Now that two COVID-19 vaccines are available in limited supply in the U.S. under emergency use authorization, officials are warning about the increased risk of counterfeit vaccines and fraud.
“With millions of people waiting for their turn to get the new COVID vaccine, it is expected that scammers will use that opportunity to prey on those willing to pay for it,” the U.S. Drug Enforcement Administration (DEA) said.
Although the vaccine is free and insurance is expected to cover administration costs, limited supplies mean that the vaccine will be offered to at-risk, prioritized groups first. The DEA warned that fraudsters may try to convince people to pay for early access to the vaccine or to pay for the vaccine itself.
In addition to the DEA warning, the Department of Homeland Security (DHS) has launched Operation Stolen Promise 2.0, an initiative aimed at protecting against counterfeit vaccines.
The first phase of Operation Stolen Promise targeted online fraud related to counterfeit personal protective equipment and drugs. As of Nov. 27, the DHS efforts have led to 187 arrests and 1,653 seizures of prohibited COVID-19 items, such as counterfeit test kits, masks and banned pharmaceuticals, according to Sens. Thom Tillis (R-N.C.), Chuck Grassley (R-Iowa), Joni Ernst (R-Iowa) and Chris Coons (D-Del.).
In expressing their support for the program, the senators asked DHS to provide Congress with a report on the trends and observations of the types of crime identified during the pandemic.
EMA updates on cyberattack
In its latest update on a cyberattack in which hackers gained access to documents belonging to sponsors, the EMA said it has engaged a specialized service provider to support a full investigation being carried out in cooperation with law enforcement and other relevant entities.
The company also will help with the additional security measures the regulator is putting in place in response to the data breach.
The EMA disclosed the cyberattack Dec. 9, but provided no details other than to say it had “swiftly launched a full investigation.” A few days later, it reported that “a limited number of documents belonging to third parties were unlawfully accessed.”
In Friday’s update, the EMA said all the parties identified to date have been contacted and informed of the data breach. Meanwhile, the agency said it “remains fully functional and its timelines related to the evaluation and approval of COVID-19 vaccines and treatments are not affected.”
CDSCO extends import leniency
As the COVID-19 pandemic continues, India’s Central Drugs Standard Control Organization (CDSCO) is once again extending its leniency on the import of drugs with a residual shelf life of less than 60%.
Citing the special conditions of the pandemic, CDSCO first issued a circular April 17 granting permission for the import of drugs with reduced shelf life and then re-issued it July 10. Under its latest circular, issued Dec. 18, CDSCO said it is extending that permission until April 30 or further notice, whichever comes first.
FDA’s obsolete human tissue rule on scrapheap
In a bit of house cleaning, the FDA is proposing to revoke obsolete regulations for human tissue intended for transplantation and for human dura mater.
The regulations to be revoked apply to certain tissues recovered prior to May 25, 2005. According to the proposed rule, the FDA “does not believe there are currently any tissues intended for transplantation remaining in inventory that were recovered prior to this date and that would be subject to these regulations.”
The revocation would not apply to regulations for human cells, tissues, and cellular and tissue-based products recovered on or after the May 25, 2005, cutoff date. Comments should reference Docket No. FDA–2020–N–1519 and be submitted by March 8.