I just got the Moderna COVID booster shot as part of a trial. Here's how it went

I had a strange feeling last week.

As the Food and Drug Administration’s panel of independent medical experts considered whether to authorize a Moderna COVID vaccine booster shot for millions of Americans, I was monitoring any side effects from my own Moderna booster. 

That's because I've been part of the company’s clinical trial over the last 13 months, and received the booster early as a result.

More than 69 million people in the United States have been fully vaccinated with Moderna’s COVID vaccine, but before the government recommends boosters for many of them — a decision that could come as early as this week — volunteers in clinical trials have already been jabbed a third time.   

As a participant in Moderna’s clinical trial of the COVID vaccine, I’ve felt a small personal stake in the evolution of scientific knowledge and vaccine policy amid the COVID pandemic. It has made me appreciate the precise, careful work of researchers, not only at Hackensack University Medical Center’s study site, where I’m enrolled, but at dozens of sites around the country.

And it has made me painfully aware of how tiny the blood vessels in my arms are. Those quick-to-close, thin blue veins present a formidable challenge to the phlebotomists who take blood samples at every study visit.

When the FDA panel met this month, it weighed the results of 171 participants in an earlier phase of Moderna’s research who received boosters similar to those the company proposes to give a broader population. But data from my experience with the booster shot – its side effects and impact on my body’s production of disease-fighting antibodies and immune cells – is still being collected.

Combined with results from nearly 30,000 other volunteers, this larger study will inform the FDA’s eventual decision on whether to give full approval – as opposed to emergency use authorization – to the booster shots. The decision expected this week concerns authorization only for emergency use during the pandemic.

Why a booster?

Three vials of my blood were drawn the day I received the booster, to compare my current antibody levels, among other things, with those a month after the original two-dose series of the vaccine I received last year. The blood sample also was to be analyzed for evidence I might have unknowingly, and asymptomatically, been infected with COVID.

For good measure, a long thin swab was twirled around the upper end of my nasal cavity to see if I had a current COVID infection. None of this information is ever reported back to me individually, with one exception: If the COVID test is positive, I’m told, I’ll get a call. (I did not.)   

There are two reasons boosters are being considered. One is waning immunity against the virus that causes COVID. The second is concern about the effectiveness of the two-dose regimen against the delta variant, a highly contagious strain that became dominant after the vaccine was developed. 

Some fully vaccinated people have developed COVID infections, prompting the White House in August to say boosters would soon be authorized. 

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It’s been almost a year since I received my second COVID shot. Moderna found that breakthrough infections were more common among the study participants who, like me, received the vaccine early, compared with those who received it more recently. These later vaccine recipients were offered it after finding out their original doses were placebos.

Of the 19 severe breakthrough cases reported among about 30,000 people in my clinical trial during the surge in the delta variant, 13 were in the group who’d been vaccinated earlier and six among more recent recipients.

The researchers track the number of infections through weekly COVID questionnaires that we submit via a phone app, and through monthly check-in calls they make to each of us. Those who do develop COVID – I have not – have additional contact with the study team.  

Myocarditis and pericarditis

At my visit recently for the booster, I also was asked to come back four days later to give more blood for testing. 

This time it was to look for markers of myocarditis and pericarditis, inflammations of the heart and heart lining that have been identified as rare potential risks of the Pfizer and Moderna vaccines. The very few cases that have been observed have occurred mostly in young men, and usually after the second shot.

It’s not known whether the risk of myocarditis or pericarditis is increased after additional doses, such as a booster shot – that’s another question being studied. I was informed of this uncertainty in an updated consent form I signed.

The actual booster shot itself was almost anticlimactic, after the paperwork, the blood tests and a brief check of vital signs. The needle was sharp, the nurse a pro. I barely felt it.

Moderna’s booster uses half a dose – 50 micrograms, compared with the two 100-microgram shots of the original series.

“We believe we should vaccinate with the lowest amount of antigen needed to boost the immune response,” said Dr. Jacqueline Miller, Moderna’s head of therapeutics, who presented the results to the FDA panel. The lower dose is enough to “activate immune memory,” she said, and it means more vaccine for others worldwide.

But this may complicate matters at the vaccine megasites and pharmacies where the booster eventually will be dispensed.

Here’s why it gets tricky: The FDA previously authorized so-called “third doses” of Moderna and Pfizer vaccines for people with compromised immune systems or organ transplants. Their immune response to the first two shots was insufficient to protect them adequately from COVID, researchers found, so it was decided a third, full dose was necessary. Those third doses are 100-microgram doses.

But people who don’t meet those criteria – who are not immune-compromised – need only a 50-microgram dose to jog their immune system into a higher level of protection. They need to ask for, or make sure they receive, the smaller booster dose.    

What's next before boosters become available?

When the FDA advisory panel met, it heard from Israeli health officials about the results of a massive booster rollout in Israel during a recent surge in COVID infections caused by the delta variant. Even in a population in which a majority was fully vaccinated, COVID infections were rising exponentially.

But 12 days after each age group received its booster shots, starting with those 65 and older, the infection rates for that group turned around. “There is no question in my mind: The break of the curve was due to the booster dose,” Sharon Alroy-Preis, director of public health services for the Ministry of Health, told the panel. Israel’s vaccination campaign relied almost entirely upon Pfizer vaccines.

The FDA last month authorized COVID boosters made by Pfizer for certain groups. Pfizer and Moderna both use the technology of messenger RNA to provoke an immune response to the virus that causes COVID.

By a unanimous vote, the panel recommended that the FDA authorize Moderna’s booster for people 65 and older, as well as those 18 and older whose occupations or health conditions put them at high risk of COVID infection or complications.

Before you race off to the pharmacy or vaccination site to receive your Moderna booster, however, here’s what else has to happen:

• The FDA must act on the recommendation of its advisory panel and authorize Moderna’s booster for emergency use in certain groups.
• The Advisory Committee on Immunization Practices, a group of independent medical professionals advising the federal Centers for Disease Control and Prevention, must meet and decide on its recommendation about which groups should receive a Moderna booster.
• The CDC director must issue a recommendation as guidance to the states. For Pfizer, that recommendation was different from the one the advisory committee made.
• The New Jersey Department of Health must recommend administration of the boosters by vaccine providers in New Jersey.

All of that could be completed this week, with Moderna boosters available shortly thereafter. Once the booster is administered, it takes about 12 days for the improved immunity to kick in, according to the Israeli researchers. 

Now, about those side effects.

Moderna reported to the advisory panel that among participants in its early study group, side effects from the booster were no worse than from the second shot. Soreness at the injection site, fatigue, headache and other aches and pains were commonly reported. No one died.

Here’s my own experience, an anecdote of one: My arm was sore for a couple days. I was tired enough the day after the shot to take a one-hour nap. 

That's it. 

Lindy Washburn is a senior health care reporter for NorthJersey.com, where this column originally appeared. Follow her on Twitter: @lindywa