Tampa Hospital Offers 1st Coronavirus Antibody Treatment In FL

TAMPA, FL — Tampa General Hospital made history when it provided the first monoclonal antibody treatment in the state to a coronavirus-positive patient Wednesday.

The monoclonal antibody therapeutic bamlanivimab from Eli Lilly is a first-in-class treatment that will allow physicians to provide protection to coronavirus-positive patients with mild or moderate symptoms before they deteriorate further or require hospitalization.

"Monoclonal antibodies are truly a testament to the scientific breakthrough in technology that we have been able to advance all these years," said Dr. Seetha Lakshmi, an infectious disease physician with USF Health and Tampa General.

The Eli Lilly monoclonal antibodies (mAbs) were approved by the U.S. Food and Drug Administration last week under an Emergency Use Authorization for the treatment of mild to moderate symptoms from the coronavirus.

"As far as we know, it seems to benefit a niche group of people that are truly immunocompromised, highest at risk for complication, and really early on," said Lakshmi.

TGH received some of the first supplies in the country and has the option to request additional doses on a weekly basis to serve the community.

This single-dose infusion-based treatment will be provided on an outpatient basis and marks a dramatic shift in coronavirus care, said Dr. Kami Kim, director of the Division Infectious Diseases and International Medicine at USF Health Morsani College of Medicine.

“Effective delivery of this treatment can be logistically complicated,” said Kim. “Tampa General Hospital and USF Health were already actively conducting clinical trials on COVID-19 and had the team, location and infrastructure in place to identify and care for the patients who can benefit most from this treatment.”

The monoclonal antibody is a man-made protein that acts like a human antibody in the immune system. It works to block the “spike protein” in the virus before it can enter human cells and cause illness.

Introduction of a monoclonal antibody in a sick person essentially neutralizes the virus and stops it from worsening and spreading. The monoclonal antibody bamlanivimab is delivered through a single hour-long infusion treatment. After the procedure, patients are monitored for another hour to ensure there are no side effects and then return home to continue their recovery.

Because production is just ramping up, there is a limited supply of the monoclonal antibodies and it is unclear whether there will be enough medicine for all patients who qualify for this treatment.

To make sure it is getting to the people who need it most, physicians are only approving its use on high-risk patients. High-risk patients are people who are COVID-19 positive within 10 days of symptom onset and meet at least one of the following criteria:

• Age 65 or older
• Currently receiving immunosuppressive treatment
• Have diabetes
• Have chronic kidney disease
• Have a body mass index (BMI) of greater than 35

“Tampa General’s commitment to treating the community during this global pandemic is what allowed us early access to this first-in-class treatment,” said Dr. Abe Schwarzberg, chief of oncology and senior vice president of oncology and network development at TGH. “Having these monoclonal antibodies will allow our medical teams to provide fast, effective treatment to those patients at highest risk for falling critically ill or possibly dying of complications from COVID-19.”

Florida Gov. Ron DeSantis said Thursday that the state has received 3,000 doses of the treatment from the U.S. Department of Health and Human Services. All were sent directly to hospitals.

Additionally, Tampa General is among five sites identified in the state that can store Pfizer's new coronavirus vaccine, which requires refrigeration at ultra-low temperatures.

DeSantis said the vaccine could arrive in Florida within three to six weeks.

He said a total of 40 million doses of the Pfizer and Moderna vaccines should be available by the end of December.

"As soon as the FDA approves, they will then go out within the next 24 hours, and we expect our hospitals, hopefully, our hospitals will receive them in the next three to six weeks. It's all contingent on when the FDA approves," he said.

Lakshmi said the hospital has already decided who will get the first vaccines when they arrive.

"The health care workers on the front lines are going to be the priority No. 1, so that's phase one, and anybody who's at risk for contracting COVID-19 because of their job. So, all the essential workers on the front line will be phase one of the vaccine," Lakshmi said.

DeSantis said CVS and Walgreens may also receive doses shortly after hospitals. He said those are doses will go to residents of long-term care facilities.

Pfizer said Friday it has submitted an application to the Food and Drug Administration to authorize its coronavirus vaccine for emergency use, accelerated the process that could allow the first Americans to get a vaccine by the middle of December.

In a video message, Pfizer’s chief executive, Dr. Albert Bourla, called it a “historic day."

“It is with great pride and joy, and even a little relief, that I can say that our request for emergency use authorization for our Covid-19 vaccine is now in the FDA’s hands.”

Pfizer and its German partner, BioNTech, said the vaccine was safe and 95 percent effective, and that it also worked well in older people and in preventing severe coronavirus.

Another pharmaceutical company, Moderna, announced this week as well that its vaccine, which is similar to Pfizer's, is 94.5 percent effective and the company expects to apply for emergency authorization soon.

FDA staff will take about three weeks to review Pfizer’s vaccine before an outside panel of experts meets to review the application Dec. 10.