Moderna has dosed its first set of patients in a second phase clinical trial for its coronavirus vaccine, the company announced on Friday.
Vaccines are a top-priority for health officials and biotech firms in the battle against coronavirus, as a shot to prevent infection would finally make it safe for people to return to work and life to return to normal.
Moderna has led the pack in the American race to make a vaccine, with share prices for the company surging last month after it announced promising early results from its first stage of human trials.
However, some controversy arose surrounding these results. Critics claimed Moderna over-hyped its results in the interest of its bottom line as it sold 17.6 million shares in the hours following its announcement.
First round testing is only intended to indicate the safety of a shot, but gives some picture of its promise for efficacy. This second round of tests, which compare the vaccine to a placebo will provide more objective evidence as to whether or not it will work.
Moderna announced Friday that it has begun its second phase of human trials for its coronavirus vaccines – but the results of its first human tests are now shrouded in controversy
Moderna’s ‘positive data’ on its vaccine was released on May 18.
On the basis of early indicators of an antibody response seen in just eight trial participants, its share prices jumped up 20 percent.
In the hours and days following the announcement, the company amassed $1.3 billion in a mass sale of shares to the public, two executives sold off nearly $30 million of their combined shares, and the Moderna’s primary venture capital investor sold a million of its shares, according to CNN.
The latter two sales were done through automated trading programs for people and firms with involvement in the company – a protection against accusations of using insider knowledge to profit.
But the timing was suspicious and, even if it didn’t meet the threshold of insider trading, it raised questions about ‘market manipulation,’ Thomas Gorman, a former Securities Exchange Commission (SEC) official told CNN Business.
‘It looks like you’re hyping stock so you can then go and sell it.’
In fact that suspicion was bolstered by concerns about the reporting on early results of a small sample of trial participants.
Moderna has led the pack in the US race to make a vaccine to prevent coronavirus infection
Moderna’s shares shot up by 20% on the heels of its May 18 announcement, and sales of the shares raked in $1.3 billion for the company, raising questions about whether it had used the early trial results to manipulate the market
The eight people in the trial had blood levels of neutralizing antibodies – immune cells that may be able to block the coronavirus – that were on par with those seen in people who had recovered from coronavirus.
Only about a third drugs that enter clinical trials make it to final stage testing. So it’s not terribly common for big announcements to be made about early stage tests, which may have little bearing on the final outcome of clinical trials.
What’s more, University of Texas vaccine expert Dr Peter Hotez noted on Twitter that some studies have suggested that the level of these antibodies in recovered patients’ plasma might not be sufficient to neutralize the virus.
So the trial’s highly-anticipated results were ‘not necessarily good news,’ he said.
Already, a handful of investigations into Moderna’s business practices have begun, although the price for its shares has fallen back to about $61.
And scientists continue to question whether the phase 1 trial was over-hyped.
The vaccine was was deemed overwhelmingly safe, but that trial was not designed to determine if the vaccine will actually work.
Now, Moderna is making a critical foray in that direction with its phase 2 trial.
All in all, the trial will include 600 healthy adults divided into two age groups: Those aged 18-55 and those over 55.
Moderna announced on Friday that the first patients in each age group and at each dosage level had been vaccinated.
Each person in the trial will be dosed twice, with a high dose, a low dose or a placebo.
They’ll be followed over the course of a year, with doctors monitoring them for side effects, as well as for signs of a neutralizing antibody.
A stage 3 trial is scheduled to start in July, using the same high dose and a lower low does (about half the concentration of the low dose shot being given in the phase 2 trial).
It’s not clear what, if any, results from the phase 2 trial will be reported ahead of its completion next year, but members of the National Institute of Allergy and Infectious Disease have intimated that a vaccine could be ready for select use by January.
The study results will ultimately give a clearer sense of whether the phase 1 trial results were in fact just hype, or predicted a successful candidate vaccine.