Read the full article on KETV 7
THE FIGHT AGAINST LYME DISEASE WITH TICK SEASON NOW UPON US IN THE NORTHEAST, ACCORDING TO THE CDC, NEARLY HALF A MILLION AMERICANS ARE DIAGNOSED WITH LYME DISEASE EVERY YEAR. THERE IS NO VACCINE TO DATE. HOWEVER, THERE’S A NEW EXPERIMENTAL VACCINE THAT’S PROVED TO BE 70% EFFECTIVE IN PEOPLE FIVE AND OLDER. THE CAVEAT TO ALL OF THIS IS THAT THE STUDY, IN TERMS OF IT, DID NOT MEET ITS PRIMARY ENDPOINT OR ITS MAIN GOAL STATISTICALLY. AND IT WAS REALLY ONLY WHEN THEY REANALYZED THE DATA THAT THEY FOUND IN A DIFFERENT WAY THAT THEY FOUND THE 70% EFFECTIVENESS. IT HAS NOT BEEN PEER REVIEWED. IT HAS NOT BEEN PUBLISHED. SO THE BIG QUESTION IS, WHEN THIS GOES IN FRONT OF THE FDA AND REGULATORY AGENCIES, WILL THEY SAY THIS IS ENOUGH IN ORDER TO APPROVE THIS VACCINE, OR WILL THEY REQUIRE MORE RESEARCH AND MORE DATA? OKAY. THIS IS DOCTOR TODD ELLERIN, AS YOU KNOW. GOOD TO SEE YOU. AND WE APPRECIATE YOU COMING IN FROM SOUTH SHORE HEALTH. HOW DOES THIS SHOT WORK? OKAY, SO BASICALLY IT’S A VACCINE, RIGHT? IT’S FOUR IT’S FOUR DOSES, BASICALLY THREE DOSES OVER THE FIRST YEAR. AND THEN IN THE NEXT YEAR YOU GET THE FOURTH. JUST YOU DON’T HAVE TO HAVE LYME DISEASE TO GET IT. THAT’S RIGHT. THIS IS PREVENTATIVE. SO YOU DEVELOP ANTIBODIES IN YOUR BODY. HERE’S THE INTERESTING PART. WHEN THE TICK BITES YOU, THE ANTIBODIES THAT ARE IN YOUR BODY, ACTUALLY THE TICK INGESTS IT AND IT GOES IN AND IT PREVENTS THE BACTERIA. THE TICK INGESTS THE ANTIBODIES. YES. AND IT GOES IN AND IT BLOCKS THE BACTERIA FROM ACTUALLY GETTING INTO YOUR BODY. THAT’S UNIQUE, THAT IS UNIQUE. AND IT’S A PFIZER SHOT. CORRECT? CORRECT. ALL RIGHT. SO IF THIS IS APPROVED, WHAT’S THE SCHEDULE. SO WE JUST HEARD HER SAY YES THIS IS APPROVED BY THE. THAT’S RIGHT. SO THREE DOSES OVER THE FIRST YEAR. AND THEN AND THEN THE KEY IS BEFORE THE SPRING BEFORE THE SUMMER YOU NEED TO GET THAT FOURTH DOSE. SO YOU HAVE KIND OF HIGHER LEVELS OF THAT ANTIBODY WHEN THE TICK IS BITING. SO ARE THERE ANY SIDE EFFECTS I’M GOING TO SAY PROBABLY RIGHT. I MEAN THERE’S ALWAYS SIDE EFFECTS. BUT WHAT THE PFIZER PRESS RELEASE SAID REMEMBER THIS HASN’T BEEN APPROVED YET. SO WE DON’T KNOW THE DETAILS. BUT THEY SAID THERE WERE NO SAFETY CONCERNS. IT WAS WELL TOLERATED. AND WHEN WE GO BACK TO THE VACCINE, THE LYME VACCINE THAT WAS BACK IN THE LATE 90S, THE BIGGEST SIDE EFFECT, THE SIDE EFFECT WAS INJECTION SITE REACTIONS, WHICH WE EXPECT WITH VACCINES. BUT AGAIN, WE DON’T KNOW THE DETAILS ON THIS. SO THIS IS NOT A TREATMENT FOR LYME DISEASE. CORRECT? THAT’S RIGHT. IT’S JUST PREVENTATIVE. SO WITH THIS VACCINE OFFER LIFETIME PROTECTION OR DO YOU HAVE TO GET IT AGAIN AND AGAIN AND AGAIN? I’M REALLY GLAD YOU ASKED. OH GOOD. I’M GLAD TOO. AND THE REASON IS THIS STUDY AGAIN, WAS BASICALLY FOR VACCINES OVER 18 MONTHS. BUT WE DON’T KNOW ABOUT AFTER THAT. MY GUESS IF YOU SAID, WHAT’S YOUR PREDICTION? I WOULD THINK THAT YOU WOULD NEED BOOSTERS IN THAT SPRINGTIME. I DON’T WANT TO SAY ANNUALLY, BUT YOU YOU MAY NEED HIGH LEVELS OF ANTIBODY, BUT THE ANSWER IS WE DON’T KNOW. AND THAT WILL BE UP TO THE COMPANY AND THE FDA. AND WE HAVE TO WAIT ON. LET’S WAIT AND LET’S CONTINUE TO TALK ABOUT IT BECAUSE IT IS VERY INTERESTING FOR SURE. THERE’S A LOT OF LYME DISEASE AND WE ARE IN THE EPICENTER. WE ARE. I WAS
Advertisement
Pfizer just announced a new Lyme disease vaccine — here’s what to know
You’ll need four doses over the course of a year.
