1218 Moderna EUA
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Regulation

EUA for second COVID-19 mRNA vaccine underscores the modality’s rapid response potential

Dec 19, 2020 | 3:58 AM GMT

FDA’s emergency use authorization for Moderna’s COVID-19 vaccine underscores the promise of mRNA to respond rapidly to viral outbreaks. 

Moderna Inc. (NASDAQ:MRNA) plans to deliver about 20 million doses of mRNA-1273 by year-end, followed by 80 million doses in 1Q21 and an additional 100 million doses in 2Q21. 

The EUA follows a 20-0 vote, with one abstention, by FDA’s advisory committee Thursday that the benefits of mRNA-1273 outweigh its risks for use in individuals 18 years of age and older.

mRNA vaccine BNT162b2 from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) is already being rolled out in the U.S., U.K. and Canada. 

While other vaccine modalities have begun to read out, the two mRNA vaccines are first to receive authorization and, so far, still the most effective.

mRNA validation

Just over two years ago, Moderna set the record for what at the time was the largest NASDAQ IPO for a biotech, raising $604.3 million to advance a large pipeline of mRNA vaccines and therapeutics.

The U.S.’s Defense Research Advanced Projects Agency (DARPA) had placed early bets on mRNA vaccine technology years prior, but in 2018, when Moderna went public, mRNA had yet to be validated in the clinic. 

That was still the case heading into 2020. The year has been transformative for the modality.

At least five biotechs with mRNA platforms have gone public on NASDAQ, and all of them have outperformed the broader biotech market in the past 12 months, even though only Moderna and BioNTech have seen their COVID-19 vaccines validated in Phase III trials. The other three companies have COVID vaccines in earlier stages of development. 

Moderna, which went public at a postmoney valuation of $7.6 billion, closed Friday at $140.23, giving it a market cap of $55.5 billion. 

In addition to its U.S. commitments for mRNA-1273, the biotech also has contracts to supply 160 million doses to the European Union; 50 million doses to Japan; 40 million doses to Canada with an option for an additional 16 million doses; 7.5 million doses to Switzerland; 7 million to the U.K.; and 6 million to Israel. 

EMA has a CHMP meeting planned for Jan. 6 to assess mRNA-1273.

Next up in vaccines

Thursday’s FDA adcomm highlighted the recruitment and data collection challenges to come for ongoing vaccine trials. 

Moderna and Pfizer have both signaled plans to unblind their trials and offer their vaccines to participants who received placebo, which would complicate matters for long-term data collection. And as authorized vaccines become more widely available, it will become less attractive for individuals to volunteer for a trial in which they may receive placebo.

Operation Warp Speed’s Chief Scientific Adviser Moncef Slaoui expects final efficacy data for viral vector vaccines from the Janssen unit of Johnson & Johnson (NYSE:JNJ) and partners AstraZeneca plc (LSE:AZN; NASDAQ:AZN) and University of Oxford by mid-January.

Janssen’s JNJ-78436735 human serotype 26 adenovirus (Ad26) is being tested as both a single-dose and two-dose vaccine; AstraZeneca’s AZD1222, a chimpanzee adenovirus vector vaccine, is administered in two doses. 

The initial data from AstraZeneca’s vaccine were not as impressive as the data from the mRNA vaccines, and questions remain about whether immunity against the vaccine’s vector may have diminished efficacy. 

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