When the needle touched Steve McKay’s left arm on Jan. 7, the Frederick County councilman was fairly certain the injection he was receiving was not going to cause him great harm.
He also had no idea if it would spare him great harm if push came to shove.
As a matter of fact, McKay (R) had no idea exactly what was being injected into him by the tending physician at the medical office in Hyattsville that day. Neither did the physician. There was a wrapper around the syringe to conceal any hints about its identity.
The 57-year-old McKay was one of 30,000 people selected to participate in the U.S.-Mexico clinical trial for the coronavirus vaccine from Gaithersburg-based vaccine manufacturer Novavax.
After passing through a thorough screening process, McKay either received two doses of the vaccine or two doses of a placebo, spaced three weeks apart in January.
If he ever learns what he received and when, it will be after the double-blind trial — neither the participants nor the researchers know what is being injected — ends in two years. However, in April, he is scheduled to receive two more shots of whatever he didn’t get the first time. So, by then, he’ll have received the vaccine and the placebo. Only the order will be unknown.
“This is something I was actively seeking to do through the last few months of last year actually,” said McKay, a longtime Novavax shareholder who turned down an offer to receive a vaccine already approved by the federal government to participate in the trial.
“When the company received its Phase 1 data last year, it knocked the socks off of all other vaccine candidates in terms of immune response,” he said. “It was an order of magnitude, a higher antibody response.”
On March 12, based on the results of its clinical trial in Great Britain, Novavax announced that its vaccine was 96.4 percent effective in preventing symptomatic illness from the original strain of COVID-19 and 100 percent effective against severe illness.
The news did not gain a lot of traction in American media, which McKay called “a very frustrating fact.”
McKay is a government contractor in Northern Virginia. When they were gauging his risk of exposure during the screening process, they asked if he used mass transit or had been frequenting public spaces such as restaurants and bars. His answer to those questions was no.
But McKay has been working in the office throughout the pandemic, and his potential day-to-day interactions raised his level of risk enough to be included in the trial.
“I think it’s a noble thing that he is doing,” said Phil Dacey (R), who serves with McKay on the Frederick County Council. “He’s a relatively young man in good health. He’s probably an ideal candidate to take that kind of risk ... We need more people like him doing things like this.”
McKay is being compensated for his participation in the trial. If he stays in it for the full two years, he said he’ll receive about $1,700.
Many participants drop out of the trial for various reasons, he said. Some convince themselves they have received the placebo and feel their risk of exposure to the virus is too great to continue.
“A lot of people are agonizing over it,” McKay said. “It’s hard to stay in a double-blinded vaccine trial during a pandemic when you have other vaccines available to you.”
Upon getting his shots, McKay said he experienced some injection-site swelling and mild fatigue, which makes him believe he received the vaccine. But there is no way to know right now. He reports daily symptoms to the researchers through an app on his phone.
He said preliminary results of Novavax’s U.S.-Mexico clinical trial will likely be published sometime in April.
If everything stays on schedule, the company will likely apply for emergency use authorization for the vaccine with the Food and Drug Administration in mid- to late-April, and the vaccine could be going to the public roughly a month later, according to McKay.
With three approved COVID-19 vaccines already being administered in the U.S., he said the Novavax vaccine could make a far greater impact in the rest of the world.
In February, Canada announced it had signed a tentative agreement to produce millions of doses of the Novavax vaccine once it receives approval in that country.
Earlier this week, the British government announced that it had ordered 60 million doses of the vaccine.
“We knew from the early data the company had a pretty strong vaccine candidate,” McKay said. “...We’ll see what Novavax does in the U.S. It seems the U.S. has taken care of their supply issue. But Novavax has pledged a billion doses by the end of 2021 and two billion more by the end of 2022. That’s three billion doses for worldwide distribution of a vaccine that has so far been shown to be very effective. That’s going to make a considerable impact.”