The threat of another influenza pandemic arising from bird-to-human and then human-to-human transmission drives continuing efforts to develop effective vaccines against avian influenza. In the latest advance in this area, researchers at Novavax Inc. have reported a new vaccine against avian influenza strain A(H5N1) clade 2.3.4.4b.
Solid phase III efficacy results for Moderna Inc.’s seasonal influenza vaccine, mRNA-1010, may lead the company to resubmit a BLA for a flu/COVID-19 combo shot it has been developing. The top-line data showed Moderna’s flu vaccine produced a superior relative efficacy that was 26.6% higher than a comparator standard-dose seasonal influenza vaccine in people ages 50 and older.
Without convening the U.S. CDC’s Advisory Committee on Immunization Practices, Health and Human Services Secretary Robert Kennedy decided to bring the government’s COVID-19 vaccine recommendations in line with the FDA’s new “evidence-based” approach to the shots.
Frets about how the new federal administration might affect prospects for vaccines were quelled at least somewhat by the U.S. FDA green light for Novavax Inc.’s COVID-19 vaccine Nuvaxovid, indicated for adults 65 and over and people 12-64 years old with at least one underlying condition that puts them at risk of severe outcomes from infection by the virus.
The BioWorld Infectious Disease Index has struggled to gain ground in 2024 but has held relatively steady in recent months. After ending July down 7.66%, it closed October down 12.07% and sat at an 8.86% decline for the year as of Nov. 22.
Shares of Novavax Inc. (NASDAQ:NVAX) dropped nearly 20% Oct. 16 to close at $10.15 after the company reported a serious adverse event had prompted a U.S. FDA clinical hold for its COVID-19-influenza combination and standalone flu vaccine candidates.
The BioWorld Infectious Disease Index (BIDI) has rebounded significantly from its lowest point this year, improving from a 25.12% drop in late April to a 7.66% decline by the end of July. Despite the recovery, BIDI still lagged behind the Nasdaq Biotechnology Index, which rose 10.82% by July’s close, and the Dow Jones Industrial Average, which gained 8.25% year to date.
A licensing deal worth potentially up to $1.2 billion with Sanofi SA has breathed new life into Novavax Inc., which has struggled to compete in the COVID-19 space with powerhouses Pfizer Inc. and Moderna Inc.
The official end of the COVID-19 public health emergency in the U.S. in May did not mark the end of interest and investment in the area. In the shifting landscape, attention has pivoted to new markets, emerging strains, boosters, and the commercialization and distribution of COVID-19 vaccines and therapies.
Instead of the bivalent COVID-19 vaccines comprising both the original and omicron BA.4/BA.5 SARS-CoV-2 strains that have been in use in the U.S. since April, the CDC’s Advisory Committee for Immunization Practices voted 13-1 Sept. 12 to recommend the universal use of updated monovalent XBB-containing COVID-19 vaccines as authorized or approved by the FDA.
