Published on: Saturday, July 17, 2021
By: Bernama
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Kuala Lumpur: The Ministry of Health (MOH) on Friday granted conditional approval to Sinopharm and Johnson & Johnson (Janssen) vaccines to be used to deal with Covid-19 threats in Malaysia.
Health Director-General Tan Sri Dr Noor Hisham Abdullah
(pic) in a statement said the approval was obtained at the Drug Control Authority’s (DCA) meeting Friday.
“The conditional registration approval requires the latest information on the quality, safety and efficiency of the vaccines to be continuously observed and evaluated from time to time,” he said.
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Dr Noor Hisham said it was to ensure the “benefit over risk” of the vaccines remains positive.
Sinopharm, Johnson & Johnson vaccines get conditional approval for use in Malaysia
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See eTable 1 in Supplement 2 for definitions of each analysis population. Among those receiving aluminum hydroxide (alum) for the first dose, 5 participants received WIV04 (n = 2) and HB02 (n = 3) vaccines for the second dose and were not included in the safety analysis population of the alum-only group (13 458 – 5 = 13 453), but were included in the WIV04 and HB02 groups, respectively. Three participants who received WIV04 for the first dose and HB02 for the second dose and 3 participants who received HB02 for the first dose and WIV04 for the second dose were included in both groups (WIV04: 13 459 + 2 + 3 = 13 464; HB02: 13 465 + 3 + 3 = 13 471). To measure neutralization antibody levels, the first 900 participants from each study site were selected. There were 9 participants in the WIV04 group, 7 in the HB02 group, and 8 in alum-only group who had adverse events or serious adverse events (SAEs) after the first dose and did not receive the secon
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Back in June, long before clinical trials had been completed (currently in Phase Three), two candidates by Sinopharm s subsidiary China National Biotec Group Company Limited (CNBG) and one by Sinovac Biotech SVA.O were given the green light to be injected into essential workers as part of an emergency use program that began that month. As of November, the experimental vaccines had been administered to one million people in China.