Flu vaccine recommendations for the 2016 - 2017 season

There will be more shots given this flu season with the loss of the intranasal formulation of the influenza vaccine, according to the American Academy of Pediatrics (AAP).

The AAP recently released its updated recommendations on influenza vaccination for the 2016-2017 season, building upon an earlier announcement from the Centers for Disease Control and Prevention (CDC) that the intranasal flu vaccine would be pulled this year after it was found to be substantially less effective than the injectable formulation.

Although this might be the most noticeable change for the year, there are other updates in the recommendations, as well as reminders of vaccination protocols and practice goals.

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Henry H Bernstein, DO, MHCM, FAAP, a pediatrician with Northwell Health in New Hyde Park, New York, helped draft the new recommendations and says that although the flu shot won’t ever be perfect, it’s better than remaining unprotected. He urges pediatricians to educate patients and their families, and promote vaccination in all children aged 6 months and older as well as their caregivers.

“People need to recognize that the influenza virus is totally unpredictable. We try to predict which strains will predominate in a given season and we do hope the strains included in the vaccine match those flu viruses that circulate in communities,” Bernstein says. “No vaccine is 100% perfect, but last year’s protection rate of more than 60% highlights an excellent track record and [is] certainly much better than not having received flu vaccine at all.”

Last year’s flu season was “moderate,” says the AAP, but peaked later-in March-than in previous seasons. The predominant strain last year was the influenza A (H1N1)pdm09 virus, with influenza A (H3N2) dominating the season from October through December, and influenza B viruses taking over from mid-April through mid-May.

Bernstein says there are thousands of deaths each year because of influenza, and pediatric deaths related to influenza average around 100 per year. Last year, there were 85.

The majority of pediatric deaths from influenza-80% to 85%-typically occur in unvaccinated children aged older than 6 months, the AAP notes. Most influenza hospitalizations among pediatric patients over the last decade occurred in children aged younger than 5 years, according to the association’s data.

“These deaths are preventable, and the vaccine certainly can help prevent infection and disease,” Bernstein says.

The updated guidelines highlight the fact that the AAP recommends that all children aged 6 months and older receive the flu vaccine, and intranasal is out.

Earlier this summer, the CDC’s Advisory Committee on Immunization Practices voted against using the live attenuated influenza vaccine-administered intranasally-for the upcoming flu season, based on data that showed poor effectiveness between 2013 and 2016.

According to data from the US Influenza Vaccine Effectiveness Network, the intranasal spray showed an estimated 3% effectiveness rate during the 2015-2016 season compared with a 63% effectiveness rate for the injectable vaccine.

Although the CDC gave no reason as to why the intranasal vaccine saw a drop in efficacy since it was introduced in 2003, both Bernstein and the CDC suspect it was due to a change in the formulation of the vaccine. The efficacy of the intranasal vaccine began to change 3 years ago when coverage was added against a fourth strain of the influenza virus, Bernstein says. Whether there is some kind of interference among the viruses making it less effective is uncertain, he adds.

“No matter how you slice the information, it appears that the inactivated flu vaccine shot always outperforms the intranasal, which was not necessarily the case 3 years prior when the intranasal product was a trivalent vaccine,” Bernstein explains.

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Bernstein says he expects that studies are under way to determine the exact cause of the change in efficacy and to see if there’s a way to return the intranasal formulation to the market, considering how popular it was with both children and parents. The CDC estimates that one-third of all children received an intranasal flu vaccine in recent years rather than an injectable vaccine. Manufacturers had projected to supply as many as 14 million doses of intranasal vaccine for the 2016-2017 flu season, accounting for 8% of the more than 170 million total projected doses.

Despite the loss of the intranasal vaccine supply, Bernstein says he doesn’t anticipate any shortages this season. There are 170 million doses expected to arrive to healthcare providers this season, he says.

Both trivalent and quadrivalent vaccines will be available for the 2016-2017 season, and the AAP says either formulation is acceptable, with no preference given to one over the other.

“Both formulations contain an A/California/7/2009 (H1N1)pdm09–like virus, an A/HongKong/4801/2014 (H3N2)–like virus, and a B/Brisbane/60/2008-like virus (B/Victoria lineage). Quadrivalent influenza vaccines contain the B/Phuket/3073/2013-like virus (B/Yamagata lineage) as well,” the AAP says.

The AAP reminds clinicians in the recommendation that influenza vaccines are not licensed for children aged younger than 6 months, and that children aged 9 years and older need only 1 dose of the vaccine. Children aged 6 months though 8 years need 2 doses if they received fewer than 2 doses of any formulation of the vaccine before July 1, 2016. For children requiring 2 doses, the AAP says these should be spaced at least 4 weeks apart.

The AAP also notes that pediatric offices may offer influenza vaccination to adult caregivers and childcare providers as a way to protect pediatric patients through “cocooning.” However, appropriate documentation and liability issues must be considered before offering adult immunizations, the AAP says.

Pediatricians and other healthcare providers should work to educate their communities about the importance of influenza vaccination, and make seasonal influenza vaccines readily accessible for all children.

The ideal window for vaccination is before the end of the October, Bernstein says, and protection is believed to last around 6 to 12 months. Healthcare providers may continue to offer flu vaccination until June, at the end of each flu season, the AAP says, because of the unpredictable nature of the viruses. It also advises pregnant women to receive the vaccine because mothers can pass antibodies to their babies through the placenta, protecting a newborn for as long as 2 months after birth.

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Bernstein says he hopes the loss of the intranasal option won’t keep people from getting vaccinated. “We do hope that people still continue to get their influenza vaccine this year even though the intranasal product is not available,” he says. “There’s no question that influenza causes serious disease in many children and many adults, and the flu vaccine is absolutely and unequivocally the best preventive measure we have.”

Another big change for the upcoming flu season is that egg allergies no longer have any impact on an individual’s ability to receive the flu vaccine. Although the vaccine is still produced in eggs and contains minute amounts of egg proteins, Bernstein says recent studies have shown that there is no significant risk of an allergic reaction after receiving the flu vaccine for children who have egg allergies.

Individuals who have had an allergic reaction to the vaccine itself should be assessed by an allergist and maybe not receive the vaccine, Bernstein says, although adding that it might not be an egg allergy causing the reaction.

“Just because someone has had an allergic reaction to the flu vaccine doesn’t immediately incriminate the egg itself,” Bernstein says. “A lot of times, it’s a different protein that has contributed to the allergic reaction and not the egg protein.”

The CDC recommends that individuals with severe egg allergies be vaccinated in a setting that allows for close supervision by a healthcare provider after the vaccination.

In terms of other groups for which flu vaccination is of particular concern, there are certain groups for which compliance is particularly important. Infants who were born preterm; caregivers of infants and those with high-risk medical problems; American Indian and Alaska Native children; all childcare providers and staff; and all pregnant women and those who are breastfeeding should strictly adhere to the recommendation, says the AAP.

Pediatricians can check the AAP Red Book Online Influenza Resource for additional updates throughout the flu season.