Pfizer Vaccine Trial Update

The Pfizer vaccine trial I’m a part of went up for review yesterday before a review panel of outside experts convened by the Federal Drug Administration. The panel recommended that the vaccine be approved. Odds are the F.D.A. will grant approval later this evening.

This comes at a very dark period in which we’re seeing an exponential increase in cases and deaths here in Los Angeles and the rest of the country. As more than one panelist noted yesterday, we’re looking at many hospitalizations, deaths and a strained hospital system in the days and weeks ahead. In short the virus is out of control. The vaccine will take many months to roll out and things aren’t returning to normal anytime soon.

Chart of side effects of the Pfizer vaccine from their presentation.

The good news is that the Pfizer vaccine is very safe and 95% effective. Before I decided to participate in the third stage of this trial I carefully went through the results of the first stage as well as the release forms that I had to sign. I’ve since closely followed the results of the third stage and can assure readers of this blog that it’s safe and that side effects are mild to moderate. I’ve heard similar good results from the other mRNA vaccine being developed by Moderna. Yes, there have been a handful of allergic reactions, but those incidents have been exceedingly rare. Your chances of getting Covid are much, much greater than any side effects from the vaccine. Most importantly, by getting the vaccine we express our love and solidarity with health care workers and respect for our elders, the two most vulnerable populations to this disease. Nobody should have to spend their last moments saying goodbye to their loved ones on an iPad especially the doctors and nurses who take care of us when we get sick.

Screen shot of TrialMax app.

My participation in the trial involved a checkup, two blood tests and two injections. This is a placebo controlled study so there’s a 50/50 chance of getting the vaccine or a saline injection. Each week I check in with an app to report if I’ve had any symptoms such as fever or sore throat. The study is projected to last for two years and I will, periodically, go in to have blood taken to monitor for antibodies. The study is blind do I won’t know the results of the antibody tests.

Both the FDA and Pfizer are considering what to do with the placebo group since it would be unethical to ask those in that group to stay un-vaccinated. Some in the F.D.A. suggested keeping the study blind and giving the vaccine to the placebo group and giving the placebo to the already vaccinated group. Pfizer balked at the cost and logistics of doing this and countered with simply vaccinating the placebo group and continuing the study to monitor for long term effectiveness of the vaccine. If this happens the study will no longer be blind and will lose some safety data, but will still yield results on long term effectiveness.

I’m going to guess that Pfizer will get their way. Pfizer proposed vaccinating the placebo group in the order that everyone else in a given state or municipality is vaccinated. This would start with health care workers, who make up around 20% of the third stage trial as well as nursing home residents. Judging from my lack of side effects, I think I’m in the placebo group and I’m more than happy to stay a part of the placebo group until my turn comes up for vaccination. I don’t think I should get special treatment and jump ahead of the line just because I’m in the clinical trial. Right now we need healthy nurses more than we need healthy bloggers (Is their anytime that equation is reversed? Probably not). Pfizer suggested that those of us in the study would jump to the head of the vaccination line within our respective age/need groups as the vaccine becomes available.

The silver lining to any crisis is that it forces us to do things once deemed not possible. A crisis, of course, can be exploited for good or bad. My hope is that one of the lessons we will take from this difficult period will be a sense that we all need to work together. The press tends to focus on anti-maskers and Covid deniers but I think, at least where I live, most people know that the reason we take precautions is for the sake of other people, particularly those who grow and deliver food as well as health care workers who take care of us when we get sick.

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8 Comments

  1. Thank you for your part in developing this remedy.

    I hope you and your wife will be able to stay well until this virus is an unpleasant if unforgettable memory.

    Meanwhile, I hope her recovery from surgery and the problems that occasioned it continue to progress smoothly.

  2. “I’ve since closely followed the results of the third stage and can assure readers of this blog that it’s safe and that side effects are mild to moderate.” I guess in today’s world, people complain of Trump’s complete incompetence and yet trust homesteaders as authorities on pharmacological best practices. My brother, who’s spent over 20 years at Pfizer should probably retire.

  3. https://www.globenewswire.com/news-release/2020/12/02/2138623/0/en/Epidemiologist-Dr-Joel-Moody-Joins-Revive-Therapeutics-as-Medical-and-Clinical-Advisor.html

    I’ve always been a fan of Paul Stamets, so really excited about this company’s role to come in epidemiology.

    “TORONTO, Dec. 02, 2020 (GLOBE NEWSWIRE) — Revive Therapeutics Ltd. (“Revive”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce the appointment of Dr. Joel Moody, MD, MPH, DTM&H, as a medical and clinical advisor to the Company to assist in the expansion of clinical studies in Canada and the clinical data analysis on the ongoing U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19.

    “We would like to welcome Dr. Moody as a medical and clinical advisor to our team and we look forward to his contributions in our ongoing FDA Phase 3 clinical study as well as expanding our COVID-19 studies in Canada,” said Michael Frank, CEO of Revive. “Dr. Moody’s experience in clinical epidemiology, data analysis and research are key to our FDA Phase 3 study as we gather clinical data from patients enrolled.”

    Dr. Moody stated: “I look forward to serving as a medical and clinical advisor to Revive for both their FDA Phase 3 study and their expansion initiatives in Canada for clinical studies in COVID-19.”

  4. Question- You may not know this, but how is the vaccine incubated? Most are incubated in egg yolks. I’m allergic to egg yolks that are not from free range or organically fed hens (I know drug developers give no thought to folks like me).I almost die from the last flu shot I got. My reaction was so bad, I actually stopped breathing.

    • mRNA vaccines are not incubated or fermented. The target proteins are generated within your own cells, directed by the very specific mRNA instruction set.

    • The Pfizer and Moderna are this type of mRNA vaccine. I don’t know about the others which will be rolling through trials shortly.

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