Saudi Arabia gets 2 million people to receive swine flu vaccines this year, requires pilgrims to have vaccination reports

Arab health ministers to strengthen system to spot mutation of flu, similar diseases

Saudi health minister says Arabia ready to combat disease in hajj, umrah seasons

Swine flu spreads worldwide, scares over further spread in winter

Saudi Minister of Health Dr. Abdullah bin Abdulaziz Al-Rabee'a, who led his country's delegation to the extraordinary meeting of the Ministers of Health of the Mediterranean, confirmed that the Saudi Ministry of Health has enough quantity of H1N1 - A vaccine to be used for pilgrims coming from inside as well as residents of Makkah and Al-Madinah, sites of hajj and umrah.

Addressing the meeting, the minister cast light on the efforts being exerted by the Saudi government under the instructions of the Custodian of the Two Holy Mosques King Abdullah bin Abdulaziz Al Saud to enhance precautionary measures to prevent the spread of swine flu during Islamic gatherings in the sacred places in the Kingdom of Saudi Arabia.

Dr. Al-Rabee'a also confirmed his ministry's commitment to enforce the recommendations put by an experts workshop recently held in Jeddah, attended by representatives of the WHO and anti-epidemic centers in the U.S. , Australia, China and Europe.

He said the protection of worshippers coming to the holy sites in the Kingdom is, by virtue of Saudi law, the responsibility of the Saudi government, lauding the instructions of the Saudi leadership in this concern which resulted in forging one of the first national plans to combat the epidemic.

He said the Kingdom is currently enforcing a package of preventive measures at its land, sea and air inlets according to its own accumulating experience and WHO policies, citing the use of advanced devices to detect virus contractors at the moment they enter the border.

Meanwhile, as a preventive measure against the swine influenza pandemic, Arab Health Ministers recommended preventing old men over 65 years of age, children under 12 years of age and those suffering from chronic diseases such as diabetes, heart, liver and kidney diseases, hypertension, obesity and other diseases from performing hajj and umrah for this year.

The recommendations were issued by Arab health ministers who participated in the emergency meeting of the World Health Organization of the Eastern Mediterranean Region Countries which was held in Cairo last week on the swine influenza. The meeting was attended by Saudi Minister Rabee'a.

The total number of pilgrims at the hajj and the lesser umrah pilgrimage will not be restricted by the kingdom, the Saudi health minister said, though numbers are expected to be lower.

"We will not change the percentage of any country. We changed certain rules," Abdullah al-Rabeeah said after a meeting of Arab health ministers and representatives of the World Health Organisation.

WHO spokesman Ibrahim al-Kerdani said the decision must be ratified by the health ministers' governments, including the government of Saudi Arabia, though WHO regional director Hussein Gezairi said it was likely to be agreed. "Some groups will be excluded from hajj: people over the age of 65, people under the age of 12 and people with chronic illnesses," Kerdani said.

Saudi Arabia in June called on elderly, ill and other unfit Muslims to postpone pilgrimages to Makkah.

Around 3 million Muslim pilgrims from over 160 countries head for the holy city of Makkah in western Saudi Arabia each year in one of the world's biggest religious gatherings.

The hajj will this year take place in November, while the umrah can be performed at any time but is popular during the Muslim holy month of Ramadan, which starts in August.

Asked if there would be less worshippers at this year's hajj due to the restrictions, al-Rabeeah said: "Probably".

WHO's Gezairi said Saudi Arabia was well equipped to deal with communicable diseases among the large number of annual pilgrims.

"The Saudi government has a very long experience now ... because Saudi Arabia every year receives between 25 and 30 cases of cholera and no epidemics are happening."

Egypt, which has struggled to contain the more deadly H5N1 bird flu virus and on Sunday reported its first H1N1 death in a woman returning from umrah, said it would ensure no Egyptian pilgrims travel to Saudi Arabia while carrying the bird flu virus, which experts say could theoretically mix with H1N1 to create yet another flu strain.

