Inovio Stock – Biotechs in the Thick of the Covid-19 Vaccine Race. Can They Get to the Finish Line?
Smaller biotechs such as
have been holding their own in the early stages of the race to develop a Covid-19 vaccine. But as drugmakers prepare to submit their vaccines for Food and Drug Administration approval, are the biotechs out of their depth?
Last week, the health-care news website Stat raised concerns about the progress of Moderna’s Covid-19 vaccine program, with a story reporting delays in the start of a Phase 3 trial. Now, Reuters has more details on those delays, which the wire service attributes to conflicts between Moderna and the government scientists with whom it is collaborating.
The reported tensions point to a risk that investors shouldn’t overlook as they play the vaccine race. Shares of a handful of biotech firms with no marketed products, including Moderna (ticker: MRNA) and Novavax (NVAX), have climbed dramatically this year as the companies have emerged as front-runners in the scramble to develop a vaccine.
Shares of Moderna are up more than 200%, while shares of Novavax are up well over 2,000%.
(INO), which announced positive interim data of a Phase 1 study of its own Covid-19 vaccine last week, has seen its shares climb more than 600% this year.
What Moderna and Novavax have in common is that both are clinical-stage biotech companies, meaning that neither has had a product approved by the FDA. That is in contrast to other companies with advanced Covid-19 programs, including
Johnson & Johnson
(JNJ)—some of the largest pharmaceutical companies in the world, with long experience bringing new drugs to market.
Now, the Covid-19 pandemic has pushed government scientists deep into the commercial drug-development process, as U.S. government programs including Operation Warp Speed funnel billions into drugmakers’ vaccine programs. On Tuesday, Novavax announced it was awarded $1.6 billion to test and manufacture its vaccine.
The Reuters report is a reminder for investors that those close collaborations could be tricky, perhaps especially for smaller companies with less experience.
Reuters reported that Moderna and government scientists have clashed over how to run the vaccine trials, leading to delays. Moderna told Reuters that there had been disagreements with the government scientists, but said it had not made errors. The U.S. Department of Health and Human Services also told Reuters that the company had been cooperative.
Reuters reported that unnamed people in government hadn’t had the same issues with the larger drugmakers with which they are also collaborating.
“Moderna has a very experienced development team in vaccines,” chief corporate affairs officer Ray Jordan said in an email, noting that “many of our colleagues have 10-20 years of experience in industry, many having run multiple Phase 3 programs at Top 5 vaccines companies…and multiple vaccine approvals.” Jordan said the notion that Moderna has less experience in vaccine development “feels factually inaccurate or not well informed.”
Who gets there first could be consequential. Once a Covid-19 vaccine is approved, or even authorized for emergency use, other vaccines may have trouble recruiting for the trials that would be needed for them to gain approval.
For investors, it is worth considering whether the relative inexperience of the smaller biotechs could prove a significant handicap in the race for approval.
Write to Josh Nathan-Kazis at firstname.lastname@example.org