Pfizer and French vaccine company Valneva last week released phase 3 clinical trial data for PF-0730740, a four-dose Lyme disease vaccine they developed together that is about 70% effective.Lyme disease impacts nearly half a million Americans each year, making this the most common vector-borne illness in the country. It is caused by Borrelia burgdorferi, a bacterium transmitted by deer ticks, which can live in tall grass. The disease is named after the town in which it was first discovered in the 1970s: Lyme, Connecticut. And though it is often associated with New England, cases have been reported in all 50 states, as well as in Europe and Asia.While an earlier Lyme disease vaccine for humans was released in the 90s, there is currently no vaccine available in the U.S. (more on this in a bit). Here’s what infectious disease doctors want you to know.Meet the experts: Amesh A. Adalja, MD, is a senior scholar at the Johns Hopkins Center for Health Security; Thomas Russo, MD, is a professor and chief of infectious diseases at the University at Buffalo in New York.What do we know about the new vaccine?PF-0730740 is given in four doses: The first two doses are given two months apart, the third dose is given between months five and nine, and the fourth and final dose is given a year later. In people who received all four shots, the vaccine was about 70% effective at preventing Lyme disease. The clinical trial included participants aged 5 and older across the U.S., Canada, and Europe.While no vaccine is 100% effective at preventing illness, an effectiveness of around 70% seems less than ideal.“It’s not optimal, obviously,” says Thomas Russo, MD, a professor and chief of Infectious Diseases at the University at Buffalo in New York. “But it’s certainly better than nothing for people who are in a high-risk area and are engaged in high-risk activities.” Some of these high-risk activities include hiking, gardening, golfing, camping, or other outdoor activities.It’s also unclear whether the vaccine would reduce the risk of Lyme disease complications, such as central nervous system issues or cardiac complications, Russo adds. “It may be that the 30 percent of people who still get Lyme disease have a much milder course of illness and fewer complications, but we don’t know yet,” he says.Still, Amesh A. Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, says that 70% is still “fairly high” and can provide “significant protection” to people who are vaccinated. (For what it’s worth, the seasonal flu vaccine is around 40 to 60% effective each year and usually worth getting.)Wait, what happened with the first Lyme vaccine?The first Lyme disease vaccine, Lymerix, was approved by the FDA in 1998. It reduced new infections in vaccinated adults by nearly 80%, but just three years later, the manufacturer pulled the vaccine from the market.“Lymerix’s manufacturer ceased marketing the vaccine after it had very poor uptake and was falsely associated with certain adverse reactions,” Adalja says.The vaccine also required three doses—given a month apart and then a year later—and was “tepidly recommended” by the Centers for Disease Control and Prevention (CDC), which made it less appealing to the general public, adds Russo.And if you’re wondering why it’s important to note that Pfizer’s new vaccine is a human Lyme disease vaccine, it’s because dogs have had access to their own version for years. But Russo points out that dog vaccines usually have less stringent requirements than those for humans and are regulated by the USDA rather than the FDA.Common signs and symptoms of Lyme diseaseLyme disease can cause a range of symptoms, and people may experience different signs depending on how long it’s been since they were infected, per the CDC. Some of the most common