Roll Up Your Sleeves, America!
Vaccines Are on the Way. Two Insiders Who Tried Them Tell Their Stories
The cavalry is coming! On Sunday, workers at a Pfizer plant in Portage, Mich. packed up the first of almost three million doses of the company’s new Covid-19 vaccine with dry ice and loaded the boxes onto waiting trucks. The destination: 145 facilities around the United States, where they will arrive, via FedEx and UPS, on Monday. Nearly 500 additional sites are slated to receive shipments on Tuesday and Wednesday. The Pfizer-BioNTech vaccine, approved on Friday by the FDA for emergency use, is reported to be 94% effective in preventing infection in adults over 65. Twenty million people are expected to get the first of two required doses by the end of December.
The vaccines can’t arrive soon enough. More than 16 million Americans have come down with the virus, with the death toll now over 300,000. Later this week, Moderna, a biotech company in Cambridge, Mass., is expected to win similar FDA approval of its own vaccine. Other companies, including AstraZeneca and Johnson & Johnson, are expected to follow suit, possibly by February or March. Leading immunologist Dr. Anthony Fauci, who will soon join the Biden Administration as a chief medical adviser to the President, told JAMA on Friday that he expects the availability of vaccines soon to rise above the 100 million dosages produced by Pfizer and Moderna. “We have a lot of companies that are in the mix,” said Fauci.
Millions of Americans are now scurrying to find sources for the new vaccines, but millions of others are worrying about the safety of the speedily developed drug. A substantial number of people are not ready to sign on yet. A new MATT: NPR/PBS Newshour/Marist College poll found that 61% of Americans say they'll choose to get the Covid-19 vaccine if it is made available to them, while 32% say they would not.
Fortunately for us, two Insiders. Dr. Fayth Yoshimura and Dr. Tony Shields, are among the limited number of people worldwide who have already been vaccinated, as part of having participated in two vaccine trials. They have agreed to give their fellow Insiders an exclusive preview of the vaccine experience. Fayth took the Pfizer vaccine in two doses on October 2 and three weeks later, on October 23; while her husband Tony took the Johnson & Johnson single-dose vaccine on November 3. (Amazingly, Tony’s brother, Lee Shields, a licensed mental health worker in Seattle, was also in a Moderna trial in August 21 and September 25. It is hard to imagine a more inoculated American family!)
It would be impossible to find more sophisticated scientific observers than Fayth and Tony. The couple, who have an adult son and daughter and live in the Detroit suburbs, have been married for nearly 40 years in what must be described as an awesome meeting of the minds. Both of them are top scientists with stunning backgrounds.
Fayth has a Ph.D. from Yale in molecular biophysics and biochemistry. Additionally, she had postdoctoral training at the University of California, San Francisco, and the M.I.T. Cancer Center, where she and Tony met. She was a professor of biochemistry, microbiology and immunology at the Wayne State University Medical School in Detroit for 20 years, until 2015, when she became a Professor Emerita.
If that weren’t enough brainpower for one household, Tony is an oncologist with an M.D. from Harvard and a Ph.D. in biology from M.I.T, where he studied viruses which cause cancer. He is currently a professor of oncology at Wayne State University, where he works on the development of new imaging methods and therapeutics. He is also a practicing medical oncologist at the Barbara Ann Karmanos Cancer Institute in Detroit, where he is Associate Center Director for Clinical Sciences. Since 1996, he has participated in more than 500 cancer research and drug trials as the principal investigator or participated as a co-investigator.
One trial that earned no mention in Tony’s 64-page CV: he was actually in a drug test in May and June to prevent Covid using hydroxychloroquine, the President’s favorite would-be coronavirus medication. Says Tony, “I figured if somebody was going to use it, you've got to do some good data, it was a low dose. I wasn't worried about it.”
Fayth and Tony have followed the politics of the vaccines closely. Says Fayth, ‘I was very leery when Trump kept saying, ‘Oh, we're going to have the vaccines; it's going to be an October surprise. And we're going to have the vaccine before the election.’ And I was very leery then that it was going to be rushed and not adequately vetted or anything like that. But then I felt better when the drug companies started to push back and said, ‘No, we're going to be very careful. We're going to do this right. It's not likely that it's going to be the end of October, beginning of November.’ They really started pushing back quite hard, and so I felt a little more confident.”
So the couple decided to seek out vaccine trials, where half of the participants would receive the actual vaccine and half would receive placebos. Why? For Tony, it was reflexive, based on his astonishing amount of experience with medical trials. Says Tony, ‘I put patients on trials every day. That’s one of my main goals and vocations. And I figured people need to be on these trials. But also, I wanted to get the vaccine. I figured there was a reasonable chance it would work, and that the toxicity was likely to be minimal. So I figured it was a good chance to do good things for science and actually get an early shot at the vaccine.”
