Sunday, November 8, 2009

Vaccines and Treatments For H1N1

A Few Things To Consider Before Deciding Not To Get Your Swine Flu Vaccine

First, despite all of the hype, vaccines have repeatedly proven to be the single best method of avoiding coming down with the flu. Those are the facts.

In 1890, one out of every five American children died before their first birthday. Another one out of five children died before their fifth birthday and not only poor children. Everyone knew children who had died of measles, mumps, rubella, polio, or whooping cough.

If you don’t believe this stop in an old cemetery sometime and read the headstones. You will see that far more children died young than today, little headstones with lambs and angels that we almost never see today.

Today, largely because of vaccination, those diseases barely exist, and many of the internet posters and anti-virus agitators do not remember these epidemics that once carried off hundreds of thousands of men, women, and children each year.

The same results were repeated in country after country around the world during the twentieth century as vaccines became more widely available. Anyone,

Furthermore, the risks of vaccination have been vastly overblown. This article provides an excellent scientific review of the safety and effectiveness of vaccination: Vaccine Concerns
H1N1 Vaccine

The following is an effort to put the best official sources of information about the Swine Flu vaccine from the Centers For Disease Control and World Health Organization into simple easy to understand language. For the full information refer to those sites.

Two kinds of H1N1 vaccines being produced:

* A 2009 H1N1 “flu shot” — an inactivated vaccine (containing dead virus) is given with a needle, usually in the arm.

The flu shot is approved for use in people 6 months of age and older, including healthy people, people with chronic medical conditions and pregnant women.

* The 2009 H1N1 nasal spray flu vaccine — a vaccine made with live, weakened viruses that do not cause the flu (sometimes called LAIV for “live attenuated influenza vaccine”).

Nasal vaccine is approved for use in “healthy” people 2 years to 49 years of age who are not pregnant.

About 2 weeks after vaccination, antibodies that provide protection against 2009 H1N1 influenza virus infection will develop in the body.

However, the 2009 H1N1 vaccine will not protect against seasonal influenza viruses, so to get the best possible protection you will need two flu shots.

Initial Target Groups Are:
When Swine Flu vaccine is first available, the CDC recommends that providers administer vaccine to people in the following five target groups (order of target groups does not indicate priority):

* Pregnant women
* People who live with or provide care for infants younger than 6 months (e.g., parents, siblings, and day care providers),
* Health care and emergency medical services personnel,
* People 6 months through 24 years of age, and,
* People 25 years through 64 years of age who have certain illnesses.

People Who Should Not Be Vaccinated
Despite all of this there are people who should NOT be vaccinated. Anyone in the following groups should not get any flu vaccine without first consulting a physician. These include:

* People who have a severe allergy to chicken eggs.
* People who have had a severe reaction to an influenza vaccination.
* People who developed Guillain-Barré syndrome (GBS) within 6 weeks of getting an influenza vaccine previously.
* Children younger than 6 months of age (influenza vaccine is not approved for this age group)
* People who have a moderate-to-severe illness with a fever (they should wait until they recover to get vaccinated.)

Vaccine Effectiveness
The ability of a flu vaccine to protect a person depends on the age and health status of the person getting the vaccine, and the similarity or “match” between the viruses or virus in the vaccine and those in circulation.

Vaccine Side Effects (What to Expect)
The same side effects typically associated with the seasonal flu shot and the seasonal nasal spray vaccine are expected with the 2009 H1N1 flu shot and 2009 H1N1 nasal spray vaccine.

These are:

The flu shot: The viruses in the Swine Flu shot are killed (inactivated), so you cannot get the flu from a flu shot. Some minor side effects that could occur are:

* Soreness, redness, or swelling where the shot was given
* Fever (low grade)
* Aches

If these problems occur, they begin soon after the shot, are usually mild, and usually last 1 to 2 days. Almost all people who receive influenza vaccine have no serious problems from it. However, on rare occasions, flu vaccination can cause serious problems, such as severe allergic reactions.

The nasal spray: The viruses in the nasal-spray vaccine are weakened and do not cause severe symptoms often associated with influenza illness. (In clinical studies, transmission of vaccine viruses to close contacts has occurred only rarely.)
In children, side effects from LAIV can include:

* runny nose
* wheezing
* headache
* vomiting
* muscle aches
* fever

In adults, side effects from LAIV can include

* runny nose
* headache
* sore throat
* cough
Read More..

