The American biotech firm leading the way in the development of a Covid-19 vaccine has been accused of trying to boost its share price and an “appalling” lack of transparency for holding a stock offering just hours after releasing the “positive” results of its early human trials.
Moderna, based in Massachusetts, revealed last week that eight patients vaccinated in the Phase 1 stage of its study had developed an immune response capable of fighting Covid-19.
The company, one of several which is currently testing its vaccine candidate on humans, said the levels of antibodies developed by the patients mirrored those seen in people who have recovered from the deadly virus.
This suggests that the vaccine, named mRNA-1273, triggers a degree of immunity in humans – but does not yet prove it, nor confirm its long-term efficacy.
Moderna’s trial, which is the first to present evidence from tests on humans, saw the company’s value rise to $29bn (£22bn) on the same day as it released the preliminary results, with its stock reaching an all-time high of $80 (£63) per share – a jump of almost 20 per cent, and four times its price at the start of the year.
However, questions have been raised over the manner in which the company disclosed its results and the absence of critical information regarding the candidate’s efficacy and suitability.
Moderna’s data, released in a press release, has yet to be peer-reviewed by the wider scientific community. “What is important at this moment is to independently verify the science and that apparently is not possible,” Ellen t’ Hoen, an expert in medicines policy and intellectual property law, told The Independent.
As such, the company’s latest result should be approached with caution, experts have warned.
“It is very difficult to be sure of the results from a press release,” said Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine. “It must be noted that this is a Phase 1 study which has an object of showing the vaccine is able to induce an antibody response and that the dose range is appropriate.
“It will not be until the Phase 3 trial is completed that it will be known whether the vaccine actually prevents Covid-19 disease.”
The data provided by Moderna is short on crucial detail. Of the 45 patients involved in Phase 1 of the trials, findings have only been released for eight subjects.
At this stage, it is unknown whether the additional 37 people who were injected with mRNA-1273 have developed neutralising antibodies capable of fighting Sars-CoV-2, the virus responsible for Covid-19.
And while Phase 1 included healthy volunteers aged 18 to 55 years, the exact age of the eight patients who showed a “positive” immune response is also not known. The study is also testing the vaccine candidate in adults aged 56 to 70, and those 71 and older.
“Whether the same benefits [of mRNA-1273] are seen in older age groups we do not know but that may be because they were recruited at a later stage,” Professor Evans said.
The durability of the antibodies – how long they last – equally remains unclear. At the time of Moderna’s press release, the trial was into its 43rd day – while only two weeks had passed after those patients who returned positive results were injected with their second dose of the vaccine.
“While having data at 40 days would be of interest for the vaccine to be beneficial it will require persistence for several months and this will not be known until Phase 3 trials are conducted,” Professor Evans told The Independent.
Scientists have also called for more detail regarding Moderna’s claims that its vaccine raised the levels of neutralising antibodies equivalent to those found in the blood plasma of recovered Covid-19 patients, urging the company to specify how many antibodies were produced in the subjects and how comparisons had been made.
Those within the sector have pointed out that on the same day Moderna released its press release, the firm also carried out a stock offering, in which shares of the company were put to public investors.
The company said it plans to primarily use the proceeds to fund manufacturing and distribution of its vaccine candidate.
However, Knowledge Ecology International, an NGO that specialises in governance, intellectual property and health policy, said there is “a jarring difference between the transparency that the public wants and what we are getting”.
Director James Love, who is currently consulting with the US Department of Health & Human Services over its vaccine research, said in relation to the stock offering: “Companies should not use the public’s acute concerns about Covid-19 and the media’s intensive coverage of the pandemic.
“This is a publicly funded vaccine, and [Moderna CEO] Stephane Bancel and the Moderna board should not be using partial release of information about trial outcomes to goose the stock.”
In April, the US government committed up to $483m (£386m) to Moderna’s vaccine development.
A senior source involved in the global coordination of efforts to research and fund a Covid-19 vaccine called last week’s press release – and the subsequent stock offer that was announced – “very questionable”.
“I’ve been appalled by what I saw,” the source said. “What they did was very questionable; they actually released some non-peer reviewed data which are very preliminary. The way you handle the data is very important in terms of credibility.
“At the same time, they did a stock offering. You make a press release and the stock is going up, and then you do a stock offering and you cash in. It’s a lot of money.
“A press release is a typical biotech approach when they want to boost their stock price.”
Moderna did not respond to questions about the timing of its stock offering.
The source expressed “fear” that with more than 100 vaccine candidates currently in development, pharmaceutical companies could be drawn into a public relations war, with each firm rushing to declare their latest achievements without providing transparent data and information.
“If we enter a battle of press releases I think we’re going to lose public trust completely,” he added. “I think if this turns into a competition of who has the best data and has made the most progress, we need some kind of neutral party that can look into the data and provide scrutiny.”
Ms t’Hoen said that communicating “signs of progress” in the public has “immediate consequences for the value” of any company that is on the stock market.
“Moderna is a company benefiting from public financing, it’s carrying out trials, they have financing from Cepi [Coalition for Epidemic Preparedness Innovations] – they should exercise much greater transparency,” she added.
While there are “encouraging signs” to the firm’s data, according to Robin Shattock, professor of Mucosal Infection and Immunity at Imperial College London, this development represents the first step of many in a long process to produce an effective and safe vaccine.
However, the company is moving fast and intends to roll out Phase 3 of its study in July, which would involve the large-scale vaccination of thousands of subjects across several sites to evaluate efficacy and safety under natural disease conditions.
“These data substantiate our belief that mRNA-1273 has the potential to prevent Covid-19 disease and advance our ability to select a dose for pivotal trials,” said Tal Zaks, Moderna’s chief medical officer.
Mr Bancel has refuted claims that the company did not release enough data, and told Fox News that more “will be published very soon”.
The Independent has approached Moderna for further comment.