October 7, 2020
I was invited to a ZOOM conference today with a panel of physicians to learn about this current research. Newswise was our host.
The goal was to update us and give those in attendance information and answer our questions.
They also informed us that the researchers are doing everything to make sure they put out safe and effective vaccines and medicines to treat people/prevent COVID-19.
Dr Susan R Bailey – President of the American Medical Association
Dr Dushyantha T Jayaweera – Infectious Disease specialist, Professor in Clinical Medicine at University of Miami Miller School of Medicine
Dr Laura Beauchamp – Infectious Disease specialist – University of Miami Miller School of Medicine
Dr Gary I Kleiner – Allergy and Immunology specialist – University of Miami Miller School of Medicine
How Many Vaccines Are in Development?
According to Dr Bailey, there are currently 6 COVID-19 vaccines in development in Phase 3 of clinical trials. 3 in the USA and 3 in other parts of the world. There are over 100 COVID vaccines in various other stages of development.
In the following video, she addresses this, and the panelists answer my other question about mutations and whether or not the vaccine(s) will be effective if the virus mutates and reinfects people:
Dr Jayaweera stated that the trial on their vaccine includes patients from all over the world. (That may be the case on all of them but there weren’t representatives from all of the companies developing vaccines for COVID.)
What is Being Done About Mutations of the Virus?
According to the panelists as seen in the above clip, while the virus may mutate, they are not seeing the mutations with Coronavirus/COVID-19 like we do with the flu. This means there is not a need for ongoing annual development of a brand new strain/vaccine each year like we need with the flu vaccines.
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How Long Does it Take to Find Out Safety and Effectiveness Information?
Normally with any new drug, it can take years – minimum 2 and sometimes up to 10.
As a general rule, the more people who use something, the more we will find out not only COMMON side effects, but rare ones will be reported or found, also.
This is the case, once again, with any drug or vaccine. More rare side effects come up the more people who use a vaccine or medication.
Regarding the Timeline of Knowing Information if Any of the Vaccines Work and Also Have an Acceptable Side-Effect Profile
We just started the Janssen study, so the way it is – the sample size is calculated is that we have to enrol roughly 60,000 patients across the world, which include South Africa, Brazil, India and United States and Europe and it’s placebo-controlled, it’s randomized, so we don’t know who gets what, and then we look for points and the side effects and compare the efficacy and safety. Now, if we start – and we are one of the first sites to start, so some people started about 2-3 days before us, so it will take at least 10-12 weeks across the world to get to 60,000. So, we are counting say October, November, December we will have finished enrolling the subjects. Now the question is – we have to follow them for a certain length of time, maybe from 3 to 6 months, the study actually we follow them for 2 years, but we don’t have to wait for 2 years, we believe that by following for 3 to 4 months we will see a separation between the placebo and the study vaccine. So, I think March – April (2021) we may have some information, it’s hard to say, but the other vaccines are ahead of us – for example Pfizer, Moderna – they started about 2 months before. So, if there is a definite signal then they may come out slightly before us, so it could be somewhere from January to April, I would say. The early information.Dr Dushyantha Jayaweera
They monitor them after injection, ongoing for 3 to 6 months, to see about safety and effectiveness of the vaccine vs placebo.
Placebo means they aren’t getting injected with the vaccine.
FYI, nobody knows who is getting the real vaccine and who is getting the placebo except whoever is labeling the bottles and keeping track of that in the records.
That’s the point of the trial and figuring out if the vaccine really works or not, and if the side effects are really related to the actual vaccine.
Many studies are done “blind” like this.
Blind means the participants and the researchers do not know if they’re getting/using the vaccine or the placebo. This is so there is not that bias of, “oh, I just got injected with sugar-water, so I’m still susceptible.”
Rest assured, SOMEONE is keeping track of who gets what. It’s just kept a secret to the study participants.
Johnson and Johnson (Janssen)’s Vaccine in Development is an Adenovirus-26 Vector Vaccine.
…The Janssen vaccine is adenovirus vector vaccine. So, there are multiple different platforms that vaccine manufacturers or researchers have developed for Covid-19 and this particular vaccine is using adenovirus 26, it’s a type of just a type of respiratory virus that we commonly see, but its genetically modified to have coronavirus part of the genome in it, so its genetically modified and what it does – and also, it’s a non-replicating virus. So, once you inject it, it gets into the cell and introduces this genetic material and then the immune system will recognise and produce antibodies. It is slightly different from some of the other vaccines, for example Moderna is a RNA vaccine and it has two injections, whereas Janssen is one injection and Janssen – one of the advantages of this vaccine is that their platform can have a rapid operationalisation and creating one billion vaccine doses over the next year. So that’s one of the advantages, provided the studies show that it works.Dr Dushyantha Jayaweera
Genome has to do with DNA or RNA.