Thursday, August 27, 2009

Trials of Candidate H1N1 Vaccines in Children

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced today that an independent safety monitoring committee has recommended that trials of a candidate 2009 H1N1 vaccine begin in children. NIAID concurred with this recommendation. Vaccinations will begin shortly in two trials being conducted through NIAID’s nationwide network of Vaccine and Treatment Evaluation Units (VTEU).

The safety monitoring committee reviewed data from more than 500 healthy adult and elderly volunteers enrolled in three VTEU trials of candidate H1N1 vaccines that began Aug. 7, 2009. The committee found no safety concerns in those trials that would preclude trials from proceeding in children.

Trial 1: Two Strengths of 2009 H1N1 Vaccine

One trial will test the immune responses to two different strengths of a candidate 2009 H1N1 vaccine manufactured by sanofi pasteur (Swiftwater, PA). This trial, led by the VTEU at the University of Maryland, Baltimore, will enroll up to 650 children aged six months to 17 years at five locations. Volunteers will receive a dose of either 15 micrograms or 30 micrograms of H1N1 vaccine at their first visit and a second dose three weeks later. Study investigators will take blood samples, which will show how the immune system responds (for example, by making antibodies against H1N1 virus) at set time points following the first and second injections. In addition to the VTEU at University of Maryland, the VTEU at Vanderbilt University, Nashville, TN, will participate in this trial along with sites at Duke University, Durham, NC; Children’s Mercy Hospital, Kansas City, MO; and Children’s Hospital, Seattle.

Trial 2: Seasonal Influenza Vaccine Plus 2009 H1N1 Vaccine

The VTEU at Saint Louis University is leading a second trial testing the candidate sanofi pasteur vaccine together with a licensed seasonal influenza vaccine. The trial will enroll up to 650 children aged six months to 17 years at Saint Louis University and five additional locations nationwide. It will assess the candidate vaccine’s safety and also how immune responses vary when the H1N1 vaccine is given before, after or at the same time as the seasonal flu vaccine. Other participating sites are the VTEUs at Baylor College of Medicine, Houston; Cincinnati Children’s Hospital; Emory University, Atlanta; and the University of Iowa, Iowa City. In addition to those VTEUs, the University of Texas Medical Branch at Galveston also will enroll volunteers in this trial.

The sanofi pasteur candidate 2009 H1N1 flu vaccine contains inactivated (killed) virus. It is impossible to become infected with 2009 H1N1 flu virus by receiving this vaccine.

Safety data will be assessed continuously throughout the two trials by the study investigators and by the independent safety monitoring committee. Initial results on how the immune system responds to the vaccine are expected in the next several weeks.

Further information about the trials can be found at ClinicalTrials.gov at the following links:

* 09-0054 Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine Administered at Two Dose Levels to Children
o NCT00944073
* 09-0047 Licensed Seasonal Flu Vaccine Given Together or Sequentially with Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine in Previously Primed Children
o NCT00943202

For more information about the 2009 H1N1 clinical trials, see Questions and Answers: Pediatric Trials of Candidate 2009 H1N1 Vaccine at NIAID Vaccine and Treatment Evaluation Units (VTEUs) and Questions and Answers: Clinical Trials of 2009 H1N1 Influenza Vaccines Conducted by the NIAID-Supported Vaccine and Treatment Evaluation Units.

For more information on influenza, visit www.flu.gov for one-stop access to U.S. government information on avian and pandemic influenza. Also, visit NIAID's Flu Portal.

Media inquiries can be directed to the NIAID Office of Communications at 301-402-1663, niaidnews@niaid.nih.gov.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

The National Institutes of Health (NIH)—The Nation's Medical Research Agency—includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
Read More..

Monday, August 17, 2009

Swine flu vaccine

The first swine flu vaccines are likely to be licensed for use in the general population in September, the World Health Organization has announced.

Several manufacturers have produced initial batches of a H1N1 vaccine and some clinical trials are already underway.

WHO director of vaccine research Dr Marie-Paule Kieny also sought to calm fears about safety of new vaccines.

She said the vaccines were based on "old and proven technology".

Figures show continuing rises in cases in the southern hemisphere in the past seven days.


Argentina has particularly seen a large increase and deaths now stand at 337.

And there has been a rise in cases of 25% in Australia.

Although it has not yet been clarified who would be first in line for a vaccine, it is likely to be those who are most vulnerable, such as pregnant women and young children.

Some experts have raised concerns about the lack of safety data on flu vaccines in these groups.

In particular, a very rare neurological condition called Guillain Barre syndrome affected 500 people during a US vaccine programme against swine flu in 1976.

