First COVID-19 The vaccine tested in the U.S. boosted people’s immune systems just as scientists expected, researchers reported Tuesday. The shots are set to begin the key final test.
“No matter how this is cut, this is good news” Dr. Anthony Fauci, the U.S. government’s leading infectious disease expert, told The Associated Press.
The experimental vaccine, developed by Fauci’s colleagues at the National Institutes of Health and Modern Inc., will begin its most important step around July 27: a study of 30,000 people to test whether the gunshots really are strong enough to protect against the coronavirus.
But on Tuesday, researchers reported eagerly awaited results from the first 45 volunteers who they rolled up their sleeves Already in March. Indeed, the vaccine provided an expected immune boost.
Those early volunteers developed what is called neutralizing antibodies Key molecules in blocking your infection in your bloodstream, at levels comparable to those found in people who survived COVID-19, the research team reported in the New England Journal of Medicine.
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“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.
“Our goal is to have a vaccine available for wide distribution by the end of the year or early next year.” Modern President Stephen Hoge said “CBS this morning” in May, after looking at preliminary data from the Phase 1 trial. “If we and others create data showing that the vaccine has a potential for benefit, that it is safe and has a potential for efficacy, then of course there are circumstances where the vaccine could be implemented in high-risk populations before under something called Emergency Use Authorization. However, that is a decision that regulators, in particular the FDA, must make. “
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 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 illnesses that make them more vulnerable to the virus, and black and Latino populations will also be seen. affected.
Almost two dozen possible COVID-19 vaccines they are in various stages of testing throughout the world. China and Great Britain Candidates Oxford University They are also entering the final stages of testing.
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 “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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