New Data on Moderna's Zika Vaccine Could Raise Hopes for Covid-19 Vaccine

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Data on Moderna’s Zika Vaccine Could Raise Hopes for Its Covid-19 Vaccine New Data on Moderna’s Zika Vaccine Could Raise Hopes for Its Covid-19 Vaccine New Data on Moderna’s Zika Vaccine Could Raise Hopes for Covid-19 Vaccine

CEO of Moderna says the positive experience with experimental vaccines so far makes him more confident that the biotech company’s Covid-19 vaccine will work.

New Data on Moderna’s Zika Vaccine Could Raise Hopes for Covid-19 Vaccine

Biotech company’s CEO says the positive experience with experimental vaccines so far makes him more confident that the Covid-19 vaccine will work.

https://investors.modernatx.com/news-releases/news-release-details/moderna-host-virtual-vaccines-day-april-14-2020 https://www.barrons.com/articles/coronavirus-covid-19-vaccine-program-51585341169 https://www.barrons.com/articles/health-care-workers-could-get-a-coronavirus-vaccine-by-fall-moderna-ceo-says-51584982422 https://www.barrons.com/articles/mrna-is-the-next-frontier-in-treating-disease-but-will-it-work-51567205845?mod=article_inline mailto:josh.nathan-kazis@barrons.com New Data on Moderna’s Zika Vaccine Could Raise Hopes for Its Covid-19 Vaccine By Josh Nathan-Kazis Photograph by Adam Glanzman/Bloomberg

The biotech company Moderna unveiled promising early data from a Phase 1 trial of its experimental Zika vaccine on Tuesday morning -- which could be a good sign for the company’s Covid-19 vaccine, currently in Phase 1 trials.

The company made the announcement at the start of its vaccines day, an online investor meeting about Moderna’s (ticker: MRNA) vaccine programs. The investor meeting begins via webcast at 8 a.m. Eastern time on Tuesday.

Moderna’s Covid-19 vaccine, which has drawn enormous attention in recent months, is among nine experimental prophylactic vaccines the company is developing. All of the vaccines employ the same approach, in which small bits of messenger RNA are used to activate the immune system against a particular virus.

The Zika vaccine is Moderna’s seventh to return positive data in a Phase 1 trial. In an interview on Monday, Moderna’s CEO, Stéphane Bancel, said that the positive experience with Moderna’s experimental vaccines so far makes him more confident that the Covid-19 vaccine will work.

“This is the 10th vaccine we’ve put in the clinic with Moderna’s mRNA platform,” Bancel said. “We expect the safety and tolerability profile of the Moderna Covid-19 vaccine to be very similar from the other vaccines. And so I think we start to be in a place where we are cautiously optimistic.”

Moderna is one of a handful of companies working on mRNA-based vaccines for Covid-19; its program has attracted the most attention.

Shares of Moderna are up 33.7% so far this year, while the S&P 500 is down 5%.

Also on Tuesday morning, Moderna said that the ongoing Phase 1 study of the mRNA vaccine, which is being run by the National Institutes of Health, is now enrolling subjects to receive the 250-microgram dose that will be the highest dose to be delivered in the trial. Bancel says that he expects safety data from the study this spring, and immunogenicity data — that is, data on whether the vaccine appears to be working — by early this summer.

Bancel says the company hopes to begin a Phase 2 trial involving hundreds of subjects in the spring, after the safety data from the Phase 1 trial is available, but before the immunogenicity data comes in. That is an accelerated schedule by the standards of normal vaccine development. The company will then seek to start a phase Phase 3 trial, involving thousands of subjects, by early this fall.

But Bancel also said the company would consider applying for emergency-use authorization to allow limited access to the vaccine in the fall, likely exclusively to health-care workers, if the safety and immunogenicity data from the Phase 1 trial, and the safety data from the Phase 2 trial, are all positive.

That would be an extraordinary circumstance, given that vaccines are usually tested in tens of thousands of people before they are released for the public.

“It would be something that the FDA would have to define very clearly who they think there’s a good risk-reward ratio to potentially be exposed to the vaccine,” Bancel said. “In our current thinking, it will be mostly health-care workers.”

Moderna announced these plans in late March, though the details at the time were vague.

“Our only goal here is we want to be helpful,” Bancel said. “We are in very close communication with several agencies of the U.S. government.”

In the meantime, Moderna is ramping up manufacturing, and says it should be able to make millions of doses a month this year, and tens of millions of doses a month next year. The company is also in preliminary conversations with outside manufacturers aimed at expanding that capacity.

Still, science is hard, and vaccine development particularly so. Bancel said that the odds of at least one of the vaccines for Covid-19 currently in development around the world being available for widespread use within 18 months was “pretty high.”

“The virology of SARS-CoV-2 is not very complicated,” he said, referring to the virus that causes Covid-19. He said that if the virus were as complicated as the HIV, for which there is no vaccine, the situation would be different.

But the world got lucky, in a sense, Bancel argues, in that the scientific community seems to think that the SARS-CoV-2 virus is not extraordinarily complex.

Until Covid-19 emerged in January, it wasn’t Moderna’s vaccine programs that drew the most attention from investors. The company was best known for its rare disease programs, in which it sought to use mRNA-based drugs to get the body to make proteins it otherwise couldn’t. But its vaccines have now come into focus amid the interest around its Covid-19 vaccine.

“I think the pandemic has reinforced, in other people’s mind, the importance of vaccines,” Bancel said. “To Moderna’s team, they’ve always been important.”

Moderna said that more than 80 viruses have been discovered since 1980, and that vaccines exist for only 4% of them.

“We believe that vaccines offer a large total addressable market and an opportunity to reduce health-care costs,” Bancel said in a statement. “The totality of data from our vaccines platform gives us reason to be optimistic about the prospects for our vaccines to come, including our vaccine against the novel coronavirus.”

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.