Philippine Pharmaceutical Firms Developing H1N1 Vaccines

4 RP firms developing H1N1 vaccines

Four Philippine pharmaceutical firms in the Philippines are now manufacturing vaccines against the Influenza A(H1N1) virus, the Pharmaceutical and Healthcare Association of the Philippines (PHAP) said yesterday.

PHAP said that research and development for vaccines against Influenza A(H1N1) has entered the production phase and vaccines might be out before November.

PHAP president Oscar

Aragon noted that four PHAP members are involved in vaccine manufacturing.

These are the GlaxoSmithKline, Novartis, Sanofi-Pasteur and Baxter. PHAP is an organization composed of research-based pharmaceutical companies.

“People are working round-the-clock to come up with the vaccines. The development process began when the companies received the ‘seed virus’ from the World Health Organization (WHO) last May. They need that to start the production,” he told The STAR.

The receipt of the virus signals the start of the development process called “passaging” which will eventually yield a “working seed.” Passaging is the process for acclimating the virus to grow in a production environment at optimum yield.

It takes four to six months to produce any influenza vaccine because it will have to undergo the research and development process and the regulatory approval to ensure the safety and efficacy of the new vaccine.

But Aragon claimed that since Novartis and Baxter are using “different technology,” they might have the finished products ahead of time.

He added the companies have been working closely with the WHO, which is monitoring “how the virus behaves or if there is a mutation.”

“Vaccine should be specific to the virus and that is the reason why vaccine production is being done in cooperation with the WHO,” Aragon said.

“As an organization committed to protecting the health and lives of the people, research and development (R&D) to discover breakthrough medicine and prevent this new virus from further spreading is non-stop so that we could lessen the probability of a pandemic,” he added.

But the vaccines would be distributed around the world through the WHO. The GSK will donate some 50 million vaccines while Sanofi-Pasteur will give some 100 million vaccines to the WHO.

“The stocks of vaccines are to be allocated by the WHO. At this point, maybe it’s the Department of Health that’s going to influence the WHO (for the Philippines),” he maintained.

WHO commends DOH chief

Meanwhile, the WHO commended DOH Secretary Francisco Duque III for “his leadership and tireless efforts in responding to this emerging threat to the health of the people of the Philippines.”

In a letter to Duque, WHO director for Western Pacific Dr. Shin Young-soo said the first case of A(H1N1) in the Philippines was “swiftly detected and laboratory confirmation was promptly made at the Research Institute for Tropical Medicines (RITM)” while “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 also add that WHO is also confident about the quality of the laboratory diagnoses carried out by RITM and about the epidemiological activities conducted by the National Epidemiology Center,” he maintained.

Shin added that communication between the DOH and the WHO “has been transparent and conducted in accordance with the International Health Regulations (2005).”

Duque announced that the Philippines would adopt the WHO-recommended changes in reporting of A(H1N1).

“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. This means that the DOH will issue updates probably on a weekly basis.

The health chief had reiterated that while the virus has been proven to be mild, the public should not let their guard down. He warned that there are some cases that “become serious” especially if the patients have underlying medical conditions.

“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 added.

The DOH said yesterday that 95 percent of the 1,709 cases of Influenza A(H1N1) in the country have already recovered, proving that the virus is “mild in nature.”

Dr. Yolanda Oliveros, director of the DOH’s National Center for Disease Prevention and Control, noted there was also no indication that the virus was mutating.

“According to the WHO, it seems there’s no mutation. It has still the same protein particles, meaning to say if there is resistance (to Oseltamivir), it’s not that much. It could be an isolated case,” she added.

Oliveros said the WHO had instructed countries to monitor “specific resistance” to Oseltamivir.

“So in shifting to mitigation, one of the functions or objectives of getting throat swab (samples) is not only to confirm cases but also to study if there could be some resistance already to Oseltamivir,” she added.

Based on its June 27 update, there were 1,709 cases in the Philippines. A total of 1,568 of them are Filipinos and 235 have history of travel to countries with confirmed cases.

Meanwhile, the Philippine National Police has recorded its first cases of A(H1N1) in four police recruits in Cordillera, but the PNP leadership has already taken measures to prevent the spread of the virus.

