South Africa skips national regulatory approval to secure Covid-19 vaccines

JOHANNESBURG – South Africa will begin launching Covid-19 vaccines without requiring local regulatory approval for vaccines, a step that other low- and middle-income countries struggling to inoculate their populations against the coronavirus must follow.

South Africa’s health ministry said the country will receive in January 1 million doses of the vaccine developed by the University of Oxford and AstraZeneca PLC of the Serum Institute of India, which has an agreement to manufacture and distribute the vaccines. A second shipment of 500,000 doses is scheduled for February. The vaccine requires two doses to achieve its full effect.

Other countries in sub-Saharan Africa and the developing world are likely to emulate South Africa’s decision to circumvent local regulators in an effort to expedite getting injections for at least some of its most at-risk citizens. Some do not have their own national drug approval authorities and must be certified by the World Health Organization to launch Covid-19 vaccines.

The vaccines South Africa has ordered from India will be applied to healthcare professionals, who have borne the brunt of a sudden increase in new cases of Covid-19. The researchers believe that the new wave of infections was exacerbated by a new variant of the coronavirus, probably more transmissible, discovered in the country. In December alone, 5,000 health workers tested positive for the disease, placing an additional burden on hospitals that were already struggling.

South Africa, a country of 60 million, reported 21,832 new cases of Covid-19 on Wednesday, its highest daily count, and 392 deaths. Nearly a third of coronavirus tests are positive – an indication that the true number of infections is likely to be much higher – and the South African Medical Research Council said it recorded almost 7,000 excess deaths in the week of Christmas, most probably due to Covid-19.

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