BREAKING NEWS: Primate study suggests mRNA vaccine effective in fending off SARS-CoV-2

The great hope in getting society "back to normal" in the face of the covid-19 pandemic is the development of herd immunity through vaccination.  A new publication reporting research conducted at the National Institutes of Health was released today in New England Journal of Medicine. The study assesses Moderna's mRNA vaccine, which is currently entering Phase III human trials.

Meanwhile, researchers studied viral replication in the upper and lower airways of a well-known port of entry for SARS-CoV-2: angiotensin-converting-enzyme 2 (ACE2) receptors.  Non-human primates (rhesus macaque) were used, given that species' similarity to humans with respect to immune response to this and other viruses. Typically, when infected with SARS-CoV-2, these animals develop lung disease resulting that resolves within 14 days.  

The non-human primates were randomized to receive 10 or 100 micrograms of a messenger RNA vaccine mRNA-1273 or a sham injection with no vaccine (fluid only).  The vaccine mRNA-1273 encodes parts of the surface spike protein of SARS-CoV-2 which cells then manufacture and the immune system recognizes by making antibodies and other immune cells and proteins. The vaccine was administered intramuscularly twice, four weeks apart.  Antibody and T-cell responses were assessed initially and then the airways were "challenged" with SARS-CoV-2 (i.e. high quantities of virus were placed) eight weeks later. The challenge consisted of 3 milliliters of virus, delivered endotracheally and 1 milliliter given intranasally.  Bronchoalveolar lavage (BAL, which removes fluid and cells from the lower airway tract) was then performed. Thee fluid was analyzed for viral replication and viral genomes.  Nasal swab specimens were also obtained for genetic analysis and quantifying.  Specimen were obtained on days 1, 2, 4 and 7 after the viral challenge.  Post-mortem lung tissue was also examined.

Did it work? Results suggest the answer is yes. The vaccine was found to induce antibody levels that exceeded those found in samples taken from forty-two humans who had recently recovered from SARS-CoV-2 infection. The vaccine induced antibody levels in the non-human primates that were 12 to 84 times higher than those found in the "convalescent-plasma serum" samples from the recovered humans. (Giving convalescent plasma to patients with covid-19 is a therapy that is currently used to treat some patients, though results from clinical trials have been mixed.) By the second day after the vaccine was giving to the primates, SARS-CoV-2 viral replication was not detectable in the fluid taken from the lower respiratory tract of the animals ("broncheoalveolar lavage" fluid in) seven of the eight animals in both the low and high dose vaccine groups.  Among the animals that received 100 micrograms of vaccine group, no detectable viral replication was found in the noses of the 8 animals two days after the challenge. Animals that did not receive the vaccine had measurable viral replication for far longer.  Pathologists then assessed tissues taken from the lungs of the animals. No pathological changes were found in the lungs of the vaccinated animals—but disease-like changes were seen in the control animals.

These results show promise for this candidate mRNA vaccine. The published data suggest that vaccination at the higher dose in particular was effective in offering protection to the upper and lower airways of non-human primates against SARS-CoV-2.  However, given other recent studies that have shown rapid decline in antibodies of infected humans by 30 to 90 days, the looming question is how long this vaccine offers protection.  Another unresolved question regards the potential development of vaccine-associated enhanced respiratory disease, a fatal complication seen during H1N1 vaccine development.  The final and most crucial question however is whether this non-human primate vaccine and infection model will translate to humans. 


Editorial Board Memorandum

Race as a social determinant of health takes center stage.

