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FDA Chief Tells Senate Agency Is Preparing for Bird Flu Mutation
The Food and Drug Administration (FDA) informed legislators on Wednesday that the agency is making preparatory measures in case the current avian flu is able to mutate and transmit to humans on a massive scale.
FDA Commissioner Robert Califf told the Senate Appropriations Committee that although the risk to the public is low, early investment is critical: “If we institute the countermeasures now, and reduce the spread of the virus … we’re much less likely to see a mutation that jumps to humans for which we’re ill-prepared.”
The FDA has found that about 20% of raw, unpasteurized milk from bulk tanks contained virus samples. The agency noted that “no evidence of live virus” was found in pasteurized milk, which is the vast majority of milk consumed in the United States.
“So we’ve got to have testing. Gotta have antivirals, and we need to have a vaccine ready to go. So we’ve been busy, getting prepared for if the virus does mutate in a way that jumps into humans on a larger level,” Califf told the senators.
“We’re in an enviable position compared to any time in the history of the world,” Califf said. “Viruses are relatively simple, so coming up with a matching vaccine is entirely possible in a short period of time.”
Adult RSV Shots Given to More Than 30 Babies by Mistake — ‘Administration Errors Are Preventable With Proper Education and Training,’ Say Study Authors
Nearly three dozen babies and young children have received respiratory syncytial virus (RSV) vaccines, which are only approved for adults, according to a brief CDC report.
Data from the Vaccine Adverse Event Reporting System (VAERS) revealed 27 reports of the Pfizer RSV vaccine (Abrysvo) and seven reports of the GSK RSV vaccine (Arexvy) being mistakenly administered to children under the age of 2 between Aug. 21, 2023, and March 18, 2024, Pedro Moro, MD, MPH, of the CDC in Atlanta, and colleagues detailed in Pediatrics.
Eric Simões, MD, a pediatric infectious diseases expert at Children’s Hospital Colorado in Aurora, told MedPage Today that he was “not surprised” by the vaccine errors. “Mistakes will happen, especially with COVID vaccines being given to [both] adults and children, with pneumococcal vaccines being first given to children and now to adults, etc.” Simões said that he did not personally know of any cases where the RSV vaccines had been administered to children, but emphasized that “adult RSV vaccines should absolutely not be given to children.”
Twenty-seven of the reports noted no adverse health events associated with the erroneous vaccines, but the remaining seven described at least one adverse event. One of those events occurred in an infant with a history of congenital heart disease who received the GSK RSV vaccine in combination with routine childhood vaccinations. That child required hospitalization for cardiorespiratory arrest within 24 hours after vaccine receipt. The remaining six reports described injection site reactions or systemic reactions, such as irritability, after receiving the RSV vaccines.
Moderna’s First Vaccine Was a Big Hit. Its Second Is a Let Down
Moderna Inc.’s pioneering COVID shot turned the company into a nearly $200 billion biotech giant and a public health hero. Its second vaccine, meant to prevent a common respiratory virus, is calling into question the premise on which the company has staked its entire business.
The forthcoming RSV shot, expected to get U.S. regulatory approval this month, is Moderna’s first chance to show the versatility of mRNA technology to more effectively treat and prevent a range of illnesses from the flu to cancer. It will be the first mRNA product for something other than COVID.
Yet the vaccine doesn’t clearly perform any better than what’s already on the market. Early signs from clinical trials suggest that Moderna’s shot wears off faster than offerings from GSK Plc and Pfizer Inc. Analysts only expect it to bring in $340 million in revenue this year — less than half of what competitors made off their RSV vaccines last year and a tiny fraction of Moderna’s COVID shot revenue.
Investors have taken notice. Moderna’s stock dropped 45% last year, making it the worst-performing large biotech in the US. It’s also a popular target for short sellers. Moderna Chief Executive Officer Stéphane Bancel swats away the skepticism, portraying a seemingly unshakeable belief in what he calls the mRNA “platform.”
Moderna is all in on mRNA. Each of the more than 40 drugs in its pipeline relies on the technology. The company’s new Cambridge, Massachusetts, headquarters welcomes visitors with a giant screen featuring a rotating mRNA molecule. “Everybody that works here wakes up in the morning thinking about mRNA,” said Kyle Holen, Moderna’s head of development for oncology and therapeutics.
UK Refuses to Sign Global Vaccine Treaty, The Telegraph Reports
Britain is refusing to sign the World Health Organization’s (WHO) pandemic accord because the country says it would have to give away a fifth of its vaccines, the Telegraph reported on Wednesday.
According to a draft of the pandemic accord being negotiated at the WHO, richer countries should be asked to pull their weight in helping the world cope with pandemics, including reserving 20% of tests, treatments and vaccines for the WHO to distribute to poorer countries during emergencies.
“We will only support the adoption of the accord and accept it on behalf of the U.K., if it is firmly in the U.K. national interest and respects national sovereignty,” a spokesperson for Britain’s Department of Health and Social Care said in a statement to Reuters.
One of the main points of disagreement between wealthy countries and developing states is the vexed issue of sharing drugs and vaccines fairly. Countries are due to finalize negotiations on the accord on May 10, with a view to adopting it at the WHO’s annual meeting later this month.
FDA Postpones Advisory Committee Meeting on Next COVID Vaccines
The U.S. Food and Drug Administration (FDA) yesterday announced that it has changed the date of its upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) from May 16 to June 5, during which the group will discuss and make recommendations on the strain or strains to include in 2024-25 COVID vaccines.