Dr Kieny said much was known about flu vaccines in these groups from seasonal vaccines given every winter and added that regulatory agencies would be monitoring for any signs of adverse reaction.

"The quality controls on today's vaccine are much better than they were 30 years ago," she added.

Fast track

Regulators in the US and Europe have special plans in place to fast-track swine flu vaccines, some of which are based on conventional seasonal flu vaccines and some which use newer technology.

Clinical trials are already underway in China, Australia, USA, UK, and Germany.

It comes as drug company, Baxter, has announced the production of the first commercial batches of its swine flu vaccine Celvapan.

The vaccine has been grown using cell culture, a much faster method than the traditional way of growing it in eggs.

Baxter is one of two companies contracted to provide pandemic flu vaccine to the UK, the other being GlaxoSmithKline, and both plan to start clinical trials this month.

One key part of the trials is to work out whether people need one or two doses of the vaccine.

Ministers have repeatedly said they expect to have enough doses for half the UK population by the end of the year.
Read More..

Sunday, August 16, 2009

Canada to order 50.4 million H1N1 vaccine doses

The federal government will order 50.4 million doses of swine flu vaccine, and will pick up 60 per cent of the cost, Health Minister Leona Aglukkaq announced Thursday.

The number of doses is enough for all Canadians who want and need to be vaccinated against the H1N1 pandemic virus, said Dr. David Butler-Jones, chief public health officer of Canada.

The total cost will be more than $400 million, Butler-Jones told reporters.

A spokesperson for the pharmaceutical company GlaxoSmithKline said the entire order for the vaccine will be produced at its factory in Quebec City.

Canada's pandemic influenza plan calculated that about 75 per cent of Canadians might want or need to be vaccinated during a pandemic.

Results from trials of the avian flu vaccine suggest one dose should be enough, particularly since Canada's flu vaccine supplier, GlaxoSmithKline, is using an additive known as adjuvant, he said. Adjuvants are used to boost immune response from vaccines.

The vaccine order is large enough to give one dose to every Canadian, or two doses to 75 per cent of the population, he said.

"If we did need two doses for everybody and everybody in the country wanted to be and needed to be immunized, then we would at that point have to order more," Butler-Jones said.

Polling done for the Public Health Agency of Canada suggests about 60 per cent of Canadians may want pandemic flu shots. The agency recommends the vaccine to slow down the spread of H1N1 virus, and for people to protect themselves and their families, he added.

First Nations and Inuit will have access to the pandemic vaccine once it's available, Aglukkaq said.
Vaccine safety

In Canada, pandemic vaccine production is on target, Butler-Jones said, with clinical trials set to begin in late September. People could start receiving shots in November, if not sooner, he said.

Butler-Jones said that risks of swine flu far outweigh any theoretical risks of the adjuvanted vaccine, including for groups such as pregnant women and children.

"We will be monitoring it closely when it comes on to the market, and if there are any concerns, they'll be addressed," he said in an interview.

Public health officials could offer vaccine without adjuvant for some people, said Dr. Allison McGeer, an infectious disease specialist in Toronto.

"We get back to, if I can vaccinate 200,000 women instead of 50, 000 women, that may be the right thing to do," McGeer said. "Or it may be that we'll get enough data from the Southern hemisphere about the actual risk in pregnancy to know that we don't need to offer it to all pregnant women."

Earlier on Thursday, an official with the World Health Organization said the first swine flu vaccines will likely be approved by regulators in September.

Manufacturers initially said they were finding low yields in making vaccines for the H1N1 pandemic strain of the virus, but that it is now improving.

"We are on track in development," Marie-Paule Kieny, WHO director of the Initiative for Vaccine Research, told a news conference in Geneva.

Small batches of the pandemic vaccine have been made and clinical trials have started in Australia, China, the United States, Germany and Britain, with more set to begin.

Creating the batches and giving the shots to people are two separate steps, Kieny said, noting various regulators must first license the vaccine for use.

Kieny also aimed to quell fears about the safety of the pandemic vaccine, saying it is based on proven technology, and much is known about seasonal flu vaccines that would also apply to H1N1.

She said the agency expects to see reports of side effects once millions of people have received the vaccine, but that deadly side effects will be rare. Vaccines commonly provoke reactions such as nausea, fever, pain from the injection, and diarrhea.

"We see no apparent safety signal," she said. "There is no safety concern with using adjuvanted vaccine."
Read More..

