COVID-19 Interest Group

                         Sept 13, 2020

                                     CIG Bulletin #20 Bits and Pieces

                                                     By Eva Gero and Tina Etcheverry

Disclaimer:  The opinions expressed were based on data derived from public sources.  However, these are our opinions and our attempt to assimilate multiple viewpoints.  We do not pretend to be experts in the infectious disease field but bring our expertise from our prior training in science, engineering and medical fields to these issues as interested viewers.

 #1 Vaccines Update – When Bad News is Good

The clinical trial by Pfizer–BioNTech, using the novel mRNA approach to a vaccine, has expanded their trial from 30,000 participants to 44,000. This expansion allows for a broader population of patients (youth under 16 and people with underlying chronic conditions like HIV and Hepatitis). The companies state they will reach their original target of 30,000 subjects next week and even with the expansion of the trial they will have data available by the end of October. 

The good news is they will provide a better understanding of safety across a broad spectrum of participants. 

AstraZeneca/Oxford, the clinical trial using a traditional Adenovirus type vaccine, had temporarily halted their trials to examine an adverse event. The woman developed symptoms consistent with transverse myelitis, an inflammatory condition of the spinal cord. This could be unrelated to the vaccine, but it is consistent with viruses or a person’s immune response to viral infection generating a known, but potentially serious, inflammatory event. An independent safety panel (Data Safety and Monitoring Board) evaluated the incident. The trail will resume this weekend, September 12th after they completed the safety review. 

The good news about this temporary pause in the clinical trial: "It is very reassuring that in this political era, with very significant political pressure on the pace of vaccine development, that the regular order here prevailed," Ruth Faden, M.P.H., Ph.D., founder of the Johns Hopkins Berman Institute of Bioethics, told ABC News. 

 

#2 Fewer Hospitalizations – Better Habits

A very good piece of news is that the increasing incidence (PCR positivity) rates are accompanied by markedly fewer hospitalizations, ICU admittance and mortalities in the US and also throughout Europe. It is believed that more efficient Covid protection habits: more widely accepted mask-wearing and social distancing, perhaps better hygiene are the reasons: by limiting the dose of the infectious virus at exposure, these good behaviors lead to milder disease manifestations in every age group. 

From The Washington Post (questions answered)

“We know that wearing a mask protects people from us. Does that protection work in reverse? Am I protected from others if I wear a mask?”

Several readers have written in some version of this question. We know from many studies that masks can significantly reduce the spread of coronavirus if the wearer is contagious, which is why the Centers for Disease Control and Prevention urged face coverings in early April. Until very recently, we've had little evidence to support the theory that a mask would also protect the wearer.

But a recent study gathered what we've learned during the pandemic both in real cases and lab experiments, and found that yes; our own masks do seem to protect us to some extent. At the least, it suggests that if we are exposed to the coronavirus while wearing a mask, our illness could be less severe or even asymptomatic because masks reduce the number of virus particles we breathe in. (from The Washington Post).

  

#3 Convalescent Plasma – More than a Campaign Topic

Convalescent plasma therapy involves using cell-free blood (the antibody containing plasma) from recovered COVID patients to boost the immune response of infected patients and help them recover faster. This approach is considered safe and has been used historically for more than 100 years across many diseases. 

The decision to issue the EUA for convalescent plasma is widely criticized by the scientific community referencing unsubstantiated clinical benefits. Under appropriately designed studies it may be helpful, but uncertainties exist around transfusion safety, timing of use in COVID progression, quality and lack of standardization of the plasma (low versus high neutralizing antibody titer), and correct patient population. Clinical trials are being designed to address these issues, but the cart has been placed before the horse. Using this as a campaign topic has hurt the clinical trial enrollment rate and ability to scientifically evaluate the benefits.

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