Testing It Up

A CNN report shared that Federal officials are urging Americans to get vaccinated against swine flu. Lately, states have been reporting “sporadic or local flu activity,” but that should not make people complacent, according to the Head of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, Dr. Anne Schuchat. Dr. Schuchat stressed that “the virus is still a threat.”

To date, 70 million Americans, a figure that comprises 23.4% of the population, have been vaccinated against swine flu, according to the CDC. This figure is satisfactory, according to Dr. Schuchat; nevertheless, she continued to urge those who have yet to get vaccinated to do so. She was quoted with the following statement: “Individual cases of H1N1 continue to occur and people are being hospitalized and they’re dying.”

The comment thread to the CNN article, though, seems to indicate that the public is not all too convinced about the need to get swine flu vaccines. Some readers went as far as saying that only the pharmaceutical companies that manufacture the vaccine are benefiting from the drive to get vaccines.

Doctors in Indiana are getting worried about the fact that a majority of children – roughly two-thirds – who have received their first dose of the H1N1 vaccine have yet to receive their second dose. Without the second dose, children are still not fully protected from the H1N1 flu strain.

It may be a good time as any to remind parents about this fact. It is imperative that children are brought back for the second dose in order to become fully protected from getting sick with swine flu.

In Indiana, an estimated 300,000 children have received the H1N1 flu vaccine. Only 85,000, however, received both doses.

Dr. Joan Duwve, the medical director for public health and preparedness for the Indiana State Department of Health, explained how the flu vaccine doses work in children. The first dose only serves to “wake up” the immune system, introducing it to a virus that it has not seen before. It is the second dose, also known as the booster shot, which serves to protect the child.

In order to remind its citizens of the need to bring their children back for the second dose, the Health Department will be mailing postcards to the parents of children who have already received their first dose over the next few weeks. The postcards will remind them to take their child to the local clinic or their doctor for the booster shot.

The State Department of Health will continue to provide its free public clinic on Tuesdays at the Carew Medical Park through the end of February.

Eight hundred thousand doses of H1N1 flu vaccine intended for young children aged 6 months to 35 months have been recalled, as periodic tests from early this month indicated that the vaccine was “not as potent as it should be”. It was stressed, though, that the recall does not mean that there should be concerns among parents regarding the safety of these vaccines.

The vaccines were produced by Sanofi Pasteur, which also tested the vaccines. According to company spokesman Len Lavenda, it takes between three to four months to make flu vaccine and most of that time is spent on testing. Sanofi Pasteur subjects the vaccine that it produces to a series of tests, both within the production process and after the process is completed. The vaccine has to pass end-of-phase tests before moving on to the next phase, and is again sent through a series of tests before it finally gets shipped out.

On top of these steps, Sanofi Pasteur keeps samples of each batch of vaccine that it produces and periodically tests these samples. The 800,000 doses of vaccine that is being recalled constitute four batches of vaccines that were shipped out from the Sanofi Pasteur manufacturing facility in Swiftwater, Pennsylvania in early November. At the time that the vaccines were shipped out, these had past all tests that had be done on them; however, in early December, tests conducted by Sanofi Pasteur indicated that the potency of these batches were 12% below the ideal potency level.

Sanofi Pasteur promptly informed the Centers for Disease Control and Prevention as well as the Food and Drug Administration about their findings. Sanofi Pasteur has been asked to retest their samples; it will reportedly take about a week to complete the tests.

Doctors are advised, though, to check their supply of vaccines and return vaccines that belong to the following lots to Sanofi Pasteur:

- 0.25 mL pre-filled syringes, 10-packs (NDC . 49281-650-25, sometimes coded as 49281-0650-25): UT023DA, UT028DA, UT028CB
-  0.25 mL pre-filled syringes, 25-packs (NDC . 49281-650-70, sometimes coded as 49281-0650-70): UT030CA.

The week ended at a rather optimistic note as far as swine flu is concerned. According to the Centers for Disease Control and Prevention, there are now 43 states compared to the previous week’s count of 46 that have widespread flu activity. The difference is slight and the statistics, if compared with previous years, are still rather high, according to director for the National Center for Immunization and Respiratory Diseases Dr. Anne Schuchat. To that we say, though, the a slight improvement is certainly way better than none at all.

The CDC, in addition to monitoring swine flu since it first appeared in April, is also constantly working towards raising awareness. With the expected influx of travelers this Thanksgiving weekend, the Center has launched yet another public awareness campaign to ensure that travelers are kept safe and that the increase in travel will not necessarily mean an increase in the spread of the flu – both the H1N1 and seasonal variants.