TIME Examines International Fight Against H1N1

TIME examines the international fight against H1N1 (swine) flu, including current efforts to produce an H1N1 vaccine and prepare the northern hemisphere for the expected surge in infections this fall. "While some companies have [vaccine] donation schemes for the developing world … the lion's share will go to wealthy countries, despite the fact that underlying health conditions make populations in the developing world particularly vulnerable," the magazine writes. As such, "Developing countries need to be clever about managing the doses they receive, for instance by immunizing front-line health workers, says Richard Coker of the Communicable Diseases Policy Research Group at the London School of Hygiene and Tropical Medicine."

Still, even a mild pandemic would prove challenging for developing countries, Coker said. "We've looked at the pandemic preparedness plans in developing countries and we've found that almost across the board the resources just aren't there to implement plans effectively. It's going to be very difficult for these countries," Coker said (Scherer/Harrell, 8/12).

The Miami Herald examines the efforts being made in Costa Rica - the country with "the highest number of [H1N1] cases - and fatalities" in Central America - to stop the spread of H1N1. There, according to the newspaper, the country health officials have shifted their focus from testing for the H1N1 virus to "protecting the most vulnerable from further medical complications, including pregnant women, obese persons, asthmatics and those suffering from lung and heart conditions," as recommended by the WHO. The article includes information about the complications posed by the fact both the seasonal flu and H1N1 flu are circulating in the region at the same time (Long, 8/13).

Fox News explores the debate over whether to treat children with flu-like symptoms with the antiviral Tamiflu after a group of scientists released a study Monday showing "the antiviral drug does little to 'cure' sick children with the H1N1 virus, and the medication's potentially harmful side effects outweigh the benefits." The news organization notes, "it appears those researchers are all alone in their thinking. In a statement to journalists, the WHO said people severely sick with the H1N1 virus - including children - need to be promptly treated with Tamiflu." The FDA is also on board with the recommendation to treat children with Tamiflu, "deeming the drug safe for children as young as 1 year old"
Read More..

H1N1 Vaccine

By September, the first H1N1 (swine) flu vaccines will be approved and ready for use, WHO director of the Initiative for Vaccine Research Marie-Paule Kieny said Thursday, Reuters reports. Kieny also expressed optimism that "vaccine production yields were improving, following a disappointing start that triggered some worries about supplies," the news service writes.

By early next month, Kieny said scientists will have the results of the first H1N1 vaccine clinical trials, which aim to determine "how many doses of the new vaccine will be required to provide sufficient protection against the virus," the Los Angeles Times' blog "Booster Shots" reports. "Preliminary studies have suggested that the antigen being used does not provoke as strong a response as that in the seasonal flu vaccine, and that it may be necessary to use two doses -- which would halve the total number of people who could be immunized" (Maugh, 8/6).

Reuters reports that "[o]nce initial clinical trial results are in, regulators will be able to approve the vaccines from next month and the first countries are expected to start mass vaccination programmes, Kieny added"
Read More..

Saturday, July 25, 2009

First Victim A H1N1 Virus


Mexico City - Kasus flu H1N1 (flu babi) pertama kali dilaporkan di Meksiko. Namun siapa sangka, penderita pertama flu babi di negeri itu ternyata seorang bayi berumur 6 bulan!

Bayi perempuan itu diketahui tidak pernah melakukan kontak dengan hewan babi ataupun peternakan babi. Demikian disampaikan kepala laboratorium Meksiko yang mempelajari virus flu babi seperti dilansir kantor berita AFP , Jumat (24/7/2009).

"Dia seorang bayi perempuan berumur 6 bulan asal San Luis Potosi yang masih hidup, dan yang pertama menunjukkan gejala-gejala virus influenza A (H1N1) tipe baru pada 24 Februari," kata Celia Alpuche, kepala Institute of Epidemiological Diagnosis and Reference (INDRE) di Mexico City.

Fakta ini mengejutkan. Sebab selama ini media-media mengarahkan dugaan pada dua orang lainnya. Dugaan media diarahkan pada seorang bocah laki-laki berusia 5 tahun yang tinggal di dekat peternakan babi di Meksiko timur serta seorang wanita asal Oaxaca di Meksiko tenggara. Kedua orang itu terkena flu babi pada April lalu.

Dari Meksiko, virus flu babi menyebar ke Amerika Serikat dan hingga kini telah meluas ke seluruh dunia. Sejauh ini lebih dari 700 orang di berbagai negara telah meninggal akibat virus tersebut.

Jumlah kematian akibat flu babi di Meksiko saat ini sebanyak 138 orang dengan hampir 14.800 kasus yang dilaporkan.

Source : detik.com
Read More..