Questions & Answers

How much of the development of the current front runner vaccines (Moderna, AstraZeneca & Pfizer are funded by public funding (e.g., NIH grants)?  Will the pricing eventually reflect this collaboration?  Or should we expect the initial dose to be discounted, then subsequent doses be inflated?

There are 5 COVID-19 vaccine development programs that have received substantial funding from the U.S. government as part of “Operation Warp Speed”.  These vaccine development programs include (in order of stage of clinical trials:  Moderna / NIH; AstraZeneca / Oxford; Pfizer /BioNTech; Johnson&Johnson; and Merck).  Most of these efforts reflect public/industry or industry/industry interactions.  There are also U.S./International collaborations reflected in this list.  As part of U.S. government funding, vaccine development programs typically must adhere to U.S. government policies on making the vaccines available to U.S. citizens as a priority, and at a cost that is different from that if the companies were to have funded their development without U.S. government aid.  For example, as part of the Pfizer/BioNTech funding agreement, the U.S. government secured 100 million doses (i.e. vaccine for 50 million Americans) at a cost of about $40 for the vaccination regimen (2 doses).  Whether the cost of vaccines will inflate after the pandemic “crisis” period is over remains to be determined.     

 Michael Yeaman, PhD, 8/1/2020
 

 

Can you clarify why recent blood donation would exclude a potential subject from participation in the vaccine trials?

The SARS-CoV-2 virus that causes COVID-19 disease is known to cause abnormalities in blood coagulation in some infected patients.  This effect, known as coagulopathy, can lead to blood clots and blockages to small blood vessels essential to delivering oxygen and nutrients to tissues.  For individuals donating or receiving blood products, some of the vaccines being tested require a waiting period (often up to 3 months) before they could receive the vaccine.  The reasoning is that individuals who have less blood volume (e.g. having donated blood) or have received other’s blood products (e.g. blood donation recipient) may have a slightly higher risk of adverse outcome.  A key aspect of all the vaccine trials is safety, so out of an abundance of caution individuals who have donated or received blood products are restricted from participating in some of the trials for at least some period of time, even if risks of adverse outcome from the vaccine are extremely remote.

 Michael Yeaman, PhD, 8/1/2020
 

 

There is information out there about the development of the vaccines and about the nano microchip.  Is there some truth to this, that it will be injected to individuals to change their DNA or genes of people?

Claims that COVID-19 vaccines will come with a “microchip” or “nanobot” or other clandestine injectable component to secretly track information or alter DNA have been strongly refuted as false and misinformation by essentially all credible scientific and news agencies.

 Michael Yeaman, PhD, 8/1/2020
 

 

I am 62 year old female who has smoked for 40 years.  Should I become part of the vaccine trials?

The basic eligibility requirements for inclusion in most of the COVID-19 clinical trials is greater than 18 years of age of any gender, race or ethnicity, and if a pre-existing condition that it be managed in a stable status.  For these reasons, it would seem you would certainly be eligible, so long as you do not already require oxygen supplementation or are being treated with steroids (e.g. for COPD).  Your 40-year smoking history may or may not present risk factors for COVID-19 infection or disease, or vaccine impact on these outcomes, but your participating may contribute to answering such questions.  Thank you very much for considering participating in these important clinical trials.

 Michael Yeaman, PhD, 8/1/2020

  

Does zinc play a role in minimizing disease course?

There are differing views of whether zinc can prevent COVID-19 infection or minimize the severity of disease in symptomatic individuals.  Supplements such as zinc and other metals have been studied in the past regarding the possibility that they prevent or reduce duration of common cold and flu-like illnesses.  In general, the use of such supplements has not to date been demonstrated to have efficacy in formal clinical trials.  There are currently some clinical trials in progress that involve zinc as part of a treatment regimen for COVID-19, but the data from these studies have not been made publically available as yet.  To search clinical trials involving zinc as a treatment for COVID-19, you may wish to visit the U.S. National Institutes of Health Clinical Trials registry resource (https://clinicaltrials.gov/).  When you reach the home page, there is a search box entitled “Find a Study”.  Here, you can specify the medical condition of interest (e.g. COVID-19) and then fill in the “Other Terms” box with “zinc” to see each clinical trial that is currently registered.  You can then click on any specific trial to learn more about the study design, sites participating in the study and additional information.

