Moderna Study and unblinding

[red-beard]

As you all know, I was in the Moderna study. I volunteered last July. My appointment was September 2nd and I had my first jab. Second jab was September 30th.

I convinced 2 of my friends to join the study. The conversation generally went something like this:

"You're getting the experimental vaccine?

Yep

I don't know if I'd do that. Being a lab rat

Someone has to do this if we're going to have a vaccine.

Do they pay you?

Some

How much?

They say up to $2000

SIGN ME UP!"

So they joined and had appointments a little later than mine.

The study was to see how effective the vaccine could be. 30,000 volunteers. 20,000 receiving the vaccine and 10,000 receiving a placebo. Double blind study, so the researchers did not know who received the vaccine, nor the patients. In the end, Moderna was shown to be 94.5% effective. FDA approved it for emergency use in December and everyone is getting the shots.

Part of the "deal" was that if the vaccine was approved, we could request to be "unblinded". And if it turns out you had the placebo, you would be given the vaccine. And either way, you could continue in the study, since the second part is to study how long the anti-bodies last.

All three of us requested to be unblinded. Buddy #1 went to a different clinic and was unblinded last week. Vaccine. Myself and Buddy #2 went in on Monday to be unblinded, me at 8AM and him at 10AM.

A month back, I went ahead and had an antibody test and it came back negative. I read somewhere on the internet that the antibodies produced by the vaccine were different, so I blew off the test.

About 8:10AM, nurse walks in with her clipboard & computer. She pulls up my information.

Placebo. Placebo? PLACEBO!!!

I convinced 2 other guys to go in to the study. One of three of us was likely to get the placebo. And it was ME. Damn-it-all! Both of them had the real vaccine.

So going over the original "reactions" we had, I had no arm pain at all and only felt tired and some slight muscle/joint pain. And I only had a headache after second injection. The other two guys had significant injection site pain on the day of the first injection and for a day or so after. And for the second injection, both felt like Crap the second day with fever.

10:27AM on Monday, they gave me the first real injection. And yes, I had arm pain. Crap, picking stuff up with my left arm hurt on Monday night. Best description is it felt like one of my high school buddies had punched me in the arm, like high school buddies do. Feel fine now. I'm scheduled to have injection #2 on February 19th.

Just thought I'd share my little adventure...

[Steve Carlton]

Good story- thanks for sharing it. At least you didn't need the vaccine originally. In a way, it worked out best for you. If there had been a problem, you wouldn't have suffered it. And you got the vaccine after it was proven effective.

Could I borrow $300?

[dad911]

Thanks for sharing. It's a good thing you didn't need it yet......

Every time I think it can't hit closer to home, it does. This week, we found out my niece, her husband, and 10 mo baby tested positive. Last week it was my daughter's in-laws. Unrelated.

My father-in-law and I are getting first round of the Pfizer vax tomorrow. Even though my wife is his primary care giver, she isn't eligible for the shot. We got lucky, hit the website just as slots opened up. My Brother had a spot for monday, and about an hour after receiving the confirmation email, his appointment was cancelled.

[rusnak]

That is an abnormally high rate of effectiveness. What is the correlational R-value?

[red-beard]

I still did the right things and have always worn an N95 mask.

[RNajarian]

Well. . . at least the money you got was real.

[Evans, Marv]

I got my first shot today at 10:30 AM (Oh, the perks of being old!). My second is also sceduled for 2/19. The injection was almost unnoticeable, and no shoulder pain until maybe ten hours later at around 8 PM with a bit of tenderness under the injection site. I still will be wearing a mask and keeping my distance until this whole thing is over. I asked and they were unsure how long before the 95% level kicks in after the booster. I'm sure the internet has the answer. I take a statin and currently having another reaction to it so discontinued it yesterday. I've had reactions to three out the four statins I've taken over time. So I'm experiencing muscle aches in the upper body & arms, & the injection site just blends in.

[pmax]

Well, you didn't grow a tail, did you ?

[ckelly78z]

Shouldn't your friends also be getting another dose of the vaccine, I heard that it is effective for 6 months after the second shot, and should be winding up sometime in February ?

[red-beard]

Originally Posted by Evans, Marv

I got my first shot today at 10:30 AM (Oh, the perks of being old!). My second is also sceduled for 2/19. The injection was almost unnoticeable, and no shoulder pain until maybe ten hours later at around 8 PM with a bit of tenderness under the injection site. I still will be wearing a mask and keeping my distance until this whole thing is over. I asked and they were unsure how long before the 95% level kicks in after the booster. I'm sure the internet has the answer. I take a statin and currently having another reaction to it so discontinued it yesterday. I've had reactions to three out the four statins I've taken over time. So I'm experiencing muscle aches in the upper body & arms, & the injection site just blends in.

With the 3 week schedule, it sounds like you have the Pfizer vaccine. That is supposed to reach full effectiveness 1 week after the second injection.

The 95% effectiveness also counts those people who became infected between the shots and before full effectiveness. It produces 2-4 times the antibodies of a person who gets actual COVID-19.

