Pfizer/BioNTech to speed up vaccination of placebo arm in COVID-19 trial
- In the ongoing late-stage trial for the COVID-19 vaccine developed by Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX), the participants in the placebo arm will now have the option to receive the investigational vaccine by March 01, 2021, according to an announcement on a website about the study.
- All subjects in the placebo arm will have two doses of the vaccine reserved. In the coming weeks, the volunteers will be offered the option to go unblind (To know if they were in the vaccine or placebo group) on a priority basis and receive the vaccine, the statement added.
- Despite arguments against such a move by the FDA and its advisors, the Vaccine Transition Option arrives a few months ahead of the initial plan, according to STATNews, as the coronavirus pandemic rages across the U.S. with the total number of cases exceeding 20M.
- Meanwhile, citing the federal data, the Wall Street Journal reports that only 2.8M of 12M doses shipped by Pfizer/BioNTech and Moderna (NASDAQ:MRNA) have been administered, risking the smooth rollout of the next phase targeting the older adults and essential workers.
- Involving 44,000 participants, the Phase 2/3 study of the COVID-19 vaccine from Pfizer/BioNTech is currently in progress across 150 clinical trial sites in the U.S.
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Comments (32)
Okay, folks, here it is. I am a PFE/BNTX, COVID-19 Phase III Study participant. Did it because I thought it was the right thing to do, like being an Army Officer for a combination of 28 years Active Duty and Reserve Duty. Also, cause when you throw that much money against anything, the pharmaceutical industry is going to be successful, especially the big guys like Pfizer, JNJ, Eli Lilly, etc. So, that just meant having a 50-50 chance of getting vaccinated with the good stuff (the BNT162b2 vaccine) instead of the Saline Water placebo. Well, rolled the dice and it came up 7's and 11's.........Ventavia Research (VR) who is conducting the Pfizer COVID-19 Study here in Fort Worth, TX, has done a really good job of keeping the participants informed as to the conduct of the study and our participation. I had sent them an E-Mail in response to one of their alert notices about the ongoing conduct of the study (on or about 25 November 2020) stating that I wanted to be notified about what group I was in (actual vaccine vs placebo in my response of 18 December 2020) when that information was available to participants. True to their word, on 31 December 2020, at 1817 Hours (6:17pm for civilians) CST, I got a phone call from a VR nurse who told me that I had received the actual vaccine when I was vaccinated on first, 26 August 2020 and again on 14 September 2020. I told the nurse that I wished to continue in the Phase III Study (it is 26 months in length) and I have gone to 3 of the required 6 visits, the first two of which you receive the two vaccinations, and the last four are those where they draw 20cc's of your blood for analysis; for me visit #3 was on 14 October, 30 days after the 2nd vaccination. My next visit, #4 of 6, will be in April 2021, followed by Visit #5 in (I think) October 2021, and then Visit #6 in October 2022. Also, I continue reporting in weekly on an App installed on my cell phone regarding if I feel any of a list of eight symptoms are present in my body. So far, absolutely nothing.....and I officiate Youth, Middle School, and High School sports (Baseball, Basketball, Football, Soccer, and Softball) from 4-6 days each week and have been the last four years since my retirement from Lockheed Martin. So I am around non-masked transmitters virtually every day at very close range. That was another reason for doing this study and hoping that I was vaccinated with the good stuff....Anyway, there you have it, transparency from an actual participant. Glad to have done it and am continuing to do it.....and as a Texan, to look the virus in the eye and simply put it as the residents of Gonzales, Texas said in 1835, "Come and Take it".....Victory !!!!!.....Texas Hoosier
@robertlgriffin I am going to trust that your comment was real and not sarcastic in nature. I am no big deal. Just feel that simply reporting what is going on in the PFE/BNTX study from a participants point of view makes the process transparent to those who are curious or not part of the study. I don't have a iron in the fire on this, don't and have never held any stock in PFE or BNTX. To me, its not simply the vaccine or the placebo, its also who am I dealing with, how are they conducting themselves, and how responsive they are to questions about this study that mattered....and they have done what they said they were going to do in a timely fashion. That's how you gain trust in something....simply telling the truth....anyway, you are welcome !!! Texas Hoosier
@Kurt Licherovsky Fake news! You will most likely, as a matter of fact, 100% develop natural immunity, but studies have shown that immunity wanes over time. Vaccine-induced immunity is warranted. Active immunity = natural immunity + vaccine-induced immunity. I work in healthcare, see, treat, diagnose and care for Covid-19 patients. I have had COVID-19, as I expected. I developed IgG antibody (natural immunity) and received the Covid-19 vaccine on 12/24/2020 (vaccine-induced immunity). Don't propagate fake news.
@Virtue16way to overthink it!
Based on the STAT article, MRNA has plans to vaccinate the placebo group even sooner than BNTX/PFE proposal: www.statnews.com/..."But then, on Dec. 17, the FDA held another advisory meeting, this time for Moderna’s vaccine, which had been developed more closely with Operation Warp Speed. Again, Goodman made his presentation. A researcher representing Moderna made a case, as Pfizer had, that his idea was impractical, and laid out a plan for giving placebo-receiving volunteers the vaccine much faster than Pfizer would. They would not have to wait until they were eligible to get vaccinated outside the trial.The FDA’s advisers spent considerable time comparing Goodman’s plan to Moderna’s, eventually agreeing that Goodman’s was unworkable. But they spent little time comparing Pfizer’s plan, which delayed vaccine longer, to Moderna’s.That left Pfizer in a bind, as more and more volunteers publicly protested that they should be offered the vaccine if they received placebo." Not sure how much longer it will be ethical to withhold effective vaccines from the volunteers and the public. Hope it does not turn into a Tuskegee experiment. For those who are familiar, this "experiment" is considered a travesty in modern medical history.
@Novavax Op Warp Speed I love your optimism. Novavax will be less efficient than Moderna and Biontech. If it cannot beat AstraZeneca on efficiency then it will be liquidated by the market! I own Moderna, Biontech. AstraZeneca and Curevac but I would never ever touch the late comer and trial spoiler Novavax!!!
@Novavax Op Warp Speed It will be a bloodbath if NVAX does not hit 70% efficacy. Anything less than that and in two months from now, think about it. Widely available shots from Pfizer and Moderna will be well distributed and healthcare workers will be familiar with them. Who would want a loser vaccine then, with way less than 94% efficacy?