Login
U.S., European Nations Consider Vaccinating Workers Exposed to Bird Flu
The United States and Europe are taking steps to acquire or manufacture H5N1 bird flu vaccines that could be used to protect at-risk poultry and dairy workers, veterinarians and lab technicians, government officials said, moves influenza experts say could curb the threat of a pandemic.
U.S. officials last week said they were moving bulk vaccine from CSL Seqirus (CSL.AX) that closely matches the current virus into finished shots that could provide 4.8 million doses of vaccine. European health officials told Reuters they were in talks to acquire CSL’s pre-pandemic vaccine.
Canadian health officials said they have met with GSK (GSK.L), the maker of Canada’s seasonal flu shots, to discuss acquiring and manufacturing a pre-pandemic bird flu vaccine once its seasonal flu production capacity is freed up. Other countries, including the U.K., are discussing how to proceed on pre-pandemic vaccines, scientists said.
Dawn O’Connell of the U.S. Administration for Strategic Preparedness and Response said the government is “looking closely” at the possibility of vaccinating farm workers and others in close contact with the virus.
CDC Says Vaccination Could Protect the U.S. From More Dangerous Mpox Virus
As concerns mount about a large outbreak of an especially virulent form of mpox in central Africa and an uptick in U.S. cases since early last year, the mpox vaccine appears to give long-term protection, the Centers for Disease Control and Prevention reported Thursday.
In a separate report, the CDC indicated that overall new mpox infections across the U.S. have remained at a steady, low level — about 60 cases weekly, compared with 3,000 cases a week at the outbreak’s summer 2022 peak — in recent months. However, cases so far this year are elevated nationally compared with the same period in 2023 and have seen a sharp increase in New York City.
On May 16, the CDC published an ominous report about nearly 20,000 recent cases of what is known as clade 1 of mpox that have been documented in the Democratic Republic of Congo, or DRC, since January 2023.
Novavax Awaits FDA Decision on Whether Its Next COVID Shot Can Be Offered in U.S.
Novavax (NVAX.O) will only be able to offer a COVID-19 vaccine in the United States this autumn if regulators accept the shot it has started manufacturing that targets a variant that was dominant earlier this year, the company said.
Novavax’s updated vaccine targets a variant called JN.1, which is in line with European recommendations. The European Union’s regulator told vaccine makers last month to update their vaccines for that variant because they would likely be effective against its descendant lineages.
The U.S. Food and Drug Administration has not yet made a decision on the makeup of the next round of COVID vaccines and a JN.1 subvariant known as KP.2 has become dominant in the United States over the past month.
Moderna and Pfizer each told Reuters they are waiting for the FDA’s advisers to discuss vaccine design at a June 5 meeting before settling on which variant their next vaccines will target.
COVID: South African Disclosures Reveal Secretive World of Nations’ Vaccine Contracts
Documents detailing negotiations between COVID vaccine manufacturers and the South African government show how drug companies pressured low and middle-income nations into accepting high prices and unusually harsh terms, say public health activists who secured the documents’ release from South Africa’s Supreme Court.
Fatima Hassan, director of the Health Justice Initiative, which reviewed the papers with help from the U.S. advocacy group Public Citizen and other analysts, said that the documents revealed “attempts to extract one-sided terms, especially by pharma giants Moderna and Pfizer, all while they profiteered from a global health emergency.”
The contracts that South Africa signed — with Pfizer, with Johnson and Johnson’s subsidiary Janssen, with the international vaccine alliance Gavi, and with the Serum Institute of India, maker of the AstraZeneca vaccine — are still the only vaccine contracts signed by a national government during the pandemic to see the light of day. Governments around the world were held to strict confidentiality agreements that kept terms, prices, and the details of negotiations secret, typically for at least a decade.
South Africa was legally obliged by the contracts’ terms to resist calls for their public disclosure, but government lawyers lost their bid to keep them confidential before the country’s highest court last August. The four contracts were then released to the Health Justice Initiative, which published a damning report last September.
Weight-Loss Drug Forecasts Jump to $150 Billion as Supply Grows
As millions seek access to weight-loss drugs from Novo Nordisk (NOVOb.CO) and Eli Lilly (LLY.N), increasing supplies, possible wider usage and a growing number of would-be rivals are leading some experts to raise annual global sales forecasts for the treatments to about $150 billion by the early 2030s.
A year ago, top sales estimates were in the $100 billion range.
Supplies of both Novo’s Wegovy and Lilly’s Zepbound remain constrained, but the companies have been increasing production.
Even After Sharp Sales Drop, Pfizer Sees Bright Side With Priority Review Voucher From Paxlovid Approval
In a change of pace from the recent COVID-related business struggles for Pfizer, the drugmaker has picked up a valuable reward from the FDA in the form of a priority review voucher (PRV). The agency doled out the PRV after determining that Pfizer’s COVID-19 antiviral Paxlovid meets the bar for classification as a medical countermeasure to a material threat, according to a notice (PDF) in the Federal Register. Paxlovid won its full FDA approval about one year ago.
Such vouchers, an extra incentive for developing treatments against diseases with high unmet need, have proven to be quite lucrative. Companies can either use them to speed up high-stakes drug reviews at the FDA or sell them to other drug developers.
A 2020 study found that 17 of the 31 PRVs awarded between 2009 and 2019 were sold for anywhere between $67 million and $350 million. Vaccine maker Valneva, for example, recently sold the PRV it received for commercializing the first vaccine to protect against mosquito-borne virus chikungunya, Ixchiq, to an unknown buyer for $103 million.
However Pfizer opts to use it, the PRV will surely come in handy. After a sharp drop in COVID-19 sales last year, the company is now underway with two large cost-cutting campaigns.
Lilly Invests Further $5.3 Billion in New Indiana Site as Obesity Drug Demand Soars
Eli Lilly (LLY.N) said on Friday it has invested another $5.3 billion in its new Lebanon, Indiana manufacturing plant, more than doubling its previous investment, as it scrambles to meet soaring demand for its weight-loss and diabetes drugs.
The new investment, which brings the total to $9 billion, will help boost production of the active pharmaceutical ingredients (API) for Lilly’s powerful weight-loss drug Zepbound and diabetes treatment Mounjaro, the company said.
“Today’s announcement tops the largest manufacturing investment in our company’s history and, we believe, represents the single largest investment in synthetic medicine API manufacturing in U.S. history,” said Lilly CEO David Ricks.
Lilly has committed a total of $16 billion to building new manufacturing sites since 2020, including $2.5 billion for a plant in Germany, and another $1.2 billion to update existing facilities, it said.