In his report to PNP chief Director General Jesus Verzosa, Cordillera Police Regional director Chief Superintendent Orlando Pestaño said the four recruits are confined at the St. Louis University Medical Center.

Meanwhile, seven students tested positive for A(H1N1) virus in Los Baños, Laguna, according to Dr. Alvin Isidro, head of the Municipal Health Office. He said they are already implementing measures to contain the spread of the virus.

By PhilStar


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Poor Nations Need More Money for H1N1

Poor nations need $1 bln to combat swine flu says United Nations

Developing countries could need about one billion dollars by the end of the year to fund measures against the swine flu pandemic, especially vaccines, UN Secretary General Ban Ki-moon said Monday.

Asked about his estimate of their needs ahead of a meeting with donor nations on funding for influenza A (H1N1), Ban said: "For the remainder of this year our estimate is that we may need a little over one billion dollars."

Funding had "not been flowing as expected," following appeals in recent weeks, he added.

More resources were needed especially to fund swine flu vaccines for developing nations that could not afford them, he added.

"This pandemic flu is also a sort of a global crisis which needs global response through global partnership and solidarity," said Ban.

WHO Director General Margaret Chan was due to take part in the meeting with representatives of main potential donor nations in Geneva.

Chan said last week that access to a swine flu vaccine remained a "critical question."

A senior official at the UN health agency suggested that obtaining "political goodwill" for support to poor nations was problematic.

Ban noted that a swine flu vaccine was in the pipeline for August and that pharmaceutical companies had made commitments on supply.

Latest figures from the World Health Organisation released Monday showed that swine flu was continuing to spread around the world since first being detected in Mexico and United States last April.

Some 94,512 people have been infected in more than 130 countries and territories, as the virus continues to make inroads in the southern hemisphere during the main flu season.

However, countries such as the United States believe they have had far more untested cases because of its relatively mild symptoms.

US officials have estimated that there have been a million cases in the country.


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World Health Organization Sees H1N1 Not Spreading

WHO sees little Tamiflu-resistant H1N1 flu spread.

WHO says Tamiflu-resistant cases sporadic, not spreading. Not changing recommendations about H1N1 patient treatment

Tamiflu-resistant H1N1 flu does not appear to be spreading in a sustained or worrisome way, a World Health Organisation official said on Tuesday.

"At this point we are not recommending any clinical changes to the approach in treating patients," WHO Acting Assistant Director-General Keiji Fukuda said, responding to the discovery of drug-resistant H1N1 viruses in three people.

"Right now these examples of oseltamivir resistance remain sporadic cases. We do not see any evidence of widespread movement of oseltamivir resistant viruses," he told a briefing, using the generic name for Tamiflu, an anti-viral tablet made by Roche and Gilead Sciences.

The three people whose H1N1 virus samples did not respond to Tamiflu -- in Denmark, Japan and Hong Kong -- have recovered completely from their infection, Fukuda said. He described the Tamiflu-resistant viruses as mutations and not a reassortment or combination with other influenza strains.

So far all discovered Tamiflu-resistant viruses have been sensitive to treatment with the other anti-viral recommended by the WHO, the inhaled drug Relenza made by GlaxoSmithKline under license from Biota, according to Fukuda.

Relenza is known generically as zanamivir.

The WHO, a Geneva-based United Nations agency, raised its global flu alert to the highest level on June 11, declaring the first influenza pandemic since 1968 was underway.

While the H1N1 virus has caused mild flu symptoms in most people, 440 people have died from it and health experts are keeping close watch in case it changes into a more serious form and stops being treatable with existing drugs.

WHO Director-General Margaret Chan has said that patients with mild symptoms may not need any medicines to recover, and that hospital visits are not necessary unless those infected with flu have certain warning signs.

These include long-lasting high fever in adults and a lack of alertness in children. Pregnant women and people with health problems including diabetes have also been identified as vulnerable to more severe effects from the new flu strain.

Last month, Chan also said that the H1N1 virus was stable and there were no signs yet it had mixed with other influenza viruses such as the deadly H5N1 bird flu strain.

