More Vaccine News

[indigo girl]

Sinovac: Chinese Vaccine `Protects' With 1 Dose

http://afludiary.blogspot.com/2009/08/sinovac-chinese-vaccine-protects-with-1.html

If they are only going to give one injection, yet getting a good immune response, that means that they have to be using an adjuvant. Here in the US, it was decided not use adjuvants for the swine flu vaccine, at least for now. So any vaccine that will be given out in the US, even if from a foreign source, cannot use adjuvants.

Now, what would your first thought about using the Sinvac product be if you were allowed to do so?

I can guess what many would be thinking.

"This is from China, right?"

With so many to vaccinate, not much time left to do it in, and perhaps less worry about possible side effects, the Chinese chose to go with the adjuvants. We'll know more later if they release the data.

If, as suggested by Sinovac's overnight announcement, reasonable immunity can be created with just one shot, it would greatly expand our capacity to vaccinate large numbers of the public.

Sinovac offered no data with their announcement, and so we have no idea about the dose, whether it was adjuvanted or unadjuvanted, the level of antibody response it elicited, or the age groups of those that showed this response.

In other words, all we have is a broad statement by company, and no data to back it up. Yet.

[NurseForChange]

I'm sorry I miss wrote,

Novartis sumitted application for patent for Flu composition for Split viruses with specific influenza virus antigen from a H1, H2, H3, H5, H7 or H9 influenza A virus subtype, In 2006, and was accepted 2/19/09.

Patent #20090047353 Look it up...

[WalkieTalkie, RN]

The Swine Flu Vaccination was patented in 2003 by Novartis. The swine flu virus was described as being "Man-Made" including spliced DNA from the bird flu viruses, human flu viruses, and several diffrent swine flu viruses. And most recently 8/13/09 Novartis has launched a legal action against Glaxo Smith Kline claiming that it is infringing one of its patents. That makes me want to ask questions... will I be refusing any and all flu vaccinations this year, and I question if I should administer Flu vaccinations to my Patients.

And your point is? The H1N1 virus has been around since at least 1976 and I do not doubt that big pharma has anticipated an outbreak of swine flu just as they have been anticipating an outbreak of bird flu. Just because the virus has naturally mutated over time doesn't mean that there is some conspiracy going on. Don't you think someone else would have noticed by now? Maybe the thousands of independent scientists all over the world?

I remember talking about H1N1 and H7N1 viruses as long ago as 2003, well before there was an outbreak. It was part of our pandemic education.

http://www.hhmi.org/news/lamb20090501.html

The study of disease is founded on science, not misinformation and conspiracy theories.

[indigo girl]

US - H1N1 Vaccine Trials on Children Soon

http://www.indianexpress.com/news/us-h1n1-vaccine-trials-on-children-soon/506102/

The manufacturer is Sanofi Pasteur. Participants get two shots, three weeks apart which means there is no adjuvant.

As the August 7 clinical trials of an H1N1 vaccine in the US have found it to be safe, the US National Institute of Allergy and Infectious Diseases has announced two trials involving children.

The decision was taken after the Safety Monitoring Committee recommended on August 18 that trials of a candidate vaccine against the novel influenza A (H1N1) virus begin in chidren. Vaccinations will begin shortly in two trials being conducted through the agency’s Vaccine and Treatment Evaluation Unit (VTEU) network.

The Safety Monitoring Committee reviewed data from more than 500 healthy adult and elderly volunteers enrolled in three VTEU trials of the candidate novel H1N1 vaccine, which began on August 7, and found no safety concerns, the NIAID said on its website.

Of the two trials of the vaccine to be done now on children, one will investigate the immune response to two different strengths of the vaccine manufactured by Sanofi Pasteur. Led by the VTEU at the University of Maryland, Baltimore, the trial will enroll up to 650 children, between the ages of six months and 17 years, at five locations. Immune responses will be measured following doses of either 15 micrograms or 30 micrograms of the vaccine on the first visit and a second dose three weeks later.

[indigo girl]

US: Yale Study Questions Fed Guidelines on Vaccination

http://crofsblogs.typepad.com/h5n1/2009/08/us-yale-study-questions-fed-guidelines-on-vaccination.html

...new research by Yale School of Public Health has found that more people are likely to avoid both illnesses if vaccines are given out first to those most likely to transmit them, rather than to those at highest risk for complications.

The findings differ from current vaccination recommendations of the Centers for Disease Control (CDC) and the Advisory Committee on Immunization Practices (ACIP). The ACIP currently recommends that groups at high risk for complications of swine flu (novel influenza A or H1N1) be given priority for vaccination. The CDC recommends the same for seasonal flu vaccination.

High-risk groups include children younger than 5 years old, adults 65 years of age and older, pregnant women, and those suffering from pulmonary, cardiovascular and other disorders.