[red-beard]

Originally Posted by ckelly78z

Shouldn't your friends also be getting another dose of the vaccine, I heard that it is effective for 6 months after the second shot, and should be winding up sometime in February ?

That is not correct. They are finding that the antibody levels are not dropping off fast. The people in Phase 1 (nearly a year ago), still have 90% of their Antibodies. That seems like 5 years before a booster might be needed.

I expect a yearly booster will be needed to go after the mutant strains. Moderna is already working on a booster to cover the SA and European strains.

[VillaRicaGA911]

Wife has had both rounds of the vaccine, Pfizer version by virtue of working at a large local hospital system here in Atlanta GA area. She is not overweight and no co-morbidity, over all good health in late 40 year old. Her experience is the same as what everyone here has posted with round one of the vaccine. Round 2 from my first hand observation, be ready to feel like crap with a low to mid grade fever for a day to possibly 2 days post second injection. On set of these symptoms seems to be about 6 to 8 hours post injection. Nearly everyone in her department reported the same response to the second round only variation was if you were down and out for 24 or 48 hours.

[cabmandone]

Originally Posted by VillaRicaGA911

Wife has had both rounds of the vaccine, Pfizer version by virtue of working at a large local hospital system here in Atlanta GA area. She is not overweight and no co-morbidity, over all good health in late 40 year old. Her experience is the same as what everyone here has posted with round one of the vaccine. Round 2 from my first hand observation, be ready to feel like crap with a low to mid grade fever for a day to possibly 2 days post second injection. On set of these symptoms seems to be about 6 to 8 hours post injection. Nearly everyone in her department reported the same response to the second round only variation was if you were down and out for 24 or 48 hours.

I have 4 people in my house who will be getting the second dose starting in the next week or so ages 18,21,49,49 (the two younger work in a hospital... wife too so I got mine) It'll be interesting to see if there are differences in how each of us respond. Each of us had some level of soreness at the injection site after dose 1. The 21yr old and my wife both noticed fatigue after dose 1 where my son and I didn't have that issue.

[Sooner or later]

My brother in law had his second shot last week. Felt a little crappy. He said a 3/10. Niece got hers the same day. She felt really crappy. 12/10. Little sis gets her 2nd today. I get mine Monday. My older sis and her husband received their first and had no problems, not sure when they are scheduled for their 2nd.

All Moderna

[pmax]

Originally Posted by red-beard

That is not correct. They are finding that the antibody levels are not dropping off fast.

Who are "they" when the Moderna study is still ongoing ?

Moderna Announces Publication of Results from the Pivotal Phase 3 Trial of the Moderna COVID-19 Vaccine in The New England Journal of Medicine
December 31, 2020 at 9:22 AM EST

The Phase 3 COVE study is ongoing and will continue to follow participants for two years. Additional data to be collected will include longer term safety follow-up, duration of protection against COVID-19, and efficacy against asymptomatic SARS-CoV-2 infection. Moderna is also conducting a Phase 2/3 study of the Moderna COVID-19 vaccine in adolescents 12 to under 18 years of age. Additional studies are planned to evaluate the Moderna COVID-19 Vaccine in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.

[MMiller]

My experience with the Pfizer, 1st shot only side effect was a very sore arm, 2nd shot this week on Tue, sore arm along with about 24hrs of flu like symptoms (tired, aching body).

Feel great now.

[hcoles]

Got 1st shot of Moderna yesterday. Sore arm today. 2nd shot scheduled for 28 days later.

[Noah930]

Mrs. Noah got her 2nd Moderna shot this week. Achy arm, headache, low grade fever, fatigued, and generally crappy for about 36 hours. Back to normal last night. I get my 2nd dose next week, but had arm pain and mild headache for about 36 hours after the first one.

[red-beard]

Originally Posted by pmax

Who are "they" when the Moderna study is still ongoing ?

Moderna Announces Publication of Results from the Pivotal Phase 3 Trial of the Moderna COVID-19 Vaccine in The New England Journal of Medicine
December 31, 2020 at 9:22 AM EST

The Phase 3 COVE study is ongoing and will continue to follow participants for two years. Additional data to be collected will include longer term safety follow-up, duration of protection against COVID-19, and efficacy against asymptomatic SARS-CoV-2 infection. Moderna is also conducting a Phase 2/3 study of the Moderna COVID-19 vaccine in adolescents 12 to under 18 years of age. Additional studies are planned to evaluate the Moderna COVID-19 Vaccine in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.

You are only looking at the Phase 3 study, which started in July 2020. Moderna also "published" some preliminary information on the Phase 1 and Phase 2 subjects and their antibodies. The data was promising, with an anticipated loss of only 10% of antibodies per year. The sample is small, which is why it is preliminary information.

I am in the phase 3 and will continue to be monitored for 2 years to check antibody levels. Admittedly, I'm only entering this phase now, as I was Placebo for the main phase 3 efficacy study.