News Scan for Jul 19, 2018

Low UK flu vaccine protection
FDA mulls sole-source drug supply
Evaluating Ebola vaccine
Ebola medical treatments
HPV vaccine in boys, men

UK study finds no flu vaccine protection against H3N2 last season

Public Health England (PHE) yesterday released its provisional seasonal flu vaccine effectiveness (VE) estimates for the 2017-18 flu season, which revealed low overall effectiveness and no protection against H3N2, but variable findings in different age-groups.

Based on test-negative case-control studies at five surveillance sites, the overall adjusted VE was 15% (95% confidence interval [CI], -6.3% to 32%), a finding that did not reach statistical significance. VE was higher for children ages 2 to 17 who received the nasal spray vaccine (26.9%) and lower those ages 10 to 64 who are at risk for flu complications (12.2%). In seniors age 65 and older, VE was 10.1%. But, again, none of these levels reached statistical significance.

Researchers found no significant effectiveness against H3N2, consistent with a drop in protection against that strain that other countries such as Canada and the United States have reported. They saw higher levels of protection against influenza B and 2009 H1N1 subtypes, especially in children in whom the vaccine was 60.8% effective against influenza B and 90.3% effective against 2009 H1N1, but confidence intervals were broad, indicated less robust data.

Paul Cosford, MBBS, PHE's director for health protection and medical director, said in a statement that the vaccine offered lower protection against H3N2 due to several factors, including a suboptimal match between the main circulating strain and the vaccine.

He also said for the upcoming season, health officials recommend the quadrivalent vaccine for all those under age 65. He also said an adjuvanted vaccine will be available for seniors to improve immune response.
Jul 18 PHE statement


FDA to explore drug imports to boost supply of certain sole-source drugs

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, today announced the formation of a new work group to explore policy options to address shortages of certain medications that only have one US-based source.

In a statement, Gottlieb said the work group will focus on a narrow subset of mainly generic drugs that don't have blocking patents or market exclusivities, such as when there's only one US-approved version of an old drug that's not commonly used but is still medically important. He said some conditions develop with the drugs that can threaten patient access, such as disruptions in the supply chain or sudden, significant price increases.

The work group will assess if additional market competition from short-term imports of foreign versions of the drugs would help meet US needs until new competition enters the domestic market.

Gottlieb emphasized that any resulting policy would be narrowly tailored to avoid the risk of counterfeit or unsafe drugs entering the US supply chain.

"Americans greatly benefit from our vibrant, competitive market for medicines. Patients shouldn't face inordinate challenges in getting necessary access to needed drugs," he said. "The FDA's mission is to support the long-term availability of safe and effective versions of medically important medicines."

Today's move follows a Jul 12 FDA announcement of a new task force to address other drug shortages and long-term strategies for preventing them.
Jul 19 FDA statement
Jul 12 CIDRAP News scan "FDA announces efforts to tackle supply problems causing drug shortages"


Use of vaccine may have shortened DRC's Ebola outbreak, experts say

The Ebola outbreak in the Democratic Republic of the Congo (DRC) is most likely almost officially over, and an article in Science suggests the use of the experimental Ebola vaccine may have led to its short duration.

Health officials began administering Merck's vaccine on May 21, and approximately 3,300 people were vaccinated in a ring campaign. Of the 53 confirmed cases in the outbreak, none occurred in a person who had received the vaccine.

But it may have been the enhanced surveillance (ring vaccination campaigns require a detailed record of patient contacts) that went with administering the vaccine—-and not the vaccine itself—that proved the most useful in containing the outbreak, experts quoted in the story said.

Another benefit of the vaccine was that it was offered to healthcare workers. Jean-Jacques Muyembe-Tamfum, director of the National Institute of Biomedical Research in Kinshasa told Science, "At the beginning, there was a kind of a panic among the health care workers. With the arrival of the vaccine, the health care workers had more confidence that they could stay and work in the hospitals."

Experts agreed there were no adverse events seen during the ring vaccination campaign, and 1,000 recipients will provide blood samples regularly throughout the next year to measure immune response to the vaccine.

A total of 29 people died during this latest outbreak, the DRC’s eighth since 1976. The last known person infected with Ebola recovered on Jun 12. The outbreak is expected to be declared over on Jul 24, after 42 days (two transmission cycles) of no new confirmed cases.
Jul 18 Science article


Experts suggest next steps for Ebola treatment studies

In related news, Ebola experts agree that a randomized, controlled clinical trial based on a combination strategy of a monoclonal antibody and a direct-acting antiviral would be the most useful to conduct during the next Ebola outbreak, but they cautioned that achieving the desired sample size would be challenging.

Their opinions were gathered by researchers from the National Institute of Allergy and Infectious Diseases and published yesterday in the Journal of Infectious Diseases.

Because of a number of factors, including logistical challenges and lack of controls, onlyone clinical trial of an Ebola treatment was conducted during the 2013-2016 West African Ebola outbreak. That trial, PREVAIL II, compared treatment with ZMapp (an experimental monoclonal antibody) to standard of care, but the trial ended prematurely and suffered low enrollment. 

According to leading pharmaceutical experts, academics, and government officials, monoclonal antibodies should be the backbone of future Ebola treatment studies, and could be combined with direct-acting antivirals in any study conducted during a future outbreak.

"There is a clear scientific and moral imperative to develop consensus on the most appropriate clinical research strategies to be undertaken in advance of the next outbreak," the authors concluded. "Having this consensus clearly articulated in advance might lead to earlier and more-effective introduction of clinical research initiatives in areas of disease outbreak and more-rapid acceptance both internationally and by the affected communities."
Jul 18 J Infect Dis study


HPV vaccine protective in young males, meta-analysis finds

A new meta-analysis of seven studies finds that, in boys and men, the human papillomavirus (HPV) vaccine is protective against anogenital and oral infections. The results were published yesterday in BMC Medicine.

Though the HPV vaccine has been proved safe and effective for widespread use in young girls and women, fewer studies have been conducted on male patients. And only a handful of countries (including the United States) recommend the routine use of HPV vaccine in pre-sexual boys, despite the fact that 33% of penile cancers and up to 90% of anal cancers are attributed to high-risk HPV infections, primarily with HPV type 16.

Four randomized controlled trials and three non-randomized studies were included in this analysis. The results showed the vaccine was 46.9% effective against persisting anogenital HPV 16 infections, 88.0% effective against persisting oral infections, and 61.9% and 46.8% (the latter not statistically significant) against anal intraepithelial neoplasia grade 2 and grade 3 lesions, respectively.

No data were identified in the analysis for anal, penile, or head and neck squamous cell cancer.

"This supports a recommendation for vaccination of boys before the onset of sexual activity with the goal of establishing optimal vaccine-induced protection," the authors said.
Jul 18 BMC Med study

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