Virginia CVS Fined $75K After Teen Given 6 COVID Vaccine Doses, Drug Theft: Report
The Virginia Board of Pharmacy has revealed a list of shocking health and safety violations from a CVS in Salem. CVS/Pharmacy #3794, located at 11 Chestnut Street, was ordered to pay $75,000 for violations, including improper COVID-19 vaccine administration by an inadequately trained nurse and the theft of substantial amounts of pharmaceutical drugs by a pharmacy technician trainee.
According to a Consent Order from the Virginia Board of Pharmacy, on October 5, 2021, the pharmacy delegated the administration of COVID-19 vaccines to a contract nurse who had been inadequately trained in diluting and administering vaccines.
On the first day of her job, the contract nurse gave a 17-year-old girl six undiluted doses of the Pfizer COVID-19 vaccine, according to the report, and the girl reported suffering from arm swelling, insomnia, headache, forgetfulness, fatigue, and increased heart rate.
The Consent Order states that the nurse said after the incident that she did not know the vial containing the vaccine required dilution, nor did she have any prior experience administering the COVID-19 vaccine. The nurse also provided a copy of an email from a district manager at CVS Health that said the “New Colleague Training class has been canceled so you will not have to complete that.”
The Consent Order also details several other violations, including the theft of pharmaceutical drugs.
Clade I Mpox Surge in the Congo Raises Concerns About Global Spread — Young Children Have Accounted for Nearly 30% of All Suspected Cases in the African Country
The increasing number of suspected clade I mpox virus cases in the Democratic Republic of the Congo (DRC) poses a global threat for potential spread, the CDC said.
From Jan. 1, 2023, to April 14, 2024, multiple outbreaks of clade I mpox occurred across 25 of the DRC’s 26 provinces, with nearly 20,000 suspected cases and 975 deaths, reported Jennifer McQuiston, DVM, of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, and colleagues in the Morbidity and Mortality Weekly Report.
Of the two distinct mpox subtypes, clade I causes more severe illness than the clade II subtype and may be more transmissible. To date, no clade I cases have been reported in the U.S. or outside of the countries of Central Africa where the virus is endemic.
If clade I mpox is introduced in the U.S. at some point, it is more likely to be sexually transmitted, affecting populations such as men who have sex with men and sex workers, and less likely to affect children, McQuiston and colleagues noted. This is because there are no zoonotic reservoirs in the U.S., household contacts are fewer, and cleaning and hygiene resources are widely available.
The FDA-approved mpox vaccine (Jynneos) became commercially available in April 2024. Previously, the vaccine had been available only through public health channels. However, only 23% of those in the U.S. at risk for mpox infection have completed the two-dose vaccine series, the authors pointed out.
EU Regulator Scraps Approval for Pregnancy Drug Over Cancer Risk
The European Medicines Agency (EMA) on Friday recommended scrapping approval for a drug used to prolong gestation, citing a “possible but unconfirmed” risk of cancer.
The EU health regulator’s Pharmacovigilance Risk Assessment Committee (PRAC), which monitors drug-related side effects, considered new studies in its review that showed the treatment, 17-hydroxyprogesterone caproate (17-OHPC), was not effective in preventing premature birth.
It also reviewed results from a study that looked at the risk of cancer in people who had been exposed to 17-OHPC in the womb. PRAC considered data on the effectiveness of the medicines in their authorized uses and decided to recommend withdrawing approval for the drug.
FDA Approves New Drug for Deadly Lung Cancer
U.S. News & World Report reported:
The U.S. Food and Drug Administration on Thursday approved a new drug to treat patients with an advanced form of deadly lung cancer.
Importantly, tarlatamab (Imdelltra) is only for patients who have exhausted all other options to treat extensive-stage small cell lung cancer.
In a company trial, tarlatamab tripled patients’ life expectancy, giving them a median survival of 14 months. But not everyone benefited: Forty percent of those who got the drug responded.
Despite the drug’s effectiveness, it does have a serious side effect called a cytokine release syndrome, the FDA said. That’s when the immune system goes into overdrive, triggering symptoms like a rash, a rapid heartbeat and low blood pressure.
In Big Pharma’s Growth Rankings, Lilly Took Top Spot From Novo Nordisk in Q1
The momentum the biopharma industry showed in the fourth quarter of 2023 has continued into this year. With 18 of the industry’s top 25 companies achieving year-over-year revenue gains, the first quarter of 2024 nearly matched the final quarter of last year, when 21 of the industry’s top 25 companies posted sales increases.
Additionally, nine companies realized double-digit growth in the first three months of this year, which was one more than in the previous period. Once again, the dominant players were the sellers of GLP-1 diabetes and obesity drugs. While Novo Nordisk dropped out of the top spot with its 22% year-over-year revenue increase, Eli Lilly took over as No. 1 thanks to its 28% quarterly boost.
Lilly may hold the top spot for a while. Last month, GlobalData projected Lilly’s Mounjaro will overtake Novo’s Ozempic as the top blood sugar-modulating treatment, generating staggering sales of $34 billion by 2029.
While Novo’s older GLP-1 medicines outsold Lilly’s by a margin of better than 2 to 1, the momentum appears to be on Lilly’s side.
UK Announces Funding to Boost Global Fight Against Antimicrobial Resistance
The British government today put forth a package worth £85 million (roughly $108 million U.S.) to support international efforts to combat antimicrobial resistance (AMR).
The funding, announced at an international meeting of ministers and health experts hosted by the Royal Society and the U.K. Department for Health and Social Care, includes £50 million ($63 million) to help countries and institutions in Africa access essential antibiotics, £25 million ($32 million) to strengthen AMR surveillance in Caribbean countries and territories, and £10 million ($13 million) to help establish an international scientific panel to coordinate action on AMR.
“Antimicrobial resistance could render our most vital medicines useless — it is a threat the world must take extremely seriously,” U.K. Health Minister Andrew Stephenson said in a press release. “This package of up to £85 million builds on the world-leading work the U.K. government is already doing to support low-and middle-income countries to monitor, research, and tackle this disease.”
Also announced at the meeting was a £45 million ($57 million) pledge by British drug maker GSK to become the first founding partner of an effort to build a global network of experts and institutions to better understand what’s driving AMR and develop new interventions.
GSK Raises $1.5 Billion From Sale of Remaining Haleon Stake
British drugmaker GSK (GSK.L) has raised 1.25 billion pounds ($1.52 billion) from a sale of its remaining stake in consumer healthcare company Haleon (HLN.L) to institutional investors.
The sale will allow GSK to sharpen its focus on vaccines, cancer and infectious diseases, which are part of CEO Emma Walmsley’s plans to boost earnings at the drugmaker.
Haleon, which also makes pain-killer Panadol, reported first-quarter revenue slightly below market estimates in early May on lower volumes amid retailer destocking in the U.S. and cooling demand for some of its medicines after a surge last year.
