Login
Merck’s Pneumococcal Vaccine Gets CDC Panel Backing
Capvaxive is Merck’s latest entrant in the pneumococcal vaccine market and offers broad coverage against 21 types of the bacteria that causes pneumococcal disease. Eight of those serotypes are not covered by other shots.
The CDC panel specifically voted to recommend a single Capvaxive dose in adults older than 65 with no prior pneumococcal vaccination or whose vaccination history is unknown. Adults aged 19 to 64 years old who have certain underlying health conditions and no previous record of receiving a pneumococcal conjugate vaccine can also receive the shot, the advisers indicated.
The panel postponed discussion of lowering the age-based recommendation for pneumococcal vaccination to 50 from 65, however. They expect to take that question up at an October meeting.
CDC Advises Updated COVID Vaccine for Everyone Over 6 Months of Age
U.S. News & World Report reported:
As a summer wave of COVID infections rolls across the country, U.S. health officials have recommended that all Americans over the age of 6 months get one of the updated COVID vaccines when they become available this fall.
The recommendation was issued Thursday by the U.S. Centers of Disease Control and Prevention after its vaccine advisory panel weighed in on who should get the shots. The panel made the same recommendation for flu vaccinations this fall, with rare exceptions.
For Americans who decide to get the latest COVID shots, there will be a choice among this year’s vaccines: The Novavax shot will target JN.1, the variant that prevailed during the winter, while the Pfizer and Moderna shots will take aim at KP.2, which until recently seemed poised to become the dominant variant.
But two related variants, KP.3 and LB.1, now account for more than half of new cases. All three variants are descendants of JN.1.
Exclusive: Congo Authorities Approve Mpox Vaccines to Try to Contain Outbreak
Authorities in the Democratic of Congo have approved the use of two mpox vaccines to try to tackle an upsurge in cases and a dangerous new strain spreading in the country.
Congo has seen 20,000 cases and more than 1,000 deaths from mpox, mainly among children, since the start of last year.
This week, the World Health Organization (WHO) and scientists warned of a new, more deadly strain spreading in Congo’s South Kivu province.
The regulator has issued an emergency-use authorization for both Bavarian Nordic’s (BAVA.CO) shot, Jynneos, and LC16, made by KM Biologics, according to documents and sources involved in the process.
What You Need to Know About Bird Flu Vaccines
Flu is generally a health concern in the fall and winter, but this spring and summer, influenza — specifically avian influenza, or bird flu — is dominating headlines and weighing heavily on the minds of health experts.
H5N1 is infecting chickens in at least 48 U.S. states and cows in at least 12. So far, only three people — all dairy workers — have had recorded infections, but health officials are keeping a close eye on whether the virus is getting better at infecting humans. Preparing for that possibility includes readying a vaccine.
Is there a vaccine for bird flu? There are three. The U.S. Food and Drug Administration (FDA) has approved H5N1 vaccines made by Sanofi, GSK subsidiary ID Biomedical Corporation of Quebec (IDB), and CSL Seqirus — all of which also make seasonal flu vaccines.
The approvals allowed all three companies to manufacture doses for the National Pre-Pandemic Influenza Vaccine Stockpile to have ready in case of a potential outbreak, but not to be sold for public use. The doses haven’t yet been made available and only will be if there are bird flu outbreaks in humans, and health officials determine people need to be vaccinated.
The national stockpile now contains hundreds of thousands of doses of H5N1 vaccine — mostly from Seqirus — that could be deployed in a matter of weeks, according to a spokesperson for the Administration for Strategic Preparedness and Response (ASPR), the government organization that oversees preparedness for health emergencies. But the doses aren’t necessarily ready to ship: the stockpile is more like a warehouse of vaccine components targeting different strains of H5N1, rather than a storage facility for final shots.
Families of Those Lost in Opioid Crisis ‘Devastated’ by Supreme Court’s Decision to Reject Purdue Settlement
Some people who lost family members to opioids expressed shock and sadness, but also a resolve to keep fighting, after the Supreme Court on Thursday torpedoed a massive settlement for victims of the drug crisis. “I felt like someone came up and punched me in the stomach,” Jill Cichowicz, whose twin brother, Scott Zebrowski, collapsed in a California parking lot and died of fentanyl poisoning after he took what he thought was OxyContin in 2017, said.
In a 5-4 decision Thursday, the Supreme Court blocked a huge bankruptcy reorganization of Purdue Pharma, the company that made and marketed OxyContin, a prescription painkiller that was abused and led to people all over the country getting addicted.
The majority ruled that the bankruptcy court did not have the authority to release the Sackler family members from opioid victims’ legal claims. But the deal also included billions for states to abate the crisis and help those who were addicted, as well as $750 million for victims of the opioid crisis.