 Michael Yeaman, PhD, 8/1/2020

 


What are your thoughts on using a vaccine for select populations (such as health care workers) after it completes phase 2 trial while it also goes through a phase 3 trial?

Based on safety and immune response demonstrated in phase 1 and phase 2 studies, the phase 3 studies of COVID-19 vaccines just beginning in the U.S. will include special populations.  For example, study recruitment will focus on those individuals who are considered at increased risk of COVID-19 infection or disease based on location (e.g. transmission hot-spots such as Southern California or Florida) or circumstance (e.g. among individuals who are elderly, have pre-existing medical conditions, have jobs that put them at risk, or of diverse ethnicities correlating to higher risk of infection or severe disease).  Interestingly, healthcare worker populations at large medical centers tend to have very low rates of infection (likely due to extensive personal protective equipment and best precautions), whereas healthcare workers at long-term care facilities and nursing homes seem to be at higher risk.  Vaccine trials are designed to include each of these special populations to rigorously assess vaccine efficacy in individuals across a broad spectrum of the community.  Thank you for your question, and we hope you found the Lundquist Institute Community Science Series on COVID-19 to be helpful.   

 Michael Yeaman, PhD, 8/1/2020

 

Why is it that WHO cannot provide a consolidated list of the vaccines (across countries) as presented by Dr. Yeaman on a regular basis to all global citizens?

There are several credible internet-based resources that may help provide latest information about vaccines.  For example, the New York Times Coronavirus Vaccine Tracker (https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html) is one very thorough resource that is updated daily.  Another is the U.S. National Institutes of Health Clinical Trials registry resource (https://clinicaltrials.gov/).  When you reach the home page, there is a search box entitled “Find a Study”.  Here, you can specify the medical condition of interest (e.g. COVID-19) and then fill in the “Other Terms” box with vaccines or treatments to see each clinical trial that is currently registered.  You can then click on any specific trial to learn more about the study design, sites participating in the study and additional information. 

 Michael Yeaman, PhD, 8/1/2020

 

Why is it that the World Health Organization (WHO) could not get together a team of specialists to provide a daily global message as to where we are in the process?

The WHO updates data and releases situation reports on its webpage daily ( https://covid19.who.int and https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports).

 Joaquin Madrenas, MD, PhD, 7/31/2020

 

What are the health concerns from wearing the same face mask or surgical mask all day (e.g., buildup of bacterial or microbial contamination)?

Masks don’t filter pathogens as well when wet or soiled. So it is recommended that you use a fresh mask if your mask is moist or visibly soiled. It is unclear how long a non-soiled, non-wet mask can be safely worn, but many experts suggest you change to a new mask at least daily.

 Loren G. Miller, MD, MPH, 7/31/2020

 

What about the masks with the valves?  Do they protect other people or only the person wearing them?  We had a health care worker come to our home wearing a valve mask and we were very concerned about this.

Masks with valves are widely believed to be poor choices. The valves provide some protection for the wearer, but the nature of the valve allows droplets to be released from the person wearing the mask, thus defeating one of the main purposes of wearing the mask (protecting other from those wearing the mask). Some municipalities and private businesses (such as Disneyland) have already made such use illegal or banned persons from using these masks.

 Loren G. Miller, MD, MPH, 7/31/2020

 

Should you quarantine groceries? And mail?

It is possible that surfaces and mail could be contaminated with the coronavirus. However, even in the most optimal situations for the virus, the virus can live on surfaces no more than 48 hours, and typically a lot shorter. Even if you were to touch contaminated groceries or mail, by doing proper hand hygiene with soap and water or alcohol hand rub after you handle these object, you will be protecting yourself from the virus. So handle away, just do good hand hygiene afterwards.

 Loren G. Miller, MD, MPH, 7/31/2020

 

How do shared forced air/heater furnaces factor into droplet transmission? Are there preferred filters for furnaces?

Forced air may play a role in airborne transmission of COVID, although airborne transmission (small airborne particles that travel >6 feet) are felt to be a very rare or impossible route of transmission for COVID (this is a controversial topic). Because of the theoretical risk of airborne transmission, many suggest that air filter grade of MERV-13 should be used. (MERV stands for Minimum Efficiency Reporting Value and range from MERV-1 to MERV-20, with 20 being the most efficient, but also the most problematic to use since the fine filtration requires very frequent changing because of dust and particle collection).

