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Pfizer reports encouraging, very early vaccine test results

The first of four experimental COVID-19 vaccines being tested by Pfizer and its German partner BioNTech showed encouraging results in very early testing of 45 people, the companies said Wednesday.

Study volunteers given either a low or medium dose, in two shots about a month apart, had immune responses in the range expected to be protective, when compared to some COVID-19 survivors, according to the preliminary results.

Side effects were typical for vaccines, mostly pain at the injection site and fever.

The report has been submitted for publication in a scientific journal but not yet reviewed. With its other potential candidates still in the earliest stage of testing, Pfizer aims to open a large-scale study this summer but can’t yet say which shot is best to include.

But researchers didn’t administer a second shot of the highest dose initially tested, sticking with the low and medium doses. The higher-dose shot caused more injection reactions without apparent added benefit.

About 15 different COVID-19 vaccine candidates are in human testing worldwide, with several poised to begin huge, last-stage studies to prove if they really work.

Different companies are pursuing different types of vaccines, boosting the odds that at least one approach might work—although there’s no guarantee. The Pfizer and BioNTech candidates use a piece of the coronavirus genetic code to prime the body to recognize and attack the virus.

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TRACE results suggest 3.4% of Newport, Oregon community infected with SARS-CoV-2

Preliminary results from door-to-door sampling by Oregon State University suggest that 3.4% of the Newport community had the novel coronavirus that causes COVID-19 on June 20-21.

The study, Team-based Rapid Assessment of Community-Level Coronavirus Epidemics, known as TRACE-COVID-19 for short, began in Corvallis the weekend of April 25-26.

In Newport, 30 two-person field teams canvased 30 neighborhoods, with 336 of the households visited, or 71%, agreeing to participate. In all, the field workers received samples from 569 people, and 13 tested positive for SARS-CoV-2, the virus that causes COVID-19.

“Our results indicate the virus is relatively prevalent in Newport,” said Ben Dalziel, assistant professor in the College of Science at OSU and co-director of the project. “We know this because previously undiagnosed infected individuals are present in a random sample of participating households across the city. This indicates the potential for significant further spread unless strong actions are taken to reverse the course of COVID-19 in Newport.”

Newport’s population is 10,600, comprising roughly 20% of the nearly 50,000 people who live in Lincoln County. In announcing prevalence results, the TRACE team follows reporting policies used by the Oregon Health Authority and local health departments.

“This kind of random sampling gives us a type of data we don’t have, and we will be working with OHA and OSU to understand how to incorporate this into the data tools we currently use,” said Lincoln County Commissioner Kaety Jacobson. “We will also be looking at the feasibility and cost of doing further sampling studies like this one.”

The TRACE study is a collaboration of the OSU colleges of Science, Agricultural Sciences, Engineering, Public Health and Human Sciences, and the Carlson College of Veterinary Medicine—in partnership with county health officials.

“We are grateful to the many Newport residents who were willing to participate in TRACE,” said Jeff Bethel, an associate professor in OSU’s College of Public Health and Human Sciences and a member of the TRACE leadership team. “The high participation rate gives us confidence that our findings are robust and a good indication of how widespread the virus causing COVID-19 is in the general population of Newport. Information about community prevalence of the virus adds to the information already gathered by health officials.”

The results mean that all residents should pay close attention to guidance provided by health officials, such as the statewide face-covering mandate that begins on Wednesday, said Javier Nieto, dean of OSU’s College of Public Health and Human Services and one of TRACE’s leaders.

“Other measures such as social distancing and avoiding large gatherings will also help slow the spread of the virus,” Nieto said. “It is particularly important that individuals who have symptoms or tested positive follow state and county health guidelines such as self-isolating and seeking medical care.”

The TRACE study originated in Corvallis and included four weekends of random neighborhood sampling. TRACE moved to include Bend on May 30-31 and then expanded to Newport three weeks later following the positive tests of more than 120 workers at Pacific Seafood, which operates five processing facilities in the city.

TRACE uses a statistical model based on the number of samples, the number of positive tests and prior information on the prevalence of the virus to estimate the proportion of the community that is infected during the period when the samples were collected.

“TRACE does two things,” Dalziel said. “First, we find and get help to participants who are infected but do not know they are, which reduces the chances of these folks unknowingly spreading the virus to other people. Second, we estimate how widespread the virus is in the general population, which informs public health strategies.”

