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Novavax Says Its COVID-19 Shot Is on Track for Full FDA Approval After Delay
U.S. News & World Report reported:
Novavax’s closely watched COVID-19 vaccine is on track for full approval after additional discussions with the Food and Drug Administration (FDA), the company said Wednesday. The news sent company shares soaring more than 21% in morning trading and appeared to resolve concerns that Trump administration officials might be holding up a decision on the shot.
Novavax makes the nation’s only traditional protein-based COVID-19 vaccine. It is still being sold under emergency use authorization — unlike mRNA vaccines made by Pfizer and Moderna that have earned full FDA approval for certain age groups.
The FDA recently asked Novavax to develop a plan for collecting additional clinical data from those who have gotten the shot, the company said in a statement. It said it is “engaging with the FDA expeditiously” in hopes of receiving approval “as soon as possible.”
At FDA, full vaccine approval is the gold standard. The agency was on track to sign off on Novavax’s license by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss confidential agency matters.
TV Drug Ad Spending Continues Upward Climb, Logging Nearly 30% Growth in Q1
Pharma advertisers have kicked off 2025 with a bang, with the top 10 spenders throwing almost 30% more money behind their TV commercials in the first quarter compared to the same period a year ago.
Across the first three months of this year, according to iSpot.TV, drugmakers have spent a combined $729.4 million to air commercials for the top 10 brands, up from $567.3 million in the first quarter of 2024. That represents a slight sequential increase, too, growing close to 2% over the $717.4 million outlay from the biggest spenders in the fourth quarter of 2024.
The spending spree was helped along by several major broadcast events throughout the period. Six of the top 10 drugs on the list counted NFL programming as their top TV program by spend, and another two listed men’s college basketball in the top slot — fitting for a quarter that included both the Super Bowl and the majority of the annual NCAA March Madness tournament.
Creators of No-Needle COVID-19 Vaccine Made in Hamilton Seeking Participants
More than 300 people are currently being recruited for the testing of a no-needle COVID-19 vaccine that’s made in Hamilton. This particular vaccine, formally named ChAd-triCoV/Mac, is inhaled instead of injected.
The vaccine is being developed at McMaster’s Robert E. Fitzhenry Vector Laboratory — the university’s immunology research centre — and is “entirely Canadian… with Canadian participants, at Canadian research sites.” The original call for participants went out in March, with 30 participants enrolled at the Hamilton site so far, AeroVax told CTV News Toronto. In total, the AeroVax study is looking for 350 people between the ages of 18 to 65 in Hamilton, Ottawa and Halifax, who have received at least three doses of a mRNA COVID-19 vaccine like Pfizer or Moderna, according to an AeroVax release.
Aerovax says the inhaled vaccine was “more effective at inducing immune responses than traditional injected vaccines because it directly targets the lungs and upper airways.” The vaccine started Phase 1 with 36 participants. Phase 1 verified that there were no major side effects, AeroVax says, and also helped to verify the appropriate dose for Phase 2.
Further details of Phase 1 will be available as soon as the study’s findings are published, AeroVax says.
Scientists Discover Drug That Could Finally End Long COVID Suffering
Researchers have discovered that a new drug compound can prevent long COVID symptoms in mice, a major breakthrough that could pave the way for future treatment of this debilitating condition. In this world-first study, mice treated with the antiviral compound, developed by a multidisciplinary team at WEHI, were protected from long-term brain and lung dysfunction, two hallmark symptoms of long COVID.
The research team hopes these groundbreaking results will lead to clinical trials and eventually the first approved treatment for the condition. Long COVID, also known as post-acute sequelae of COVID-19, is a chronic illness marked by symptoms that persist for weeks or months after the initial infection.
It is a significant health burden that remains poorly understood — with symptoms ranging from breathing difficulties to brain fog and chronic fatigue. Despite millions of people worldwide reporting these symptoms, the cause of long COVID remains largely unknown and there is no approved treatment for the disease.
Proposed Anti-Vaccine Bill May Make It Harder for SC Pharmacists to Deny off-Label Prescriptions
A push from lawmakers to crack down on post-pandemic rules related to vaccines and quarantine protocols could rope pharmacists into an uncomfortable position. While lawmakers assert a bill they’re proposing is about personal freedoms, it may hinder pharmacists’ ability to deny medications in certain situations.
“You’re forcing a pharmacist to not be able to do what they are supposed to do, and that’s to protect the public from themselves,” said Brian Clark, CEO of the South Carolina Pharmacy Association. “I would equate this into turning a pharmacy into a vending machine. There’s no protection of the patient.”
Legislation in the Senate dubbed the Medical Informed Consent Act, sponsored by Sen. Shane Martin, R-Spartanburg, would eliminate any possibility for the state or a corporation operating in South Carolina to mandate vaccines for their employees. Supporters say it ensures the COVID-19 vaccine, or any other “novel” inoculation, is not forced on anyone.
A part of the bill, however, states that pharmacists couldn’t deny a prescription for the off-label use of any drug approved by the Food and Drug Administration to treat an infectious disease or life-threatening illness during a public health emergency or a state of emergency. Under a state of emergency, which is declared by the governor, circumstances can range from wildfires to hurricanes.
