The process through which Taichung County-based biotech company Adimmune Corp came to manufacture its A(H1N1) influenza vaccine was flawed and paved the way for safety concerns that have surrounded the vaccine, a US expert on infectious diseases told the Taipei Times this week.
Ho Mei-shang (何美鄉), a research fellow at Academia Sinica’s Institute of Biomedical Sciences and former director of biotechnology research at Adimmune, disputes this view, however, saying in an interview on Tuesday that the vaccine is safe and that there was nothing wrong with the process.
The Centers for Disease Control (CDC) announced on July 13 that Adimmune, the sole bidder, had won a government contract to produce 5 million doses of the (A)H1N1 vaccine, at NT$199 per dose, for delivery by the end of October. By early this month, Adimmune had provided 6.95 million doses, while Switzerland-based Novartis had provided 2.02 million (at about NT$400 per dose), out of the government’s purchases of 10 million and 5 million doses respectively.
The government has spent NT$3 billion (US$94.4 million) purchasing vaccines from Adimmune.
The problems begin when looking at the chain of events that led to the awarding of the contract, the US expert said, speaking on condition of anonymity because of the sensitive nature of her position.
As early as May 5, the CDC said that Adimmune, in cooperation with the National Health Research Institutes, would manufacture a domestic influenza vaccine. This was more than a month before a WHO survey of global flu vaccine production capacity on July 7 concluded that countries such as Taiwan that had not placed early orders for the vaccine would not get any vaccine after November.
Adimmune’s chairman is Steve Chan (詹啟賢), deputy secretary-general of the Chinese Nationalist Party (KMT). Chan was also the deputy executive director of President Ma Ying-jeou’s (馬英九) presidential campaign.
For decades a producer of animal vaccines, Adimmune is the only firm in Taiwan with the capacity to produce human vaccines.
Prior to the A(H1N1) contract, it had never produced human vaccines on its own. All it did, the source said, was “package” vaccines made by other, mostly Japanese, companies.
Ho maintained, however, that through close cooperation with Japanese and Dutch vaccine makers, Adimmune “leapfrogged” and obtained the know-how to make human vaccines.
Most vaccine manufacturers, including GSK and Novartis, have decades of experience producing seasonal flu vaccines. While H1N1 is only a variant of the seasonal flu, major manufacturers usually obtain licensure from the US Food and Drug Administration (FDA) to expedite the process based on regulations regarding “strain change.”
Regardless, manufacturers providing H1N1 vaccines to the US have undergone clinical trials, most of which are sponsored by the National Institutes of Health (NIH).
Adimmune, which had no experience producing the vaccine, should never have been allowed to enter an “expedited process,” the source said.
Adimmune only conducted a small-scale clinical trial with less than 500 subjects, far less than the 5,000 to 6,000 that are usually required for new vaccines.
Ho said that as the vaccine is based on the seasonal flu vaccine, it is not a new vaccine and therefore there was “no point” in conducting more rigorous testing.