New companies enter vaccine race | Daily News


 

New companies enter vaccine race

 

 

It almost felt like an episode of “Shark Tank.”

One by one, vaccine developers at a White House roundtable convened by President Donald Trump in early March pitched their product as a viable solution to the coronavirus that was spreading globally and killing Americans.

John Shiver, the head of R&D for Sanofi Pasteur vaccines, said he could have a product ready for the clinic in a year -- perhaps a vaccine for the public in as “few as several years.”

Trump seemed uninterested.

“Right. OK. Thank you very much,” he said at the March 2 roundtable, which was captured on C-SPAN.

Next was Lenny Schleifer, the founder and CEO of Regeneron -- which aims to conduct clinical trials this summer -- who talked of pumping 200,000 doses per month of its therapeutic vaccine from his factory, starting in August, “if all goes well.”

This got Trump’s attention. He leaned over the table and interrupted Schleifer mid-pitch.

“So that process would be faster than John’s?” he said, pointing at Shiver.

“It would be,” Schleifer said, adding that the process could take “weeks to months.”

The only way to top that was to start talking about days, and it’s exactly what the next CEO did.

Stéphane Bancel of Moderna Inc. glanced across the table at the nation’s top infectious disease expert, Dr. Anthony Fauci, and said he is “very proud to be working with the US government and to have already sent, in only 42 days from the sequence of the virus, our vaccine to Dr. Fauci’s team at the NIH.”

The French-born Bancel went on to say that he needed just “a few months” to start phase two of a three-part clinical trial of the sort that typifies vaccine development. (The entire process often takes more than a decade.)

Trump seemed to tune out everything but the talk of time.

“So you’re talking over the next few months, you think you could have a vaccine?” he asked.

“Correct. Correct,” Bancel said, raising a hand to acknowledge Fauci shifting in his chair across the table. “With phase two,” Bancel clarified, just before Fauci interjected, for Trump’s benefit: “You won’t have a vaccine. You’ll have a vaccine to go into testing.”

To some observers, it was a classic Bancel performance -- a rare public glimpse into his uncanny ability to say the right thing to the right people in the right moment.

His supporters say, however, he was doing what he’s always done: letting Moderna’s accomplishments speak for themselves.

Either way, it turns out Moderna had an edge. Its scientists had already been collaborating with researchers from the National Institutes of Health on a vaccine for another coronavirus, Middle Eastern Respiratory Syndrome (MERS). So when Chinese researchers released the genomic sequence for the new coronavirus -- SARS-CoV-2, which causes the deadly disease known as Covid-19 -- in mid-January, they had a jump start.

On March 3 -- the day after the roundtable -- the FDA green-lit Moderna’s product for trial, making it the first vaccine candidate to advance to the first phase of a clinical study, in which an as-yet unapproved vaccine is injected into the arms of a small group of 45 human volunteers.

Established in 2010, Moderna has never brought a product to market, or gotten any of its nine or so vaccine candidates approved for use by the FDA. It has also never brought a product to the third and final phase of a clinical trial.

And yet at the moment, it represents one of the country’s -- and possibly world’s -- best hopes for a return to the normalcy that slipped away when the microscopic enemy brought civilization to a standstill.

The federally funded trial for Moderna’s vaccine candidate began in Washington state on March 16 -- two weeks after the roundtable. With a hope-starved world cheering it on, Moderna officially burst out of the gate, marking the beginning of the race for a vaccine for the new coronavirus.

The effort received another boost on April 16, when the federal Biomedical Advanced Research and Development Authority (BARDA) awarded Moderna up to $483 million to accelerate the development and manufacturing of the vaccine. That amounts to about half of what the federal agency has doled out, with Janssen Research & Development -- part of Johnson & Johnson -- receiving $456 million, and a third company, Sanofi, receiving up to $30 million.

Johnson & Johnson is a household name with a long list of approved medicines; Sanofi has been making vaccines for more than 100 years. But much of Moderna’s appeal is not what it has done, but what it says is possible: to develop a vaccine -- which normally takes years -- in record speed.

As it happens, although Moderna is not a household name, it’s a company with a storied history.

CNN Investigates interviewed more than 20 experts and former employees for this story and found that while some of the scientists expressed optimism that Moderna can pull it off, others voiced criticism about the hype the company has generated over the years, as well as what has been described as a caustic work culture.

Others raised concerns about the science, or challenged the wisdom of the federal government-sanctioned shortcuts in the ongoing clinical trial, in particular the FDA’s approval to gloss over the animal trials that normally precede injecting an untested vaccine into healthy humans.

Dr. Joseph Bolen, who served as Moderna’s chief scientific officer and president of research and development from 2013 to 2015, believes it was reasonable to give Moderna a shot, but was puzzled by BARDA’s massive allocation -- up to $483 million -- calling it a “big bet.”

“I don’t know what their thinking was,” he said. “Why so much? ... I just don’t know. When I read that, I was pretty amazed.”

Dr. Tal Zaks, Moderna’s chief medical officer, acknowledged that the company doesn’t have a product on the market, but said the government’s decision was wise.

“We’re a young company with an emerging technology and for that reason we have not yet brought anything to full licensure,” he told CNN. “But if you look at the building blocks of what we have been able to demonstrate over time -- from preclinical through our early clinical data -- this is a very promising technology.” (CNN)


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