Potency issue prompts recall of GSK flu vaccine syringes
The US Centers for Disease Control and Prevention (CDC) said yesterday that GlaxoSmithKline (GSK) has notified federal officials that it has recalled the remaining doses of its 2014-15 Flulaval quadrivalent thimerosal-free prefilled syringes, because of a reduced potency issue.
It said the recall doesn't apply to Flulaval multidose vials or any other GSK vaccines. GSK said routine potency tests found that the prefilled syringes may have reduced efficacy, and that the potency issue only pertains to the prefilled doses administered in early January or later. The CDC added that the reduced potency doesn't pose a safety concern for those who received the vaccine.
The slightly reduced potency affects only the two influenza B components of the quadrivalent vaccine.
The CDC said the potency reduction doesn't necessarily mean those vaccinated will receive less benefit, though it is possible. Amid declining flu levels, the CDC isn't recommending revaccination for those who were immunized with the recalled vaccine, and that those who got the shot in early 2015 or after, as well as those planning travel to the Southern Hemisphere, should speak to a doctor if they want to be revaccinated or have another plan in place to protect them from flu.
Apr 16 CDC statement
Apr 14 GSK recall letter
H7N9 infects Chinese boy
China's Anhui province today reported H7N9 avian influenza in a 3-year-old boy from Hefei, according to a provincial health department statement translated and posted by FluTrackers, an infectious disease news message board. The report appears to be the third new case in China in April.
According to the official and a media report, the boy started having symptoms on Apr 7 and was taken to a hospital clinic. He has since recovered from his infection, according to the report.
US sees further flu declines
In further signs that the nation's longer-than-average flu season is winding down, key flu markers showed notable drops last week, with the percentage of respiratory specimens testing positive for flu finally dropping below 10%, to 9.6%, the US Centers for Disease Control and Prevention (CDC) said today in its weekly update.
Most of the flu still circulating is influenza B, which accounted for 87% of the positive samples, a pattern often seen toward the end of the US flu season. Most of the disease earlier in the season was dominated by H3N2, which was particularly hard on seniors.
Another key indicator, the percentage of clinic visits for flulike illness, was 1.8% and below the national baseline for the second week in a row. The number of CDC regions that were above their individual baselines for that marker fell from five to three.
No new pediatric flu deaths were reported to the CDC last week, keeping the season's total at 125 so far. Overall deaths from pneumonia and flu showed another big drop, declining from 6.5% to 6%, keeping it well below the seasonal baseline for this point in the flu season.
A flu marker that continues to rise, however, is the hospitalization rate for flu, which rose from 61.1 per 100,000 population to 62.4 per 100,000. For people age 65 and over, it has been dramatically higher than the overall number all season long. The rate last week for that age-group rose from 301.8 per 100,000 to 308.0 per 100,000, again reaching its highest level since the CDC first began collecting the information for adults during the 2005-06 season.
No states reported high flu activity, and the number of states reporting geographically widespread flu spread fell from four to three: Connecticut, Massachusetts, and New York.
Apr 17 CDC FluView
Apr 10 CDC flu situation report
FDA warns Flublok maker of overreaching claims
The US Food and Drug Administration (FDA) in a recent letter to the maker of Flublok, the insect-cell-based influenza vaccine, warned the company of overstating the vaccine's effectiveness and omitting mention of potential risks in promotional materials.
In the letter, dated Mar 12 but just recently made public, the FDA said that Protein Sciences Corporation's video, "Watch Us on Lifetime—the Balancing Act," is in violation of the Federal Food, Drug, and Cosmetic Act and the FDA's implementing regulations.
The FDA took issue with the claim of President and CEO Manon Cox, PhD, MBA, in the video that Flublok "is able to put three times more protein in there, so it is also a high-dose vaccine. More protein means your body will form more antibodies that will help you fight the flu."
The FDA told Protein Sciences, "This claim misleadingly implies that the higher antigen content of Flublok translates into greater protection. Currently, there is only one licensed high-dose influenza vaccine . . . . FDA is unaware of any adequate and well-controlled clinical trials that substantiate this claim for your product."
The agency also decried the lack of discussion of risks in the video.
"Specifically, the video presents multiple efficacy claims for Flublok, such as 'helps you fight the flu,' but fails to present any important safety information from the PI [prescribing information]."
The FDA gave Protein Sciences 10 business days to respond to the letter.
Mar 12 FDA letter