(Bloomberg) – Crucial data from experimental vaccines against the new coronavirus began streaming when Moderna Inc. revealed preliminary results and new findings from the rival Oxford University shooting were reported to be imminent.
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Moderna’s vaccine raised antibodies in all people tested in an initial safety trial, federal investigators said Tuesday. The first test results of a vaccine Oxford is developing with AstraZeneca Plc will be released as early as Thursday, according to a report on the ITV.com website.
New vaccines are reaching significant milestones as the virus increases in the US and other countries, and continues to stifle economies and take lives. Governments are investing billions of dollars in the hope that safe and effective inoculations will help return to something akin to pre-pandemic life.
Investors are also enthusiastically following the vaccine race, though some drug makers have said they will sell their products at cost during the pandemic. Moderna’s shares rose as much as 18% in US trade despite a high rate of side effects among the 45 patients who received the vaccine, and three experienced severe reactions.
While ITV.com referred to the Oxford results as “promising,” without providing any data, AstraZeneca shares rose as much as 4.2% in the report. Other companies investigating the virus vaccines, including Pfizer Inc. and Merck & Co., also rose, and optimism about Moderna lifted global stock markets.
“The good news is that this vaccine induced antibodies,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “Not just any type of antibody, but neutralizing antibody.”
Fauci, in a telephone interview, described Moderna’s data as “really quite promising”. Other experts issued a cautionary note about side effects.
More than half of the participants who received half of the three doses administered in the Moderna trial 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 used in larger tests.
‘Adverse events’
“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 positive side, Moody said the antibody levels produced were “really encouraging.” 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.
Moderna’s shares have nearly quadrupled in value this year in hopes that the company’s vaccine will get quick approval. The vaccine will go into a much larger late-stage trial later this month that will likely determine whether it is fit for commercial use.
Drugs and vaccines that could end the coronavirus pandemic
Although stimulating production of neutralizing antibodies does not prove that a vaccine is effective, it is considered an important initial step in testing. The reported side effects were not severe enough in most patients to preclude further testing, according to the report by the NIAID researchers.
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The biotechnology company’s Covid-19 vaccine produces antibodies in all the analyzed patients.
The news of the vaccine came as the pandemic continued to thrive across the US While some states that suffered this spring have successfully stifled the contagion, fierce hot spots are being unleashed in the Sun Belt.
45 patients
Moderna’s initial results come from the first group of 45 patients who received the vaccine, called mRNA-1273. Three doses were evaluated and administered in a two shot regimen. The medium was selected for use in the large end-stage study that is scheduled to begin on July 27.
In the trial, participants received the two vaccines 28 days apart. After the first dose, all generated antibodies that bound to the coronavirus, but most still did not 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 trial will compare the vaccine with placebo vaccines in 30,000 healthy people at high risk for Covid-19.
A significant limitation of the data is that it includes information only from the first 45 patients in the study, all of whom were between 18 and 55 years old. Results of a second part of the phase 1 trial involving older people, a key demographic for all Covid-19 vaccines, given the high death rate in older patients, is not yet available.
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.
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