News Scan for Aug 25, 2016

Estimates of severe MERS
New FSMA guidance
TB rates in India
Intussusception and rotavirus vaccine

Cases of severe MERS in the Middle East likely much higher than reported

New data from the Centers for Disease Control and Prevention (CDC) shows that there were 3,250 likely cases of severe MERS-CoV in the Middle East between Sept 2012 and Jan 2016. This number is 2.3-fold higher than current laboratory confirmed cases, suggesting that the disease is more widespread than previously thought.

Researchers based their findings on a calculation that used instances of severe (requiring hospitalization) MERS-CoV (Middle East respiratory syndrome coronavirus) infection in travelers returning from either Saudi Arabia, Jordan, the United Arab Emirates, or Qatar.

By assuming travelers and local residents had similar per-day risk of infection, the number of suspected cases was calculated by multiplying severe case rate among travelers by each country’s total person-time at risk in the population. Based on those calculations, Saudi Arabia had the largest number of estimated cases at 2,269.

"Public health officials are concerned about MERS-CoV, both in the source countries and from exported cases in persons who can seed outbreaks elsewhere," the authors wrote. "By better estimating the epidemic size in the Middle East, our results can help guide public health preparedness efforts in source countries and contribute to projections of the number of cases that could occur among travelers."
Aug 24 Emerg Infect Dis study


FDA offers new FSMA guidance, pushes back some deadlines

The US Food and Drug Administration (FDA) this week published several guidance documents to help with compliance with the FDA Food Safety Modernization Act (FSMA), while also pushing back deadlines for complying with multiple components.

On Aug 23 the agency published the first 5 chapters on what will be a 14-chapter document designed to help businesses comply with Current Good Manufacturing Practice (CGMP), hazard analysis, and risk-based preventive controls for the production of human food. "The draft guidance explains FDA's current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls and includes a discussion about establishing a food safety plan," the agency said in a constituent update.

The FDA will release the other chapters of the draft guidance document for public comment as they are completed, planning to finish the document by early 2018.

The FDA also provided more time for manufacturers to comply with certain requirements of four of the seven FSMA rules: the two involving CGMP and preventive control rules for human and animal food, the rule on foreign supplier verification, and the one on produce safety.

Yesterday the FDA posted two draft guidance documents to help industry professionals implement preventive controls for the animal food rule, along with a third document to help businesses determine whether functions that they perform are within the "farm" definition used in the FSMA rules.

One of the animal food documents covers CGMP requirements, and the other covers human food by-products used for producing animal foods. The FDA will offer a webinar in late September to explain the draft documents in more detail.

In determining what business operations fall under the "farm" designation, the agency said in a constituent update, "In general, businesses that only perform activities within the 'farm' definition are not subject to the FSMA Preventive Controls for Human Food or Animal Food rules. Instead, when their activities involve covered produce, farms may be subject to the FSMA Produce Safety rule.

"Facilities conducting activities that are outside the farm definition generally need to register with the FDA as food facilities (unless other exemption(s) apply, such as the exemptions for retail food establishments and restaurants) and may be subject to the FSMA Preventive Controls for Human Food or Animal Food rule. Farms, including those subject to the Produce Safety rule, are not required to register with the FDA as food facilities."

The FSMA was enacted in 2011.
Aug 23 FDA update
Aug 24 FDA
Aug 23 FDA statement "
Compliance date extensions and clarifications for FSMA final rules"


India may have double the number of TB cases estimated

A study published yesterday in The Lancet Infectious Diseases suggests the number of tuberculosis (TB) cases in India could be drastically underreported —potentially two to three times higher than current estimates.

Researchers looked at data from TB drug sales to gain a more accurate picture of TB cases in India. Many Indians choose to use private doctors, and not the public healthcare system, to treat TB; private doctors often fail to report cases of the bacterial infection to health officials.

The researchers found evidence that there was possibly more than 2.2 million TB cases treated by private doctors in 2014, at least 1.9 million in the private sector and an additional 1.4 million cases managed by public health officials.

"On any given day, this translates on average to 1.46 million people being on tuberculosis treatment, more than 12% of the country's population," the authors wrote.

Besides an increased burden of disease, the authors of the study said antibiotics used to treat TB are a significant out-of-pocket expense for patients. "Our estimates imply that in 2014, over $59 million was spent in out-of-pocket expenditure on first-line tuberculosis drugs alone," the authors wrote.

According to a press release today from Imperial College London, India has the highest number of TB cases in the world, accounting for at least 25% of all cases worldwide.
Aug 24 Lancet Infect Dis study
Aug 25 Imperial College London


Study: Benefits of rotavirus vaccine outweigh risk of intussusception

A study yesterday in Pediatrics looked to see if rotavirus vaccines led to increased instances of intussusception, the dangerous telescoping of the intestines, among infants. While there was some evidence of increased risk among very young infants, the authors concluded that the benefits of the rotavirus vaccine outweighed the risk of this rare side effect.

The first rotavirus vaccine, RotaShield, introduced in 1999 caused an increased risk of intussusception. That vaccine was discontinued, and in 2006 two new vaccines were introduced.

Researchers conducted a retrospective analysis of intussusception hospitalizations between 2000 and 2013, comparing rates of hospitalizations before and after the 2006 introduction of RotaTeq and Rotarix vaccines. Among children 8 to 11 weeks of age, there were increased rates of intussusception from 2007 through 2013 compared with the pre-vaccine baseline. The increased rate was an estimated 7 to 26 additional cases of intussusception annually.

But among all children less than 12 months of age, there was no overall increased risk of intussusception.

"[G]iven the magnitude of the declines in rotavirus disease compared with the small increased risk of intussusception, the public health benefits of rotavirus vaccination far exceed the increased risk of intussusception," the authors wrote.
Aug 25 Pediatrics study

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