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August 23, 2021 - 1:12pm

In a major announcement today, the U.S. Food and Drug Administration is reporting the approval of the first COVID-19 vaccine – the vaccine known as the Pfizer-BioNTech COVID-19 Vaccine.

It now will be marketed as Comirnaty for the prevention of COVID-19 disease in individuals 16 years of age and older.

The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

In response to this news, Edward E. Walsh, M.D., head of Infectious Diseases at Rochester General Hospital, and Ann Falsey, M.D., professor of Infectious Diseases and co-director of the Vaccine and Treatment Evaluation Unit at URMC and RRH Infectious Disease Physician, took questions from media members via a Zoom call at noon.

Following is that question-and-answer session:

Q. How does this process work exactly to get to this decision made by the FDA? What does it take to get full approval?

A. Walsh: Essentially, it is to collect longer timeframe for safety data, as well as increased amount of data on efficacy. The EUA (Emergency Use Authorization) was approved essentially after 2 ½ months and this is with data that was submitted in June, so it includes data out to six months and it’s that kind of longer-term data that is required for full approval.

Q. Do you believe that this will change public confidence in people who are hesitant in getting the shot, and explain what Rochester Regional (Health) is really hoping that this could change for public perception … to show that vaccine really works now?

A. Walsh: I think for some people this may be important. It’s not clear at this point if it will come to pass that a significant number of people who are hesitant to get vaccinated will now do so. There have been surveys done … which suggest that there is a significant number of people who have been hesitant will step forward now that it has received full approval. But will have to wait and see if that actually happens.

The second aspect of this is that apparently this will make it a lot easier for organizations, including the healthcare organizations, to mandate vaccination as a requirement for working. Which is a very controversial and much debated in public spaces position. It apparently will allow that to move forward more easily.

Q. What do you see as the fallout to that (noting there is a small, vocal group of healthcare workers that said they won’t get the vaccine?

A. We’ve already seen that happen in certain institutions that have made it mandatory to be vaccinated, even during the period in which it was covered by the EUA. I imagine that there will be somewhat similar vocal outcry by some individuals and possibly groups. We’ll just have to see.

I can tell you that in the past, with influenza vaccine mandates this has been a struggle prior to potentially mandating flu vaccines in healthcare environments. Only about 75 percent of people would become vaccinated each year; once it was mandated, we now exceed 90 percent, often reaching 95 percent. So, it may allow us to move forward.

Q. (Could you address) the hesitancy of some folks, who say I’d like to see this get approved by the FDA, and now were at that point?

A. Falsey: “Basically the proof is in the pudding; We’ll have to wait and see what happens. I, took, have had numerous conversations with vaccine-hesitant people, and some raise very reasonable concerns that it’s a brand new vaccine (that) came along very rapidly and want to see more data and the FDA fully approved it. I, personally, might say I don’t think you’re assessing risk/benefit properly (but) those are reasonable concerns from reasonable people.

But, I do hope that this approval and this review of this safety data, will will give them the confidence to get what is a safe vaccine and get themselves protected.

Q. How does this approval help public confidence … for some of those people who were on the fence?

A. Falsey: I hope it will help a lot. There are some people who are anti-vaccine, and no matter what the FDA does they won’t trust it or believe it. But there is a group of people … who are just nervous and this is the reassurance that they will need. I hope it goes a long way.

Walsh; I would echo that hope that it does go a long way. I think people need to realize that these vaccines were scrutinized by a very large number of individuals and coming from different backgrounds to assess their safety. This discussions that take place are very long, they review an enormous amount of data. One thing that people should realize that following rollout vaccine in late November, essentially early December, the CDC (Centers for Disease Control) has been very meticulous in tracking side effects now for essentially nine months. And they have been able to uncover any of the concerns than anyone would have with these vaccines. So, … it’s including data that extends out nine months to the general public and for a year we are now seeing in our vaccine study here at RGH (Rochester General Hospital) with the Pfizer vaccine group … we’re seeing the now out at a year.

Q. Do you foresee that Moderna, Johnson & Johnson (approval) will be coming up soon?

A. Falsey: For a full licensure, you do need six months of safety data. Moderna had its EUA shortly after Pfizer, so I would think they would be next up to become fully approved … J&J will take a little bit longer.