The study was initially funded by OSU and a grant from the David and Lucile Packard Foundation, and has been aided by work from the OSU Foundation and the OSU Alumni Association. Funding from PacificSource Health Plans has allowed for the expansion to Bend and Newport, and additional sampling in Corvallis.

“The Newport TRACE data reinforces the continuing need for heightened care by all citizens to take precautionary actions—wearing face coverings and social distancing, even when among friends,” said Bob Cowen, director of the OSU Hatfield Marine Science Center.

At each home visited by TRACE field workers, members of the household are invited to participate in the study. Those who choose to take part are asked to provide information such as their name and date of birth; to fill out a simple consent form; and to answer a few confidential, health-related questions.

Participants are given a nasal-swab test kit that they administer to themselves inside their home and their minor children if they want them to take part. The field staff wait outside, and the participants leave the completed test kits outside their front door. Field staff maintain a safe distance at all times and do not enter anyone’s home.

The tests used in TRACE-COVID-19 collect material from the entrance of the nose and are more comfortable and less invasive than the tests that collect secretions from the throat and the back of the nose.

The field workers leave participants with information about the project and how they will receive their results—available in seven to 10 days—as well as health guidance from county health officials and the Centers for Disease Control and Prevention. Participants in the study are sent their results and those of their minor children by secure email with receipt by standard mail delivery as a backup. Everyone’s personal information is safeguarded.

The diagnostic testing component of TRACE operates through a partnership between the Oregon Veterinary Diagnostic Laboratory, which is located at OSU, and Willamette Valley Toxicology.

For more information about TRACE, visit the TRACE-COVID-19 website. The site includes a list of frequently asked questions.

COVID-19, first reported to the World Health Organization on Dec. 31, 2019, has been confirmed in more than 10 million people worldwide and has killed more than 503,000 people. In the United States, there have been more than 2.5 million reported cases—including more than 8,100 in Oregon—and more than 126,000 deaths nationwide. Lincoln County has had 300 confirmed cases and two deaths.

“The tally of cases already reported by health officials tells us how many people are known to be sick with COVID-19,” Bethel said. “This number is well understood to underestimate the actual number of infected individuals because it misses asymptomatic individuals and people who have not sought testing or do not have access to testing. In contrast, the TRACE estimate of prevalence tells us about the fraction of individuals in Newport who are infected—whether or not they have symptoms, and whether or not they have access to testing. Public health and elected officials need this kind of information to plan and deploy resources.”

In addition to TRACE sampling, other OSU researchers collected sewage samples from Newport’s wastewater system the same weekend. Those samples are still being analyzed.

The fourth and final weekend of TRACE sampling in Corvallis, originally scheduled for May 16-17, took place June 13-14 to help determine if the easing of stay-at-home orders leads to a jump in the prevalence of the virus in the Corvallis community. Those results are also pending.

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US biotech firm Inovio reports encouraging virus vaccine results

The US biotech firm Inovio reported preliminary but encouraging results Tuesday from tests of an experimental coronavirus vaccine.

Administered to 40 volunteers, it triggered an immune system response in 94 percent of those who completed the so-called phase one clinical trial, meaning they received two injections, four weeks apart.

Inovio’s vaccine, called INO-4800, is designed to inject DNA into a person so as to set off a specific immune system response against the SARS-CoV-2 virus.

The medication is injected under the skin with a needle, then activated with a device that resembles a toothbrush, which delivers an electrical impulse for a fraction of a second, allowing the DNA to penetrate the body’s cells and carry out its mission.

Inovio, which is financed by the US Defense Department and the NGO CEPI, also said it has been included in President Donald Trump’s plan to produce hundreds of millions of doses of the vaccine by January as part of Operation Warp Speed.

Inovio’s medication is the only DNA vaccine that is stable at room temperature for more than a year and does not need refrigeration for transport or storage for several years, said Inovio CEO Joseph Kim.

This is a big plus when it comes to vaccinating people in developing countries, where it is harder to maintain the cold chain needed to preserve many products.

A total of 23 COVID-19 vaccine projects have launched clinical trials on humans, says the London School of Hygiene & Tropical Medicine, and several have moved to phase two or three, which means they are being injected into thousands or even tens of thousands of volunteers.

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