Any News on a Vaccine Yet?

indigo girl · Jul 30, 2009

I don't know. I suspect that there will be multiple ways that they will proceed.

At any rate, there is nothing to do but wait until they let us know.

Take care of yourself, multi. Get some sunshine for the vitamin D. I am reading that this is important.

Multicollinearity, BSN, RN · Jul 30, 2009

I don't know. I suspect that there will be multiple ways that they will proceed.
At any rate, there is nothing to do but wait until they let us know.
Take care of yourself, multi. Get some sunshine for the vitamin D. I am reading that this is important.

Vitamin D seems to be implicated in so many diseases and immune-modulated physiological mechanisms. Maybe my 90 minute swims in the morning sunshine may payoff, dermatologists be damned. (Yes, I wear strong sunscreen, but still get deeply tanned. AZ sun is very strong despite SPF 80 sunscreen.)

indigo girl · Jul 30, 2009

http://www.reuters.com/article/governmentFilingsNews/idUSN3035657320090730?rpc=401&

Look at who is pushing for Walmart to get involved in the swine flu vaccinations.

It's the former Admiral John Agwunobi, who used to be Assistant Secretary for Health, U.S. Department of Health and Human Services. Now he works for Walmart! How about that?

Wal-Mart Stores Inc (WMT.N) is discussing with U.S. health officials the possibility of putting vaccination sites at some of its stores for an H1N1 swine flu inoculation campaign this fall, a company official said on Thursday.
Federal officials met with Wal-Mart executives on Wednesday in Arkansas to discuss the issue, Dr. John Agwunobi, president of health and wellness for Wal-Mart U.S., told public health leaders at a conference in Orlando.
"We are in discussions with CDC (U.S. Centers for Disease Control and Prevention) and others in local and state departments to see what role we might play," Agwunobi said. "It might be we are a site. It may be help with logistics and with supply chain."
Agwunobi said 140 million people walk through the doors of its 4,000 U.S. stores each week.
U.S. health advisers have said about half the U.S. population should be vaccinated against H1N1 influenza. Up to 160 million doses of flu vaccine will be available for the start of the campaign in mid-October.
The H1N1 swine flu, characterized by mild symptoms in most patients, is now so widespread that the World Health Organization has stopped counting cases.
Speaking at the National Association of County and City Health Officials (NACCHO) annual conference, Agwunobi also said Wal-Mart is planning to be a site this fall for seasonal flu vaccinations, administered by a third-party, at stores in most parts of the country.

(hat tip PFI/snowhound1)

indigo girl · Aug 1, 2009

Nasal Vaccine Holds Promise Against Swine Flu

http://www.nytimes.com/2009/07/31/business/31flumist.html?_r=2&partner=rss&emc=rss

As an alternative the to the flu shot, Flumist is still an egg based technology as are most of the upcoming vaccines that will be given in the US. If you have a concern about vaccines grown in eggs, you will have to ask around for the cell based vaccines. They do exist but will not be most of what is going to be given in the US.

MedImmune, which already makes the nasal spray vaccine FluMist for seasonal flu viruses, says it is on track to produce about five times as much swine flu vaccine as it had expected-so much, in fact, that it will run out of nasal spray devices and is looking to administer the vaccines with droppers instead.
A nasal spray vaccine could be a strong weapon against swine flu because makers of conventional flu shots have reported problems producing their vaccines.
If nasal spray vaccines emerge as a central player against swine flu, it would represent a reversal of fortune for MedImmune's efforts in the field. As a vaccine for seasonal influenza, its FluMist has been a flop from a marketing standpoint, accounting for only a few percent of the inoculations Americans receive each year.
But it appears to have a manufacturing edge. Because its vaccine uses a live but weakened virus, MedImmune uses a different viral strain than the makers of flu shots, which contain an inactivated virus.
Each approach uses chicken eggs as the culture for growing its virus strain, but flu shot makers say the strain of swine flu virus they are using is growing more slowly than expected. MedImmune's strain, meanwhile, is growing faster than expected.
As a result, MedImmune, a subsidiary of AstraZeneca, says it can make 200 million doses by next March, about five times what it had expected.
Robin Robinson, who heads procurement of the pandemic vaccine for the Department of Health and Human Services, said MedImmune alone accounted for 12 million of the 20 million doses already produced by the five companies under contract to the government.
Dr. Robinson said that the other drug makers were resolving their production problems and would catch up. He said 120 million doses should be available by October, without counting on any extra production from MedImmune. But if the extra nasal spray doses can be used, Dr. Robinson said, "our supply could possibly increase by a very large amount."
The problem for MedImmune is that the unexpected production surge left the company short of the sprayers used to squirt the vaccine into the nose. It can supply only about 40 million doses in sprayers by March.
"We now are sitting on a surplus of potentially 150 million bulk doses," Bernardus N. M. Machielse, executive vice president for operations, said in an interview.
BD, supplier of the sprayers, said Thursday that it was running its sprayer factory in Columbus, Neb., round the clock to increase annual capacity to 70 million sprayers-up from 20 million.

