Indiana man takes part in COVID-19 vaccine trial. Here’s what he has to do. – South Bend Tribune

Joe Weingarten has started each day recently the same way he will for the next two years.

The 76-year-old Fishers resident takes his temperature, then fills out an electronic questionnaire about his health, which he sends to the Indiana University School of Medicine.

The doctors there are interested in knowing if Weingarten is suffering any side effects from taking doses in a trial to develop a vaccine for the novel coronavirus. If his symptoms are severe, Weingarten has an emergency phone number to call.

My body temperature has been a little bit lower and I had a slight headache one day, but not much other than that, Weingarten, who serves as chairman of the Hamilton County Democratic Party, said. Nothing that sets off alarm bells.

Weingarten is participating in the trial by the global pharmaceutical company, AstraZeneca, and the University of Oxford, which is seeking 30,000 volunteers across the globe and has teamed with IU Health to run the trial in Indiana.

Weingarten doesnt know if hes getting the experimental vaccine, called AZD1222, or a salt water placebo, nor do any of the participants. In the double blind trial, two thirds of the participants get the vaccine and the other third, the control group, takes the placebo.

Brendan McEvoy, a spokesman for AstraZeneca, said the company is running the trial in more than 100 locations in the United States and the United Kingdom, Brazil, South Africa, Japan and India.

AstraZeneca is one of several companies that signed up with the federal governments Warp Speed program to find a COVID-19 vaccine. Another pharmaceutical company, Pfizer, announced Monday it had developed a vaccine that is 90% effective and could soon be ready for distribution. Pfizer is not part of Warp Speed.

Enrollment personal

Weingarten said part of his motivation to join the IU Health and AstraZeneca program was practical; he was toldas a participant he moves to the top of the line to receive the vaccine if the company successfully develops and distributes one.

But another reason was personal: his uncle, Martin, died in April at the age of 100 because of COVID-19 complications and a former brother-in-law, a doctor in New York, also died of COVID-19. His son is a doctor and he has a nephew who is a doctor.

Its was not difficult to volunteer, Weingarten said. If you can help society it is something you should do it. Im in pretty good health so I thought Why not?

The AstraZeneca trail was delayed for six weeks on Sept. 6 when a female participant in the United Kingdom had an adverse reaction related to a neurological disorder, according to the company and published reports. The trial resumed Oct. 23 and IU Health began recruiting volunteers, said IU Health research communications manager Anna Carrera.

Our goal is to enroll 1,500 volunteers from Indiana in eight weeks, she said. The participants are a racial and ethnic sample of the states population, she said.

Weingarten was among the first batch.

Weingarten had applied to participate when IU Health announced the program at the beginning of September and entered basic health information on their website.

Two weeks ago, Weingarten received an email asking him to go to the IU Health Simon Cancer Center for a four hour medical screening on Nov. 4.

In the interview, Weingarten was asked more detailed questions about his medical background and the risks and possible side effects were explained to him. He signed a consent firm and was handed a 40-page book of instructions.

Stay the course

Clinical trials are an essential step to develop vaccines and drug treatments and several are typically conducted around the work at any one times for a host of illness and diseases, said Zo McLaren, Associate Professor of Public Policy at the University of Maryland Baltimore County.

It is the way to determine if new drugs are effective and safe, she said. And there is plenty of illness around the world.

The side effects vary and plenty are discontinued before the clinical trial is completed because the experimental drugs werent safe, McLaren said. The COVID-19 trials are dependent on a certain number of the 30,000 participants contracting the disease so researchers can compare whether the people taking the vaccine fared better than those on the placebo.

For that reason, the researchers at IU Health told Weingarten to stick to his daily routine, except for the daily temperature checks and diary.

They said go about your daily activity, Weingarten said, they dont want a hermit.

Candidates for the AstraZeneca trial cant have any serious illness or be allergic to any component of the vaccine. They cant have been exposed to COVID-19 before or have immune system disorders.

They can drop out at any time or be expelled if they fail to follow protocols.

Weingarten was given a physical exam and rolled up the sleeve on his left arm for a shot of either the vaccine or the placebo. A nurse gave him an electronic thermometer to take home and he was assigned a number. He was paid $100.

Its a nice switch to get paid for gong to the doctor, he said. In a couple weeks, Weingarten will return for a booster shot and will need to get intermittent blood draws.

The morning diary takes less than five minutes. It has 14 basic questions any swelling in the arm, nausea, headaches, fever. If any are answered in the affirmative more questions are asked to determine if the level is something to worry about.

Closely monitored

Chills, fevers, headache, feeling tired, nausea and body aches have been the most common overall side effects for participants in the smaller early stages of the trial and have usually been mild or moderate, with a small number considered severe, according to information provided to IndyStar by AstraZeneka. Most symptoms showed within 48 hours after the shot and went away within seven days, the company said.

Weingarten said he felt fine the first few days but his temperature was running about 1 degree lower than the average of 98.6. He said if histemperature reaches 100.4 degrees he needs to call the hotline. He had a mild headache one day but the diary told him it and his temperature was nothing to worry about.

If Weingarten develops symptoms of COVID-19, he needs to submit to eight saliva samples to help determine if he has the disease, according to information provided to the participants. If he contracts COVID-19, hell have to wear an electronic monitoring device around his arm that measures breathing rate, heartbeat, temperature, blood oxygen level and general movement.

McEvoy said the company should have measurable results by the end of the year. The company signed a $1.2 billion contract with the U.S. Department Health and Human Services to develop 300 million doses of the vaccine. Three other companies also signed contacts with HHS to develop vaccines, while another seven companies are working on treatments and 17 are working on diagnostic tests, according to the HHS website.

Weingarten is a New York City native and U.S. Air Force veteran who has lived in Hamilton County for 14 years. He has run for office in Hamilton County three times and been the Hamilton County Democratic Party chairman since 2016.

He said he has never had a serious illness and never participated in a drug trial or even considered doing so.

When Weingartens 100 year-old uncle Martin Weingarten died in April in Carmel, no family was by his side because of the coronavirus restrictions. Martin was born during the Spanish flu in 1918 and escaped the Nazis in Austria a couple decades later.

That history made Joe Weingartens decision to participate easier if it could help end a historic pandemic, he said. He didnt need to consult with others, including his son, the doctor, and volunteered without hesitation.

In fact, I didnt even tell him until the other day, he said.

So far, no vaccines have been approved for production but the Pfizer experiment appears to be the furthest along.

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Indiana man takes part in COVID-19 vaccine trial. Here's what he has to do. - South Bend Tribune