Over the past weekend, we have seen our country react to the on-camera killing of George Floyd. Since the time of the killing, the police officer who ended Floyd's life has been charged with murder and manslaughter. It is more clear than ever that racism and discrimination are detrimental to the health and safety of minorities in the United States, particularly Black Americans. Since the outbreak began here in the United States, Brief19 has covered reports in the medical literature describing worse outcomes experienced by Black and other people of color with SARS-CoV-2 infection. Among the first inequities described was lower rates of viral testing among non-White persons. Later, disproportionately higher rates of hospitalization and deaths among Black persons have been repeatedly shown in various settings around the country. It seems increasingly apparent that the disparate outcomes have more to do with chronic and systemic issues which are manifestations of our country's history of structural racism than differences in acute care. That is to say, it is the effects of racism, not a patient's race (i.e. not any genetic predispositions), that accounts for many of the health inequities before us. For example, it is not just Black persons but Black Americans in particular that are known as having amongst the highest rates of elevated blood pressure in the world, a risk for poorer covid-19-related outcomes. Covid-19 has merely pulled the curtain back on the fact that many serious acute illnesses (including infections like covid-19 but also many others) are far more likely to become critical and life-threatening when pre-existing chronic illnesses such as high blood pressure go undertreated or even undiagnosed owing to lack of primary and preventative care. Lack of medical treatment can be the result of a number of factors including inadequate access to healthcare or suspicion of the healthcare system resulting from previous breaches of trust. Over the past few days the American Medical Association, and several emergency medicine societies have issued strong statements to reflect this, specifically calling out police brutality and structural racism, and urging for systemic changes that will provide care and outcome equity in the future. As the AMA writes, "racism is detrimental to health in all its forms." Brief19 remains committed to highlighting the injustices of racism and inequality in medicine, and the consequences such racism has on the health of our communities. In the meantime, experts have expressed concern for covid-19 spread during protests, and offered concrete suggestions for how demonstrators and all of the public can limit their risk.

—Brief19 Editorial Board


GetUsPPE Weekly Briefing

This document features the GetUsPPE.org's weekly briefing in an edited and condensed format for brief19.com.

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By Amanda Peery-Wolf

GetUsPPE Article in The Lancet

The Lancet recently published a Correspondence authored by several of our team members. The article analyzes data from GetUsPPE's Demand Data Hub, showing that the PPE shortage remains widespread. It looks at the breakdown of registered needs across income quadrants, regions of the country, and urban, suburban, and rural areas. This study establishes GetUsPPE as the leading source of PPE demand data in the United States.

The Fairness Framework

One of the most heart-wrenching questions our team faces is where and how to distribute a limited supply of PPE. Given the urgency of the PPE crisis, we are prioritizing speed and efficiency in getting PPE to frontline healthcare workers. But with COVID-19 continuing to have a disproportionate effect on under-resourced communities, we are also committed to not perpetuating inequities in access to medical supplies.

Public health equity and logistics experts on our team consulted with other experts and worked with developers to create what we are calling the Fairness Framework for the distribution of PPE. The Fairness Framework is built around an algorithm that allows us to consider factors such as whether a facility accepts Medicaid, whether it offers low- or no-cost treatment, and demographic data about the population it serves.

We hope that someday soon we will not need the Fairness Framework, or any framework, to think about the distribution of necessary medical equipment. We hope that someday soon every frontline worker will have the PPE they need to stay safe. 

Makers Mobilized

Makers are an important force bolstering the global supply of PPE. The GetUsPPE Makers Team works with maker networks all over the country, including a group called Open Source Medical Supplies (OSMS). In this video, OSMS tells the story of 28,000 makers signing up for their movement off the bat. They reported making 238,000 units of PPE across the world in just one week. To join the maker force and register PPE designs for vetting, visit the makers page on our site.

A Sampling of GetUsPPE Success Stories

Over the past week, GetUsPPE and its regional affiliates have delivered more shipments than can fit in a briefing, but here are a few stories from around the country:

In continuing joint efforts between GetUsPPE and Boston Scientific, 7,800 isolation gowns went out to twelve sites, including a site within a Native American reservation. Three thousand face shields arrived in Oregon, to be distributed to 60 locations across the state (below far left). Cole Grinnel at Morgan State University donated 10,000 nitrile gloves (below far right).

A Call for Volunteers

At GetUsPPE, we're growing quickly and we're looking for volunteers to join our 200-plus-person central organization. We're hoping to fill a wide variety of roles, so whether or not you have experience in healthcare or nonprofit work, you could be a much-needed volunteer. Check out our biggest needs here. Join the charge by filling out our volunteer form or emailing us with a brief description of any relevant skills and experience at volunteer@getusppe.org.

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International branches of GetUsPPE are springing up across continents, most recently in South Africa, Australia, and India. As we prepare for a potential second wave of COVID-19, volunteers around the world are getting ready to do something about it.

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In Rhode Island, a regional group distributed 1880 PPE units in a day, with another distribution day to come and the remaining PPE to be given to the RI Department of Health.