WASHINGTON – The first US-tested COVID-19 vaccine boosted people’s immune systems as scientists expected, the researchers reported Tuesday, 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 so-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 have 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 injection site pain . 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 just 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 may 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,” said Schaffner.
And 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, and 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 are also will 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 such massive testing in the U.S., Crucial to detect effects. rare side. 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 “this is a race for a winner. Me, I’m cheering for all of you,” said Fauci, who heads the NIH’s National Institute of Allergy and Infectious Diseases. “We need multiple vaccines. We need vaccines for the world, not just for our own country.”
Across the world, governments are investing in stocks of hundreds of millions of doses of different candidates, hoping to quickly start inoculations if any are proven to work.
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