Taiwan FDA Approves Novavax Emergency Use Authorization

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Taipei, June 17 (CNA) Taiwan’s Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine for adults after holding an expert meeting on Friday.

The vaccine will be for use in people ages 18 and older with a two-dose, 0.5ml regimen given three weeks apart, the FDA said in a statement after reviewing quality, safety and drug data. effectiveness of the Novavax vaccine.

Based on a comprehensive assessment and taking into account the urgent national public health needs, the experts present at the meeting reached an agreement on the approval of the import of Novavax vaccines in accordance with Taiwan’s pharmaceutical laws, a the FDA said.

In clinical trials involving people aged 18 years and older, the most common side effects were tenderness or pain at the injection site, fatigue, myalgia, headache, general weakness, arthralgia and nausea or vomiting, with mild to moderate severity, the FDA said.

The FDA said it will continue to monitor domestic and foreign vaccine safety alerts, while analyzing and evaluating vaccine-related adverse event data, and will implement a safety monitoring mechanism to ensure the safety of vaccination for the public.

Taiwanese Minister of Health and Welfare Chen Shih-chung (陳時中) said in April that Taiwan would receive around 2 million doses of the Novavax COVID-19 vaccine through the Global Vaccine Sharing Initiative. COVAX.

FDA Director General Wu Shou-mei (吳秀梅) then said in May that Taiwan had already received the US drugmaker’s recent EUA application in Taiwan.

She said Novavax’s EUA request actually arrived several months ago, but the data provided at the time was insufficient, containing only vaccine treatment information.

The company then made up for the missing information by providing data on clinical trials, pharmacology and toxicology of the vaccine, Wu said, adding that health experts would assess EUA’s application after its review was completed.

To date, 91.12% of Taiwan’s population of over 23 million have received at least one COVID-19 vaccine, while 82.53% have received two doses, according to the Central Emergency Command Center ( CCCB).

Since Taiwan began providing third doses in December 2021, 68.9% of the population has received a booster shot and 0.92% has received an additional dose, which is a third shot given to immunocompromised people, according to data. CECC data.

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