Russian Covid-19 vaccine submitted for approval in South Africa: report

The Department of Health said on Tuesday (16 February) that the manufacturers of Russia’s Sputnik V vaccine has submitted documentation to local regulator the South African Health Products Regulatory Authority for registration, Reuters reported.

The Department of Health said is it is ‘continuously engaging’ with the manufacturers of the vaccine, but did not indicate if they would be considered for use in the country.

President Cyril Ramaphosa said in a statement this weekend that South Africa is engaging with a range of countries, including Russia, to source vaccines.

The president said that the government has also set up an inter-ministerial committee to aid in this endeavour. He said that the ANC NEC endorses the plan to vaccinate healthcare workers in the first phase of the rollout.

Russian president Vladimir Putin told a government meeting on Wednesday (10 February) that peer-reviewed data published in The Lancet medical journal showed the Sputnik V vaccine to be safe and with 91.6% efficacy.

He has championed Sputnik V at talks with other leaders since boasting in August that Russia had become the first nation in the world to clear a Covid-19 vaccine for use.

Indian vaccines

The announcement comes after South Africa has reportedly asked the Serum Institute of India to take back the one million Covid-19 vaccine doses the company had sent in early February.

The Serum Institute of India, which is producing AstraZeneca’s vaccine, has emerged as a key supplier. One million doses of the Covid-19 vaccine landed in South Africa last week with an additional 500,000 due to arrive in the next few weeks.

However, the South African government has indicated that it will not be using the vaccine amid concerns around its efficacy on the ‘South African’ Covid-19 variant.

There have also been reports that the vaccines delivered had an imminent expiry date.

Speaking to the City Press on condition of anonymity, sources involved with the vaccine rollout said that the expiry dates on the vaccines – 13 April – meant an impossible rollout schedule from day one.

The AstraZeneca vaccine is a two-dose inoculation, with the recommendation that the second dose be administered 12 weeks after the first. Initial trials had the second dose administered anywhere between four and 12 weeks, with more recent studies erring on the latter end of the scale.

Even if someone was vaccinated on day one of the phase one rollout (15 February), the vaccine would have expired by the time of the second dose. A day-one vaccine recipient would require a second shot on 10 May – a month after the vaccines expire.

In the case with South Africa’s batch, the April expiry date has given government just two months to make use of them. Assuming further batches were coming, this would have required 15,000 vaccinations a day, starting Monday.

Government officials were only made aware of the expiry date on the day the vaccines arrived in the country.

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Russian Covid-19 vaccine submitted for approval in South Africa: report