Single swine flu vaccine dose may be enough

Novartis AG trumpeted the effectiveness of a single dose of its swine flu vaccine, boosting hopes that potentially tight supplies could go further when mass immunization programs start this month.

The outbreak of the H1N1 strain of flu, declared a pandemic on June 11, has spread around the world and could eventually affect 2 billion people, according to World Health Organization (WHO) estimates.

Many experts expected that two doses per person would be needed by health authorities preparing for a possible second wave of infections at the start of winter in the northern hemisphere.

Vaccination is expected to get under way in some countries this month with many others starting in October.

Novartis said on Thursday that its Celtura H1N1 vaccine had a strong immune response after just one dose in a pilot trial, and Chinese health authorities gave a green light to Sinovac, which says its vaccine also needs only one shot to be effective.

"This is good news as one dose of Celtura may be sufficient to protect adults against the swine flu. This potentially boosts that availability of flu vaccines for the upcoming flu season when a large outbreak of swing flu is expected," said Karl-Heinz Koch, an analyst at Swiss brokerage Helvea.

Another key variable is vaccine yield in the manufacturing process. Yields were initially low but the WHO said last month they were improving and one strain seemed to be yielding the same amount as seasonal vaccine.

Cell-based vaccines like Novartis's are quicker and easier to manufacture than traditional flu vaccines, which are grown in chicken eggs. However, supplies are limited for now -- they currently make up about 30 percent of the Swiss group's capacity.

Novartis said a pilot trial of Celtura run by Britain's Leicester University with 100 volunteers showed a potentially protective immune response in 80 percent of the subjects after one dose and more than 90 percent after two doses. Other studies with more than 6,000 adults and children are continuing.

Sinovac, the first company to complete clinical trials, received approval from Chinese health authorities to mass produce a vaccine for the new strain of H1N1 and raised its annual sales forecast.

Sinovac shares rose some 16 percent to $9.90 by 1351 GMT, while Novartis slipped 0.8 percent to 48.62 Swiss francs, in line with the DJ Stoxx European healthcare sector.

WINDFALLS

Other pharmaceutical companies like Sanofi Aventis, GlaxoSmithKline and AstraZeneca's MedImmune unit are also racing to develop H1N1 vaccine as governments scramble to secure supplies.

Australia's CSL is already producing H1N1 vaccine and is making 1.0 million to 1.5 million doses per week until it fills all orders.

Antiviral drugs which treat flu rather than immunize -- Glaxo's Relenza and Tamiflu, made by Switzerland's Roche -- are also in high demand.

Sales to governments will provide a revenue and profit windfall for many drugmakers this year and in 2010.

"At the beginning of this year, we forecast our sales would rise by 20 percent," Sinovac Chief Executive Yin Weidong said on Thursday. "Looking at things now, H1N1 has given us an opportunity, so the rise should be more than 20 percent."

H1N1 vaccines would be given separately from regular seasonal flu shots.

Vaccines arrived too late in the 1957 and 1968 flu pandemics to be of much use, and flu vaccines had not been developed in the 1918 "Spanish flu" pandemic which killed an estimated 50 million people.


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WHO: global death toll from swine flu now over 700

The worldwide death toll from swine flu has doubled in the past month, reaching over 700 since the start of the outbreak last spring, the World Health Organization said Tuesday.

Here in the Philippines, swine Flu related deaths is at 3 while 2,668 cases being recorded but five percent still being treated. Read More.

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D.O.H. Update 54

Update 54 - WHO Commends DOH for Anti-A(H1N1) Efforts, Adopts Weekly Reporting System of Cases as Recommended by WHO

9 July 2009

The Department of Health (DOH) today expressed gratitude to the World Health Organization (WHO) over the commendation it gave to the government agency for its swift and tireless efforts in dealing with the novel virus A (H1N1).

The WHO letter dated June 30, 2009 and signed by WHO Regional Director Dr. Shin Young-soo put on record “my personal appreciation of the exceptional collaboration established between the Government of the Philippines and the World Health Organization in the fight against Pandemic H1N1 2009. I commend your leadership and tireless efforts in responding to this emerging threat to the health of the people of the Philippines”.

“We are very grateful that our efforts were recognized and didn’t go to waste. We appreciate that the WHO finds our response efficient and that it is confident on the quality of our laboratory diagnoses,” Health Secretary Francisco T. Duque III said.