Q. Is this a normal timeframe for vaccines to be approved or was this hastily done?

A. Falsey: It was sped up quite a bit, but no steps were not done. All the phases, all the safety were done, it’s just that it was a huge public health crises and everyone was working non-stop. Things were done rapidly,

Walsh: The preliminary scientific basis for this vaccine was developed over 10 years prior to the pandemic. That’s an enormous amount of work that normally is rolled into how long it takes to make a vaccine. That whole process was done prior to the pandemic even starting; it was a real head start here.

The process of going through Phase 1, Phase 2 and then Phase 3 trials was speeded up but iwas primarily in the Phase 1 period which normally would take from six months to perhaps even a year. Through a very safe mechanism, you can make those go faster; because of the pandemic, they had to. As far as the Phase 3 study goes, because of the pandemic, the decision was to monitor the effectiveness of this vaccine – and all of the vaccines -- in real time rather than to simply say, ‘Let’s just analyze this data at the end of the year.’ They said, ‘Let’s analyze this data week by week to see how long it would take to demonstrate efficacy.’ And when you demonstrate 95 percent efficacy against all infection and 100 percent against severe disease at 2 ½ months, you have data that says, ‘Let’s move this forward in the face of a pandemic killing .. over 500,000 people.

Q. As far as efficacy against the Delta variant, some studies show that Moderna has a stronger efficacy than the Pfizer. Is this just a timeframe thing that Pfizer is being approved before Moderna?

A. Falsey: “I’m not specifically aware of which study you are discussing. A lot of the global data that looks at real world effectiveness of these vaccines as we look through the different variants, they all look very effective against severe disease and death … The full approval process really has more to do with safety. So, Pfizer finished their study and applied for EUA, and had a little bit of a jump there, and that’s why they have six months of safety data first, and they received their full licensure. I am sure Moderna will be along quickly.

Walsh: … for six months we’ve seen the data, and the efficacy seems to be very similar. Real world data from various states in U.S., suggested that the Moderna vaccine was holding up a little bit better than the Pfizer vaccine, but not in terms of hospitalization, severe disease and mortality. It had to do with whether or not a minor or mild infection would occur. And these are relatively small studies …

One of the problems with collecting data in the real world as opposed to an actual study, where you’re monitoring every person, is that it really requires people to come forward with minor illnesses and mild illnesses, and it also requires states to report all their illnesses, for instance, hospitalizations, mortality, and that is not always done. So, it’s a little difficult at times. I think at this point, I’d argue that there’s probably not much difference between these two vaccines in terms of their benefit.

Q. Do you hear from their patients that this is something that they care about – about FDA approval?

A. Falsey: From a select few. The majority of patients either fall into the category of vaccine enthusiasts versus … those who just aren’t going to get it. But, there are a group of people that this a step that gives them confidence. They are worried that these are new vaccines and they want full approval and review by the FDA. There are people that this is meaningful.

Q. How instrumental was URMC and Rochester Regional was in the studies for Pfizer?

A. Walsh: This town – URMC (University of Rochester Medical Center) and RRH -- provided Rochester the opportunity to really participate in cutting edge of development of the Pfizer vaccine … and also work locally with the Johnson & Johnson vaccine as well as the Astrazeneca vaccine and the concept of mixing different vaccine strategies with different vaccines.

So, Rochester, the University and RRH have contributed an enormous amount of effort to push this forward. In a certain sense, I will say that among the infectious disease community, to a large extent, … it was essentially like getting drafted into the army. We had to stop doing all of the normal things that we do and focus on essentially one disease and one illness.

Q. What regulations did this vaccine exactly have to pass … to be fully approved by the FDA?

A. Walsh: I can’t give you every detail that is required … I’ve not sat through committees that go through this process. But, as I mentioned before, it requires full vetting from all of the data from study subjects – and there are 42,000 of them in Phase 3 study. If you looked at all the data from those as well as the data from the Phase 1 and Phase 2 studies, which were much smaller, I think specifically, looking at safety data. In addition, they do have access to all of the safety data that has been developed after the EUA rollout in December. That information is dependent upon individual reporting, whether it be physician or people in the community who have been vaccinated. Whereas the study subject data of 42,000 individuals, that data is very meticulously collected … very granular, very detailed and highly scrutinized.

