Steve McKay vaccine trial

Frederick County Councilman Steve 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.

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.”

Follow Greg Swatek on Twitter: @greg_swatek

(23) comments

Tigerzord

I find these comments kinda funny - if you knew Steve at all, you would know that he is a down to earth, sensible, intelligent guy. He doesn't play politics - can he change his mind? Yes of course, any reasonable person can. I can understand Alzan why you might think he is playing tit for tat, because that is what FC Government has done in the past for so long, but the tides have changed. We have intelligent, reasonable, knowledgeable people in the County Council. THANK GOODNESS! Steve cannot be put in a box labeled one way or another - his political leanings are to be fiscally conservative Republican, but is also open to listening and seeing the other side. As for running again..... we'll see. [lol][lol]

KellyAlzan

Cool story.

Unfortunately we can’t be knowing everyone.

So we rely on what we see in local media.

One day staying “no”. Week later citing the opposite.

That’s what we see.

gabrielshorn2013

What you are expecting is absolute rigidity and zealotry, plumbum, and that is too bad. "My way or the highway" thinking. Have you never been convinced to change your mind? Are you that much of a zealot in your own life?

gabrielshorn2013

If you don't want a response Pb, this is not the place to be. Please look up the definition of trolling, it's your thing. If you don't like what I write, just ignore it and cruise on by.

Business Owner

He is just like all politicians -- thinking otherwise makes you look incredibly naive.

artandarchitecture

"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."

Does selling your body make you feel cheap? jk

This guy is so uncharacteristic of typical Republicans---except in Super-Majority Democrat Maryland. Everyone choosing to take these "vaccines" is a guinea pig. It's "against community standards" on mainstream social media to report on all the people dropping like flies due to these injections.

Per the CDC There Are Nearly Twice As Many Vaccine Related Deaths SO FAR in 2021 (1,755) Than All the Vaccine Deaths this Past Decade (994) By Joe Hoft, March 29, 2021

https://www.thegatewaypundit.com/2021/03/exclusive-per-cdc-data-nearly-twice-many-vaccine-related-deaths-far-2021-1755-vaccine-deaths-past-decade-994/

public-redux

From the article you linked to:. The data come from the VAERS database.

"“The Vaccine Adverse Event Reporting System (VAERS) database contains information on unverified reports of adverse events (illnesses, health problems and/or symptoms) following immunization with US-licensed vaccines. Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov.”

Unverified.

artandarchitecture

Publi-Redux what does "verified" mean to you? Mark Zukerberg's team of "fact-checkers" has approved it??

By the way, fun fact here: I was the Team Leader within the A.E.R.S. Dept of the FDA up until I left in 2015. Over the last year, I have been extremely vocal on Linked-In the only platform not censoring (simply because it was networking & resume-related) about the dangers of this vaccine, LOUDLY announcing to everybody I could possibly reach of each & every safety step that was being skipped. "Please don't take this. Don't say I didn't warn you, as someone who worked in the AERS office, & who still talks with people who (sigh) continue to work in there." This is all *public* info. People aren't willing to wade through the public MedWatch databases for the info though.

public-redux

What does verified mean?

Well let’s see. Person A gets a vaccine and dies in a car accident a few days later. Someone believes the accident was related was related to side effects of the vaccine and reports it to the VAERS database — because anybody can. Is that verified? You’re counting it.

public-redux

You were a gubbermint employee? I see.

phydeaux994

a & a, do you have a list of things you’re not afraid of?? I’m sure it’s pretty short so you wouldn’t have to waste so much time commenting on everything you fear.

artandarchitecture

You're welcome.¯\_(ツ)_/¯

artandarchitecture

Public-redux--

"Person A gets a vaccine and dies in a car accident a few days later. Someone believes the accident was related was related to side effects of the vaccine and reports it to the VAERS database"

*This*, actually, is the contrived bs that receives 24/7 media coverage worldwide, for lazy spectators who don't wish to question the incredibly contradictory, & incessantly changing, msm-blasted info.

