The experimental vaccine, developed by colleagues from Fauci at the National Institutes of Health and Moderna Inc., will begin its most important stage around July 27: a study of 30,000 people to prove if the shots are really strong enough to protect against the coronavirus.
But on Tuesday, the researchers reported the eagerly awaited results of the first 45 volunteers who rolled up their sleeves in March. Indeed, the vaccine has provided a hoped-for immune boost.These first volunteers developed what is called neutralizing antibodies in their bloodstream – key molecules to block infection – to levels comparable to those found in people who have survived COVID-19, the research team reported in the New England Journal of Medicine.
Getty Images
“This is an essential element that is necessary to move forward with trials that could actually determine whether the vaccine protects against infection,” said Dr. Lisa Jackson of the Kaiser Permanente Washington Research Institute in Seattle. , who led the study.
There are no guarantees, but the government hopes to have results by the end of the year – record speed to develop 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 says “CBS this morning” in May, after seeing preliminary data from the phase 1 trial. “If we and others build data that shows that the vaccine has potential for benefit, that it is safe and has potential for effectiveness , then, of course, there are circumstances where the vaccine could be deployed earlier in high-risk populations under something called an emergency use authorization. Really however, it is a decision that regulators, especially 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 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, these reactions were more severe; this dose is not continued.
Some of these reactions are similar to symptoms of the coronavirus, but they are temporary, last about a day, and occur right after vaccination, the researchers noted.
“Small price to pay for COVID protection,” 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 provide answers as to whether they are really safe and effective early next year.
” That would be wonderful. But that assumes that everything is running smoothly on time, ”warned Schaffner.
And Tuesday’s results included only young adults. The first stage test was then expanded to include dozens of older adults, the age group most at risk for COVID-19. These results are not yet public, but regulatory authorities 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 populations black and Latin American women also affected.
Almost two dozen COVID-19 vaccines possible are at various stages of testing around the world. Candidates from China and Great Britain Oxford University are also entering the final stages of testing.
The study of 30,000 people will mark the world’s largest study on a potential COVID-19 vaccine to date. And the snapshot developed by the NIH is not the only set for such massive American tests, crucial for spotting rare side effects. The government is planning major similar studies on the Oxford candidate and another by Johnson & Johnson; separately, Pfizer Inc. is planning its own large study.
Already, people can start registering to volunteer for the different studies.
People think “it’s a race for a winner. I encourage each and every one of them, ”said Fauci, who heads the National Institute of Allergy and Infectious Diseases at NIH.
“We need several vaccines. We need vaccines for the world, not just for our own country. ”
Governments around the world are investing in stocks of hundreds of millions of doses of the various candidates, in the hope of quickly starting inoculations, if any.
