(Bloomberg) – Moderna Inc.’s Covid-19 vaccine produced antibodies to the coronavirus in all patients tested in an initial safety trial, federal researchers said, clarifying a major milestone as the United States continues to grapple with an increase in new infections.
The findings are likely to raise hopes that a vaccine can be brought to market quickly. However, several patients in the trial experienced side effects, some of them serious. The vaccine will move into a much larger late-stage trial later this month that will likely determine whether it is approved by US regulators.
The neutralizing antibody levels in the produced assay were equivalent to the upper half of what is seen in patients who become infected with the virus and recover, according to results published Tuesday in the New England Journal of Medicine.
While stimulating production of neutralizing antibodies does not prove that a vaccine is effective, it is considered an important initial step in testing. Meanwhile, the reported side effects were not severe enough in most patients to preclude further testing, according to the report by researchers from the National Institute of Allergy and Infectious Diseases.
Moderna’s shares gained 13.3% in trading after the market closed. The action has more than tripled this year in the hope that its vaccine will get quick approval.
More than half of those who received half of the three doses suffered mild to moderate fatigue, chills, headache, and muscle pain. Furthermore, 40% of people in the medium dose group experienced fever after the second vaccination. Three of the 14 patients who received the highest dose experienced serious side effects, but that dose is not being used in larger trials.
“Man, there are a lot of adverse events,” said Tony Moody, a physician 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 the antibody levels produced were “really encouraging.”
If the researchers are measuring the right thing, the vaccine should work, he said, noting that this can only be tested in large trials.
© Bloomberg
The biotechnology company’s Covid-19 vaccine produces antibodies in all the analyzed patients.
The news of the vaccine came when the pandemic continued to thrive in the United States. Cases across the country rose to 3.4 million on Tuesday, according to data compiled by Johns Hopkins University and Bloomberg News. More than 136,117 Americans have died.
While some states that suffered this spring have managed to stifle their outbreaks, fierce hot spots are erupting in the Sun Belt. On Tuesday, Arizona reported 4,273 new cases, most in 11 days. Texas reported a daily record of 10,745. And Florida deaths rose by a record 132.
NIAID director Anthony Fauci called Moderna’s data “really quite promising” in a telephone interview after the report’s release. He said the observed side effects were not alarming and were typical of the effects seen with other vaccines.
“The good news is that this vaccine induced antibodies,” said Fauci. “Not just any type of antibody, but neutralizing antibody.”
45 patients
Moderna’s initial results come from the first group of 45 patients who received the vaccine. Three doses of the vaccine were evaluated and administered in a two shot regimen. The median dose for this initial trial will be used in a large, modern-stage, modern vaccine trial called mRNA-1273, which is scheduled to start on July 27.
In the trial, participants received two shots of the vaccine 28 days apart. After the first dose, all participants generated antibodies that bound to the coronavirus, but most did not yet produce antibodies capable of neutralizing the virus.
But the 42 people who received both scheduled doses of the vaccine raised antibodies capable of neutralizing the coronavirus, according to the study results. The final stage of the trial will compare the vaccine with placebo vaccines in 30,000 healthy people at high risk of contracting the coronavirus.
A major limitation of the data is that it only includes data from the first 45 patients in the study, all of whom were between the ages of 18 and 55. Results of a second part of the phase 1 trial involving people older than this one, a key Demographic data of any Covid-19 vaccine, given the high mortality rate in older patients, are not yet available.
‘Respectable’ levels
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 the safety of the vaccine.
Unlike traditional vaccines, which inject a weakened or inactivated virus or part of a virus to trigger an immune response, the Moderna product uses genetic material called messenger RNA to cause cells to make the spike protein of the coronavirus. 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 the antibodies against the spike
Proteins were generated, including antibodies that had the ability to neutralize the virus, “said Paula Cannon, professor of microbiology at Keck School of Medicine at USC. A key question will be how long will the antibodies last before they begin to decline, said.
The initial results of the Phase 1 trial are largely in line with the first-line results that Moderna published in a press release in May, but provide more detail on the levels of antibodies produced and the side effects that were observed.
At the time, Moderna was criticized by some scientists for publishing a statement describing positive results that temporarily raised the company’s share price, but included few numbers that allowed scientists to interpret the data.
The government-sponsored trial was led by Lisa A. Jackson of the Kaiser Permanente Washington Health Research Institute in Seattle, the NIAID said in its statement. Emory University in Atlanta also enrolled participants in the trial.
(Adds Fauci’s comments beginning in paragraph 11, details about the trial in paragraphs 13 and 14).
For more items like this, visit us at bloomberg.com
© 2020 Bloomberg LP
Video: Positive result for the first trial of the US COVID-19 vaccine.
UNTIL NEXT TIME
Keep reading