Edward Neiger, an attorney who is co-managing partner of the law firm ASK LLP and who represents victims of the opioid epidemic, called the setback devastating. He said the opioid epidemic is “the biggest healthcare crisis of our time.”
Most Kids Get Antibiotics for Pink Eye, Study Shows. Experts Say They’re Usually Not Needed
Doctors are prescribing antibiotics to most kids and teens who have pink eye, despite guidelines that discourage their use, researchers reported Thursday.
More than two-thirds of U.S. children and teens who saw a doctor for pink eye left with a prescription for antibiotic eye drops, their research found. The American Academy of Ophthalmology recommends that doctors do not routinely give out antibiotics for what’s also called conjunctivitis, which usually clears up on its own.
For their study, researchers used a nationwide database of insurance claims from 2021. Nearly 45,000 children received care for pink eye at a doctor’s office, eye clinic or emergency room and 69% were prescribed antibiotics, which come in drops and ointments.
UnitedHealth’s Optum to Pay $20 Million Over U.S. Claims It Ignored Opioid ‘Red Flags’
UnitedHealth Group’s (UNH.N) OptumRx pharmacy benefit manager unit has agreed to pay $20 million to settle claims by U.S. authorities that it improperly filled certain opioid prescriptions, the U.S. Justice Department announced on Thursday.
The settlement appeared to be the first reached by the government with a pharmacy benefit manager (PBM) over allegedly illicit opioid prescriptions.
Optum and other PBMs, which act as middlemen between insurance plans and manufacturers to negotiate prescription drug prices, have also been named as defendants in the sprawling litigation over the U.S. opioid crisis, though no case against them has gone to trial.
The litigation has yielded close to $50 billion in settlements between local governments and drugmakers, distributors and pharmacies. The local governments accused the drugmakers of concealing opioid drugs’ risks, and the distributors and pharmacies of ignoring red flags.
Pfizer Struggles to Claw Back Faith With Wall Street and Its Employees as It Recovers From the COVID Decline
Pfizer had a “phenomenal” first quarter — and Wall Street took notice, CEO Albert Bourla told thousands of employees during a companywide town hall on May 2, according to a recording heard by CNBC.
A day earlier, the pharmaceutical giant’s stock had closed 6% higher after its quarterly results topped analyst estimates and it hiked its full-year outlook. It was a far cry from the year prior, when Pfizer’s shares plunged more than 40%, making it one of the worst-performing large pharmaceutical stocks of 2023. Its market cap of about $157 billion is now less than half of its 2021 peak of nearly $350 billion.
Few companies benefited from the pandemic as much as Pfizer did. The drugmaker’s profits boomed, fueled by its COVID vaccine and antiviral pill Paxlovid. After Pfizer and German company BioNTech rapidly developed and deployed a lifesaving shot that helped the world emerge from the pandemic, Pfizer drew widespread praise.
Pfizer’s success contributed to its equally jarring fall from grace. When the virus receded in 2023, its COVID products revenue plummeted. The world, which hailed Pfizer as a pandemic hero a few years earlier, no longer needed the company in the same way.
House Panel Passes Bills to Expand Medicare Obesity Drug Coverage, Cancer Screening
A House committee overwhelmingly passed four bills on Thursday that would expand Medicare coverage of obesity drugs and cancer screening blood tests and place guardrails around Medicare’s discretion in covering drugs and devices approved by the Food and Drug Administration.
The House Ways & Means Committee passed obesity drug coverage legislation that would offer a limited pathway for adults 65 and older to get their weight loss drugs paid for by Medicare. Right now, Medicare is prohibited from covering medications used for weight loss, like Wegovy and Zepbound.
However, the new plan is significantly more restrictive than prior proposals. It’s primarily targeted at making sure that people currently taking weight loss drugs don’t get kicked off when they enter the Medicare program, such as by turning 65.
EU Regulator Backs Approval for ARS Pharma’s Nasal Spray Alternative to EpiPen
ARS Pharmaceuticals (SPRY.O) said on Friday the European Medicines Agency (EMA) has recommended the approval of its needle-free emergency treatment, EURneffy, for allergic reactions.
The nasal spray EURneffy is seen as an alternative to EpiPen and other autoinjectors that are filled with epinephrine, a life-saving drug used by people at risk of anaphylaxis and other allergic reactions.
Last year the U.S. Food and Drug Administration had declined to approve the spray, a decision that was in contrast to the recommendation of its advisory panel, as the agency sought a repeat-dose study of the treatment versus a rival injected product.
The FDA will review the nasal spray again and is expected to decide on its approval by Oct. 2.
