The Drug Controller General of India (DCGI) has given the go ahead to the pharmaceutical company to test the nasal swine flu vaccine, which has already been successfully tested on animals and is now ready to be tested on humans according to this PTI report. According to the report, Serum Institute is now in the process of identifying 50 “completely healthy” adults to undertake ‘phase- I’ human clinical trials in Pune, Delhi and Ahmedabad, according to Dr Rajiv Dhere, director of the company.

Unlike regular vaccines that are administered by injection or orally, this swine flu vaccine is in the form of a nasal spray. In other countries this is already available in spray form and is sold under the brand name ‘Flumist’. It’s actually made up of live but weakened flu viruses that allow your body to develop immunity to the flu virus.

There could be certain side effects that occur from the nasal swine flu, such as sore throat, runny nose, cough. Some people can develop muscle aches or even fever.

Although the swine flu vaccine in its spray form is easier to administer (especially for those that have a dislike for needle jabs), research done with the seasonal flu spray vaccine has shown that the spray may not be as effective in creating immunity as the injectible form of the vaccine. This is especially true for adults, however it has been seen that the spray works better is certain groups such as children. More research is required for the swine flu nasal spray however.

According to the report, the bridging trials are first step towards taking up a vaccine inoculation programme among high-risk groups in the country, such as pregnant women, children, health care workers and persons with co-existing morbidities.

“Bridging trials are needed till indigenous H1N1 vaccine is developed. The trial will help assess safety and tolerance among the diverse population in India. Several other hospitals in the country will also take part in the trials,” the swine flu coordinator in Andhra Pradesh was quoted as having said.

The process of making the H1N1 Swine flu vaccine available for commercial use in India is seems finally to have got on track. According to reports Zydus Cadila, the Indian company that is closest to producing an indigenously prepared H1N1 Swine flu vaccine for the Indian market has commenced clinical trials for their vaccine, subsequent to being given the go ahead by the Drug Controller General of India.

One of the big challenges that is to face the country’s swine flu prevention programme is the upcoming Kumbh Mela that is due to start in the hill state of Uttarakhand in the Dehradun, Rishikesh and Haridwar region on 15 January, which is among the largest periodic human congregations in the world.

The precaution of 150 doctors and 31 temporary hospitals to control the spread of swine flu at the mela has been taken by the state authorities. A stock pile of 3 lakh Tamifllu tablets have also been stockpiled by the authorities which have been supplied by the centre for the purpose.

The authorities said low temperatures and huge crowds may lead to a major outbreak of swine flu that has already killed 13 people in the hill state. Nearly 130 people have been infected by the virus in Uttarakhand. Public awareness drives about the pandemic in the Kumbh Mela region are also planned to be put in place.

“Over 120 doctors have been trained to diagnose and treat swine flu during the congregation. Besides, there are 12 others who have been trained to man Intensive Care Units (ICUs) and operate ventilators in case of emergency situations,” an official was reported as saying, in this report, adding that “There are 19 members who will form the four rapid response teams. In each team there will be at least one epidemiologist along with other doctors.”

Meanwhile the Swine flu death toll in India has now crossed the 1000 mark, with a total of 1037 individuals having succumbed to the deadly virus in the country. Over 27,000 people have tested positive so far.

According to this report in the Business Standard, permission to conduct clinical trials has finally been granted to Zydus Cadila by the Drug Controller General of India (DCGI).  This, reportedly is the all important first step that will ultimately introduce the vaccine into the market for commercial use.

“We will roll out 6 million doses in the initial phase (in April),” said Pankaj R Patel, CMD, Zydus Cadila.  These doses will be rolled out at the said time assuming that all goes well with the clinical trials according to the pharma company, which has invested 80 crores in preparing the vaccine indigenously.

We plan to invest another Rs 50 crore on the clinical study and to expand our Moraiya manufacturing facility to eventually produce 12 million doses of the vaccine,” Patel added.

Meanwhile according to this Telegraph India report, Indian pacer Sreesanth, who had been infected with the Swine flu is now fully recovered and should be fit enough to return to the Indian side.

As on date, as many as twenty six thousand individuals have been infected with the deadly virus in India, and the number of fatalities resulting there from is now hovering close to 1000. As per figures computed till yesterday, 990 deaths in all have resulted from the swine flu virus in India.

A total of 275 people have died from the infection in Maharashtra. The total number of people affected with the influenza in the national capital Delhi now stands at 9,481.

• Wash hands frequently, with soap and water. This is particularly important when one has been touching public surfaces, which harbour any number of potential infections.
• Soap and water may not always be around or available, and for situations such as this, it is prudent to keep a hand sanitizer handy. This is a useful thing to carry around in one’s bag or briefcase that can eliminate a number of infective organisms when it is not possible to find soap and water.
• Avoid touching the face. The germs that your hand carries are thus easily transferred to the face; particularly the mouth and nose.
• Sneeze into a handkerchief or paper napkin when possible  and if none of those are available, rather than sneeze into your hand, try and sneeze into the crook of your elbow; germs are transmitted less readily from there to others and other surfaces.
• If you are sick with flu like symptoms, try to stay home, limiting contact with others and trying to avoid crowds and other public places.
• If exhibiting flu like symptoms, it is important to visit a doctor so that the symptoms can be evaluated and tests conducted to determine if it is swine flu that causes them. Then the correct course of action can be prescribed.
• Do not use tamiflu as a preventive, it is not meant to prevent swine flu, rather to treat it. Besides using it for no reason makes the virus more resistant to the drug and ultimately less effective when one really needs it.
• When traveling, follow swine flu dos and don’ts vigilantly.
• Maintain high degrees of hygiene and make sure that all produce consumed has been thoroughly washed.
• Eat and drink well and exercise adequately to build up the body’s immunity to disease in general and swine flu in particular.
• As and when available in India, take the swine flu shot to prevent contracting it and passing it on to other, perhaps more vulnerable people.
• Children and pregnant women who are more susceptible should be all the more cautious and observe these guidelines.