symptoms that can appear within the first 30 days since being bitten by an infected tick include:FeverChillsHeadacheFatigueMuscle and joint achesSwollen lymph nodesErythema migrans rash (aka bullseye rash)You may also have the following symptoms days to months after you’ve been infected if your Lyme disease isn’t treated, according to the CDC:Severe headaches and neck stiffnessRashes on other areas of the bodyFacial palsyArthritis with severe joint pain and swellingIntermittent pain in tendons, muscles, joints, and bonesHeart palpitations or an irregular heartbeat (called Lyme carditis)Episodes of dizziness or shortness of breathInflammation of the brain and spinal cordNerve painShooting pains, numbness, or tingling in the hands or feetHow does Lyme disease differ from post-treatment Lyme disease syndrome?“Lyme disease is an acute infectious disease that has distinct stages, signs, and symptoms,” Adalja says, adding that there is a specific diagnostic test for Lyme disease.But there’s also something called post-treatment Lyme disease syndrome (which some people refer to as “chronic Lyme”). “Post-treatment Lyme disease syndrome is an entity that is poorly understood, but seems to occur in a minority of individuals who have persistent symptoms, despite adequate antibiotic treatment,” Adalja says. “There is no diagnostic test or established treatment for it.”Does everyone need to get this new vaccine?Probably not, according to infectious disease doctors, unless you’re at risk geographically. “Lyme disease risk is geographic, so those individuals who live in Lyme-endemic areas would be where the vaccine would have benefit,” Adalja says.In the meantime, you can always rely on old-school ways to lower your risk of Lyme disease: wear insect repellent, cover skin with long-sleeved shirts, long pants, and tuck pants into your socks, and always make sure to check for ticks after being outside.If you suspect you may have been exposed to Lyme disease from a tick bite, reach out to a medical provider as soon as possible. Early detection and antibiotic treatment are key.
Pfizer and French vaccine company Valneva last week released phase 3 clinical trial data for PF-0730740, a four-dose Lyme disease vaccine they developed together that is about 70% effective.
Lyme disease impacts nearly half a million Americans each year, making this the most common vector-borne illness in the country. It is caused by Borrelia burgdorferi, a bacterium transmitted by deer ticks, which can live in tall grass. The disease is named after the town in which it was first discovered in the 1970s: Lyme, Connecticut. And though it is often associated with New England, cases have been reported in all 50 states, as well as in Europe and Asia.
Advertisement
While an earlier Lyme disease vaccine for humans was released in the 90s, there is currently no vaccine available in the U.S. (more on this in a bit). Here’s what infectious disease doctors want you to know.
Meet the experts: Amesh A. Adalja, MD, is a senior scholar at the Johns Hopkins Center for Health Security; Thomas Russo, MD, is a professor and chief of infectious diseases at the University at Buffalo in New York.
What do we know about the new vaccine?
PF-0730740 is given in four doses: The first two doses are given two months apart, the third dose is given between months five and nine, and the fourth and final dose is given a year later. In people who received all four shots, the vaccine was about 70% effective at preventing Lyme disease. The clinical trial included participants aged 5 and older across the U.S., Canada, and Europe.
