South African suppliers of flu vaccines have run out, with new stocks expected only in May, the companies said on Wednesday.
”All our wholesalers are completely out of stock of the vaccine,” said Trevor Phillips, executive director of the National Pharmaceutical Wholesalers.
Sanofi Pasteur, one of the largest suppliers, confirmed that its 2005 southern-hemisphere flu vaccine, branded as Vaxigrip or Mutagrip, will not be available in South Africa before May this year, ”and might not be available at all”.
Tests conducted by the national control laboratory of South Africa confirmed that one of the three virus strains in the vaccine, the A/Wellington strain, is under-formulated due to a miscalculation, MD Stephen Alix said.
The vaccines have the required level of antigens for the other two strains, A/New Caledonia and B/Jiangsu.
Alix said there is no problem with safety, as the vaccines have not been allowed to enter the South African market — there is only uncertainty about their efficiency.
The company is conducting clinical trials in Australia and hopes the data will support its belief that the vaccine will still work.
The results are expected at the end of April and, if the South African health authorities accept them, vaccines could be released in May. If not, the company will not supply any vaccines to South Africa this year.
To make a new vaccine from scratch will take six months, by which time the ”flu season” will have passed.
”The flu season only starts mid- to end-May, so there is still plenty of time to get your flu shots and be protected,” Alix added.
International shortages
Hashim Bhikha, business development manager for manufacturer Camox, said the shortage in South Africa is compounded by international shortages caused by British company Chiron being ordered to suspend production.
This followed concerns about standards at one of the company’s labs.
Other manufacturers were asked by the United States government to cover the shortfalls, which then led to production delays and shortages for the southern hemisphere.
He added that it is also difficult to forecast how much vaccine will be needed every year, and pharmacies, doctors and clinics are reluctant to commit to volumes because at the end of the season they have to throw the remaining vaccine away.
To protect again unscrupulous health professionals using unsold supplies from last year, Bhikha advised people having the vaccine to check the expiry date. Last year’s vaccine has an expiry date of December 2004 or January 2005. The latest batch will have the expiry date of December 2005 or January 2006.
Meanwhile, the National Institute for Communicable Diseases (NICD) cautioned that a shortage of vaccine does not mean that a flu pandemic is imminent.
”We may have more cases, but not in huge numbers,” the NICD’s Lucille Blumberg said.
The impact of the vaccine shortage is difficult to predict.
”Individuals who would normally access the vaccine may not be protected. However, in South Africa, influenza vaccine has in any event been accessible to only a small proportion of the population.”
No dangerous flu samples in SA
NICD director Barry Schoub said there is ”no chance” that there are any samples of a flu virus known as H2N2 in South Africa.
Samples of the virus, which is believed to have killed up to four million people in the 1950s, were inadvertently sent to laboratories with test kits.
The H2N2 virus samples were distributed by the US-based College of American Pathologists to the laboratories, mainly in North America, in October last year.
A campaign is under way to have the samples destroyed. — Sapa