"We are separating patients who are positive for avian flu in hospitals," said Hatem el-Gabali, health minister in the most populous Arab country.

"But if you have avian flu and you have been treated successfully you can go and do the hajj and umrah, there is no danger at all because we never discharge anybody from any hospital until we are sure that they do not have the virus."

The airborne H1N1 virus has now been diagnosed in tens of thousands of people worldwide, and has killed more than 430 people, according to the WHO.

Saudi Arabia on Monday confirmed that a man had died of swine flu.

The health ministry said this was the first such death and that it had taken place in a private hospital in Dammam in the eastern part of the country.

Health ministry officials said that the dead man was 30 and that he was admitted to the hospital on Wednesday with a fever and pneumonia.

He expired on Saturday despite being treated with antibiotics and the anti-flu drug Tamiflu, the ministry said.

The report of the death is likely to have an impact on this year's hajj pilgrimage. In the normal course, several million people from all over the world undertake the umrah and the hajj to the Muslim holy cities of Makkah and Medina during the next five months.

It was the second reported swine flu death in the region. On July 19, a 25-year-old woman returning from a pilgrimage to Makkah died in hospital in Egypt, although it was not clear where she contracted the flu.

Saudi health officials say that there already over 300 people suffering from swine flu symptoms.

According to the World Health Organization (WHO), the flu has moved from 'imported' stage to the second epidemiological stage of locally generated transmission in Saudi Arabia.

At an emergency meeting in Cairo last week, Arab health ministers recommended that children under 12 and people over 65 be banned from undertaking the hajj this year to reduce the risk.

As of July 25, a total of 1,028 cases had been reported in the WHO Eastern Mediterranean region, which spans 22 countries from Afghanistan to Morocco.

Swine flu has caused the deaths of 816 people around the world, with most of the victims in the Americas region, according to data published Monday by the World Health Organization.

In the Americas, 707 people have been confirmed to have died from infections of the A(H1N1) virus. This is followed by 74 deaths reported in the Asian-Pacific region.

Europe has recorded 34 deaths, and one person has died in the eastern Mediterranean region which covers the Middle East and parts of northern Africa.

No death has been reported in the rest of Africa.

Meanwhile, several countries and territories have reported first cases since the previous WHO bulletin on July 6, including Afghanistan, Andorra, Belize, Bhutan, Botswana, Haiti, the Seychelles, Solomon Islands and Sudan.

Overall, 134,503 cases of infections have been reported to the WHO, but the UN health agency added that since countries are no longer required to test and report individual cases, the figure reported "understates" the actual caseload.

In a drive to inoculate people against swine flu before winter, many European governments say they will fast-track the testing of a vaccine, arousing concern among some experts about safety and proper doses.

The European Medicines Agency, the EU's top drug regulatory body, is accelerating the approval process for swine flu vaccine, and countries such as Britain, Greece, France and Sweden say they'll start using the vaccine after it's greenlighted — possibly within weeks.

In an interview with The Associated Press, Dr. Keiji Fukuda, the World Health Organization's flu chief, warned about the potential dangers of untested vaccines, although he stopped short of criticizing Europe's approach outright.

"One of the things which cannot be compromised is the safety of vaccines," he said Friday. "There are certain areas where you can make economies, perhaps, but certain areas where you simply do not try to make any economies."

Flu vaccines have been used for 40 years, and many experts say extensive testing is unnecessary, since the swine flu vaccine will simply contain a new ingredient: the swine flu virus.

But European officials won't know if the new vaccine causes any rare side effects until millions of people get the shots. Still, they say the benefit of saving lives is worth the gamble.

"Everybody is doing the best they can in a situation which is far from ideal," said Martin Harvey-Allchurch, a spokesman for the European Medicines Agency. "With the winter flu season approaching, we need to make sure the vaccine is available."

In Europe, flu vaccines are usually tested on hundreds of people for several weeks or months, to ensure the immune system produces enough antibodies to fight the infection.

But to ensure swine flu vaccine is available as soon as possible, the European Medicines Agency is allowing companies to skip testing in large numbers of people before the vaccine is approved.

