CORONAVIRUS/First 4 batches of Taiwan-made vaccine ready for use

Taipei, Aug. 2 (CNA) The inspection of the first four batches of the locally made COVID-19 vaccine has been completed, and the doses will be sent for the national rollout, the Taiwan Food and Drug Administration (FDA) said on Monday.

Wang Teh-yuan (王德原), head of the FDA's research and inspection division, said the inspection of the four batches of the vaccine made by Medigen Vaccine Biologics Corp., totaling 265,528 doses, was completed on July 30, and they are undergoing the process of sealing at the designated warehouse in preparation for use.

The sealing is expected to be completed Monday evening, Wang said.

Wang said the inspected doses of the Medigen vaccine, the first protein-based COVID-19 jabs in Taiwan, will be good for six months before they expire.

The announcement by the FDA showed the government was trying to speed up its pace to provide the Taiwan-made vaccine at a time when the country is faced with a vaccine shortage amid an outbreak of domestically transmitted COVID-19 cases in mid-May, which has prompted many people to receive their jabs, making the vaccine supply even tighter.

According to Wang, it took the FDA about one month to carry out inspection of the first four batches of the Medigen-made vaccine since the protein-based vaccine, which is different from the spike protein-based AstraZeneca vaccine and the mRNA-based Moderna vaccine Taiwan had previously received from overseas, needed longer inspection, including 21 days in animal tests to ensure its efficacy.

Since Medigen secured an emergency use authorization (EUA) from the FDA on July 19, based on the inspection time Wang disclosed, the local vaccine developer has been suspected of sending the four batches of the vaccine to the FDA for inspection even before it received the EUA.

Wang, however, declined to comment on the speculation.

He said when the rollout of the inspected Medigen vaccine will begin is up to the Central Epidemic Command Center (CECC).

A move by the FDA to grant the EUA to Medigen sparked concerns over the safety and efficacy of the vaccine as the company only completed two phases of clinical trial without a large scale third phase trial to show its efficacy, while the company said it would hold a small scale of 1,000-person third phase trail in Paraguay.

When the FDA issued the EUA to Medigen in mid-July, the agency said a subgroup of the company's Phase 2 clinical trial participants who were tested for EUA purposes showed a seroconversion rate of 95.5 percent, indicating that almost all trial participants developed specific antibodies to the COVID-19 virus in their blood.

The trial participants were also found to have generated a concentration of virus neutralizing antibodies (expressed as geometric mean titers GMTs) that was 3.4 times higher than that found in a control group of 200 people in Taiwan who received two doses of the AstraZeneca vaccine.

However, the EUA received by Medigen seemed to fail to ease concerns over the use of the vaccine among many people in Taiwan, even though the CECC announced on July 25 that the locally-made vaccine has been included in the rollout nationwide.

To quell the concerns, President Tsai Ing-wen (蔡英文) said on July 28 that she has chosen to take the Medigen vaccine when the rollout starts.

Vice President Lai Ching-te (賴清德) said he is opting to receive the vaccine made by United Biomedical Inc., another Taiwan-based COVID-19 vaccine developer, which has secured an EUA from the FDA at the end of June.

Like Medigen, United Biomedical completed only two phases of clinical trial, while it said it would seek to conduct the third phase.

Before the EUA was granted to the two vaccine developers, the government said at the end of May that it had signed agreements with the two companies to buy 5 million doses of the vaccine from each of them.