Signs of mutations in the H1N1 virus are also critically important to vaccine makers who are trying to develop formulas to match the strain that is now spreading around the world, most commonly known as swine flu.

Leading flu vaccine makers include Sanofi-Aventis, Novartis, Baxter, GlaxoSmithKline and Solvay.

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More Money for H1N1

DOH seeks additional P19.6-B budget for H1N1

AS cases of Influenza A (H1N1) virus infection in the country continue to rise, the Department of Health is seeking a supplemental budget of P19.6 billion, the bulk of which will be used to buy vaccines that are expected to be available a few months from now.

At the hearing of the House Committee on Health on Monday, Health Secretary Francisco Duque III said at least P16 billion is needed for the procurement of vaccines and P3.6 billion for the treatment and confinement of patients found positive with the pandemic influenza.

But Liberal Party Rep. Rozzano Rufino Biazon of Muntinlupa said that the proposed P16-billion budget would be better spent on capability upgrading of Department of Health (DOH) hospitals and laboratories to prepare for the next pandemic, which, he said, “is sure to come.”

“[The] P16 billion will go a long way in serving more of the 90 million Filipinos through upgraded health facilities than the 400,000 people who will be vaccinated,” said Biazon.

Lakas Rep. Eduardo Zialcita of Parañaque proposed that the P19-billion supplemental budget should not be limited to the A(H1N1) flu virus cases but also for other emerging diseases.

Besides the amount, the department is also asking P22 million for personal protective equipment, P150 million for the establishment of Centers for Health Development or regional offices, P21 million for laboratory equipment and P46 million for hospital support and rehabilitation.

Although the virus is being considered a mild strain, still, Duque said early preparation must be done now as the flu may mutate into another type or lead to a second wave of cases from a stronger strain.

This was supported by Dr. Soe Nyunt-Yu, representative of the World Health Organization, who was also present at the hearing. He said while the strain in the country could be considered mild, there is no reason to be complacent since the virus may change if mixed with other diseases.

“I mentioned severe pandemic, it is an overall observation. Almost all countries have cases of A(H1N1) but there are cases with only mild [ones]. No country can say that they are adequately prepared because we are dealing with the unknown,” Soe Nyunt-Yu said.

In the same hearing, Duque reported that as of June 27 the department had recorded 1,709 cases with 86-percent recovery rate and only .06 percent mortality rate.

As for the treatment of the flu virus, Duque said the government has a stockpile of oseltamivir or Tamiflu tablets, given for free to those who exhibit flu-like symptoms. The supply, Duque said, is good for at least 450,000 patients expected to be affected by the virus.

“We will only give these capsules to patients who manifested symptoms; it is safe to give in the next 48 hours but we want to clarify that this is not the cure for A(H1N1),” Duque said.

Last week, in a conference sponsored by GlaxoSmithKline (GSK) in Singapore, Christophe Weber, GSK’s senior vice president and area director, said that with recent studies showing Tamiflu flu resistance to, governments should also have a stockpile of Relenza, with zanamivir as active ingredient, a drug produced by GSK.

“Those countries who have stockpiles of Tamiflu should at least [have a] stockpile also of Relenza so that if resistance [to Tamiflu] occurs, you have a fallback,” Weber told the BusinessMirror in an interview at the sidelines of the event.

Weber gave assurances that Relenza has no reported case of resistance. Tamiflu is made by Roche.

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DOH Launches H1N1 Hot Line

Got any questions about H1N1?

Try calling Hotline 155, a help line set up by the Department of Health (DOH) in partnership with Smart Communications, Inc.

Launched on Tuesday, the hot line will be manned by call center agents trained by the DOH to accommodate A(H1N1)- or swine flu-related queries.

The service, however, is available only to Smart, Talk and Text, and Red Mobile subscribers, which means queries can only be made using a cellular phone.

Smart public affairs head Ramon Isberto also clarified that the services are not free and normal rates apply “to screen out prank calls." Isberto said it would consider the suggestion of Health Secretary Francisco Duque III about giving discounted call and text rates for the DOH hot line.

