First coronavirus vaccine tested in US poised for final testing | Chronicleplanet.com

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First coronavirus vaccine tested in US poised for final testing

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“No matter how you slice this, this is good news,” Dr. Anthony Fauci, the U.S. government’s top infectious disease expert, told The Associated Press.

US researchers say COVID-19 vaccine under study seen to boost immune systems as several countries report surge in cases.

Researchers in the United States say that the first vaccine tested in the country had worked to boost patients’ immune systems and is set for final testing. This is as the number of cases nationwide rose by 65,682 for a total of 3.45 million with at least 919 new deaths added to the tally of around 136,000.

The blood from seriously ill coronavirus patients on ventilators was found by researchers to be highly inflammatory and harmful to the body, the South China Morning Post reported on Wednesday, citing a study by Dutch scientists.

South Africa has surpassed the United Kingdom in its number of confirmed coronavirus cases, according to its health ministry and data compiled by Johns Hopkins University. It now has the world’s eighth-highest number of confirmed cases with 298,292 and over 4,300 deaths.

More than 13.29 million people around the world have been diagnosed with COVID-19, 7.37 million have recovered, and more than 577,900 have died, according to data from Johns Hopkins University. The US, Brazil, the United Kingdom, Mexico and Italy have recorded the most deaths.

Moderna Inc.’s Covid-19 vaccine produced antibodies to the coronavirus in all patients tested in an initial safety trial, federal researchers said, clearing an important milestone as the U.S. continues to grapple with a surge in new infections.

The findings are likely to increase hopes that a vaccine can be brought to market quickly. However, a number of patients in the trial experienced side effects, some of them severe. The vaccine will move into a much larger late-stage trial later this month that’s likely to determine whether it’s approved by U.S. regulators.

The neutralizing antibody levels in the trial produced were equivalent to the upper half of what’s seen in patients who get infected with the virus and recover, according to the results published Tuesday in the New England Journal of Medicine.

“Man, that is a lot of adverse events,” said Tony Moody, a doctor and researcher at the Duke Human Vaccine Institute. He said it would be “unusual” for a vaccine to have this rate of side effects. On the plus side, he said that the antibody levels produced were “really encouraging.”

If researchers are measuring the right thing, the vaccine should work, he said, noting that this can only be proved in large trials.

The vaccine news came as the pandemic continued thriving throughout the U.S. Cases nationwide increased Tuesday to 3.4 million, according to data collected by Johns Hopkins University and Bloomberg News. More than 136,117 Americans have died.

While some states that suffered this spring have managed to quell their outbreaks, fierce hot spots are breaking out in the Sun Belt. On Tuesday, Arizona reported 4,273 new cases, the most in 11 days. Texas reported a daily record of 10,745. And Florida deaths rose by a record 132.

William Haseltine, a former Harvard Medical School researcher who chairs Access Health International, said the levels of neutralizing antibodies produced were “respectable” and possibly protective. But he said “the jury is out” on safety of the vaccine.

Unlike traditional vaccines, which inject a weakened or inactivated virus or a piece of a virus to trigger an immune response, the Moderna product uses genetic material called messenger RNA to cause cells to produce the coronavirus spike protein. The goal is to produce antibodies to the virus that protect against the disease when someone is later exposed to the coronavirus.

The vaccine “clearly worked in that antibodies against the spikeprotein were generated, including antibodies that had virus neutralizing capability,” said Paula Cannon, professor of microbiology at Keck School of Medicine of USC. A key question will be how long will the antibodies last before they start to wane, she said.

The initial findings from the Phase 1 trial are largely in line with top-line results Moderna published in a press release in May, but provide more details on the antibody levels produced and side-effects that were seen.

At the time, Moderna was criticized by some scientists for putting out a release describing positive results that temporarily drove up the company’s stock price, but included few numbers that would allow scientists to interpret the data.

The government-sponsored trial was led by Lisa A. Jackson of Kaiser Permanente Washington Health Research Institute in Seattle, the NIAID said in its statement. Emory University in Atlanta also enrolled participants in the trial.