.

Zika can be transmitted through sexual activity, so Alonso suggests the use of condoms or abstaining from sex for people who have traveled to infected areas in the Caribbean and South America.

And Alonso doesn’t shy away from the fact that Zika can cost the state plenty.

“Because it is affecting pregnant women, it is affecting our tourism. It is very important,” she said.

Last week Gov. Rick Scott held a news conference with Alonso to talk about efforts to combat Zika. With serious tourist dollars at stake, Scott can claim some initial victories.

He has called on the CDC for advice and assistance. A Zika hotline was created. Lab testing capacity was expanded. He has demanded more money from Washington. He used emergency power to release $61 million from the general fund for research, prevention and response. Mailers were sent out to residents in multiple languages.

Researchers are working furiously to find a vaccine.

The National Institute of Allergy and Infectious Diseases has announced that vaccination trials have begun using an experimental DNA serum.

The trial aims to enroll at least 2,490 healthy participants in areas of confirmed or potential active mosquito-transmitted Zika infection, including the continental United States and Puerto Rico, Brazil, Peru, Costa Rica, Panama, and Mexico.

“A safe and effective Zika vaccine is urgently needed to prevent the often-devastating birth defects that can result from Zika virus infection during pregnancy,” NIAID Director Anthony S. Fauci said on March 31.

“Evidence also is accumulating that Zika can cause a variety of health problems in adults as well. This trial marks a significant milestone in our efforts to develop countermeasures for a pandemic in progress.”

 

Gov. Rick Scott may be the mosquito’s worst enemy.

 

CDC: Sperm donated in South Florida may contain Zika

Zika not only can be transmitted through the bite of the Aedes mosquito, the birth-defect causing virus can be transmitted through sex, as well.

So the Centers for Disease Control & Prevention have issued a warning for men in Palm Beach County and two others not to donate sperm because of the risk of spreading the disease, according to a story by The Associated Press.

The guidance applies also to Broward and Miami-Dade, the later the only place in Florida where there’s proof the virus was spread by mosquitos. Most cases diagnosed in Florida have been of those who contracted the disease by traveling to infected zones in the Caribbean or South America.

“When semen is donated it can be stored frozen for periods of time. It does not necessarily inactivate Zika, so it could be stored in tissue banks, used subsequently and people should be made aware,” Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration, told CNN. 

He said women “might want to use these donations from other sources.”

The CDC advisory is mostly precautionary.  There have been no cases of pregnant women being infected by Zika through a sperm donation. The risk is considered low but the consequences are severe. Infection during pregnancy can lead to severe brain-related birth defects

“Now we understand more than we did months ago is that evidence of the Zika virus is present in semen for up to three months after a man is infected and people may not have accurately recalled potential exposure [to the virus] especially if in a local area,” said Dr. Matthew Kuehnert, who is part of the CDC Zika emergency response team and director of the CDC office of blood, organ and other tissue safety.

He was quoted in the story on the sperm alert for CNN.

The FDA, which regulates sperm donations, said the 12 donor banks in South Florida should consider the CDC’s new advice discouraging donations from men in the three South Florida counties an FDA spokeswoman said.

The last case of mosquito transmission of Zika in Florida was in December. But officials expect another outbreak this summer.  There were 221 people who contracted got Zika from mosquitoes in the continental U.S. last year, most in the Miami area. There were six cases in Texas.

Vaccination hesitation leads to measles case in Miami-Dade

With the confirmation of a measles case in an unvaccinated child in Miami-Dade, officials are in a wait-and-see mode to see if it is an isolated incident or if there is a pocket of people not vaccinated in South Florida.

This is how the outbreak started in California among the crowd who have mistakenly linked vaccinations to autism and other disorders. By not vaccinating their children, such parents compromise all of the population’s herd immunity.

Click here to learn about herd immunity and how it has kept us from major outbreaks for decades.

 

measles-virus-particle-1312
Is South Florida in line for a measles outbreak? The first case in an unvaccinated child confirmed in Miami-Dade.

 

“Measles is a very serious disease,” Florida Surgeon General Dr. Celeste Philip said as reported by WPLG-TV in Miami. “The best way to protect yourself and others against measles is to get vaccinated.”

Philip said the Miami-Dade case serves as a reminder for all residents to check their immunization records or contact their primary care provider’s office to make sure they are up to date on the measles vaccine, as well as all recommended vaccines.

The airborne disease is spread by breathing, coughing or sneezing. Health officials said a typical case of measles begins with a mild fever, cough, runny nose, red eyes and sore throat.

 

Syphilis sufferers now must face penicillin shortage

Drug giant Pfizer says it is experiencing “an unanticipated manufacturing delay” in producing the penicillin type used to treat the sexually transmitted disease Syphilis. Pfizer is the producer of the medication and the shortage comes just as the STD is making a comeback.

Pfizer wrote to consumers that it would be providing just one-third of the usual monthly demand until July, according to a story by National Public Radio.

Syphilis
The bacteria Syphilis, in a photo courtesy of the National Institutes of Health, is on the come back — and to make matters worse penicillin is currently in short supply by its manufacturer, Pfizer.

“Bicillin L-A” is the recommended treatment for people with syphilis and the only one available for pregnant women who are infected with or exposed to the STD. Syphilis is caused by a bacterium and like other bacteria, such as the one that causes strep throat, this type of penicillin is the cure.

The Centers for Disease Control and Prevention has asked that health care providers save the drug for people with syphilis, especially pregnant women. “And the real tragedy is that it is a treatable infection,” says Dr. Sarah Kidd, a medical epidemiologist with the CDC’s Division of STD Prevention.

 

Erin Fox, director of the Drug Information Service at University of Utah Health Care, says it’s hard to plan for drug shortages.

“Almost every hospital has a set plan for how they deal with drug shortages. The surprise that happens on a daily basis is ‘What product is going to be short?'” she says.

Pfizer says the crisis should be short-lived and the supply should be back to normal in July.

To read NPR’s full report click here.

Hepatitis C tops list of killer infectious diseases in U.S.

Two new reports from the U.S. Centers for Disease Control and Prevention say hepatitis C  is now the No. 1 infectious disease in the country.

The virus now infects an estimated 3.5 million Americans, and in 2014, it killed 19,659 – the highest number of people in the country to die from this liver-damaging disease, CNN reports.

The liver-damaging virus primarily is spread by injecting drug use. New drugs can cure most hepatitis C infections in 12 weeks, but half the infected people in the United States do not know they are living with the virus.

hepatitis-c-virus-restricted-exlarge-169
CDC: Baby-boomers at risk to develop Hepatitis-C from blood transfusions years ago.

“This is a very alarming trend,” Dr. John W. Ward, director of CDC’s Division of Viral Hepatitis, told CBS News.

Ward says many baby boomers were infected in the years after World War II when injection and blood transfusion technologies still carried the virus.

Baby boomers — those born from 1945 to 1965 — carry the greatest burden associated with the disease, as many have been unknowingly living with it for years. In 2013, over 50 percent of hepatitis C-related deaths occurred among people aged 55 to 64.