US orders 29 million more doses of swine flu nasal spray which can transmit disease

US orders 29 million more doses of swine flu nasal spray which can transmit disease

Last Updated on Tuesday, 22 September 2009 18:43
Tuesday, 22 September 2009 17:39

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U.S. health officials have ordered more swine flu vaccine, bringing the nation's eventual total to 251 million doses, reports AP.

The government on Monday ordered an extra 29 million doses of the nasal-spray swine flu vaccine, MedImmune's FluMist.

A sanitised document on prescribing information on FluMist reveals Guillain-Barré syndrome is just one of its side effects, and that it should not be given to pregnant women, very young children, the elderly or sick, and that it can administration of FluMist can infect others.







http://www.medimmune.com/pdf/products/flumist_pi.pdf

WARNINGS AND PRECAUTIONS - - - - - - - - - - - - - - - - - - - - - -

• Do not administer FluMist to children <24 months of age because of increased risk of

hospitalization and wheezing observed in clinical trials. (5.1)

• FluMist should not be administered to any individuals with asthma or children < 5 years of age with

recurrent wheezing because of the potential for increased risk of wheezing post vaccination. (5.2)

• If Guillain-Barré syndrome has occurred with any prior influenza vaccination, the decision to give

FluMist should be based on careful consideration of the potential benefits and risks. (5.3)

• Administration of FluMist, a live virus vaccine, to immunocompromised persons should be based

on careful consideration of potential benefits and risks. (5.4)

• Safety has not been established in individuals with underlying medical conditions predisposing

them to wild-type influenza infection complications. (5.5)


6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of FluMist. Because these

reactions are reported voluntarily from a population of uncertain size, it is not always possible to

reliably estimate their frequency or establish a causal relationship to vaccine exposure.

Congenital, familial and genetic disorder: Exacerbation of symptoms of mitochondrial

encephalomyopathy (Leigh syndrome).

Gastrointestinal disorders: Nausea, vomiting, diarrhea

Immune system disorders: Hypersensitivity reactions (including anaphylactic reaction, facial edema

and urticaria)

Nervous system disorders: Guillain-Barré syndrome, Bell’s Palsy

Respiratory, thoracic and mediastinal disorders: Epistaxis

Skin and subcutaneous tissue disorders: Rash


It is not known whether FluMist

can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

FluMist should be given to a pregnant woman only if clearly needed.

8.5 Geriatric Use



FluMist is not indicated for use in individuals



≥

65 years of age. Subjects with underlying high-risk

medical conditions (n=200) were studied for safety. Compared to controls, FluMist recipients had a

higher rate of sore throat.

8.6 Use in Individuals 50-64 Years of Age

FluMist is not indicated for use in individuals 50-64 years of age. In Study AV009, effectiveness was

not demonstrated in individuals 50-64 years of age (n

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

FluMist has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair

fertility.

14.5 Transmission Study

FluMist contains live attenuated influenza viruses that must infect and replicate in cells lining the

nasopharynx of the recipient to induce immunity. Vaccine viruses capable of infection and replication

can be cultured from nasal secretions obtained from vaccine recipients. The relationship of viral

replication in a vaccine recipient and transmission of vaccine viruses to other individuals has not

been established.

Using the frozen formulation, a prospective, randomized, double-blind, placebo-controlled trial

was performed in a daycare setting in children <3 years of age to assess the transmission of vaccine

viruses from a vaccinated individual to a non-vaccinated individual. A total of 197 children 8-36 months

of age were randomized to receive one dose of FluMist (n=98) or placebo (n=99). Virus shedding was

evaluated for 21 days by culture of nasal swab specimens. Wild-type A (H3N2) influenza virus was

documented to have circulated in the community and in the study population during the trial, whereas

Type A (H1N1) and Type B strains did not.




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Profesor 2009-09-22 18:16:27

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17.2 Vaccination with a Live Virus Vaccine

Vaccine recipients or their parents/guardians should be informed by the health care
provider that FluMist is an attenuated live virus vaccine and has the potential for transmission to
immunocompromised household contacts.