With more than 130,000 deaths from COVID-19 in the United States and the number of confirmed cases rising in 39 states, the need for a vaccine is growing.
However, Moderna, the “leader” in vaccine development, which the federal government has high hopes for, was recently reported to have fallen out with the government over its coVID-19 vaccine program.
Exclusive: Modena brawl with U.S. scientist over Novel Coronavirus vaccine trial (Reuters
Modena and government scientists are at loggerheads over procedures and rules for conducting large-scale human experiments and are resisting expert advice, Reuters reported Wednesday, citing three people familiar with the matter.
For example, experts recommend closely monitoring subjects’ oxygen levels in an experiment, which could be a sign of dangerous complications.
But when other vaccine companies accepted the advice, Modena executives objected, saying it was an “inconvenience” that would slow the trial.
The experts come from the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and include experts in immunology and other vaccinology designated by THE NIH.
They are responsible for helping to oversee vaccine design.
In a joint meeting between the government and the drug companies, Modena declined to share details of its trial plans with PPD, the outsourcing company that handles its clinical trial data.
Finally, Modena initially tried to lower the standard for vaccine effectiveness set by the FDA.
The company’s submission of clinical trial specifications has also been delayed by several weeks.
These specifications include the details and objectives of the researchers to ensure the safety of the trials.
As a result, the NIH, which was scheduled to begin large-scale human trials on July 10th, has been pushed back by the controversy by at least two weeks and is now tentatively scheduled for the end of July.
Modena claims to have asked for the delay, but people familiar with the matter say it actually lacks enough staff to complete the specification on time.
“If Modena had been more co-operative, [the vaccination] could have gone ahead,” says a source.
The young company, they argue, has not produced any officially approved vaccines and lacks the staff and expertise to carry out the most critical large-scale human trials, raising some concerns.
By contrast, the U.S. government has not had similar problems working with established drug companies like Astrazeneca PLC and Johnson & Johnson To develop vaccines.
Modena responded to the report by denying any wrongdoing but acknowledging that there were “disagreements” with experts involved in the trial.
Spokesman Ray Jordan said the process was “not without its problems” and that “no one has ever done an experiment like this, not Modna, not NIH, not any other company.”
Founded in Cambridge, Mass., in 2010, The company’s product portfolio includes about 20 potential vaccines and treatments, but none has yet been officially approved.
Before joining coVID-19, the company’s largest human trial involved 250 people.
The coVID-19 vaccine is expected to require 30,000 subjects.
In March, Modena was selected by the US National Institute of Allergy and Infectious Diseases to develop a coVID-19 vaccine because of its messenger RNA potential, making it the first company in the world to conduct human trials and a priority for FDA review.
A month later, high hopes were pinned on Modena winning a $480 million contract from the U.S. Department of Health and Human Services to speed up production of the vaccine.
The company says it has begun work on expanding capacity to produce at least 100 million doses of the vaccine this year before it is proven safe and effective.
Reuters describes Modena’s CEO, French businessman Stephane Bancel, as a ‘master fund-raiser.’
Its 2018 IPO raised about $7.5 billion, a record for the pharmaceutical industry.
Buoyed by the prospect of coVID-19 vaccine development, Modena’s market value has recently grown to about $23 billion.
But since the start of the year, Buncel and Zacks, the company’s chief medical officer, have continued to sell shares, earning $21 million and $35 million, respectively.
Modena CEO Bonsell
In May, When The company announced that some of its first clinical trials had successfully produced antibodies, its shares rose 20 per cent.
But some scientists have questioned the results and called for full clinical data to be released.
Investors have also found that Buncel has been taking advantage of the company’s high share price to continue to reduce its holdings and cash out.
As a result, Modena’s shares fell more than 10% on May 19.
In June, Bonsell boasted to investors that Modena’s mRNA therapy was “unique.” “We haven’t seen anyone else able to sustain this scale, focus and speed.”
In response, Peter Pitts, a former assistant commissioner at the F.D.A., said That Bonsell’s overconfidence in the company’s technology could dangerously provide people with the illusion that a vaccine is just around the corner.
“In vaccine development, the louder the boast, the less likely it is to actually succeed.”