Because most low risk settings like homes are very unlikely to be transmitting virus in an airborne fashion, I think worrying about a filtration system because of theoretical risk, while fine, distracts from demonstrated highly effective interventions such as frequent hand hygiene, social distancing, and mask use. To complicate matters, the availability of filters is currently (as of July 2020) very limited and they are hard to obtain.

So in summary, the likelihood that filtration systems in homes will make a difference is probably very small. One could make a stronger argument for businesses that have more people to lower this theoretical risk.

 Loren G. Miller, MD, MPH, 7/31/2020

 

How long do you have to wait to have a COVID test after exposure for it to be effective?

Current data suggest that PCR testing for COVID-19 may have the best sensitivity between 3 to 5 days after symptoms of COVID-19 start (which in most cases represent 5 to 7 days after exposure).  Before symptoms start or after 5 days of having symptoms, the probability of a false-negative result for a PCR test is higher.

 Joaquin Madrenas, MD, PhD, 7/31/2020

 

Is it known why young people are not as likely to get the coronavirus?

Young people probably get COVID as frequently as older people.  However, they are much more likely to develop and asymptomatic infection.  The reason for this is not fully understood.

 Scott Filler, MD, 7/31/2020

 

In a case where a 70-year-old woman who has tested positive for COVID-19, but has had no symptoms for over one week, how long would it take to show symptoms, if they were going to surface?

Most patients develop symptoms within 2 to 5 days after infection.  If there are no symptoms after 10 days of a positive PCR test, the likelihood of developing symptoms is very, very low and isolation can be discontinued.

 Joaquin Madrenas, MD, PhD, 7/31/2020

 

Can someone just carry the virus and come out negative on the test results?

Yes.  As for any other test in Medicine, there is a false-negative rate for PCR testing, for antigen testing and for serology.  The false-negative rate for PCR testing is still unclear, but some evidence suggests that may be on average close to 30%, oscillating from 21% to over 65% depending on factors such as the time in which the test is performed (e.g., too early after exposure or late while the disease is resolving).

 Joaquin Madrenas, MD, PhD, 7/31/2020

Like any test, the current tests for COVID-19 infection are not 100% sensitive.  Patients with early COVID-19 infection can have a negative test and may still develop symptomatic disease.

 Scott Filler, MD, 7/31/2020

 

Is the initial viral load, encountered at the time of exposure, predictive of disease severity and course?

There is some evidence to suggest that patients exposed to a low inoculum of COVID-19 are more likely to have mild disease as compared to those exposed to a high inoculum.  In fact, one of the benefits of wearing a mask is that it likely decreases the amount of virus to which a person may be exposed.

 Scott Filler, MD, 7/31/2020

 

I have heard that one can get infected through the eyes.  Is it as important to protect your eyes as it is your nose and mouth?

Yes, cases of people contracting COVID-19 infection through the eyes have been reported.  The CDC now recommends that eye protection should be worn by health care providers who interact with patients in areas with moderate to substantial community transmission.

 Scott Filler, MD, 7/31/2020

 

Is research being done on how long immunity lasts, either from having had COVID-19 or receiving a vaccine?

Yes, research is being done on finding out how long antibodies against the SARS-C0v2 virus last, as well as whether they are neutralizing or not.  Research is also examining the development of memory T cells in the presence and or absence of antibodies against the virus.  The emerging evidence suggests that immunity is developed, both in terms of antibodies and T cells, and that there is some degree of cross reactive immunity with other coronaviruses.  How long will immunity last is still unknown.  For other coronaviruses, immunity usually lasts between 1 to 1.5 years.

 Loren G. Miller, MD, MPH, 7/31/2020

 

Is it possible that something that appears as a second round of infection is merely the first with a slight remission?

Yes.

 Scott Filler, MD, 7/31/2020

 

Is there any role for the use of inhaled steroids in any phase of infection?

This is currently being studies in clinical trials.

 Scott Filler, MD, 7/31/2020

 

I take Ocrevus for MS and I’m wondering if it might help me by tamping down my immune response in the event I’m exposed to COVID.