In addition to Hotline 155, Smart subscribers can also reach the DOH via “Text 700-DOH." To use the service type: DOH (space) FEEDBACK (space) question and send to 700364.

Isberto said Hotline 155 is available from Monday to Friday, 8 a.m. to 5 p.m, while Text 700DOH functions 24 hours.

He clarified that it is the DOH that would reply to queries via text messaging.

Secretary Duque, meanwhile, reported that the number of A(H1N1) cases in the Philippines has jumped to 473 after 28 more people tested positive for the new strain.

In a press conference, Duque said the new cases included 16 males and 12 females, with ages ranging from seven months to 49 years old.

The good news is that 400 of those infected have recovered, or an 85 percent recovery rate. No additional Influenza A(H1N1)-related death have been recorded in the Philippines, he added.

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H1N1 Health Staff Training

Health staff training, new anti-flu tack.

With the failure of containment, the Department of Health has shifted focus against the A (H1N1) flu virus to mitigation by training as many health-service personnel as possible on the basic handling of the disease.

“As we anticipate more cases in the coming months, we must institute effective mitigation measures to save lives and prevent deaths, and to reduce the impact of the pandemic to our nation and the economy,” said Health Secretary Francisco Duque III on Thursday.

Even far-off Mindanao has not been spared as 13 suspected cases have been found with one, a student in Zamboanga City falling ill, six people cleared, with the remaining six still waiting for results of their tests.

President Arroyo has, meanwhile, checked out of the Asian Hospital and Medical Center on Thursday after observing two nights of “self-quarantine” upon arrival from her latest foreign trips. She was pronounced free of the flu.

While the health department lifted the requirement for self-quarantine for travelers arriving from abroad, the President decided on the measure amid criticisms the quarantine lifting may be for the benefit of the Chief Executive, who was then flying in from Hong Kong, her last stop in a swing through Latin and North America.

In other developments, the Trade Union Congress of the Philippines (TUCP) urged the labor department to compel large firms employing more than 500 workers to promptly submit their “preparedness plans” in dealing with the spread of the swine flu.

In a statement, TUCP secretary-general and former senator Ernesto Herrera said, “The DOLE [Department of Labor and Employment] has to ensure that business establishments, particularly the labor-intensive ones, are taking adequate preventive measures” since the illness could very well affect economic activities to the disadvantage of workers, businesses and the public alike.

Manila Tops Asean Tally

This developed as the World Health Organization (WHO), in its latest global situation update, reported the Philippines has eclipsed Thailand among countries in Southeast Asia, with confirmed A(H1N1) cases of 861, including one death as of 5 p.m. on June 29.

Closely following the Philippines in the region are Thailand (774 cases, no death); Singapore (599 cases, no death); New Zealand (587 cases, no death); Spain (541 cases, no death); and Israel (469 cases, no death).

The WHO update shows the greatest number are in the United States (27,717 cases, 127 deaths); Mexico (8,279 cases, 116 deaths); Canada (7,775 cases, 21 deaths); Chile (5,186 cases, seven deaths); the United Kingdom (4,250 cases, one death); Australia (4,038 cases, seven deaths); Argentina (1,488 cases, 23 deaths); China (1,442 cases, no death); and Japan (1,212 cases, no death).

In the Zamboanga case, the 9-year-old flu-stricken boy—he is now well—was reported to have had contact with a relative in Manila found positive of A(H1N1) infection.

The boy and the entire family placed themselves on home quarantine from June 22 and were provided antiviral treatment by the Department of Health.

Meanwhile, the health department is intensifying its information drive on swine flu and Duque said, “We have also requested the NDDC member agencies, especially DepEd, CHED and Tesda and PIA to help us in our nationwide campaign against A [H1N1]. This is to make sure that our information and education activities reach all schools, barangays and provinces in the country.”

The DOH have not yet recommend the public to use face masks or any personal protective equipment, but several companies manufacturing face masks have been taking advantage of the fear and are offering such protective gear.

Health experts warned, however, that not all face masks are effective and the only ones capable of preventing infection are the N95 class face masks and those treated with antipathogen solutions.

The experts said that the best protection is not to frequent crowded places and boost one’s immune system by adequate rest, hydration, fresh air, balanced diet, and moderate exercise.