But even that will not be enough. So MedImmune wants to use droppers in addition to sprayers. Some early clinical trials of the vaccine were conducted with droppers, so the company hopes to win approval from the Food and Drug Administration to use them.
Pandemic vaccines could bolster the total sales of AstraZeneca, the pharmaceutical giant based in London that acquired MedImmune, a Maryland biotechnology company, for $15.6 billion in 2007.
The government has ordered 12.8 million doses of pandemic vaccine from MedImmune for $151 million, Dr. Robinson said. AstraZeneca might get many hundreds of millions more in sales if the government buys the rest of the 40 million or so doses in sprayers and potentially the some 150 million doses in droppers.
Simon Lowth, AstraZeneca's chief financial officer, told analysts on Thursday that FluMist had a lower-than-average profit margin and that the pandemic vaccine, being sold under government contract, had margins that are "lower still."
The pandemic might also allow AstraZeneca to achieve a foothold outside the United States, the only country that has approved FluMist. The company is applying for approval in other countries and is talking to the World Health Organization about supplying some pandemic vaccine to poorer countries, David Brennan, its chief executive, said Thursday.
When MedImmune agreed to buy Aviron, the developer of FluMist, in 2001, executives predicted sales would grow to more than $1 billion a year. But in 2008, the best year yet for FluMist, sales reached only $104 million.
Several missteps nullified any appeal a needle-less vaccine might have. When it was initially sold in 2003, FluMist was priced at about $50, two to six times as much as a flu shot. And FluMist had to be frozen, a problem for some doctors' offices.
Because of safety concerns FluMist was approved only for healthy people 5 to 49 years old. But those are not typically the people who get flu vaccines.
FluMist is now approved for children as young as 2, it can be refrigerated instead of frozen and the wholesale price is down to $18.95.

indigo girl · Aug 1, 2009

more information on flumist

http://www.drugs.com/flumist.html

this info is about their seasonal vaccine, but i would expect that it would still apply to the new swine h1n1 vaccine as well.

for at least 21 days after receiving flumist, avoid close contact with anyone who has a weak immune system caused by disease (such as cancer, hiv, or aids), or by certain medicines such as steroids, cancer chemotherapy, or radiation treatment. a person with a weak immune system can become ill if they have close contact with you after you have recently received a an influenza vaccine.
you can still receive a vaccine if you have a cold or fever. in the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving flumist.
keep track of any and all side effects you have after using flumist. if you ever have to receive another influenza virus vaccine in the future, you will need to tell the doctor if the first vaccine caused any side effects.
like any vaccine, flumist may not provide protection from disease in every person. flumist will not prevent illness caused by avian flu ("bird flu").
becoming infected with influenza (commonly known as "the flu") is much more dangerous to your health than receiving the vaccine to protect against it. influenza causes thousands of deaths each year, and hundreds of thousands of hospitalizations. like any medicine, flumist can cause side effects, but the risk of serious side effects is extremely low.
influenza virus (commonly known as "the flu") is a serious disease caused by a virus. influenza virus can spread from one person to another through small droplets of saliva that are expelled into the air when an infected person coughs or sneezes. the virus can also be passed through contact with objects the infected person has touched, such as a door handle or other surfaces.
before using flumist
do not use flumist if you have ever had an allergic reaction to a flu vaccine, or if you have:
a history of guillain-barr� syndrome (especially if you had it within 6 weeks after having a flu vaccine);
a weak immune system caused by disease (such as cancer, hiv, or aids), or by taking certain medicines such as steroids;
if someone in your household has a weak immune system;
if you are under 18 years old and have recently taken aspirin or other similar medicines such as disalcid, doan's pills, dolobid, salflex, tricosal, and others; or
if you are allergic to chicken or egg products.
before receiving flumist, tell your doctor if you are allergic to any drugs, or:
asthma or other lung disorder;
a history of seizures;
a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);
a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or
if you have used a flu medication such as oseltamivir (tamiflu) or zanamivir (relenza) within the past 48 hours.
you can still receive a vaccine if you have a cold or fever. in the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving flumist.
vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. however, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. your doctor will decide whether you should receive flumist, especially if you have a high risk of infection with influenza. it is not known whether flumist passes into breast milk or if it could harm a nursing baby. do not use this medication without telling your doctor if you are breast-feeding a baby. flumist should not be given to anyone younger than 2 or older than 49 years of age.

indigo girl · Aug 1, 2009

Thimerosal Free Vaccine and the Use of Adjuvants

http://easthampton.htnp.com/2009/07/30/pregnant-women-first-in-line-age-65-and-older-last-for-new-h1n1-vaccine/

Most of the vaccines will contain thimerosal, but some will be available without it.

