U.S. CDC Advisers Set to Vote on Updated COVID Vaccines Next Month
A panel of independent advisers to the Centers for Disease Control and Prevention (CDC) will meet next month to make recommendations on updated COVID-19 vaccines ahead of the fall season, according to a U.S. government website on Friday.
The CDC’s immunization panel is scheduled to vote on the vaccines at a Sept. 12 meeting, a notice posted on the federal register website showed.
Vaccine makers such as Pfizer (PFE.N) and its German partner BioNTech SE (22UAy.DE), Moderna (MRNA.O) and Novavax (NVAX.O) have created versions of their shots aimed at the XBB.1.5 subvariant of the virus.
EU Approves Pfizer’s RSV Vaccine to Protect Infants and Older Adults
The European Commission on Thursday approved U.S. drugmaker Pfizer‘s (PFE.N) vaccine for respiratory syncytial virus (RSV) to protect both babies and older adults in the European Union.
The approval makes the vaccine, which is sold under the brand name Abrysvo, the first to protect infants up to six months of age from the virus when given to pregnant women.
RSV typically causes mild, cold-like symptoms, but is a leading cause of pneumonia in toddlers and the elderly, causing thousands of hospitalizations and deaths each year.
The European Commission in June approved British drugmaker GSK‘s (GSK.L) vaccine Arexvy to protect older adults. Sanofi (SASY.PA) and partner AstraZeneca‘s (AZN.L) long-acting therapy against RSV infections was approved last year by the European Commission for use in infants.
Pfizer and GSK’s shots are already approved in the United States for protection against RSV in older adults, making them the frontrunners in a market estimated to cross $10 billion by 2030.
California Doctor Lauded for COVID Testing Work Pleads Guilty to Selling Misbranded Cosmetic Drugs
A “rock star” doctor who tested tens of thousands of people for COVID-19 in the pandemic’s early months in a badly-stricken California desert community has pleaded guilty to misbranding cosmetic drugs, authorities said Thursday.
Dr. Tien Tan Vo acknowledged in a plea agreement that none of the injectable botulinum toxin, or lip fillers, used by his Imperial Valley clinics from November 2016 to October 2020 were approved by the U.S. Food and Drug Administration, federal prosecutors said.
Vo, who endeared himself to patients for his boundless energy to contain the virus’ spread, admitted purchasing most of the cosmetic drugs from the operator of a “med spa” in Mexicali, Mexico, who smuggled them into the United States without declaring them.
Vo is scheduled to be sentenced on Nov. 16 for receipt of misbranded drugs and being an accessory to an accomplice who smuggled the unapproved drugs from Mexico. Each charge carries a maximum penalty of one year in prison.
Australian COVID Deaths Lowest Since December 2021 Despite Falling Booster Numbers
Australia’s COVID-19 deaths are at the lowest levels observed since December 2021, with fewer hospitalizations and intensive care admissions — despite fewer people receiving a booster vaccine this year. Australia’s fifth COVID wave, spread largely due to the XBB Omicron subvariant, began in March 2023, but was not as severe as the previous wave.
In March, the World Health Organization (WHO) advised that only high-risk groups should receive ongoing COVID-19 booster doses because strong population-level immunity meant ongoing boosting of the general, healthy population offered little additional impact on curbing the virus.
The advice recommends a 2023 COVID-19 vaccine booster dose for adults aged 65 years and over and for adults aged 18-64 years who have medical comorbidities that increase their risk of severe disease, or who have a disability combined with significant health needs.
Across the general population, however, fewer people have received a COVID-19 booster this year than previously.
AstraZeneca Sues U.S. Over Medicare Drug Price Negotiation Plans
AstraZeneca (AZN.L) said on Friday it has sued the U.S. government to block parts of a program that gives the Medicare health insurance plan the power to negotiate lower drug prices.
The British drugmaker, which filed its complaint in a Delaware district court, joins other drugmakers and business groups claiming that the program would restrict the development of new medicines.
The program faces at least seven other court challenges, including from leading industry group PhRMA and drugmakers Johnson & Johnson (JNJ.N), Merck & Co (MRK.N), Bristol Myers Squibb (BMY.N) and privately-held Boehringer Ingelheim.
Novo, With New Data, Builds Case for Using Wegovy to Protect Heart Health
Two weeks ago, Danish drugmaker Novo Nordisk released results of a large trial showing its weight loss drug Wegovy can help prevent heart attacks and strokes in overweight people with cardiovascular disease. It followed up on those landmark data Friday with further evidence the injectable drug helps protect the heart.
In people with a form of heart failure, Wegovy reduced disease symptoms and improved quality of life and exercise duration by more than placebo, according to results from the trial, codenamed “STEP-HFpEF.” The data were released at the European Society of Cardiology meeting and published in The New England Journal of Medicine.
The newly released data could further help Novo persuade insurers to provide broader coverage for Wegovy, which carries a list price of more than $17,000 a year. Insurers might be more open to offering coverage if they know the shot can avert expensive hospitalizations and episodes of care.
Broad coverage also could help Novo retain its lead over rival Eli Lilly, which has a similarly acting drug Mounjaro that is approved to treat diabetes but not yet weight loss.
Charles River Lab Signs Joint Agreement for Protection of Crabs Used in Medical Tests
Charles River Laboratories (CRL.N) has signed a joint agreement with four entities to enhance protections in South Carolina for horseshoe crabs and a bird that feeds on their eggs, they said on Thursday.
The crabs, prized for their milky-blue blood that is used to detect bacterial contamination in intravenous drugs or implants, have been listed as vulnerable by the International Union for Conservation of Nature.
Wildlife advocates have long criticized the use of the blood of horseshoe crabs in safety tests for medical products, including those needed before a COVID-19 vaccine.
The agreement restricts the collection of horseshoe crabs on the beaches of over 30 islands across the South Carolina coast and prohibits the temporary placement of female horseshoe crabs in holding ponds so they continue to spawn on the state’s beaches, among other measures.
CVS Health Will Begin Manufacturing Cheaper ‘Biosimilar’ Drugs
CVS Health is launching a new subsidiary unit, Cordavis, that will collaborate with drug manufacturers to produce biosimilar products, or medications that are nearly identical to an already approved and existing drug.
This unit will commercialize and co-produce FDA-approved biosimilar products to U.S. markets, which will likely have a trickle-down effect on the way consumers buy drugs by increasing competition and driving down prices.
This subsidiary will not reinvent the wheel with new drugs. All the biosimilar products produced will be highly similar to an already approved biologic medicine but will still undergo testing and approvals to ensure they are highly comparable in terms of safety, efficacy and quality.
If generic drugs are the Kirkland brand of medication — an identical product made cheaper through the expiration of a patent — biosimilars are more like Amazon Basics: less expensive, legally distinct but functionally the same as what they imitate. CVS claims that Cordavis will “help ensure the consistent long-term supply of affordable biosimilars” when it officially debuts at the beginning of 2024.