But the study by Alison P. Galvani, Ph.D., an associate professor in the division of Epidemiology of Microbial Diseases, suggests that vaccines targeted at groups more likely to transmit the viruses, rather than those at highest risk of complications, would result in fewer infections and improved survival rates.

Galvani used mathematical models to measure outcomes based on deaths, years of life lost and economic costs. Strikingly, these models found that schoolchildren and their parents, generally in their thirties, are the best groups to vaccinate when even a modest amount of an effective vaccine is available, because schoolchildren are most responsible for transmission and their parents serve as bridges to the rest of the population.

By targeting these two age groups, the study found, the remainder of the population is better protected.

[indigo girl]

http://www.reuters.com/article/healthNews/idUSTRE57P5BF20090826

Now we are hearing that it is unlikely that the vaccines will be ready before mid-October. Here are the 5 companies making the vax for the US. We should try to gather some info about their different vaccines.

Scientific advisers to President Barack Obama may have asked the government to speed up the availability of swine flu vaccines, but they are unlikely to be ready before October, the new head of the U.S. Centers for Disease Control and Prevention said on Wednesday.

On Monday, the President's Council of Advisors on Science and Technology said the government should speed up the supply of swine flu drugs and vaccines, making at least some shots available by mid-September.

The group also said the government should take advantage of the pandemic to improve flu surveillance.

Frieden said it was unlikely vaccines against H1N1 could get out to the public sooner than mid-October, when mass vaccination is scheduled to start.

"We wish we had new vaccine technology that would allow us to turn on a dime and make new vaccine in terms of weeks or months. It's not possible with today's technology to do that," he said.

Five companies are making swine flu vaccine for the U.S. market -- AstraZeneca's MedImmune unit, CSL Ltd, GlaxoSmithKline Plc, Novartis AG and Sanofi-Aventis SA. Tests have begun to determine if people will need one or two doses to be protected.

[indigo girl]

Recently we were asking about vaccines that were not egg based. There are some individuals with egg allergies that will need these vaccines. We knew that cell-based vaccines were being developed, and now there is another technique which also does not use eggs. It appears however, that these technologies are not yet licensed for use in the US at this time according to this report.

http://www.whitehouse.gov/assets/documents/PCAST_H1N1_Report.pdf

From Page 60:

Cell-based vaccines, in which viruses are grown in cultured cells rather than eggs. This method obviates the need for large quantities of embryonated eggs and potentially permits increased levels of production beyond those currently achievable. The method, however, does not substantially shorten the timeline between identification of the virus strains to be included in the vaccine and the vaccine’s availability. This approach is currently being used by several companies to produce candidate 2009-H1N1 vaccines, but such cell-based vaccines have not yet achieved licensure in the United States.

Recombinant vaccines, in which molecular biology techniques are used to clone influenza virus vaccine proteins into various expression systems. There are several such methods currently under development and evaluation, including some by industry and by the Defense Advanced Research Projects Administration (DARPA). This approach has potential to shorten the time between vaccine strain identification and final vaccine production to as little as a few months, as well as provide a large increase in vaccine production volume. However, considerable additional development and clinical work is required to firmly prove the effectiveness of these technologies and to provide the necessary data for eventual licensure.

[indigo girl]

My facility now has seasonal flu vax available, I was told via email last night. I think that they are talking about the patient's vaccine, but they could mean the staff. I'll have to ask.

Amazing! It is quite strange to be getting seasonal flu vax in late August.

How times have changed, and we must change with them.

[Kringe38]

I heard that "they" are saying you should get the seasonal flu shot at least a month before getting the H1N1 vaccine, assuming the latter ever becomes available.

[indigo girl]

Defense Department to Start H1N1 Flu Vaccinations

I don't think that this report is correct about the timing. We are hearing everywhere else that the vaccine for H1N1 will not be ready before mid October.

All military personnel will be vaccinated against the H1N1 flu virus, and the vaccine will be available to all military family members who want it, a Defense Department health affairs official said today.

The H1N1 vaccination program will begin in early October, said Army Lt. Col. (Dr.) Wayne Hachey, director of preventive medicine for Defense Department health affairs.

The vaccine, which has been licensed by the Food and Drug Administration, will be mandatory for uniformed personnel, the colonel said. “What we want to do is target those people who are at highest risk for transmission,” he said.

Health-care workers, deploying troops, those serving on ships and submarines, and new accessions are at the top of the list. “Any place where we take a lot of people, squash them all together and get them nice and close and put them under stressful conditions will get the vaccine first,” he said.

The department will use the usual seasonal flu vaccine distribution chain for the H1N1, Hachey said, noting that while the mass H1N1 vaccinations are new to the general population, the process for vaccinating against seasonal flu is old hat for the Defense Department. “We’ve been doing this for decades,” the colonel said. “The system is tried and true.”

