Moderna (NASDAQ:MRNA) MRNA is nearing the much-anticipated event for the company this year as the FDA’s Vaccines and Related Biological Products Advisory Committee will discuss its emergency use request for its coronavirus vaccine candidate, mRNA-1273, on Dec 17.
The company is looking to get an emergency use authorization (“EUA”) for the candidate for use in individuals 18 years of age and older.
The company’s investors have shown much enthusiasm during the development of mRNA-1273 as evident from its stock’s rally of more than 650% so far in 2020. Favorable voting for the candidate’s EUA by the advisory committee can drive share prices higher. Like Pfizer PFE/BioNTech BNTX, Moderna may also get an EUA from the FDA in a day or two if the advisory committee gives the green signal. A vote in favor of mRNA-1273 is highly likely as the candidate has been proved effective and safe in a late-stage study.
The FDA has released a briefing document ahead of the meeting that also suggests that the reviewers of the EUA had found Moderna’s coronavirus vaccine candidate to be safe and effective.
Moderna’s shares have skyrocketed 652.7% so far this year compared with the industry’s rise of 8.7%.
Please note that mRNA-1273 demonstrated encouraging efficacy rate of 94.1% during primary efficacy analysis from the phase III COVE study evaluating it in adult patients. Moreover, the candidate demonstrated full protection against severe COVID-19 cases as well.
Meanwhile, with rising COVID-19 infection cases in the United States, crossing 200,000 per day mark, and large requirement of vaccine doses, rapid approval/launch of multiple vaccines is the need of the hour. Companies like AstraZeneca (NASDAQ:AZN) AZN and J&J with vaccine candidates still in late-stage studies may see get approval next year.
However, we note that the briefing documents mentioned three cases of facial paralysis (Bell’s palsy) in the vaccinated group in the COVE study compared to one in placebo group. Moreover, the FDA has opined that three serious adverse events are likely related to the vaccine candidate. The company has also stated that its candidate may lead to potential risks including vaccine-associated enhanced disease and anaphylactic reactions. Moreover, long-term effectiveness of any vaccine is yet to be determined.
Although a small number of adverse events may not deter the advisory committee from voting in favor of mRNA-1273, but any negative outcome will significantly hurt Moderna’s share price. The share price of Moderna has been consolidating within a range since the start of this month. The advisory committee outcome is likely to set the future course for the stock.
Meanwhile, Moderna has started evaluating mRNA-1273 in adolescent patients aged 12 years or more. The company plans to generate sufficient data by mid-2021 to support regulatory filings, seeking emergency authorization/approval for use of mRNA-1273 in adolescents. The company also has plans to initiate one surveillance study for evaluating the candidate in pregnant women and two other surveillance studies — active follow-up for safety and real-world effectiveness study.
Zacks Rank
Moderna currently carries a Zacks Rank #3 (Hold).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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