First COVID-19 vaccine ready for final test

By Lauran Neergaard | Associated Press

Scientists reported Tuesday that the first COVID-19 vaccine tested in the US boosted people’s immune systems as scientists expected, as the vaccines are about to begin key final tests.

“No matter how this is cut, this is good news,” Dr. Anthony Fauci, the top infectious disease expert for the US government, told The Associated Press.

The experimental vaccine, developed by Fauci’s colleagues at the National Institutes of Health and Moderna Inc., will begin its most important step around July 27: a study of 30,000 people to test whether the vaccines are really strong enough to protect against coronavirus.

But on Tuesday, researchers reported eagerly expected results from the first 45 volunteers who rolled up their sleeves in March. Indeed, the vaccine provided an expected immune boost.

Those early volunteers developed what are called neutralizing antibodies in their bloodstream, key molecules to block infection, at levels comparable to those found in people who survived COVID-19, the research team reported in the New England Journal of Medicine. .

“This is an essential component that is needed to move forward with trials that could really determine if the vaccine protects against infection,” said Dr. Lisa Jackson of the Kaiser Permanente Washington Research Institute in Seattle, who led the study.

There is no guarantee, but the government hopes to see results by the end of the year: record speed in developing a vaccine.

The vaccine requires two doses, one month apart.

There were no serious side effects. But more than half of the study participants reported flu-like reactions to vaccines that are not uncommon with other vaccines: fatigue, headache, chills, fever, and pain at the injection site. For three participants who received the highest dose, those reactions were more severe; That dose is not being sought.

Some of those reactions are similar to coronavirus symptoms, but they are temporary, last about a day, and occur immediately after vaccination, the researchers noted.

“Small price to pay for protection against COVID,” said Dr. William Schaffner of Vanderbilt University Medical Center, a vaccine expert who was not involved in the study.

He called the first results “a good first step”, and is optimistic that the final tests could offer answers on whether it is really safe and effective early next year.

“It would be wonderful. But that assumes everything is working on time,” Schaffner said.

Moderna’s share price rose nearly 15 percent in trading after US markets closed. Shares of the Cambridge, Massachusetts-based company have nearly quadrupled this year.

Tuesday’s results only included younger adults. The first-step test was later expanded to include dozens of older adults, the age group most at risk for COVID-19. Those results are not yet public, but regulators are evaluating them. Fauci said the final tests will include older adults, as well as people with chronic health conditions that make them more vulnerable to the virus, and black and Latino populations will also be affected.

Nearly two dozen potential COVID-19 vaccines are in various stages of testing worldwide. Candidates from China and the Oxford University of Great Britain are also entering the final stages of evaluation.

The 30,000-person study will mark the world’s largest study of a possible COVID-19 vaccine so far. And the injection developed by the NIH is not the only set for mass testing in the US, Crucial for detecting rare side effects. The government plans similar large studies of the Oxford candidate and another of Johnson & Johnson; separately, Pfizer Inc. is planning its own large studio.

Already, people can start volunteering for the different studies.

People think that “this is a race for a winner. I am encouraging you all, ”said Fauci, who heads the NIH National Institute of Allergy and Infectious Diseases.