United Biomedical Inc Asia (UBI, 聯亞生技) yesterday said that it would again apply for emergency use authorization (EUA) for its COVID-19 experimental vaccine after its first application was rejected last week.
The company would organize data and statistics generated from its ongoing phase 2 clinical trial that indicate its experimental vaccine’s effect on fighting the Delta variant of SARS-CoV-2, and it would again apply to the Food and Drug Administration (FDA) for an EUA, a company statement said.
That marked a turn in the company’s position concerning its failed application.
Photo: Screen grab from United Biomedical Inc virtual news conference
United Biomedical chairwoman Wang Chang-yi (王長怡) on Sunday slammed the FDA, saying the agency’s standards were “bold and outdated,” and that the company would appeal the FDA’s decision soon.
Shares of UBI Pharma Inc (聯亞藥), a United Biomedical subsidiary, yesterday rallied 3.94 percent to NT$132 in Taipei trading. The shares had gained 12 percent since Monday last week, when United Biomedical’s application was rejected. However, that was less than half of its peak price of NT$290 on June 24, Taipei Exchange data showed.
United Biomedical yesterday apologized for Wang’s comment on Sunday, saying that she was too emotional as she was anxious amid concern over the possible effect of the Delta variant, which has rapidly spread in other countries.
The company said it was sorry if Wang’s comments had upset regulators, including the FDA and the Center for Drug Evaluation, the statement said. The company said it appreciated their assistance during its development of the vaccine since June last year.
The company reiterated that even though its experimental vaccine, dubbed UB-621, failed to meet the FDA’s standards on neutralizing antibodies, UB-621 is still comparable to other COVID-19 vaccines in terms of fighting the Delta variant.
United Biomedical believes that its experimental vaccine could be an effective tool in curbing the Delta variant, it said.
The company has produced seven batches of antigens of 2,000ml, which would be enough for the company to make 60 million doses of the UB-621 vaccine, company data showed.
Shares of Medigen Vaccine Biologics Corp (高端疫苗), another local developer of a COVID-19 vaccine, yesterday gained 1.22 percent to close at NT$289.50, Taipei Exchange data showed.
The stock is sharply down from NT$337 on Monday after five people died since inoculations with the Medigen vaccine began.
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