In an X post, the FDA said the new date will allow more time to obtain surveillance data and other information so that the group has the most up-to-date information for making its recommendations. The agency added that it doesn’t expect that the date change will hamper vaccine availability for the fall.
Current vaccines target the XBB.1.5 variant, but JN.1 has become the dominant strain. The World Health Organization (WHO) COVID vaccine advisory group recently met and recommended a switch to a monovalent (single-strain) vaccine containing the JN.1 antigen.
However, scientists have been tracking a steady rise in JN.1 offshoots that have two added spike mutations, nicknamed the FLiRT (F for L at position 456 and R for T at position 346), which may give them more immune-evasive properties. In the United States, for example, the proportion of KP.2, which has the FLiRT mutations, recently topped the parent JN.1 strain.
Was COVID Vaccine Recalled Over Health Danger Fears? What We Know
Pharmaceutical company AstraZeneca has initiated a global withdrawal of its COVID-19 vaccine just months after it admitted it could cause a rare side effect. The news sparked speculation on social media that the vaccine was being withdrawn because of concerns about associated health risks.
Despite media reports and social media speculation, AstraZeneca has withdrawn the vaccine, but not recalled it. A recall, which would mean the medication was removed from shelves, typically takes place when there are safety concerns, defects, or regulatory issues posing risks to public health. A withdrawal means that the vaccine is no longer being actively manufactured or supplied by the company.
The company said it had withdrawn its marketing authorizations for the vaccine in the European Union on March 5, which came into effect on May 7. AstraZeneca will make similar applications in the coming months in the U.K. and other countries that had approved the use of the vaccine, the Telegraph reported. The vaccine was never approved for use in the United States.
The withdrawal comes as the company faces a class-action lawsuit in the U.K. over allegations of side effects associated with the vaccine.
The company is contesting the claims, but admitted in a February legal document that its COVID vaccine “can, in very rare cases, cause TTS,” according to the Telegraph. TTS, or Thrombosis with Thrombocytopenia Syndrome, is a rare side effect linked to certain COVID-19 vaccines, which can manifest in the form of blood clots and a low blood platelet count.
Revolving Doors: Board Memberships, Hedge Funds, and the FDA Chiefs Responsible for Regulating Industry
At his public confirmation hearing in late 2021, Robert Califf, President Biden’s nominee to lead the U.S. Food and Drug Administration (FDA), faced pointed questions about his financial relationships with industry.
Bernie Sanders, the senator from Vermont, asked, “At a time when the American people are outraged by the high cost of prescription drugs, deeply disturbed about what happened with Purdue and Oxycontin, what kind of comfort can you give to the American people when you have been so closely tied to the pharmaceutical industry yourself?” He added, “How can the American people feel comfortable you’re going to stand up to this powerful special interest?”
Califf responded: “Senator Sanders, I have a history of doing that. But I’d also point out that this administration has the most stringent ethics pledge in the history of administrations.”
Califf did not earn Sanders’s vote, but he got the job. With it, the incoming FDA commissioner committed to selling his pharmaceutical stocks and severing his financial relationships with biotech companies such as Alphabet-owned Verily Life Sciences, which paid Califf $2.7m as a senior adviser, according to his federal disclosure (see supplementary files on bmj.com).
The revolving door between the FDA and industry surprises few anymore, despite the widely acknowledged potential it has for undermining public trust in government. And stories about FDA commissioners’ heavy ties to industry have become commonplace: nine of the FDA’s past 10 commissioners went on to work for the drug industry or serve on the board of directors of a drug company.
A New Cholera Vaccine Will Increase Supply, but Will It Be Enough to Manage Global Outbreaks?
Weeks after the global public health community sounded the alarm on the shortage of cholera vaccine, the World Health Organization moved to prequalify a new cholera vaccine last month. The vaccine is a simplified version of the two existing oral vaccines, both produced by Korean vaccine manufacturer EuBiologics Co.
The company will begin making the new vaccine, called Euvichol-S, this year. “We simplified the formulation, which reduces the complexity, the cost, and the time for producing the vaccine,” said Julia Lynch, the director of the cholera program at the International Vaccine Institute, a nonprofit that codeveloped the cholera vaccines with EuBiologics Co. “With this simplified formulation, it’s expected that we’ll increase the production capacity by about 40% — using the same personnel, the same facilities.”
Along with a new manufacturing plant that will be at full capacity next year, EuBiologics will be able to produce 50 million cholera vaccine doses in 2024, and 80 million in 2025, said Lynch — most of which will be Euvichol-S. But even this increase in production may not be sufficient to address the surging global demand.
Novo Taps Another Flagship Startup in Search for Next Obesity Drugs
Novo Nordisk is again turning to a Flagship Pioneering startup to find new weight loss drugs, announcing on Thursday a deal with Metaphore Biotechnologies to develop up to two medicines for obesity.
Through the partnership, Novo could pay the startup as much as $600 million in upfront and milestone payments and has committed to participate in a future financing round, Metaphore said in a statement. The biotech didn’t disclose the amount of the initial cash payment.
In return, Metaphore will help Novo discover up to two drugs aimed at the GLP-1 receptor — the target of Novo’s popular weight loss therapy Wegovy — and “related biology,” the companies said. The goal is to create “scalable” drugs with longer-lasting effects. Currently approved GLP-1 drugs for obesity, like Wegovy and Eli Lilly’s Zepbound, require weekly injections and are in short supply.