Anne Schuchat is the Director of the National Center for Immunization and Respiratory Diseases.

What about Thimerosal?
Schuchat also was asked about supplies of Thimerosal-free vaccine. She said the government has procured doses of Thimerosal-free vaccine to be delivered as shots and as nasal spray.
The nasal spray is licensed for children age 2 and older, and for adults up to age 49.
"So, we do think that there will be Thimerosal-free formulations available for those people who are interested in that sort of preparation," Schuchat said and added, "In general, the ACIP and CDC do not express a preference for Thimerosal-free [vaccine]."
Adjuvant-form set aside
Adjuvants are components of vaccines often included to increase the immune response to the vaccine. Schuchat said the committee discussed the fact that this form might mean a smaller effective dose - thus stretching supply - and possibly combating a new strain of the flu.
"The way that we are thinking right now, is that our base case is unadjuvanted vaccine... which could be available probably a little bit quicker than the adjuvanted form," she said.
She added, "With adjuvanted vaccines, you have tradeoffs... what are the safety constraints?"
"Here in the U.S., none of adjuvants that are being considered are licensed right now, so if we went for adjuvanted vaccine, it would be under what we call an emergency-use authorization... our working plans right now are that we are expecting not to need them," she said.
"In Europe, there are licensed adjuvanted vaccines, primarily for the elderly," she said.
If certain circumstances change, she added, the adjuvant-form could be useful. This would include, "major antigenic changes in the virus that make the immune response with a nonadjuvanted vaccine unacceptable," she said, or if it is taking unusually large doses of the nonadjuvanted vaccine to combat the virus.
"Neither of these two circumstances are considered by the experts very likely, but we are going through the steps to make sure we have adjuvant available and to study it," Schuchat said.

(hat tip PFI/pixie)

indigo girl · Aug 5, 2009

No Eggs in This Vaccine

http://www.forbes.com/feeds/ap/2009/08/05/ap6743404.html

Although they don't state it in this article, Novavax must be using cell based technology. Most of the vaccine used in the US however, will be egg based.

Using a gene sequence provided by the U.S. Centers for Disease Control, Novavax ( NVAX - news - people ) said it produced a virus-like particle, which is similar to particles of swine flu but does not have the genes necessary to replicate. Novavax said it plans to make more of the vaccine for use in clinical studies and to meet demand.
The company said it developed the virus-like particle 11 weeks after getting the gene sequence. The company said the result shows it is able to quickly make vaccines under real pandemic conditions.
Novavax says it developed the vaccine using its own production technology. Unlike other vaccine makers, the company said it does not grow the flu virus in chicken eggs.

(hat tip flutrackers/GennieF)

lamazeteacher · Aug 5, 2009

No Eggs in This Vaccine
http://www.forbes.com/feeds/ap/2009/08/05/ap6743404.html
Although they don't state it in this article, Novavax must be using cell based technology. Most of the vaccine used in the US however, will be egg based.
(hat tip flutrackers/GennieF)

It's my understanding from reading CDC and NIH news articles, that there are several plants manufacturing the antiH1N1 flu vaccine in the US without eggs, and that is the vaccine that will be administered at pharmacies, sipermarkets, etc.

indigo girl · Aug 5, 2009

It's my understanding from reading CDC and NIH news articles, that there are several plants manufacturing the antiH1N1 flu vaccine in the US without eggs, and that is the vaccine that will be administered at pharmacies, sipermarkets, etc.

Can you give us some links, lamaze?

I suspect that both will be available, but more of the egg based here in the US.

But, let's both research it, and see what we can come up.

indigo girl · Aug 28, 2009

It's my understanding from reading CDC and NIH news articles, that there are several plants manufacturing the antiH1N1 flu vaccine in the US without eggs, and that is the vaccine that will be administered at pharmacies, sipermarkets, etc.

I finally found some information on these non-egg based technologies. While I believe that they will be available at some point down the road, and certainly should be for those people that are allergic to eggs, as of right now, these vaccines are not yet licensed according to this report to the president.

This is a very long and informative report. The section I am posting is from page 60.

As far as I am aware, these are the only technologies that do not require any eggs. I would appreciate it if anyone else comes across more information on other technologies, that you would post them if not here than in one of the other threads on swine flu vaccines.

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

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.