Vaccine volunteer on being a ‘guinea pig’
Reporter takes part in Moderna’s effort
I volunteered for Moderna’s COVID-19 trial. Here’s why I think I got the vaccine, reporter writes.
WOODLAND PARK, N.J. – When Pfizer announced last week that its COVID-19 vaccine was testing far better than expected, I had an odd reaction.
Of course, like everyone else, I saw it as good news. But it also felt a bit like the other team had scored.
That’s because I’m one of 30,000 volunteers in a clinical trial of a different vaccine developed by a competing company, Moderna.
My rooting interest aside, the Pfizer news last Monday was a counterweight to the grim statistics charting the virus’s unchecked spread across the country.
Those soaring infection rates, ironically, may bring us closer to ending the pandemic. The more infections there are among study participants, the quicker we’ll find out whether the vaccine works better than the placebo in preventing its recipients from getting sick.
On Thursday, there was more good news. Moderna, the Massachusetts biotech company in whose study I am enrolled — said that it, too, had passed the threshold for its first interim analysis of results and was preparing data for an independent review board.
Pfizer’s results appeared to prove that attacking the oft-depicted “spikes” on the surface of the coronavirus works. That’s especially fortunate, because other vaccine candidates being studied use the same strategy.
Even better, Pfizer’s method for provoking that immune response – by injecting a snippet of genetic material rather than live or killed virus – seems to work, too. That method hasn’t been
used in an approved vaccine and could help protect against future pandemiccausing viruses.
More important for me, however, it’s the same technique used by Moderna in the vaccine for which I’m a guinea pig. That makes me optimistic that “my” vaccine will have equally positive results.
Getting the second shot
I care more about this than I did a month ago. That’s because after the second of two shots, I feel fairly sure I didn’t get a placebo.
It’s a double-blind clinical trial, which means that none of the study leaders at Hackensack University Medical Center, where I enrolled in Moderna’s COVE study, know whether the syringe that was stuck into my arm contained a placebo or the real thing. And none of Moderna’s 30,000 trial participants, including me, have been told which group we’re in.
But here’s why I think I got the vaccine candidate: My body reacted.
After the first shot in September, I had no reaction, other than a pink welt the size of a mosquito bite on my arm and some stiffness around the site of the injection. I was sure it was the placebo.
A month later, the second shot went in painlessly enough. The nurse who prepared the syringe, with its long needle and barrel of swampy brown stuff, joked that I’d have to kill her to find out what it contained.
The COVE Study’s principal investigator at Hackensack Meridian Health, Dr. Bindu Balani, had asked clinical staff to warn volunteers that they might experience more soreness, perhaps a fever and headache after this injection.
It would be slight and transient, my nurse said, “not enough to interrupt your daily life.” I was to record my temperature and other symptoms daily on a phone app, just as I did after the first injection.
The next morning, my arm did feel stiff, and it didn’t want to bend and stretch. At my 8 a.m. appointment with a personal trainer, lifting an 8-pound weight above my head – normally no problem – was painful.
Afterward, I was so tired I had to take a nap. A slight fever, which subsided with ibuprofen, peaked around suppertime at 100.3. I went to bed early, after what had been a crummy day.
But that was it.
Two days after the shot, I felt completely normal.
Keep in mind, I am one anecdote in a study involving thousands of participants. But from what I’ve read and been told, my reaction was not uncommon.
Challenges after vaccine approval
If these two research vaccines are approved, the communication and logistics challenges are immense.
First, each requires two shots, Pfizer’s spaced three weeks apart and Moderna’s four weeks. You can’t mix and match – if you start with Pfizer, you must finish with Pfizer.
Second, the injections must be transported and stored at subzero temperatures. This will require special freezers or dry ice, a “cold chain” of transport that Operation Warp Speed, the federal vaccination project, is working on.
Finally, there is the question of acceptance. A vehement minority of Americans already express skepticism about the need for and safety of vaccines. In recent months, others have expressed concern that development and approval of the COVID-19 vaccine has been rushed and politicized. A Gallup poll in mid-September found that only 50% of Americans were willing to be immunized.
A survey of New Jersey doctors and nurses for the Health Department in mid-October found that two-thirds of doctors expressed willingness to get a vaccine against COVID-19, while fewer than half of nurses – 47% – would definitely or probably get vaccinated.
Add to that the possibility of pain. Will people return for a second injection if they know it could make them sick for a day? What if they have to take off work?
Safety results not complete
There is much more still to be learned about the short-term and long-term safety of the vaccines. Neither the Pfizer nor the Moderna safety results have been revealed. But they are further along than studies by Johnson & Johnson and AstraZeneca, the two other companies with vaccines in clinical trials in the United States.
Study participants must be followed for two months after the second injection to check for serious side effects or other adverse events before any of these companies can apply to the federal Food and Drug Administration for emergency use authorization for their vaccine.
So every week, like every participant, I get a call from a researcher to ask about any new health problems. Side effects like those I experienced don’t count as serious.
My weekly caller also asks if I’ve been in close contact with someone known to have COVID-19.
I haven’t.
But a late October cross-country trip to see my nonagenarian parents – two flights, two hotels, a rental car and many takeout meals together inside their home – may have put my precautions and potential immunity to the test. So far, I am symptom-free.
Full approval from the FDA – as opposed to an emergency use authorization – comes only after several years of follow-up to see if the inoculation of a large population produces more safety concerns. But production can start after the emergency authorization.
For Pfizer, that two-month follow-up period for most of its participants ends this week.
If no safety problems have developed – and the company’s press release said that so far, they had not – Pfizer can go ahead and apply for authorization to use the vaccine.
Ready to go
Factories are already geared up to produce millions of doses, thanks to Operation Warp Speed. If the timetable holds, the first priority group – health care workers – could start being vaccinated before the end of the year, state health officials say.
Approval of other vaccines could follow quickly.
Moderna, my vaccine maker, needs about a month more follow-up data to meet the FDA’s safety requirements for emergency use authorization. If the independent data safety and monitoring board to whom it submits the data finds that 60% or more of Moderna’s COVID-19 cases are in the placebo group, Moderna, too, could apply for such authorization, since that indicates the vaccine reduced COVID-19 cases in the group that actually received the vaccine rather than the placebo.
On the other hand, if its results show about the same number of cases in each group, the independent board could end the trial, Politico reported. And if the data is inconclusive, the study could continue until more COVID-19 cases accumulate – 106 cases to trigger the second interim analysis and 151 to complete the study.
But what these vaccines will not do is as important as what they might do. None of them is a silver bullet.
Even with 90% efficacy, as Pfizer announced, one in 10 vaccinated people exposed to the virus will still get sick. And it will be several months before any vaccine becomes widely available to the public.
We can’t throw our masks away yet. So many questions remain unanswered. Among them:
How long will immunity last – will we need annual shots?
Will one vaccine work better than another for some age groups or demographics?
Will different vaccines vary in the side effects they cause, or the groups that experience those side effects?
Will a vaccine decrease the severity of illness in those who do get COVID-19?
Will a vaccine prevent asymptomatic illness?
When will we know whether it is safe for children?
In an effort to build confidence in the research and approval process, the companies have released more information than usual about their study protocols. But these and other questions must be answered if people are going to have the information they need to make their vaccination decisions.
As for me, in a few days I’ll return to Hackensack to have more samples of my blood drawn. They’ll test it to detect whether there are various antibodies to COVID-19. I’ll never know the results, but I hope I have plenty.
I won’t be returning to the same location where I had the first shot, though.
The research office has moved from its original location in the hospital. With COVID-19 again on the rise, the space is needed to be ready to treat the growing number of victims of the virus.