"You were a gubbermint employee?"

No, I was not a 'federal' employee, but contractor who was hired to work for the NCI, & then the FDA (a total of 15+ years all together for HHS.)

P.S. You will no longer be allowed to copy the correct answers off my spelling quizzes.

gabrielshorn2013

@A&A Apr 2, 2021 10:07am

I am also very familiar with the VAERS database, as well as the reporting to it.

From the FDA VAERS Database home page (https://vaers.hhs.gov/data.html):

Disclaimer

VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.

The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.

Key considerations and limitations of VAERS data:

Vaccine providers are encouraged to report any clinically significant health problem following vaccination to VAERS, whether or not they believe the vaccine was the cause.

Reports may include incomplete, inaccurate, coincidental and unverified information.

The number of reports alone cannot be interpreted or used to reach conclusions about the existence, severity, frequency, or rates of problems associated with vaccines.

VAERS data is limited to vaccine adverse event reports received between 1990 and the most recent date for which data are available.

VAERS data do not represent all known safety information for a vaccine and should be interpreted in the context of other scientific information.

In short, you are doing exactly what the VAERS database was never meant to be used for.

KellyAlzan

Still angry with McKay for supporting the silly balloon bill. First he said he would not. Then, it’s obvious there was political squandering for his sudden change of mind.

stevemckay

Lol, at least you’re consistent! Personally, I think anyone who is either angry or happy about that relatively minor piece of legislation needs a reality check on what really matters.

Dwasserba

I’m intrigued by “political squandering”?? 🤔

Business Owner

If it is a "relatively minor piece of legislation" then why do we need it?

KellyAlzan

Right.

As I stated above, I don’t care about the bill itself.

I care about the dirty politics.

gabrielshorn2013

Dirty politics, Pb? Please explain. Politics is all about negotiation to find an agreeable outcome. How much time did Mr. McKay actually spend working on this bill? Not nearly as much time as Kai Hagen. All it took was agreement that it would be a good practice. With your mindset, nothing would ever get accomplished unless it fit exactly with your small-minded definition. Like I said, get over it and move on.

phydeaux994

Personally I really hate balloons flying over my house all the time.

KellyAlzan

Steve was correct when he publically states he would not support the bill.

Steve was correct when he explained why he would not support the bill.

But, when Steve is downplaying, is that he caved. Steve’s sudden support is this:

“I’ll support your balloon bill if you support my bill”, or, Vice versa.

It’s not the balloon bill itself that I am angry about, and pointing out (being its election season).

It’s the matter that Steve engaged in playing politics. The Who beauty to Steve, was that he was not a politician, and that’s why he had so much support.

But now, he’s a politician.

“Steve, If you support my balloon bill I will support your bill”

gabrielshorn2013

Get over it and move on Pb. It was the right thing to do. If you ever saw, or cared about the absolutely unnecessary damage balloons cause, you would think so too. Have all the balloons you want, just don't purposely let them go.

https://balloonsblow.org/

Welcome to the discussion.

Keep it clean. No vulgar, racist, sexist or sexually-oriented language.
Engage ideas. This forum is for the exchange of ideas, not personal attacks or ad hominem criticisms.
TURN OFF CAPS LOCK.
Be civil. Don't threaten. Don't lie. Don't bait. Don't degrade others.
No trolling. Stay on topic.
No spamming. This is not the place to sell miracle cures.
No deceptive names. Apparently misleading usernames are not allowed.
Say it once. No repetitive posts, please.
Help us. Use the 'Report' link for abusive posts.

Thank you for reading!

Already a member?

Login Now
Click Here!

Currently a News-Post subscriber?

Activate your membership at no additional charge.
Click Here!

Need more information?

Learn about the benefits of membership.
Click Here!

Ready to join?

Choose the membership plan that fits your needs.
Click Here!