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HealthCOVID-19 vaccines

J&J’s COVID vaccine could make its global debut as soon as next week

By
David Meyer
David Meyer
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By
David Meyer
David Meyer
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February 10, 2021, 11:05 AM ET

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South Africa hopes to start rolling out Johnson & Johnson’s COVID-19 vaccine as early as next week, in what would be the highly anticipated vaccine’s first deployment anywhere.

The country is desperate to kick-start its inoculation program after it paused in recent days the rollout of the Oxford-AstraZeneca low-cost vaccine, owing to uncertainty over its efficacy in fighting the 501Y.V2 or B.1.351 variant of the coronavirus that emerged in South Africa and has become dominant there.

Health Minister Zweli Mkhize said Wednesday that South Africa might swell or swap its stock of the AstraZeneca jab, pending scientific advice. A million doses have already arrived from the Serum Institute of India, which has a license to make the AstraZeneca vaccine, and more will come soon.

The first AstraZeneca batch, which will expire in April, was intended to be used on South Africa’s health workers. The plan is to now use J&J’s vaccine for that purpose instead, then Pfizer-BioNTech’s vaccine when it becomes available to South Africa.

If it goes ahead, next week’s deployment would come in advance of the J&J vaccine’s rollout in the U.S., where its use is yet to be authorized.

Rapid pivot

According to Mkhize, the initial J&J vaccinations will take the form of an “implementation study,” with researchers observing the results. “It’s possible that the first batch would actually be not paid for, because it would be covered more as the research stock. So if we are able to achieve that it’s fine, but if we have got to pay for it we have got no problem,” he said in a press conference.

“The emergence of COVID-19 variants highlights the urgency for continued global coordination and partnership. Johnson & Johnson is in advanced discussions with the South African government about potential additional collaborations to combat COVID-19 in the country, and we hope to be able to share more details in the coming days,” the company said in a statement.

“We are committed to addressing the needs of the most vulnerable and at-risk populations worldwide and to supporting further clinical understanding of the variants to help stop their spread.”

J&J has applied for emergency authorization from the South African Health Products Regulatory Authority (SAHPRA). A spokesman for the regulator said Wednesday that approval can be granted “very quickly, as long as all the data is submitted.”

The J&J vaccine is probably the most highly anticipated of all the COVID-19 shots at the moment because it requires only one dose, doesn’t need extremely low storage and transport temperatures, and is relatively low-cost—though not quite as cheap as AstraZeneca’s vaccine.

J&J applied for emergency use authorization in the U.S. last week. The U.S. Food and Drug Administration (FDA) is due to make a decision at the end of this month.

South Africa already has 9 million J&J doses on order. J&J has an agreement with Durban-based Aspen Pharmacare, Africa’s largest drugmaker, to manufacture the vaccine locally.

New variant

Like the AstraZeneca jab, J&J’s vaccine was trialed in South Africa. This trial produced lower efficacy rates than others J&J conducted around the world—57% protection against moderate to severe infections, compared with 66% in Latin America and 72% in the U.S.—but it appears to be able to handle the South African variant of the coronavirus more ably than AstraZeneca’s offering.

It is still not clear how effective AstraZeneca’s vaccine is against 501Y.V2. The study that triggered South Africa’s rollout pause appeared to show very low efficacy—under 25%—against mild COVID-19, but it was a small study that used mostly young, healthy volunteers, and its results have also not yet been peer-reviewed.

However, the tiny kingdom of Eswatini (formerly known as Swaziland) has already followed neighboring South Africa’s lead. “The country has considered its close proximity with South Africa,” Health Minister Lizzie Nkosi said Tuesday. “We felt that the variant could be in the country already. We will no longer be using the AstraZeneca-Oxford vaccine.”

Eswatini’s government has itself been badly hit by the coronavirus, which in the past two months claimed the lives of Prime Minister Ambrose Dlamini, Minister of Public Service Christian Ntshangase, and Labor Minister Makhosi Vilakati.

The South African variant of the virus has also been found in the U.K. and in several places across Europe. While it represents a very small proportion of COVID-19 infections there at the moment, its high transmissibility and apparent semi-resistance to current vaccines is causing concern among public health officials and lawmakers, particularly as countries such as Germany contemplate easing their lockdowns.

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