The things that the CDC would like to remind people with the intent to travel over the holidays are simple. Among them is the basic reminder to travel only when one is well. As always, people are enjoined to wash their hands (often and properly), to cover their nose and mouth when coughing or sneezing and to do so into a tissue to be disposed of immediately or into one’s sleeve, and to get vaccinated if one is considered as among those who should be prioritized for the vaccine.

Getting to those vaccines will no longer be that much of a problem, as more vaccines have now become available. Across America a total of 54.1 million doses of H1N1 vaccine have reportedly been ordered, which is 11 million more than what states were able to order in the previous week, according to Shuchat.

In a previous post, we shared that China was looking into two separate cases of two people who died after being administered with swine flu vaccine. At the global level, the World Health Organization monitored the efforts of various health officials towards investigating suspicious deaths of people who have received vaccination against H1N1 flu.

As of Thursday, 41 cases of death after inoculation have reportedly been proven to NOT being caused by the vaccine.

This further emphasizes what health authorities have been trying to say to assure people — the vaccine is safe, just as the seasonal flu vaccine is. Marie-Paule Kieny, top vaccine expert for the WHO, stated this fact in a telephone conference after saying that there has been “no new safety issue” based on the reports that have been issued.

There are, however, still investigations that are ongoing. For the time being, though, among the investigations that have been completed revealed that the causes of the deaths of these people are not related in any way to the fact that they were vaccinated and cannot be traced back to the vaccine itself.

The WHO pegs the number of vaccinations worldwide at about 65 million, spread over 16 countries; more should be added to this figure, though, as immunization is reportedly ongoing in at least 40 countries.

Eleven million of these vaccinations were done in China, the first country to start immunization programs against swine flu. As mentioned in an earlier post, two deaths have been reported, and these have been proven to be “coincidental” to the administration of the vaccine and caused by underlying medical conditions; the vaccine has already been ruled out as the cause of death. There are reportedly 15 cases of severe side effects.

The Christmas Tree being put up at the Rockefeller Center will be lit on December 2nd, signaling the start of the Christmas season, and department stores and malls all across America will definitely have a resident harbinger of joy: Santa and his happy helpers. And while they are handing out presents without expecting anything in return, they would nevertheless like to be protected from something that they might unknowingly receive – swine flu.

Jolly old Santa, his round belly and his snowy white beard, however, are not on the priority list of people who should receive swine flu shots. When we come to think of it, however, at this time of year, it does seem that Santas everywhere fit the description of someone who ought to be on the priority list — they will be exposed to and associate closely with potential swine flu carriers. This is especially true for Santas who will be volunteering to visit sick children in hospitals and health care facilities.

Also mentioned was their generous bellies, as obesity is considered as a major risk factor – except, of course, the Santa with the fake belly. Since we have not even gotten through immunizing all those who are in the priority list, we think there is no telling whether they will get their shots in time for their scheduled appearances at shopping halls.

Santas are already meeting and talking ways through which they can protect themselves, even sans vaccine. Organizations such as the Amalgamated Order of Bearded Santas and Santa America are reportedly organizing seminars and talking strategies and health guidelines, such as using hand sanitizers and ensuring that their immune systems are bolstered by taking vitamins.

Parents are also advised to be keen about the health condition of their children, and if their children are sniffling and coughing or having intermittent fevers, then it is more prudent to keep them at home. Santa could wait another day.

There may be an answer to what is being experienced in the United States as far as supply of the swine flu vaccine is concerned, brought to us by the company Novartis.

Supply has been a rather sensitive topic since the United States officially started immunizing high priority groups, with delays being experienced in the delivery of vaccines and people – patients and health care providers alike – began to feel frustrated with the entire process.

Novartis recently announced, however, that based on the results that the company has gathered from ongoing trials, a 7.5 µg dose of Novartis’ A(H1N1) 2009 unadjuvanted vaccine was able to meet the immune response criteria set for protection of adults as well as the elderly. The dose is only half of the current 15 µg dose that is approved in the United States for adolescents, adults and the elderly.

Andrin Oswald, CEO of Novartis Vaccines and Diagnostics, verbalized what this may potentially mean to the United States’ immunization efforts: we may just be able to double the current vaccine supply – at least the vaccines manufactured by Novartis, which was presumably the only vaccines that the company can accurately vouch for – and inoculate more people. We wonder whether the same possibility holds true for vaccines manufactured by other companies and facilities. If so, then it means that the entire supply of swine flu vaccine doses can indeed be doubled.