Q. Why do you believe it wasn’t approved fully for those 12-15 (years old)?

A. Walsh: Again, this has to do with timing. The data for 16 and up, or 17-18 and up was part of that first phase of the Phase 3 studies were once that starts moving, they went into 12-16 groups, so that is somewhat behind so we don’t have the data yet … to be fully approved.

Q. What do you think this says for the future of mRNA technology?

A. Walsh: I think it opens up opportunities in many areas where we have been unsuccessful in developing vaccines. There are many diseases that we do not have effective vaccines, or have not event attempted to look into the possibility of vaccines -- especially for viruses, It also opens up the possibility of an effective strategy to improve our existing vaccines, such as influenza. In good years, we’re happy to see 50 percent effectiveness … If we could get very high degree of efficacy it could really do a lot of public health good. I think you can make the same argument for a lot of diseases for which we really haven’t pushed hard for vaccines.

This technology may be very effective. And those studies will be slowly starting … we’re obviously still mired down in the pandemic and the problems with that issue. Boost the doses, and the variants of coronavirus that may arise and have to be dealt with. At some point, this technology will be applied to other vaccines.


Update: 4 p.m. in response to comment below:

Under the Public Readiness and Emergency Preparedness Act, companies like Pfizer and Moderna have total immunity from liability if something unintentionally goes wrong with their vaccines. And, although the vaccines have been approved by the FDA, people can't sue that government agency as it has what is known as "sovereign immunity."

April 10, 2021 - 11:11am

img_2608.jpgFamily, friends and the bowling community are coming together to support Tanya Harmon, of Batavia, who has been undergoing rigorous treatments and procedures after being diagnosed with Stage III cervical cancer last November.

Harmon, a longtime employee of Angelica Textile Services Inc., has been placed on disability by her doctors while receiving chemotherapy and radiation.

The mother of two teenage sons said she is optimistic despite the fatigue she is feeling as a side effect of the treatments.

“I am very tired, but the doctors said things look good thus far,” she said by telephone on Friday.

Unfortunately, she wasn’t able to talk for more than a couple minutes. Her boyfriend, Dan Campbell, took over from there.

“Back in November, we noticed that she was having problems,” he said. “They found a polyp or cyst or something like that on her cervix. We then had scans done and found out that she has what they call Stage III c2 cervical cancer.”

Campbell, a tractor-trailer driver for Batavia-based Lily Transportation, said the cancer has migrated to the lymph nodes in her stomach and that a tumor has formed in the area of one of her kidneys, causing further complications.

He went on to share that doctors have had to insert tubes and stents to ensure proper drainage of her bladder.

Treatments in Batavia and Rochester

Harmon, 41, had initial radiation and chemo at the Lipson Cancer Institute in Batavia, affiliated with United Memorial Medical Center, and now she is going to Rochester General Hospital twice a week for both internal and external radiation, Campbell said.

“Right now, this is her first week of internal radiation,” Campbell said. “Doctors have placed ovoid implants on the right and left side of her cervix and she has a sleeve inserted that goes into her uterus to do the internal radiation – the center, the left and the right ovoid sections.”

He said radiation at Lipson and Rochester General will continue five days a week at least for another week and a half.

Campbell said Harmon’s primary physician said “she has a good chance of beating this, and we’re staying positive, believing that she will beat this.”

He mentioned that she has insurance but there still are the co-pays and things insurance doesn’t cover.

“Every time she goes to Rochester, there’s another bill. Every time she goes to Batavia, five days a week, there’s another bill. It’s stressful for her, I know that,” he said.

Family Is By Harmon’s Side

Harmon’s family has helped to reduce that stress, providing emotional support and transportation.

“Devin, who is 16, just got his license and he’s been taking her to any appointments in Batavia, and we’re making arrangements for the ones in Rochester,” Campbell said.

She also is being cared for by her son, Skylar, 19; sisters, Janette and Jessica, and mother, Sheila Meyer.

And now, the couple’s friends from the bowling community are helping by organizing a three-person, no-tap benefit tournament at Mancuso Bowling Center on April 24.

Campbell’s coworker, Geoff Harloff, and supervisor, Ed Doody, have set up the event for April 24 with the proceeds through entry fees, basket raffles and other fundraisers to go toward her medical expenses.

