AZN Astrazeneca Plc

By Gabriele Steinhauser 

JOHANNESBURG -- South Africa will start rolling out Covid-19 vaccines without requiring local regulatory approval of the shots, a step that other low- and middle-income countries scrambling to inoculate their populations against the coronavirus are expected to follow.

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

Other countries across Subsaharan Africa and the developing world are likely to emulate South Africa's decision to bypass local regulators in an effort to expedite getting shots for at least some of their most-at-risk citizens. Some lack their own national drug-approval authorities and are expected to rely on certification from the World Health Organization for rolling out Covid-19 vaccines.

The shots South Africa has ordered from India will be given to health care workers, who have borne the brunt of a surge in new cases of Covid-19. Researchers believe that the new wave in infections has been exacerbated by a new, likely more transmissible variant of the coronavirus discovered in the country. In December alone, 5,000 health care workers tested positive for the disease, placing an additional burden on hospitals already struggling.

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

Allowing the distribution of the Oxford-AstraZeneca vaccine without first registering it with the South African Health Products Regulatory Authority is an unusual step for the country, which has established procedures for certifying new drugs. It highlights the public pressure on the government for not moving faster to secure vaccines, as well as fears that some manufacturers were dragging their feet on applying for approval in South Africa.

A senior health-ministry official said Sunday that no vaccine maker had filed the final paperwork for approval in South Africa. During a news conference, Anban Pillay, a deputy director at the ministry, detailed how officials had "tried to persuade" U.S.-based Moderna Inc. to register its vaccine -- already approved in America and the European Union -- in South Africa. "It's clear they have no intention of filing a dossier with SAHPRA at this stage," he said.

A Moderna spokesman said the company didn't understand South African health officials to be requesting it to register its vaccine there. He said Moderna remained in productive talks with South Africa on supplying its vaccine to the country and when it could do so.

Dr. Pillay said Sunday that he expected Pfizer Inc., whose shots have also been approved in the U.S. and the EU, and Johnson & Johnson, whose vaccine has yet to be approved anywhere, to complete their applications for registration with SAHPRA by the end of the month.

The main reason for some vaccine makers' slow pace of requesting approval in less significant markets is a lack of available doses. Most makers of approved or promising Covid-19 vaccines have already sold all doses due to be manufactured this year to governments in rich countries.

Many poor countries have pinned their hopes on getting Covid-19 vaccines on a global initiative -- sponsored by richer nations and charitable organizations such as the Bill & Melinda Gates Foundation -- that is ordering doses in bulk. That initiative, called Covax, aims to supply vaccines to 20% of participating populations by the end of 2021.

The deal with the Serum Institute of India is South Africa's first bilateral agreement with a vaccine maker and comes after the company said previously that it would only start exporting doses in March or April. South Africa has also ordered vaccines for 10% of its population from the Covax initiative. As an upper-middle-income country, South Africa will have to pay for these vaccines itself.

On Thursday, South Africa's Health Minister Zweli Mkhize noted that the Oxford-AstraZeneca vaccine had already been approved in several countries, including the U.K. and India. "As part of expediting the regulatory process, SAHPRA is applying reliance on that regulatory work, " he said.

It is unclear whether the shots will be distributed before getting the results of a South African trial of the vaccine, which are expected in the coming weeks. That trial will show whether the shots are equally effective against the new Covid-19 variant spreading in the country.

Shabir Madhi, the chief investigator of the trial, said the variant -- which in laboratory tests appeared to be resistant to some of the antibodies the body employs to fight Covid-19 -- may make the vaccine less effective, without given details. Earlier trials in the U.K. and Brazil showed that the Oxford-AstraZenca vaccine was 62% effective in preventing symptomatic Covid-19.

Aaisha

Dadi Patel

contributed to this article.

Write to Gabriele Steinhauser at gabriele.steinhauser@wsj.com

(END) Dow Jones Newswires

January 07, 2021 14:32 ET (19:32 GMT)

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