MedTecs International Corp. Ltd. vice president Earl Montero said they are manufacturing an “all-Filipino” made face masks (N95 and 3-ply N88), isolation gowns, shoe covers and bouffant hats. (With M. Gonzalez, S. Fabunan, B. Garcia, Jr.)


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RP's H1N1 Flu Cases Balloon to 1,709

The Department of Health (DOH) on Wednesday said it is stepping up its mitigation efforts against influenza A (H1N1), as the number of cases in the country rose to 1,709 from 861 last Friday.

In its July 1 update, the DOH said the Philippines had a total of 1,709 cases of influenza A (H1N1) since May 1, but the DOH said 86 percent or 1,485 patients have already recovered from the illness.

The remaining 224 patients (14 percent of total) are still under treatment, most of them under home management, the DOH said.

Only one A (H1N1)-related death has been recorded so far.

The DOH is also monitoring the case of a five-month-old patient, the youngest victim of the virus so far.

"All cases exhibited mild symptoms with the most common as fever, cough, and nasal congestion," Duque said.

"The ages of cases range from 5 months to 79 years old, with 18 years old as median age. Most of them belonged to the 10-19 years age group (831 cases). Majority of the cases were male (894 cases)," Duque described.

Duque disclosed that of the 1,709 reported cases, 1,568 (92 percent) were Filipinos; the rest were American (with 17), Japanese (8), Chinese (4), Korean (3), German (2), and one each from Australia, Canada, India, Iran, Kyrgyzstan, Lebanon, Sweden, Thailand, and Turkey.

"Two hundred eighty-five had history of travel to a country which has reported A (H1N1) cases. Most came from the USA, China, Japan and Singapore," Duque noted.

Most of the cases come from the National Capital Region, Regions IV-A, III, and VIII.

Globally, as of June 29, the World Health Organization has recorded a total of 70,893 cases, with 311 deaths, from 109 reporting countries.

Mitigation efforts

Health Secretary Francisco Duque said the DOH is stepping up its efforts against the disease as they anticipate more cases in the coming months.

"As we anticipate more cases in the coming months, we must institute effective mitigation measures to save lives and prevent deaths and to reduce the impact of the pandemic to our nation and the economy," he said.

This comes after Duque convened another DOH Command Conference, attended by members of the A (H1N1) task force, DOH regional directors and chiefs of hospitals, and representatives form the private sector.

With the move towards mitigation, the DOH said that they are ensuring all government hospitals, at all levels, have the capacity to administer care to high-risk patients, in accordance with the directives of President Arroyo.

Duque has also called for meetings with the member-agencies of the National Disaster Coordinating Council (NDCC) to "engage them... in strengthening the involvement of local government units in the A (H1N1) response."

"We have also requested the NDCC member agencies, especially DepEd, CHED and TESDA and PIA to help us in our nationwide campaign against A (H1N1). This is to make sure that our information and education activities reach all schools, barangays and provinces in the country," Duque added.

The DOH will also meet with medical and health associations, such as the Philippine Medical Association and the Philippine Hospital Association regarding treatment and management of A (H1N1) patients.

'Preparedness plans'

The Trade Union Congress of the Philippines (TUCP), meanwhile, is urging the Department of Labor and Employment (DOLE) to compel large firms employing more than 500 workers to submit their "preparedness plans" in dealing with the spread of the virus.

"The DOLE has to ensure that business establishments, particularly the labor-intensive ones, are taking adequate measures to monitor, prevent and control the potential proliferation of Influenza A(H1N1) among their workforces," TUCP secretary-general Ernesto Herrera was quoted in a statement.

The DOLE earlier issued Department Advisory No. 4, providing "Guidelines on Influenza A(H1N1) Prevention and Control at the Workplace," for all employers and workers in the private sector.

Herrera, however, said the guidelines were not enough, saying the DOLE's Occupational Health and Safety Center (OHSC) should require large employers to submit their plans to deal with influenza A (H1N1).

TUCP earlier said that the virus, if left unchecked, could soon invade the country's factories and impair labor productivity.

From ABSCBN News


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