JN.1 Subvariant SARS CoV-2 rS Vaccine(Novavax)

iStock, hapabapa The FDA was scheduled to release its decision on Novavax’s updated, protein-based COVID-19 vaccine on April 1. The FDA has missed its deadline for issuing a decision regarding the 2024-2025 formulation of Novavax’s COVID-19 vaccine, several media outlets reported on Wednesday. In a Wednesday statement, Novavax confirmed that the FDA should have released its verdict on Tuesday, April 1. “We had responded to all of the FDA’s information requests and we believe that our [Biologics License Application] is ready for approval,” the company noted. “We continue to wait on action from the agency and have not yet received an official decision from the U.S. FDA.” “We are confident our well-tolerated vaccine represents an important alternative to mRNA COVID-19 vaccines for the U.S.,” the company said in its statement. The missed deadline, which was first broken by the Wall Street Journal , comes just days after Peter Marks, the regulator’s top vaccines expert, stepped down from his post. Marks served as head of the FDA’s Center for Biologics Evaluation and Research before he was asked over the weekend to either resign or be fired, as per media reports . Marks’ exit triggered a sweeping selloff across the biopharma space, sending stocks of several companies crashing on Monday. In his resignation letter , Marks warned that Robert F. Kennedy Jr., recently confirmed as Secretary of Health and Human Services, doesn’t seem to be open to learning more about vaccines. “It has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Marks wrote. During his confirmation hearings, lawmakers blasted Kennedy for what Senator Michael Bennet (D-CO) called “peddling half-truths,” and questioned how having a known vaccine critic as HHS head would affect public health in the U.S. Since Kennedy’s confirmation, U.S. health agencies have suffered several setbacks, most of which involve vaccines. In February, for instance, a meeting for the Centers for Disease Control and Prevention’s vaccine advisory panel was postponed to April . A few days later, a meeting for the FDA’s advisory panel on vaccines was canceled . The regulator nevertheless came out with new flu immunization recommendations without convening its expert advisors. Novavax is seeking approval for a new formulation of its COVID-19 vaccine, to be used in the upcoming 2024-2025 season. This latest formulation is designed to target the JN.1 strain, which is the parent of the currently circulating variants. In an August 2024 announcement, the biotech said it was working with the FDA to facilitate the review of the COVID-19 shot, and claimed that the regulator “has committed to moving swiftly on regulatory action.”

International vaccine organization Gavi has discontinued a COVID vaccine partnership with China's Clover Biopharmaceuticals and is asking for repayment of $224 million. Last year, Novavax reached a settlement with Gavi, the Vaccine Alliance, after the international partnership demanded repayment following the termination of an advance purchase agreement for COVID-19 vaccines.Thirteen months later, Gavi may be on its way to a similar skirmish with China’s Clover Biopharmaceuticals after discontinuing another purchase agreement surrounding COVID shots.In a regulatory filing, the Shanghai-based company said that Gavi has sent notice of the termination of their vaccine deal and is demanding that the company return an advance payment of $224 million. “The Company rejects such claim for a repayment, believing it is without merit based on the terms of the Advance Purchase Agreement, and will defend itself vigorously,” Clover wrote, adding that it was not aware of any associated legal claims.Gavi did not respond immediately to a request for comment. In June of 2021, Clover and Gavi signed on to their partnership, with the company agreeing to provide up to 414 million doses of SCB-2019, its protein-based COVID shot, through 2022. But like Novavax, Clover struggled to meet regulatory targets in developing its vaccine.If Gavi succeeds in its latest demand, Clover may not have enough cash to pay the organization back. The biotech is struggling financially. In its most recent earnings release, after the first half of 2024, the company reported negative revenue. Its cash and cash equivalents had shrunk from 1.8 billion Chinese yuan ($248 million) at the end of 2022 to 830 million Chinese yuan ($114 million).  With the COVID shot now a dud, Clover is banking its future on a respiratory syncytial virus (RSV) vaccine candidate coded SCB-1019. The company also revealed on Monday that the FDA has cleared its application to start an in-human clinical trial of the non-adjuvanted bivalent RSV vaccine.The company added that it has enrolled the first participants in a phase 1 revaccination trial of the prefusion-stabilized F (PreF)-Trimer subunit shot. Results from another phase 1 trial last year indicated that SCB-1019 is a potential best-in-class vaccine compared to GSK’s Arexvy, Clover said.