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Chinese Covid-19 vaccine seen as safe in early stage trials, study finds

November 18, 2020. Summarized by summa-bot.

BEIJING, March 16, 2020 . A staff member tests samples of the COVID-19 inactivated vaccine at a laboratory of Sinovac Biotech Ltd., in Beijing, capital of China, March 16, 2020. China has approved two COVID-19 inactivated vaccine candidates for clinical trials, according to the State Council joint prevention and control mechanism against the coronavirus Tuesday. The two vaccine candidates are developed by Wuhan Institute of Biological Products under the China National Pharmaceutical Group ,Sinopharm, and Sinovac Research and Development Co., Ltd, a company based in Beijing. Clinical trials of the two vaccines have started. (Photo by Zhang Yuwei/Xinhua via Getty) (Xinhua/Zhang Yuwei via Getty Images)

A mid-stage trial shows that a Chinese made Covid-19 vaccine seems to be safe, according to a study published in the Lancet Infectious Diseases Tuesday.

One volunteer in the high dose group had a severe allergic reaction within 48 hours of the first dose, which researchers said may be related to the vaccine, but the volunteer was treated for the reaction and recovered within three days.

The levels of antibodies produced by vaccination were lower than in the volunteers who were infected by, and had recovered from, Covid-19 during the trial, but the researchers said they still expected it could provide protection.

The US Food and Drug Administration has called for a meeting of its vaccine advisory committee in three weeks to consider whether the agency should authorize two Covid-19 vaccines, according to a source familiar with the process.

The FDA reached out last week to members of its Vaccines and Related Biological Products Advisory Committee, a group of outside experts, asking them to hold Dec. 8, 9 and 10 for meetings, according to the source.

The agency could make a decision at the end of the meeting on Dec. 10 about whether to issue emergency use authorizations for the vaccines, the source said.

The Pfizer vaccine trial has reached its safety milestone and the company is preparing to file for emergency use authorization, Pfizer CEO Albert Bourla said Tuesday.

But the company did not yet have enough data to seek emergency use authorization from the US Food and Drug Administration, which said it also wanted at least two months of safety data on at least half of a vaccine trial’s volunteers starting from when they got their second immunization.

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