Fayth felt similarly, In addition, she notes, “I guess I was not so concerned about the toxicity of this because I've worked with nucleic acids my entire scientific career. I've probably already injected it into myself, ingested it, inhaled it and I've survived this long, so I didn't think that taking the Pfizer vaccine was going to be a terrible health issue.”
Moderna’s vaccine trial was the first one in the Detroit area. Fayth and Tony applied, but they never heard back. Then, the couple read about the Pfizer test in the Detroit Free Press. Says Fayth, “They were recruiting locally and were looking for people from minority groups, like Asians, Hispanics, African Americans and Native Americans. And so, I thought, "Oh, wow, I should give this a call." So, I called the number and they first said, "Well, we've closed the trial. We already have 30,000 white people who have volunteered." But then I said, "Well, I'm not white. I'm Asian." And they said, "Oh, yes, we're very interested." They signed me up immediately and wanted to give me the injection the next day! And I said, ‘Well, no, I want to read the patient consent form. I want to see what I'm signing up to get.’ I got the injection about a week and a half later.”
In the meantime, Tony had found another vaccine trial at Henry Ford Hospital in Detroit. “I applied there. They just had the Johnson & Johnson. Subsequently, Ford called me and sent me a notice asking, ‘Are you interested?’ And I said "Yes." Actually, I went into Ford the very first day they were giving it and I was, like, Patient No. Six to get that vaccine at Ford.” Fayth’s Pfizer vaccine, just as the Moderna vaccine, involved two shots, but Tony’s Johnson & Johnson vaccine involved just one. After filling out detailed consent forms, the couple were well on their way to inoculation.
On October 2nd., Fayth went to a local outpatient clinic in Farmington Hills, Mich., to receive the first shot. “When I went in, they went over what the side effects were going to be. And then I got the shot in my left arm, and then they gave me the nasopharyngeal swab, the one that practically goes up to your brain. They then drew 20 ml of blood. Fayth, ever the researcher, recalls “they didn't really tell me what they were testing for. I did ask them and I said, "Well, are you looking for antibodies, I assume? What about T-cells involved in immunity, cytokines, et cetera?" And the people at the local clinic said, "We don't know and we've contacted the people at Pfizer to get the information." And it's been several weeks now and I still have not heard back from them.” Little did the people at the clinic know that they were treating someone who was a virologist.
Fayth was told by the clinic personnel what side effects she might experience. “They said that it could be pain in the arm.” Additionally, she says, ‘they wanted to make sure that I wasn't going to have any kind of severe immune response. So, after the shot, like the flu shot, they want you to sit around for half an hour to make sure you're not going to go through some kind of anaphylactic shock. So I sat there for a half an hour afterwards,”
But the real Pfizer vaccine experience came after Fayth left the clinic. ‘Basically, what I experienced was a very sore arm. I couldn't even raise it. And I got back and muscle pains, fatigue, which lasted about 48 hours.” Clearly, she had received the real thing, she says. ‘The placebo was just saline, – 0.3 ml of saline, which is a very, very small quantity. It's about half the amount in a flu shot. And in fact, in the patient consent form they said, ‘The side effects we're describing, you're not likely to get them with the placebo, with the saline.’”
Initially, Tony’s experience at Henry Ford Hospital was a carbon copy of Fayth’s. “It took about two and a half hours all told. They went through basically the same things. You can get fever and chills and aches. They ask you a bunch of questions about your health and take your temperature and blood pressure. Then they drew about five tubes of blood. They did a swab for the virus. And then they gave me the shot.”
And then, after he left? “I had absolutely zero reaction to it,” says Tony. The reason, he believes, is that unlike his wife, he had received the placebo. “Most people who get these shots get some reaction if they get the vaccine. So, I’m pretty certain. There's still a small chance, though.” And how does he feel about going through the trial and getting the placebo? Tony is philosophical, to say the least. “Meh. That's the way those trials go.”
But hold your tears, Insiders. Because Tony is a front-line medical professional who treats some patients with Covid-19, he has already been offered and has accepted the opportunity from his hospital to receive the Pfizer vaccine—the real one—later this week. So at 3:30 pm on Saturday, look for Dr. Tony Shields, researcher par excellence, at the Walgreen’s at 6331 E. Jefferson Avenue in Detroit, rolling up his left sleeve.
As for Fayth? Been there, done that!