While no vaccine is 100% effective at preventing illness, an effectiveness of around 70% seems less than ideal.
“It’s not optimal, obviously,” says Thomas Russo, MD, a professor and chief of Infectious Diseases at the University at Buffalo in New York. “But it’s certainly better than nothing for people who are in a high-risk area and are engaged in high-risk activities.” Some of these high-risk activities include hiking, gardening, golfing, camping, or other outdoor activities.
It’s also unclear whether the vaccine would reduce the risk of Lyme disease complications, such as central nervous system issues or cardiac complications, Russo adds. “It may be that the 30 percent of people who still get Lyme disease have a much milder course of illness and fewer complications, but we don’t know yet,” he says.
Still, Amesh A. Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, says that 70% is still “fairly high” and can provide “significant protection” to people who are vaccinated. (For what it’s worth, the seasonal flu vaccine is around 40 to 60% effective each year and usually worth getting.)
Wait, what happened with the first Lyme vaccine?
The first Lyme disease vaccine, Lymerix, was approved by the FDA in 1998. It reduced new infections in vaccinated adults by nearly 80%, but just three years later, the manufacturer pulled the vaccine from the market.
“Lymerix’s manufacturer ceased marketing the vaccine after it had very poor uptake and was falsely associated with certain adverse reactions,” Adalja says.
The vaccine also required three doses—given a month apart and then a year later—and was “tepidly recommended” by the Centers for Disease Control and Prevention (CDC), which made it less appealing to the general public, adds Russo.
And if you’re wondering why it’s important to note that Pfizer’s new vaccine is a human Lyme disease vaccine, it’s because dogs have had access to their own version for years. But Russo points out that dog vaccines usually have less stringent requirements than those for humans and are regulated by the USDA rather than the FDA.
Common signs and symptoms of Lyme disease
Lyme disease can cause a range of symptoms, and people may experience different signs depending on how long it’s been since they were infected, per the CDC. Some of the most common symptoms that can appear within the first 30 days since being bitten by an infected tick include:
- Fever
- Chills
- Headache
- Fatigue
- Muscle and joint aches
- Swollen lymph nodes
- Erythema migrans rash (aka bullseye rash)
You may also have the following symptoms days to months after you’ve been infected if your Lyme disease isn’t treated, according to the CDC:
- Severe headaches and neck stiffness
- Rashes on other areas of the body
- Facial palsy
- Arthritis with severe joint pain and swelling
- Intermittent pain in tendons, muscles, joints, and bones
- Heart palpitations or an irregular heartbeat (called Lyme carditis)
- Episodes of dizziness or shortness of breath
- Inflammation of the brain and spinal cord
- Nerve pain
- Shooting pains, numbness, or tingling in the hands or feet
How does Lyme disease differ from post-treatment Lyme disease syndrome?
“Lyme disease is an acute infectious disease that has distinct stages, signs, and symptoms,” Adalja says, adding that there is a specific diagnostic test for Lyme disease.
But there’s also something called post-treatment Lyme disease syndrome (which some people refer to as “chronic Lyme”). “Post-treatment Lyme disease syndrome is an entity that is poorly understood, but seems to occur in a minority of individuals who have persistent symptoms, despite adequate antibiotic treatment,” Adalja says. “There is no diagnostic test or established treatment for it.”
Does everyone need to get this new vaccine?
Probably not, according to infectious disease doctors, unless you’re at risk geographically. “Lyme disease risk is geographic, so those individuals who live in Lyme-endemic areas would be where the vaccine would have [the most] benefit,” Adalja says.
In the meantime, you can always rely on old-school ways to lower your risk of Lyme disease: wear insect repellent, cover skin with long-sleeved shirts, long pants, and tuck pants into your socks, and always make sure to check for ticks after being outside.
If you suspect you may have been exposed to Lyme disease from a tick bite, reach out to a medical provider as soon as possible. Early detection and antibiotic treatment are key.