Non-replicating virus means it can’t reproduce itself.
This vaccine would be introduced to the human body in order to produce antibodies. Antibodies are what the body makes to protect itself from the recurrence of the symptoms once you have a virus.
Other Types of COVID-19 Vaccines in Development
mRNA vaccines are being developed by Pfizer and Moderna. The side effects are so far unknown.
Regeneron’s Medicine in Development is a Prevention Medicine and in the Trial Phase.
They are taking 2 antibodies to bind to the S-protein of the virus to prevent replication. It is a biologic/monoclonal antibody medicine.
Developed for the protection of non-responders/those with higher risk/immune issues.
The hope is to decrease transmission and symptoms.
In addition, if there ARE mutations that may cause another outbreak, the hope also is that because there are 2 different antibodies in this vaccine, if one fails, the other will kick in. This was mentioned by Dr Kleiner in the previous video clip.
Barriers to Physician and Patient Acceptance
Dr Bailey stated that it is critical for the FDA to be completely transparent in these drug/vaccine trials. Otherwise, doctors will not have the confidence to order or administer the vaccine(s), which also leads to patient confidence in them.
Dr Jayaweera states that their follow-up is very close:
They vaccinate, then check antibodies on days 29 and 70, and again at 6 months, 12 months, and 18 months. And the patients have access to researchers’ phone numbers in case they need to get hold of them at any time.
There is a fair amount of distrust about the vaccine and that we are rushing through and that we will cut corners. So, I can reassure everybody that that is not the case, we will follow these patients very carefully for anything. Now, regarding the common question that I have gotten is – is this placebo-controlled? So, half the people will get the vaccine and half the people will get placebo, and so some people have asked me – why should I take part in the study because I may end up with a placebo, which is true – that’s the whole idea of doing the study – but on the other hand if you were to get COVID for some reason, and if you were in the study and you end up with placebo, very likely you will get better healthcare because if you’re on the study we give you a pulse oximeter, we give you a thermometer, we give – my cell phone number is there in the consent form, my team cell phone number is in the consent form and then we will come to your home and take care of you, I’ll bring you to the hospital if you do come down with Covid-19. So that way – even if you get a placebo, you still get better care. Regarding the suspicion about the vaccine, I think one has to feel comfortable that academic centers like the University of Miami or the other major universities are taking part in it, and the FDA has their own mandate, so, therefore, we will make sure that science will follow the approval and the patients will be monitored very carefully by people like us.Dr Dushyantha Jayaweera
What Do Antibody Levels Mean Regarding COVID?
Dr Bailey stated that they don’t know what antibody levels mean in terms of getting infected again.
Not only the antibodies, but our T-cells and other fighter-cells in our immune system (which are harder to measure) also protect us from getting the virus.
In this clip, the physicians discuss questions regarding antibody levels known to decrease after a couple months and what this means for how long the vaccines will be effective:
Other Related News
Newly-Discovered Adult Inflammatory Syndrome After Recovering from COVID-19
Remember those children in NYC who presented with an inflammatory syndrome after COVID exposure?
Dr Beauchamp, another panelist researcher, has been seeing this just in the past couple weeks in adult patients, presenting back to the hospital after recovering from COVID.
They recovered, but now are presenting with the Inflammatory syndrome, related to complications from their initial sickness with COVID. There are still a lot of unknowns and they need to study the patients more.
Inflammatory syndrome has so far presented as neurological symptoms…encephalopathy, can’t think well, headaches. They are currently treating patients with steroids.
The prevalence of this Inflammatory syndrome is so far unknown, but is occuring in any adult age, with the majority of patients being between ages 25-50 who have had COVID and recovered.
Clinicians are starting post-COVID clinics for those with the Inflammatory syndrome.
See this video clip for more information:
Stay safe and please share this article if it was helpful to you, so you can help us help others.
For more information on these and any other Clinical Trials, see clinicaltrials.gov.
Have more questions? Post them in the comments below and I’ll see what I can find out.
Many thanks to the physicians on the panel for taking the time to answer questions and provide insight, and to Newswise for hosting and inviting us to participate in the event.