COVID-19 Vaccine(Janssen)

Invivyd has received advice from the US Food and Drug Administration (FDA) on a rapid pathway to potential Biologics License Application (BLA) approval for its novel monoclonal antibody (mAb) candidate VYD2311, for the prevention of COVID-19. The FDA provided advice for pursuit of a traditional BLA pathway for the prevention of COVID-19 caused by SARS-CoV-2 in adults and adolescents weighing at least 40 kg, including immunocompromised people, subject to agreement on safety database size and pending full protocol review. A phase 2/3 randomised, double-blind, placebo-controlled trial with a primary endpoint of RT-PCR-confirmed symptomatic COVID-19 was recommended, with a timepoint for measuring the primary endpoint coinciding with the expected duration of protection. This was anticipated as 12 weeks (three months), and the potential for selection of an additional, longer duration timepoint, which Invivyd anticipates as 24 weeks (six months). “We believe monoclonal antibodies such as VYD2311 can serve as a powerful alternative to vaccines for COVID-19 prevention, and represent an important potential paradigm shift to move American medicine beyond the real and perceived limitations of COVID-19 vaccines,” said Marc Elia, Chairman of Invivyd’s Board of Directors. “COVID-19 monoclonal antibody medicines work alongside natural human immunity without needing to activate the immune system and, amid declining public trust in vaccines, we want to offer Americans a new, non-vaccine choice.” FDA advice and background statements to Invivyd cited observations on Invivyd’s phase 3 randomised clinical trial of pemivibart for the prevention of COVID-19 (CANOPY), the antiviral durability of pemivibart and the strong protection demonstrated by pemivibart in CANOPY Cohort B, while recognising that Invivyd antibodies stem from a common molecular lineage. Multiple such Invivyd antibodies have undergone successful randomised, placebo-controlled clinical trials, including efficacy assessment. In agreement with FDA advice, Invivyd plans to study two doses of VYD2311 to assess any differences in resulting levels of protection or differences in safety. “The FDA’s clear and constructive feedback provides a well-defined path forward for our COVID-19 development programme. We believe the FDA’s feedback underscores the shared urgency to advance innovative solutions for prevention of COVID-19,” said Rachael Gerlach, Vice President, Regulatory Affairs at Invivyd. “Combined with Invivyd’s unique discovery platform, this alignment is a critical step in bringing forward a potentially important, medically attractive and patient-friendly alternative to COVID vaccination.” “Our completed first-in-human study of VYD2311 demonstrated high SARS-CoV-2 antiviral titers and an attractive safety profile at very high doses, well beyond doses we contemplate going forward with in development. We look forward to opening a US IND and moving as quickly as possible to finalise a pivotal clinical trial design with the FDA,” said Mark Wingertzahn, Senior Vice President, Clinical Development at Invivyd.

During a tense Senate hearing, Robert F. Kennedy Jr. blamed the pharma industry and fell back on misinformation as he sought to defend his eight-month tenure. During a tense and at times incendiary senate hearing Thursday, Robert F. Kennedy Jr. blamed the pharmaceutical industry and fell back on vaccine misinformation as he sought to defend the tumult that has consumed the federal health apparatus during his first eight months as the nation’s Department of Health and Human Services (HHS) secretary. Lawmakers from the U.S. Senate Committee on Finance laid into RFK Jr. Thursday over the HHS chief’s chaotic tenure, which has materialized in high-profile leadership turnover at key agencies and mounting influence of vaccine skepticism at the Centers for Disease Control and Prevention (CDC).Several Democrats on the committee took their criticism a step further, suggesting that RFK Jr. is a danger to public health and should be fired by President Donald Trump if he does not resign first. ACIP dismissals Much of the hearing Thursday revolved around RFK Jr.’s decision to fire every member of the CDC’s Advisory Committee of Immunization Practices (ACIP) in June and subsequently slot in his own personal appointees.“No one in your job has ever fired every committee member all at once,” Michael Bennet, D-Colo., said. “That month, you told the American people that were, ‘going to bring great people onto the ACIP panel,’ not anti-vaxxers.”“Robert Kennedy fired every member, every single one, of the group responsible for making vaccine recommendations to doctors across the country under the false pretense of conflicts of interest,” Oregon Democrat Ron Wyden said. “Meanwhile, many of the new members of the panel are outright vaccine deniers who have appeared as paid witnesses in lawsuits against vaccine makers. Their conflicts of interest and ethics disclosures remain hidden under lock and key.”When asked by Bennet about whether the ACIP shake-up—and potential future changes to immunization recommendations—could lead to fewer vaccinated kids, RFK Jr. said he “did not anticipate a change in the [measles, mumps and rubella] vaccine,” caveating that the ACIP is an “independent panel.”At that point, the hearing devolved into a shouting match, with Bennet suggesting that the American people “deserve so much better than your leadership.”RFK Jr. responded that Americans “deserve the truth, and that’s what we’re going to give them for the first time in the history of our agency.” It’s unclear whether he was referring to the ACIP, the CDC or the HHS more broadly.When Virginia Democrat Mark Warner pressed Kennedy to respond to a recent warning by the American Academy of Pediatrics that ACIP has been politicized at the expense of children's health, the HHS secretary fell back on claims of undue industry influence. "I think the American Academy of Pediatrics is gravely conflicted," Kennedy said. "Their biggest contributors are the four largest vaccine makers; they run a journal, Pediatrics, which they make a lot of money on, that is completely dependent on pharmaceutical companies. So, I wouldn't put a big stake in what they say that benefits pharmaceutical interests."  