There is even more potential for increasing vaccine supply when using adjuvanted vaccine – these are vaccines to which a substance that will improve immune response, which means that less vaccine may be used to achieve the desired protection – is added. For adjuvanted vaccines, even less dose is reportedly needed, at least according to the trials: 3.75 µg. The company’s flu manufacturing facility based in Liverpool, the output of which is destined exclusively for the use of the United States, can quadruple its output if the vaccines are adjuvanted.

The Ministry of Health of China has reported that two people have died after receiving swine flu shots. While death after immunization does not necessarily mean that the death was caused by the administration of the vaccine, these occurrences need to be monitored and investigated.

Both fatalities reportedly died within hours after receiving the vaccine. One of them was a teacher from Hunan province. The preliminary autopsy report, however, reveals that the cause of the teacher’s death may have been a heart attack while playing basketball. The Ministry is ruling the death as a “coincidental medical incident” that is not in any way tied with or caused by the administration of swine flu vaccine. There were no details regarding the circumstances surrounding the death of the other person.

While investigation is ongoing regarding the second death, health officials have reportedly pulled all the batch of vaccines to which the dose used to immunize the teacher belonged. This may have been done in order to ensure that if a tie-in will be made to the batch of vaccines, no other people will receive the doses in question.

China has taken a rather aggressive approach towards swine flu, with the government asking biotech companies to develop a pandemic swine flu vaccine way back in June. It was Sinovac, a company based in Beijing, that was able to develop the first approved swine flu vaccine. They were also the first to conduct trials and report that a single dose of vaccine is enough protection against swine flu.

China started its swine flu vaccination programs in September, the first country in the world to do so.

Health officials in the United States can probably take a cue from what is being done in Europe in as far as the distribution and administration of swine flu vaccine is concerned.

In London, for instance, one will not see long, snaking lines of frustrated and disappointed people waiting to be vaccinated against swine flu. Doctor’s offices are not inundated with calls for vaccine. There are also no issues regarding seeming injustice as to who gets to get swine flu first. In North America, people have complained about the fact that bigwigs such as Goldman Sachs and Citigroup were able to acquire swine flu vaccine while community clinics still waited for vaccines to arrive. In Canada, professional hockey and basketball players were administered with swine flu vaccine before children.

European countries employed an approach that is the exact opposite of the free-for-all system being practiced in North America. Instead of announcing the availability of vaccines and launching campaigns to encourage people to get them, some European countries have decided to adopt a by-invitation system. Health officials in Britain, for instance, made a list of those who are to be prioritized for vaccination, and these identified citizens were sent notices. These include pregnant women, health workers, and people with chronic health conditions such as diabetes, cancer and AIDS.

Probably due to the fact that the cases of swine flu in European countries are not as widespread as those in the United States – Britain reportedly has an estimated 600,000 flu cases against the millions of cases in the United States – some Europeans have been relatively indifferent and unconcerned. There are those who have received notices to come in for shots who have opted to ignore these notices.

But then again, what works for one may not necessarily work for another. Whether this system will work in the United States cannot be assured at this time, although it does seem like the European system is more effective in reaching those who ought to be reached.

All this vaccine talk for the past couple of weeks or so has definitely led to mixed opinions and emotions. Should you or shouldn’t you get vaccinated? And if you do, will there be a vaccine available for you? And how sure are you that what you will be doing will help you or only cause you more problems down the line?

The issue about vaccines has been going on for quite some time, way before the swine flu pandemic even came to being. There has been talk that vaccination in children eventually led to autism or other major health issues. This has actually brought the advantages of vaccines to question — are vaccines defeating the very purpose they were created to serve?

A feature on MedPage Today tells of a study that seems to discount the relationship between vaccination and health problems. Researchers went through the electronic medical records of Northern California Kaiser Permanente, focusing their search on the records of children who were diagnosed with an inborn error of metabolism from 1990 until 2007, remaining in the system until the age of three.

An analysis was also made of emergency room visits as well as hospitalizations of children until the age of 18 who had an inborn error of metabolism, who also received at least one vaccine at some point.

In both cases, researchers reportedly did not find a clear-cut connection between the administration of vaccine and health problems. Although researchers were quick to clarify that these were preliminary findings, the results were still touted as “very reassuring”.

The results simply affirmed further the fact that despite the side effects that vaccines may have on some people, the positive effects still far outweigh the negative effects.

That is, of course, if the vaccine gets administered in time. Going back to the ongoing swine flu pandemic, reports are saying that it seems that the flu is overtaking the arrival of the vaccines. We certainly hope that more doses arrive when they are needed the most.