The main issue is probably that without thorough testing it's difficult to gauge the effective dosage — meaning Europeans might get too weak a vaccine. It's unlikely the vaccine would endanger anyone, but until it is used in large numbers of people, no one will know for sure.

Europeans appear ready to use the vaccine widely before conducting any big studies to prove it is safe and effective.

Neither the vaccine makers nor the European Medicines Agency would specify what basic safety tests are being done.

The U.S. is taking a more cautious approach: the government called Wednesday for several thousand volunteers to be injected with the swine flu vaccine in tests beginning in August to assess the vaccine's safety. American officials said results should be ready by the time the U.S. plans to roll out a vaccination campaign in October.

Results from the U.S. tests will be of limited use to Europe, since countries like Britain plan to start vaccinating as early as August — before any American trial data is available.

The vaccines used in the U.S. will also be different from those in Europe.

Some experts favor urgent action.

"The consequences of not having a vaccine if this virus gets worse are very high," said Leonard Marcus, a public health expert at Harvard University. "If (regulatory authorities) took all the time that was necessary to make sure there are no side effects, ironically, in the effort to save a few lives, many lives could be lost."

But critics say dangers lurk in any strategy to vaccinate without robust testing.

Scant information exists on flu vaccines with adjuvants, a component used to stretch the active ingredient that is commonly found in European flu vaccines. There are no licensed flu vaccines with the ingredient in the U.S. There is also limited or no data on the safety and effectiveness of vaccines with adjuvants in children under 3 and pregnant women — two of the most vulnerable groups in a pandemic — a global outbreak.

Mass swine flu vaccination campaigns will also take place in the shadow of the 1976 swine flu disaster, when hundreds of people in the U.S. developed Guillain-Barre syndrome, a paralyzing disorder, after being vaccinated.

Experts don't know why that happened, but say modern vaccine production techniques have improved since 1976. To avoid a similar episode, some say comprehensive testing before the vaccine is rolled out is essential.

"I can't see any possible excuse to not test it for safety before it's given to anyone," said George Annas, a bioethics expert at Boston University.

If the vaccine turns out to have dangerous side effects, it could generate a public backlash, particularly in a country like Britain, where many people remain suspicious of vaccines because of unsubstantiated allegations linking the measles, mumps and rubella vaccine to autism. That could lead to millions of people refusing vaccination.

When the bird flu crisis hit several years ago, the European Medicines Agency designed a special protocol to approve a vaccine for use in a pandemic as soon as possible.

The agency let companies submit data for a "mock-up" vaccine, using H5N1 bird flu. The idea was to do most of the testing before the global epidemic hit so when it did, drugmakers could insert the pandemic virus into the vaccine at the last minute.

When the first swine flu vaccine doses are ready, the European Medicines Agency will approve them largely based on data from the bird flu vaccine, since both will have the same basic ingredients.

If the agency thinks the bird flu data predicts how the swine flu virus will work, they will approve it, said spokesman Harvey-Allchurch.

The agency will then require regular reporting of the vaccine's effects as it is being administered — monitoring that is normally done beforehand.

WHO's Fukuda said everyone involved in making the vaccine, from manufacturers to regulatory agencies, is looking at what steps can be taken to streamline the process.

"But there is no one who disagrees that one of the absolutes is that there can't be any question whether the vaccine is safe or not," he said.

WHO reported that the swine flu viruses aren't producing enough of a key vaccine ingredient, which may limit how much vaccine is available. Its laboratory network is now working to produce a new set of viruses that it hopes will work better.

Drugmakers including Baxter International, GlaxoSmithKline PLC, Novartis and Sanofi-Pasteur, however, insist they will be able to start shipping the first batches of vaccine soon.

British health officials have repeatedly said they will start vaccinating in August, as soon as the vaccine is approved.

Other European countries, including Greece, France, Sweden, say they will use the vaccine after it gets the green light from the European agency, but none other than Britain expect to start the shots next month.