COVID-19 Vaccine(Janssen)

Pfizer/BioNTech’s Omicron JN.1-adapted monovalent COVID-19 vaccine has been recommended by the European Medicines Agency’s (EMA) human medicine committee for individuals aged six months and older. The Committee for Medicinal Products for Human Use (CHMP) recommendation was based on positive results and real-world evidence supporting the safety and efficacy of the Comirnaty vaccines. In addition, results showed that the JN.1-adapted vaccine generated a substantially improved response against several Omicron JN.1 sublineages, including KP.2, KP.3, as well as other currently circulating sublineages, in comparison to the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. The adaptation of Comirnaty JN.1 follows the recommendation from the World Health Organization’s Technical Advisory Group and the EMA’s Emergency Task Force (ETF) to update COVID-19 vaccines to target the SARS-CoV-2 variant JN.1. Differing from the XBB family, JN.1 is currently the most widely circulating variant worldwide, which continues to grow quickly compared to other variants and is either more transmissible or better at evading the immune system. The ETF said that the “evidence indicates that targeting JN.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve” and urged companies developing new COVID-19 vaccines “to discuss strategies for changing the composition of their vaccines” to target JN.1. The European Commission will review the CHMP’s recommendation and is anticipated to make a final decision soon. If successful, the updated vaccine will be available to ship immediately to EU member states, with the companies’ already manufacturing Comirnaty JN.1 to ensure supply readiness ahead of the upcoming COVID-19 vaccination season. The companies have also submitted applications with the US Food and Drug Administration for the approval of their Omicron KP.2-adapted monovalent COVID-19 vaccine for individuals aged six months and older. The recommendation follows the companies’ announcement that the Medicines and Healthcare products Regulatory Agency approved a change to the licence of their Comirnaty Omicron XBB.1.5-adapted COVID-19 vaccine in February, following approval from the UK regulator in September 2023, for use in individuals aged six months and older. In addition, the companies’ announced positive results from an ongoing phase 1/2 study of their mRNA-based combination vaccine for influenza and COVID-19 in October 2023 and outlined plans to enter late-stage development.

General Merrick Garland announcing the results of a nationwide healthcare fraud investigation at a 27 June press conference at the US Department of Justice. Credit: Samuel Corum via Shutterstock. The US Justice Department has charged 193 people in a major enforcement action, accusing them of participating in healthcare fraud schemes worth $2.75bn. The two-week crackdown involved 76 doctors, nurses, and other medical professionals. The defendants are accused of several scams, such as illegally distributing millions of Adderall (amphetamine) pills and other stimulants. This also included fraudulent activity that involved corporate executives distributing tainted and misbranded HIV medication, which amounted to $90m in losses. Ruthia He, founder and CEO of San Francisco-based digital technology company Done Global, was arrested on 13 June. He has been charged with participating in a scheme to distribute Adderall (amphetamine / dextroamphetamine) over the internet and conspired to commit healthcare fraud in connection with the submission of fraudulent claims for reimbursement for the drug and other stimulants. Adderall is a drug used to treat attention deficit hyperactivity disorder (ADHD). Also included in this crackdown were three executives of a pharmaceutical distributor who allegedly bought HIV medications through fraudulent schemes and resold them with falsified documents to pharmacies nationwide. This led to patients unknowingly receiving mislabelled drugs, one of whom fell unconscious for 24 hours after taking the wrong medication. Attorney General Garland said in a statement: “It does not matter if you are a trafficker in a drug cartel or a corporate executive or medical professional employed by a healthcare company. If you profit from the unlawful distribution of controlled substances, you will be held accountable.” See Also: CHMP recommends authorisation for Pfizer-BioNTech’s Covid-19 vaccine Verona scores FDA approval for Ohtuvayre as COPD maintenance therapy Other instances involve allegations against two owners of wound care firms who allegedly accepted over $330m in kickbacks in a scheme to fraudulently bill Medicare for amniotic wound grafts— biological dressings used to promote the healing of wounds. In Arizona, a woman is accused by prosecutors of improperly billing the state’s Medicaid agency for substance abuse treatment services that either lacked genuine benefit or were never actually administered. The agency announced that they had also seized $230m in cash, luxury vehicles, gold, and other assets in connection with these cases, adding the schemes resulted in $1.6bn in losses. “Through this action, we in federal law enforcement send a clear and strong message—that we will hold accountable those healthcare providers and prescribers who prey on their patients for profit and disregard the first rule of medical care: do no harm,” said US Secretary of Homeland Security Alejandro Mayorkas.