Moderna stock rose Wednesday after the biotech said its experimental RSV vaccine proved nearly 84% effective against respiratory symptoms in older adults.
The company tested its vaccine in people age 60 and older. It was 83.7% effective against mild respiratory syncytial virus, or RSV. The virus causes cold-like symptoms. It can be deadly in infants who have virtually nonexistent immune systems and older adults who have weakened immunity.
The results are competitive with Pfizer and GSK, both of which are approaching Food and Drug Administration review dates for their RSV vaccines in May. Johnson & Johnson and Bavarian Nordic trail with potential vaccines.
Moderna is planning to file for approval of its RSV vaccine in the first half of this year. Needham analyst Joseph Stringer expects the FDA to approve the shot before year's end.
"We think Moderna's profile is competitive and has the potential to capture a meaningful share of the multi-billion dollar RSV market," he said in a note to clients.
Moderna Stock: A Battle Brewing In RSV
On the stock market today, Moderna stock jumped 3.3% to close tat 197.02. Pfizer stock sank 2.3% and closed at 45. GSK stock ended the regular session at 35.19, down 1%.
Moderna Chief Executive Stephane Bancel says the results further prove the capabilities of the company's platform in messenger RNA, or mRNA. In the body, messenger RNA carries the genetic instructions for making proteins. Vaccines take advantage of this process, telling the body to make specific proteins in order to prompt an immune response.
"Today's results represent an important step forward in preventing lower respiratory disease due to RSV in adults 60 years of age and older,"Bancel said in a written statement issued late Tuesday. "These data are encouraging and represent the second demonstration of positive Phase 3 (study) results from our mRNA infectious disease platform."
Moderna tested its RSV vaccine in 37,000 adults age 60 or older in 22 countries, including the U.S. The company reported an interim analysis, examining the number of participants to develop two or more symptoms of RSV. Of the 64 people to develop symptoms, 55 received the placebo. Nine were vaccine recipients.
Another measure looked at participants to develop three or more symptoms of RSV. Moderna said there were 20 people in the study to hit that mark, including 17 placebo recipients and three vaccinated people. That put the effectiveness at 82.4% against so-called severe RSV.
An independent team of data monitors reviewed Moderna's test results and said there have been no safety concerns.
The results help Moderna stock continue trending higher. Shares have turned around this month and have a strong Relative Strength Rating of 90 out of a best-possible 99, according to IBD Digital. This puts Moderna stock in the leading 10% of all stocks in terms of 12-month performance.
Comparing RSV Vaccines
Now, Moderna plans to submit the data to a peer-reviewed publication and present more data at a future infectious diseases conference.
By comparison, GSK has said its RSV vaccine was almost 83% effective overall and more than 94% protective against severe RSV in adults age 60 and older with underlying health problems. Pfizer's shot was close to 67% protective overall and about 86% effective against severe disease.
"Based on high level comparison with vaccine effectiveness from RSV vaccines from competitors Pfizer, GSK and J&J, we see these results as likely approvable and plausibly competitive with those agents," SVB Securities analyst Mani Foroohar said in a note. He noted the results are still early and comparing the various competitors' studies "should consequently be taken with a grain of salt."
Trailing, Bavarian Nordic plans to have its Phase 3 RSV vaccine results in the middle of the year. J&J is also in final-phase testing with results possible in the second half of 2024, Needham's Stringer said.
Foroohar, the SVB analyst, expects Moderna to ask for a speedy review of its RSV vaccine.
This would allow "approval in time to give Moderna a more fulsome opportunity to participate in the 2023 contracting season," he said. Foroohar boosted his price target on Moderna stock to 111 from 102, but kept his market perform rating.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
