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Coronavirus: Third phase vaccine trials start in Egypt

Egypt is recruiting volunteers to take part in the clinical trials for a Covid-19 vaccine

Reem Leila , Wednesday 23 Sep 2020
Coronavirus: Third phase vaccine trials
Coronavirus: Third phase vaccine trials
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The Ministry of Health and Population announced on 12 September the beginning of clinical trials for a Chinese developed COVID-19 vaccine.

According to Health Ministry spokesman Khaled Megahed said the vaccine will be tried on 6,000 volunteers between the ages of 18 and 60. Volunteers must be free of chronic diseases and will be free to withdraw from the trial at any time.

Minister of Health Hala Zayed pointed out the third stage of the trials of the vaccine developed by the Chinese  company Sinopharm will be conducted worldwide.

The 10 countries taking part in the current phase include Egypt, Jordan, the UAE, and Bahrain, and the trials are being conducted in cooperation with the Chinese government and the UAE healthcare company G42. Egypt’s Holding Company for Biological Products and Vaccines (VACSERA) has said it will produce the vaccine if it is licensed.

Megahed says the vaccine’s side effects are expected to replicate common reactions to other medicines and typically will be mild. They may include moderate pain, redness and stiffness at the place of vaccination and/or symptoms such as fever, headache, fatigue, nausea, vomiting, diarrhea, allergies, muscle pain, joint pain, lethargy, and seizures.

“If any of the volunteers suffer these symptoms they must inform the responsible medical official within 24 hours through the hotline 15530,” explained Megahed.

The trial protocols include giving 2,000 volunteers a dose of a first vaccine prototype and 2,000 a dose of a second prototype. The remaining 2,000 will receive a placebo.

Hossam Hosni, head of the Health Ministry’s scientific committee, noted that earlier suggestions that Egypt conducts clinical trials of a Russian vaccine were eventually abandoned due to safety concerns. Unlike its Russian counterpart, the Chinese vaccine has been produced under the World Health Organisation (WHO).

Last week the health minister inspected the VACSERA premises which will assess volunteers for the third phase trials. Anyone interested in volunteering can visit the website http://www.covactrial.mohp.gov.eg/ to apply. The trials themselves will be conducted at VACSERA, the Abbasiya Chest Hospital and the National Liver Institute.

Volunteers will take two doses of the vaccine, 21 days apart, and will be closely monitored by the Ministry of Health for a year.

“Prior to the trial volunteers will take a PCR test to ensure they have not been previously infected with Covid-19,” said Megahed.

Zayed confirmed in a press release that a national committee has been formed to monitor the clinical trials. The committee is headed by Mohamed Hassan, assistant minister for public health initiatives, and includes representatives from the Ministry of Health, the Armed Forces’ Health Services, the Egyptian Drug Authority, the Ministry of Higher Education and Scientific Research and the Ministry of Justice.

So far more than 500 volunteers have applied to take part in the vaccine trials. Volunteers are paid LE250 for each trial. To ensure the objectivity of results they will not be informed which vaccine they will be taking. Egypt’s 6,000 volunteers will join a further 30,000 around the world who are taking part in the trials.

 

*A version of this article appears in print in the 24 September, 2020 edition of Al-Ahram Weekly

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