Covid-19 Trial Restarted in South Africa After Safety Concerns

Grant Boone
September 20, 2020

The tie-up between Russian Direct Investment Fund and Indian pharma giant Dr Reddy's Laboratories to conduct Phase 3 trials of the Sputnik V vaccine has raised hopes that, if all goes well, the all-important shot will be available in India later this year.

The group says the results suggest there are great inequalities between countries.

Besides these, two vaccine candidates developed by Indian companies, Bharat Biotech and Zydus Cadila, are now undergoing combined phase-1 and phase-2 trials. But now, the country's health minister said that one in seven volunteers who were part of the vaccine trial showed side effects. Phase 3 trials test the vaccine on thousands of people to observe the vaccine's effectiveness in preventing Covid-19 infection.

The Health Ministry (MoH) has a responsibility to explain to the people why Malaysia is not among the 172 countries that have signed up for the Covax Covid-19 vaccine access plan as the participation deadline was Sept 18, said the Malaysian Medical Association (MMA).

To help meet the expected demand if their contender wins approval, both drugmakers are ramping up manufacturing for the antigen and adjuvant used in the shot, which is scheduled to enter phase 3 human testing later this year.

FILE - The Pfizer company logo is photographed at Pfizer Inc. headquarters, in New York, Dec. 4, 2017.

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"Agreements with other companies will be concluded soon and build a diversified portfolio of promising vaccines, based on various types of technologies, increasing our chances to find an effective remedy against the virus".

The revelations are aimed to address concerns that pressure to bring out a vaccine before the November US presidential election could lead to unsafe products. Nearly 2.6bn doses have been earmarked for developing countries including India, Brazil and Indonesia. The requirements appear to be those from drug-makers Pfizer and Moderna.

"Malaysia's approach in joining COVAX, cooperating strategically with other countries, and negotiating directly with pharmaceutical companies, will ensure that Malaysia gets a quick and sufficient supply of vaccines at an appropriate price when the vaccine is proven to be safe and effective", said Khairy.

In an interview with MSNBC, Bancel said the company cares "deeply that this vaccine is trusted". No wonder the country is desperate to have a potent vaccine at the earliest.

It is unclear when a vaccine will be available for children as major drugmakers have yet to include them in late-stage trials. Caty Weaver was the editor.

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