“We’ve been friends for about three years,” said Doody, the general manager for Lily Transportation. “I met Dan through Geoff and we started hanging out – having cookouts, going to the casino, things like that. When Dan and Tanya began dating, she joined us and the whole group would go out together.”

Shirts from the Bills Mafia

Doody said Harloff brought up the idea of a benefit bowling tournament, and asked him to assist.

“I said, ‘Sure, whatever you need,’ ” Doody said.

Since then, Doody has solicited businesses and friends through phone calls, letters and social media and has received about three dozen prizes for the basket raffle.

“The response has been great. I was able to make contact through Facebook with Del Reid, founder of the Bills Mafia, and he was generous enough to give me four shirts to put in a basket. We’ve got a lot of nice stuff,” he said.

Doody said it’s all about “just trying to be good friends.”

“We all have bad moments and bad things in our lives, but this is one of the worst. So, we’re just trying to be good friends and step up to help with the financial burden,” he said. “One-hundred percent of anything we make from this is going back to them, and we’re just trying to lighten the load a bit so the focus can be on where it needs to be – getting better.”

Those wishing to donate are asked to call or text Doody at (585) 813-7700.

Tourney Spots Are Filling Fast

Harloff reports that 36 teams already have registered to bowl in the handicap tournament, which features a $750 first prize, based on the maximum number of 48 teams.

The entry fee is $90 per team. Squad times are at 2 and 4 p.m. One out of six teams will cash.

To enter, contact Harloff at (585) 409-6507 or Mark Brown at (716) 474-7960.

December 6, 2020 - 1:58pm

ROCHESTER – A vascular surgeon at Rochester General Hospital has announced the hospital is one of 10 locations chosen nationwide to introduce a new option of treatment for patients who suffer from iliofemoral venous outflow obstruction, commonly known as venous obstruction.

In a Zoom conference Thursday, Dr. Ryan Lydon said he was the first in the Northeast to use the Medtronic Abre venous self-expanding stent system.

“As of the end of last week, I was the number-one implanter in the United States,” Dr. Lydon said. “One of the most exciting aspects of this is that after more than 10 years of research and development, the largest medical device company in the nation chose Rochester General Hospital to be one of their launch sites.”

This self-expanding stent (inset photo right) allows doctors to perform a treatment they’ve been unable to offer in the past. Dr. Lydon said this procedure is relatively new in the past five years.

Previously, he said doctors were limited in the number of patients they’ve been able to help, due to the lack of a product which offers the flexibility of this stent. This new stent will allow doctors to treat younger patients than they could in the past.

He explained the venous system drains blood from all parts of the body and returns it to the heart. When an obstruction occurs a patient can become increasingly disabled. Dr. Lydon explained all the veins in the leg drain into the area between the groin and the belly button.

A patient, often a younger person, can develop an obstruction in a vein or a compression can occur on the outside for various reasons. He said the self-expanding stent can help these patients return to a normal life. 

“We have been waiting for a product that will stand up to the stress of a younger, more active, individual,” the doctor said. 

Medtronic estimates 24 million people are affected by deep venous obstruction, with less than 1 percent of that population receiving treatment.

“Being chosen as one of the first 10 locations in the country with this newly approved FDA product provides us with a new option of treatment for patients with this disease,” Dr. Lydon said.

He said in the past a patient may have one leg three to four times larger than the other, yet doctors have been unable to come up with an answer to the cause.

“Now, in 2020, we have the ability to increase or dramatically improve their quality of life,” the doctor said. “Up until now, doctors didn’t feel comfortable putting a stent in a 30-year old.”

He said the data and clinical trials on the self-expanding stent to this point have been very encouraging. The biggest concern was for stent migration or stent fracture, and with this new product they have seen 0-percent migration and 0-percent fracture.

Dr. Lydon said he was not so excited for himself, but for Rochester General Hospital.

“Historically new products have only been released to university institutions and the fact they chose Rochester General Hospital shows the quality of care we are delivering,” Dr. Lydon said. “People are coming from farther and farther away to seek treatment at our facility. This shows the level of care being offered at Rochester Regional Health.”

Top photo: Dr. Ryan Lydon, left, and Medtronic representative Jason Fishkin.

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