So let’s make the attempt this year to minimize the spread of swine flu and stay healthy and stay safe during the coming year.

The national death toll from the swine flu virus is now up to 831 with more than 24,000 people in all being infected with the highly contagious flu virus.

Maharashtra continues to have the highest number of fatalities, with 251 deaths. The national capital is another area from where there is a steady stream of news of swine flu infections. Out of the 137 new cases reported recently, as many as 59 are children and the total number of persons affected by swine flu in Delhi now stands at 8,888.

Meanwhile Australian researchers have confirmed the recommendation previously made by the World Health Organization, that for children, a one shot dose of the swine flu vaccine is likely to be enough. Although it is school aged children that have been targeted most by the swine flu virus owing to lower immune response to the infection, the Australian researchers have opined that one shot will be enough for children to build up immunity according to this DNA report.

According to experts, it is advisable to provide one dose to as many children as possible over the age of 6 months and under 10 years as possible. The vaccines have been seen to be safe for children as well as pregnant women; and the benefits from the vaccine are seen to far outweigh any risks. The researchers found that most of the adverse reactions to the vaccine were mild to moderate, but the immune responses were strong.

Though the WHO recommends that one shot is enough for children to build up an immune response to the Swine flu virus, a note of caution has been injected by the American National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDCP), Atlanta. “The immunogenicity data suggest that at least some children will be protected after a single 15-microgram dose, but the findings cannot be generalized to all children, which is why it is prudent to give two doses,” CDCP experts were reported as having said.

The swine flu vaccine is only likely to be available to Indians by about March 2010; they are not likely to reach Indian markets before that time according to the report.

Singhvi said that for India requisite permission was needed to hold clinical trials in the country, which is awaited. India wants ingenious technology so it does not have to be dependent on other countries for the cure he added. He stressed that under any circumstance, the vaccine has to come into the market within the next three to four months after which it could be too late.

Meanwhile yesterday, a record number of positive swine flu cases were reported in India. As many as 290 positive cases were reported and this takes the total number of infections from H1N1 swine flu in the country over 19,000; 19,162 to be precise.

A total of 57 people have died from swine flu in Rajasthan and 28 people in all have died in Delhi from the virus. The total number infected in that national capital is 5,603, with 186 cases reported yesterday and 176 reported the day before.

‘The Defence Research and Development Organisation (DRDO) has developed a rapid and cost-effective swine flu virus specific isothermal gene amplification assay for reliable and early clinical diagnosis of H1N1 in human patients,’ the minister was reported as having said according to this report.

This methodology developed by the DRDO is a single-tube one. It is very cost-effective as compared to WHO approved Centre for Disease Control (CDC) recommended real-time Reverse Transcriptase (RT) Polymerase Chain Reaction (PCR) test system. The assay is based on the principle of the isothermal gene amplification protocol. No expensive real-time PCR equipment is required as the result can be monitored by the naked eye, the minister added.

The national death toll from Swine flu has now reached 555. One death was reported from Maharashtra, and one from Rajasthan. 221 have died in Maharashtra from Swine Flu and 120 have succumbed in Karnataka. 237 fresh cases of Swine Flu were reported across the country, taking the number of affected people to 16,820.

Roche’s Tamiflu and GlaxoSmithKline’s Relenza are two of the most popular brands of the generic swine flu drug, Oseltamivir and there is actually a short fall in supply of these drugs when compared to demand.

To meet this shortfall, online scamsters are selling fake drugs online fooling gullible people into parting with their cash and also endangering their lives. While swine flu itself may not be a lethal infection, drugs such as these fake ones sold online could actually prove far more dangerous than the actual illness.

According to the report, British security software firm Sophos has found thousands of fake drug web sites and millions of bogus promotional materials, many being generated by Russian criminals. In a statement last week, the company said some criminals were claiming to be making “more than $100,000 every day” from gullible buyers of fake flu drugs. The report adds that the drugs will not work, and the identities of the purchasers may be stolen as criminal networks use their credit card details to further defraud them.

It has been suggested that a deficiency of vitamin D can occur in the winter months because of less sun exposure during this time, which may be one of the reasons why there is greater proliferation of the infection during the colder periods of the year. It is also seen that Flu outbreaks tend to occur in places where solar radiation is low.

This is why, many medical practitioners advise that those who are not getting sufficient sun exposure should consider a vitamin D supplement, which will also strengthen the immune system.

Some doctors and in particular proponents of alternative medicine even go so far as to say that if one is not deficient in vitamin D, then one does not even need the flu shot, which allegedly has side effects ranging from headaches to allergic reactions. However, the mainstream thought still favors the vaccine and urges people to take the swine flu vaccine if and when available.

The first priority for vaccination will be given to those medical workers in hospitals who will come into direct contact with infected patients in the process of screening, testing and treating people with swine flu.

“Four international vaccine manufacturers — Novartis, GlaxoSmithKline (GSK), Sanofi-Aventis and Baxter International — have quoted rates to the government,” Vineet Chawdhry, joint secretary, Union ministry of health was quoted as having said. Orders are to be placed next week and all four companies have expressed their ability to be able to provide and deliver on the volumes required.

Earlier there was the concern that the vaccines being produced abroad may not be efficacious or safe to be used on Indians. “Vaccine safety is the biggest concern more than efficacy as H1N1 can be treated,” said Chawdhry, however, the trials to confirm safety of the vaccines in respect of the Indian population have commenced so the concern is being addressed.

It is being said that one dose of the vaccine is needed to offer protection against H1N1.