Mixed messaging on drug pricing Multiple lawmakers took issue with the HHS secretary’s claims that the administration’s actions are wresting influence away from the powerful pharmaceutical industry.While RFK Jr. has claimed that he and Trump are looking to push back against pharma middlemen and confront high U.S. drug costs, his “record tells a different story,” Catherine Cortez Masto, D-Nev., said during the hearing. The senator argued that, instead, Trump’s “big, beautiful bill” has handed a “massive win” to the industry by shielding lucrative drugs like Merck’s Keytruda from Medicare price negotiations.Cortez Masto was referring to the Orphan Cures Act provision included in the bill, which exempts drugs with multiple rare disease indications from Medicare price negotiations. While the move is meant to avoid disincentivizing follow-on studies of approved rare disease therapies, concern has mounted that the provision will also protect highly profitable—and expensive—drugs like Keytruda that were initially approved in orphan indications before massively expanding their scope.Under the Inflation Reduction Act (IRA), the three best-selling cancer drugs in the U.S.—Keytruda, Opdivo and Darzalex—were “widely expected” to be selected for Medicare price negotiations next year, Cortez Masto said. But now, through the passage of Trump’s big bill, those medicines are “exempt from negotiation for at least several additional years, if not permanently.”In response, RFK Jr. said that “the Medicare drug negotiations in IRA were very well intentioned, but they were poorly structured,” claiming that the pricing talks that have taken place have raised costs for Medicare instead of reducing them.Vermont Democrat Peter Welch voiced similar concerns around prices, alleging that RFK Jr.’s policies are making the “healthcare affordability crisis in this country” worse, not better.“Citizens of the United States, our employers, our taxpayers and our families pay the most and get the least,” Welch said. “That has been persistent and chronic, and it’s not being addressed, it’s being aggravated.”Welch ended his time by challenging his peers in the Senate "to do our job,” noting the legislative body's “constitutional responsibility to be a check and balance.” He stressed his belief that “we have to fight Big Pharma and bring down the prices” and urged RFK Jr. to support his and Wyden's legislation that seeks to reverse those aforementioned price negotiation exemptions. COVID-19 shots and other vaccines RFK Jr. doubled down on past efforts to upend the science behind COVID-19 mRNA shots and other vaccines.The hearing started off with the committee’s ranking member Wyden asking Chair Mike Crapo, R-Idaho, to formally swear RFK Jr. in as a witness under oath, arguing that the HHS secretary has told lies in the past. Crapo denied the request. “This is a witness who has lied to members of the Senate Finance Committee in response to over 35 written questions, including from me,” Wyden explained. “He said, and I quote, that he would do nothing as HHS Secretary that makes it difficult or discourages people from taking vaccines. That was clearly not true—his unprecedented unilateral actions to restrict access to COVID vaccines, that alone proves it.”Minnesota Democrat Tina Smith pointed to RFK Jr.’s contradicting statements to the Senate versus on social media that she argued erode his credibility, citing his claims that he has never been an anti-vaxxer despite alleging that “no vaccine is safe” on the “Lex Fridman Podcast” in July 2023. After canceling $500 million in federal money for mRNA vaccine research projects in August, RFK Jr. today stated that he believes mRNA vaccines can cause a form of AIDS and can damage children’s brains, hearts and immune systems or even lead to death. The beliefs stems from Robert Malone, M.D., a physician and biochemist known for his criticism of mRNA COVID-19 vaccines and one of RFK Jr.’s new appointees for the CDC’s immunization advisory panel.The claims are untrue, having been disproven by numerous peer-reviewed studies.Colorado's Bennet cited the multiple studies that have demonstrated that the COVID-19 vaccine reduced infections and severe disease and saved at least 3 million lives in the U.S. in the first two years of use. RFK Jr. wrote the data off because they were “modeling studies.”When asked by Texas Republican John Cornyn whether he believes COVID-19 was politicized, RFK. Jr. said, “We were lied to about everything.”“We were told again and again the vaccines would prevent transmission, they prevent infection. It wasn't true. They knew it from the start,” RFK Jr. said.But RFK Jr.’s argument is a red herring, as reducing viral transmission was never necessary for COVID-19 shots to gain FDA approval or for the vaccines to provide protection against severe outcomes.Washington’s Democratic Sen. Maria Cantwell used her time to tell RFK Jr. that she didn’t support his continued efforts as HHS secretary.“Sir, you're a charlatan,” Cantwell said. “The history on vaccines is very clear … You are perpetrating hoaxes.”When asked by Virginia’s Warner whether he accepted the fact that a million Americans died from COVID-19, the HHS leader said he didn’t know how many Americans had died. “You’re the secretary of health and human services. You don't have any idea how many Americans died from COVID?” Warner clarified.“I would like to see the data,” RFK Jr. said. “I don't think anybody knows, because there was so much data chaos coming out of the CDC.”“You’ve had this job for eight months, and you don’t know the data?” Warner asked incredulously.“The problem is that they didn't have the data, the data by the Biden administration,” RFK Jr. said.Several senators also called into question RFK Jr.’s ability to continue serving as head of the nation’s health department.Near the end of the three-hour hearing, Georgia Democrat Raphael Warnock deemed the leader a “hazard.”“You ought to resign,” Warnock said. “And if you don’t, President Trump should fire you.”Click here for CDC updates from the hearing by Fierce Healthcare or here for coverage on HHS employees call for RFK Jr.’s resignation.