The WHO letter further said that “Contact tracing has also been thorough, allowing the DOH to detect further cases and slow down the spread of the virus. The efficiency of the response indicated to me that the Philippines has the fundamental capacity to detect and respond to the new influenza virus. I should add that WHO is also confident about the quality of the laboratory diagnoses carried out by the Research Institute for Tropical Medicine and about the epidemiological activities conducted by the National Epidemiology Center (NEC)”.

Meanwhile, Duque also said that the Philippines, as a member country of the WHO, will now be adopting the WHO recommended changes in the reporting of A (H1N1) cases.

According to the WHO, for countries already experiencing community-wide transmission, the focus of A (H1N1) surveillance activities must shift to reporting against the established indicators for the monitoring of seasonal influenza activity. Those countries are no longer required to submit regular reports of individual laboratory-confirmed cases and deaths to the WHO.

“The WHO will no longer be issuing global table updates that show the number of confirmed cases for all countries but will instead continue to document the global spread with updates describing the situation in newly affected countries,” Duque said.

The WHO said that as the pandemic evolves, the data needed for risk assessment are also changing and that at this point, its further spread is considered inevitable. It said that the increasing numbers of cases in many countries with sustained community transmission is making it extremely difficult to confirm them through laboratory testing.

Because the DOH is set to abide by the newly recommended reporting system of WHO for A (H1N1), it is now reviewing and adjusting its surveillance systems to fit the monitoring of the novel virus in its regular surveillance of Influenza-like illnesses (ILI) in the country.

Duque stressed that globally and locally, the novel virus has caused mild illness in the majority of affected patients with expected full recovery even without medical treatment. However, there are some cases that become serious especially if the patients have underlying pre-medical conditions. Like the other seasonal flu strains, A (H1N1) can cause severe viral pneumonias and other flu complications” Duque said.

“So, again, we are urging the public to be more vigilant in guarding their health against A (H1N1) despite its generally mild clinical manifestations in most of the cases reported in the country,” Duque stressed.

The Secretary said that such highly vulnerable conditions include uncontrolled diabetes, frank cardiovascular disease, chronic obstructive pulmonary disease, chronic liver and kidney disease. He added that those who are organ transplant recipients, immunocompromised, and suffering from other infections like HIV/AIDs and TB; pregnant women and the very young and the elderly are more at risk of developing serious cases of A (H1N1).
“We are stressing this point because of the first previously reported case of death in the country involving a patient with an incidental finding of A (H1N1). We now have to be more aggressive in targeting segments of patients with a high vulnerability to fatal flu complications,” Duque pointed out.

“We want to make it clear that high-risk groups, once they have the flu symptoms, should immediately go to their doctor. They should not wait for their symptoms to worsen because they are prone to many other infections such as our seasonal flu strains,” Duque clarified.

“We also advise parents and guardians to seek immediate professional help if they see danger signs in children and other family members which indicate rapid progression of the disease or a worsening of symptoms. Likewise healthcare providers should stick to the basic protocol of managing acute respiratory infections among children by being vigilant of these danger signs which include rapid breathing, excessive drowsiness, poor intake or dehydration. In adults, chest pain, prolonged fever or labored breathing should prompt warnings to see a doctor,” Duque reminded the public.
Meanwhile, Duque advised the public to continue following the recommendations of the DOH on proper handwashing, cough etiquette, and other hygiene practices.

“The best defense against A (H1N1) and other diseases is to boost your immune system. Most people can fight off this virus without special medications or hospitalization. You can stay at home and take supportive care like plenty of fluids, vitamins and bed rest,” Duque stressed.

In this connection, Duque strongly advised the public to be vigilant over advertisements or fraudulent sales promotion practices of food supplements, vitamins or other products that create an erroneous impression that the product concerned could cure or treat the A (H1N1) virus.

“It must be stressed that to date, there are no food supplements, vitamins or vaccines that cure or treat the novel virus,” Duque stressed.

“We are warning manufacturers and distributors of these products that any claim in their advertisements that it can cure or treat A (H1N1) can be an outright violation of Section 112 of the Republic Act No. 7394 (The Consumer Act of the Philippines), Bureau Circular 2007-002 (The Guidelines in the Use of Nutrition and Health Claims in Food), and Republic Act No. 3720 (Violating the Misbranding Provisions),” Duque said.

“We are encouraging the public to report to the Bureau of Food and Drugs (at 809-4390 local 1051) any advertisement or fraudulent sales promotion practices involving the above-mentioned products that create an erroneous impression that it could prevent, cure or treat the novel virus,” Duque concluded.

Department of Health

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