This is an excerpt from the March 23, 2021 edition of Medically Necessary, a health care supply chain newsletter. Subscribe here.
Good afternoon. Medically Necessary is a newsletter by Matt Blois about the health care supply chain — how we get drugs, devices and medical supplies to health care providers and patients.
Fake vaccines, protective equipment threaten the supply chain
An Immigration and Customs Enforcement agent inspects international cargo with personal protective equipment in the Los Angeles area. (Photo: ICE)
Threats: Criminals are trying to sell fake COVID-19 vaccines to desperate governments and citizens, threatening trust in the real health care supply chain.
- Reports of counterfeit vaccines follow months of problems with counterfeit personal protective equipment.
Fake shots: Early this month, the international law enforcement agency INTERPOL reported seizing thousands of fake COVID-19 vaccines.
With support from INTERPOL, South African authorities recovered about 400 ampules in a warehouse near Johannesburg. In China, police raided the manufacturing facility producing the fakes and seized 3,000 counterfeit vaccines.
- “This is only the tip of the iceberg when it comes to COVID-19 vaccine-related crime,” INTERPOL Secretary General Jürgen Stock said, according to a press release.
- Existing networks for distributing fake drugs have provided an infrastructure for trafficking fake COVID-19 vaccines, Stock told TIME magazine in an interview about the operation.
Mexico’s Secretariat of Security and Citizen Protection also confiscated fake vaccines in the northern part of the country last month.
- A health clinic was selling fake doses of the Pfizer vaccine for about $2,000, according to the Secretariat of Health.
In an excellent video about counterfeit vaccines, The Wall Street Journal reports that, as of mid-January, the U.S. government hadn’t received any reports of fake vaccines being administered to patients.
Empty promises: Confiscation of counterfeit vaccines follow numerous reports about criminals making empty promises to provide vaccines to government entities or desperate citizens.
- A spokesperson from the European law enforcement agency Europol told VICE that the agency is investigating the sale of black market COVID-19 vaccines.
- Italian officials received offers to buy counterfeit vaccines, according to the Associated Press. The Czech Republic also received offers to buy fake vaccines, Reuters reports.
In February, the Justice Department charged three men in Maryland with trying to sell fake vaccines online. Officials expect the scams to continue.
- “As the public seeks vaccines to protect themselves and their families from COVID-19, fraudsters are waiting to take advantage of their desperation,” James Mancuso, a federal law enforcement agent, said, according to a press release.
Immigration and Customs Enforcement reports that it has carried out 58 seizures and seven arrests, part of an effort to crack down on fake vaccines and treatments for COVID-19.
Fake supplies: Counterfeit maks, gowns and gloves have also been a major problem during the pandemic, and the problem continues.
- Immigration and Customs Enforcement reported seizing nearly 10 million fake masks in the first two months of 2021.
The mask manufacturer 3M, which has been working closely with law enforcement officials, has had to dedicate an enormous amount of effort to prevent fake masks from getting into the supply chain.
- The company reports that it has received more than 13,000 calls to a hotline about counterfeit equipment.
- It estimates that more than 33 million fake respirators have been seized during the pandemic.
Still, a Kaiser Health News investigation found that millions of fake masks made their way into the U.S. health care supply chain.
Warnings: Law enforcement officials and supply chain researchers have been warning about the threat of counterfeit vaccines for months.
The Department of Justice shut down a website hawking fraudulent coronavirus vaccines as early as March 2020, less than 10 days after President Donald Trump declared a national emergency.
By December, as several vaccines neared approval, INTERPOL issued a warning about the possibility of theft and counterfeiting of coronavirus vaccines.
- “As governments are preparing to roll out vaccines, criminal organizations are planning to infiltrate or disrupt supply chains,” Stock warned in the press release.
Robert Handfield, a supply chain researcher at North Carolina State University, warned in a December webinar that waste from COVID-19 vaccination efforts could be used for counterfeiting efforts.
- “The risk there is that rather than throwing them away they end up in the hands of someone who’s going to market them on the black market … or try to use the containers and refill them with material that’s counterfeit,” he said.
- “Do not keep or share empty #COVID19 vials, containerso or packaging as souvenirs. COVID-19 vaccine-related materials can be repurposed to commit fraud,” the Office of Inspector General for the Department of Health and Human Services warned on Twitter.
Countermeasures: Those warnings prompted serious countermeasures by companies transporting the vaccine, which Bloomberg called “worthy of a Bond film.”
- The security measures include armed guards, alarms and panic buttons, according to Bloomberg.
Despite stumbles, AstraZeneca is still poised to be a huge part of the vaccination effort
The stumbles: On Monday, drugmaker AstraZeneca published a press release announcing promising results from a clinical trial of its COVID-19 vaccine in the U.S.
- Hours later, U.S. health officials said those results may have been misleading. AstraZeneca says it will update its results soon.
These communication snafus follow confusing preliminary results published in November.
The company also had to pause clinical trials last year to ensure the vaccine wasn’t causing serious side effects. More recently, some European countries stopped administering the vaccine over concerns about side effects.
- In both cases, regulators determined the vaccine was still safe.
Heavy hitter: Despite those missteps, AstraZeneca’s vaccine is still poised to be the most abundant COVID-19 shot in the world.
- The company already has agreements to provide more than 3 billion vaccine doses to a laundry list of countries, according to Bloomberg’s vaccine deals tracker. (The tracker is updated through March 1.)
- That would cover more than twice as many doses as Novavax, the second most prevalent vaccine measured by the number of doses ordered.
- The U.S. has ordered 300 million doses of the AstraZeneca vaccine, though it hasn’t approved its use yet. That’s on par with orders for Moderna and Pfizer’s vaccines.
Still promising: Those problems have slowed approval for the vaccine in the U.S., but it has already been approved for emergency use in more than 70 other countries.
National Institute of Allergy and Infectious Diseases director Anthony Fauci told Good Morning America he still believes the vaccine is effective.
- “This is likely a very good vaccine,” Fauci said in the Good Morning America interview. “This kind of thing does … nothing except really cast some doubt about the vaccines and maybe contribute to hesitancy.”
According to a useful summary of the company’s mistakes from STAT, these recent mistakes are frustrating to scientists because the AstraZeneca vaccine has several advantages from a supply chain perspective.
- “Compared to other government-authorized vaccines, it’s cheap and easy to manufacture and store,” STAT’s Andrew Joseph and Lev Facher wrote.
Reading list: The best stories about the health care supply chain
- Vaccine Rollout Leaves Behind the Blind, Paralyzed, Autistic — Bloomberg
- Inside the scramble to bring Covid-19 vaccines to homebound Americans — STAT
- Covid-19 Vaccine Manufacturing in U.S. Races Ahead — The Wall Street Journal
- Here’s how to get billions of COVID-19 vaccine doses to the world — Peterson Institute for International Economics