This medication targets B cells expressing CD20 molecules on their surface.  How the medication works is uncertain but it is likely that it down-regulates the function of these cells.  B cells are the cell type responsible for the production of antibodies. Thus, the use of this medication down-regulates immunity and it has been linked to an increase risk for infections, including COVID-19.

 Joaquin Madrenas, MD, PhD, 7/31/2020

 

If we come down with this, what medicines help it heal?  Why hasn't there been more information on how to handle the disease when someone first gets it?

Currently, the best studied drugs for treating COVID infections are remdesivir and dexamethasone.  Unfortunately, remdesivir can only be given intravenously and so it is not practical to give it to patients who are at the initial stages of infection, before they become very sick.  Dexamethasone works best in patients with severe disease.  Scientists are working on new treatments that can potentially be given to patients as soon as they are diagnosed with COVID, but these treatments are still in development.

 Scott Filler, MD, 7/31/2020

 

Why were the mortality rates so high—roughly twice the reported mortality—in the remdesivir and dexamethasone studies you talked about?

The subjects enrolled  in these studies were predominantly older (mean age 58-67) and male (64%). Most had coexisting conditions (56-79%).

 Scott Filler, MD, 7/31/2020

 

Dr. Stella Immanuel has claimed to have successfully treated hundreds of COVID-19 patients using Hydroxychloroquine. What can be said about this possibility? Is this true?

Large, randomized controlled trials have clearly shown that hydroxycholoroquine is not effective for treating COVID-19.  Dr. Immanuel did not treat her patients as part of a clinical study and there was no control group of patients who did not receive the drug, which makes it impossible to draw any firm conclusions about her results.

 Scott Filler, MD, 7/31/2020

 

Has IVIg been tried/considered? And since steroids help and it's primarily a lung issue, are there trials of inhaled steroids?

Yes, trials of both intravenous immunoglobulin (IVIg) and inhaled steroids for the treatment of patients with COVID-19 are in progress.

 Scott Filler, MD, 7/31/2020

 

What about RPI 27 seaweed extract that stops the spike protein from entering the ACE-2 receptors? Maybe administered by nasal spray?

RPI-27 is a complex sulfated sugar that has been shown to bind to the S protein of SARS-Cov2 virus in-vitro, and therefore, it could prevent COVID-19 infection by stopping viral entry into cells.   However, there is no in-vivo data available yet.  Once active in animal models of COVID-19, it may be considered as a therapeutic candidate for humans.  The way of administration of the drug will depend on the physico-chemical properties of the compound.

 Joaquin Madrenas, MD, PhD, 7/31/2020

 

I saw a study was retracted regarding the potential harm of ACE inhibitors or ARBs in COVID. Do we know if these meds are potentially harmful?

Although there were some initial reports that patients on these drugs were more likely to develop severe COVID infections, more recent studies have suggested that these drugs do not worsen and may possibly improve outcome.

 Scott Filler, MD, 7/31/2020

 

If i have a blood disorder, where I have an over-producing platelet, does that mean I can't be part of the testing for a vaccine?

Vaccine studies typically have exclusion criteria that excludes persons with certain conditions from participating in the study. A condition like yours may not exclude you from studies, but each one is different and if you are interested in the study, I would let them know of your condition and they can tell you if you are eligible.

 Loren G. Miller, MD, MPH, 7/31/2020

 

Is it known to what degree a congenital heart defect would make someone high-risk for COVID-19 complications?

It is prudent to say that a person with a congenital heart disease might be at risk for severe COVID-19 but as of July 30, 2020, there is no firm evidence of the magnitude of the risk for severe COVID-19 in a person with congenital heart disease. 

 Joaquin Madrenas, MD, PhD, 7/31/2020

 

I'm here in New Zealand. Please comment on how New Zealand should proceed in opening borders.

New Zealand has been very effective in controlling the outbreak through a proactive confinement policy that includes an almost complete border closing.  It is prudent to continue that policy for the moment especially when considering that its neighbor country – Australia – is currently going through what seems to be a second wave of new cases.  Deconfinement and reopening borders will likely happen gradually and on the basis of COVID-19 control in the source country of the traveler.

 Joaquin Madrenas, MD, PhD, 7/31/2020