The department initially will receive 1 million doses of the H1N1 vaccine, and another 1.7 million doses later in October.

Officials don’t know yet whether people will need one dose or two, Hachey said. “The assumption right now is that people will need two doses, 21 days apart,” he said. “That may change.”

Read more at: http://www.defenselink.mil/news/newsarticle.aspx?id=55698

(hat tip pfi/snowhound1)

[indigo girl]

Canada To Offer Unadjuvanted Vaccine To Pregnant Women

http://afludiary.blogspot.com/2009/09/canada-to-offer-unadjuvanted-vaccine-to.html

Canada to buy unadjuvanted vaccine for pregnant women, health officer says

Friday, 04 September 2009

TORONTO - Canada will purchase supplies of unadjuvanted swine flu vaccine to offer to pregnant women who might otherwise choose not to be vaccinated, the country's chief public health officer has revealed.

Dr. David Butler-Jones told The Canadian Press that Canada will buy 1.2 million doses of unadjuvanted pandemic vaccine which will be reserved for pregnant women, who are at significantly greater risk of becoming severely ill and dying if they contract the virus.

"I'm anticipating for pregnant women we will have an option," he said in an interview.

The vaccine will be supplied by GlaxoSmithKline, Canada's pandemic vaccine manufacturer, and is expected to be available at the same time as the country's other supplies of vaccine.

http://www.medicinehatnews.com/content/view/131936/

[indigo girl]

Flu Shots at the Airport

http://www.usatoday.com/travel/flights/2009-09-24-tampa-airport-flu-shots_N.htm

Gee, our airport has everything. Who knew?

Flu vaccines will be available at the Tampa International Airport starting next month.

As of Oct. 1 the airport will open kiosks delivering the antiserum for the virus. Vaccines are available at drug stores and other health-related facilities around Hillsborough County.

Kelly Figley, an airport spokeswoman, said five kiosks will be set up on the first day of the official flu season. They initially will offer only the standard influenza shots, not inoculations against swine flu.

The kiosks will administer inoculations through Nov. 30. Shots will cost $35 each.

(hat tip pfi/helblindi)

[indigo girl]

Little kids to need 2 shots for swine flu

http://www.baltimoresun.com/health/bal-md.vaccine22sep22,0,3954003.story

The swine flu vaccine works in just one dose for older children, but kids younger than 10 will likely need two shots, according to early results of clinical trials, federal health officials said Monday.

The findings mean that younger children could need as many as four shots this fall, to protect against both the seasonal flu and the swine flu.

In the clinical trials, the swine flu vaccine produced a strong immune response in children 10 to 17 years old in just 10 days; younger children generally had a weaker reaction over the same time period. They will likely need two shots given 21 days apart, officials said.

The results in children come from data gleaned at National Institutes of Health-sponsored trials of a vaccine made by French manufacturer Sanofi Pasteur. The trials are being conducted at the University of Maryland's Center for Vaccine Development and a handful of other sites. The studies tested two doses of the vaccine (15 micrograms and 30 micrograms) on 600 healthy children in three age groups: 10 to 17 years old, 3 to 9 years old, and 6 months to 36 months.

In the oldest group, 76 percent had a strong immune response to one 15-microgram dose. But for kids 3 to 9 years old, that figure was 36 percent. Of the youngest volunteers, just 25 percent produced a strong response.

The findings are something of a surprise to infectious disease experts who initially assumed that children of all ages would need two doses of the vaccine, since their immune systems are less mature than those of adults. In fact, up until data two weeks ago showed one dose was strong enough for adults, many experts assumed everyone would need two doses. The H1N1 virus is so different from typically circulating flu strains that most of the population has no immunity to it.

But so far, the immune response to the H1N1 inoculation is "acting strikingly similar" to seasonal flu shots in both adults and children, said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases.

"Overall, this is very good news for the vaccination program, both for supply of the vaccine and potential efficacy," he said.

Typically, children 9 and under who have never received a seasonal flu shot before must receive two shots to trigger enough immunity to fight off the virus.

But how those shots should be given isn't entirely clear. Federal health officials said Monday that children can receive both the seasonal flu shot and the swine flu inoculation on the same day. But if they receive the Flu Mist, which is inhaled and contains a live form of the virus, then getting both types of vaccine on the same day won't "take," according to Anne Schuchat, the director of the National Center for Immunization & Respiratory Diseases at the Centers for Disease Control and Prevention.

Another NIH trial designed to look at the timing of when to give the two flu vaccines is not expected to produce results until sometime in November.

Officials are urging parents to have their children vaccinated now for the seasonal flu - that vaccine became available last month - and to immunize them against the H1N1 virus once the swine flu vaccine arrives, likely in the beginning of October.

(hat tip pfi/pixie)